Thursday, August 30, 2012

Hydrap-ES


Generic Name: hydralazine/hydrochlorothiazide/reserpine (hye DRAL a zeen/hye droe klor oh THYE a zide/re SER peen)

Brand Names: Diuretic Ap-Es, Hydrap-ES, Ser-Ap-Es, Serpazide, Tri-Hydroserpine, Uni Serp


What is Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine)?

Hydralazine is a vasodilator. It lowers blood pressure by relaxing (widening) blood vessels (veins and arteries) and making it easier for your heart to pump.


Hydrochlorothiazide is a thiazide diuretic (water pill). It helps to lower your blood pressure and decrease edema (swelling or water retention) by increasing the amount of salt and water you lose in your urine.


Reserpine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels (veins and arteries) to relax and your heart to beat more slowly and easily.


The combination, hydralazine/hydrochlorothiazide/reserpine, is used to lower high blood pressure.


Hydralazine/hydrochlorothiazide/reserpine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine)?


Stand up slowly from a sitting or lying position. Hydralazine/hydrochlorothiazide/reserpine may make you feel dizzy. Do not stop taking hydralazine/hydrochlorothiazide/reserpine suddenly. Even if you feel better, you need this medication to control your condition. Stopping suddenly could cause severely high blood pressure, anxiety, and other dangerous side effects. Use caution when driving, operating machinery, or performing other hazardous activities. Hydralazine/hydrochlorothiazide/reserpine may cause dizziness. If you experience dizziness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking this medication.

What should I discuss with my healthcare provider before taking Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine)?


Do not take hydralazine/hydrochlorothiazide/reserpine without first talking to your doctor if you

  • have an allergy to sulfa-based drugs such as sulfa antibiotics;




  • have coronary heart disease or mitral valvular rheumatic heart disease;




  • have peptic ulcer disease (stomach ulcers);




  • have ulcerative colitis;




  • are suffering from depression (especially if you have suicidal thoughts);




  • are receiving electroconvulsive shock therapy; or




  • have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.



You may not be able to take hydralazine/hydrochlorothiazide/reserpine if you have any of the conditions listed above.


Before taking this medication, tell your doctor if you



  • have gallstones,



  • have kidney or liver disease,


  • have diabetes,




  • have gout,




  • have a collagen vascular disease such as systemic lupus erythematosus,




  • have pancreatitis,




  • have asthma,




  • have any type of heart disease,




  • have had a stroke or a transient ischemic attack (mini-stroke),




  • have high cholesterol or high levels of fat in your blood, or




  • have pulmonary hypertension (a type of lung disease).



You may require a dosage adjustment or special monitoring during therapy with hydralazine/hydrochlorothiazide/reserpine if you have any of the conditions listed above.


Hydralazine/hydrochlorothiazide/reserpine is in the FDA pregnancy category C. This means that it is not known whether hydralazine/hydrochlorothiazide/reserpine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Hydralazine/hydrochlorothiazide/reserpine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from hydralazine/hydrochlorothiazide/reserpine therapy. You may require a lower dose of this medication.

How should I take Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine)?


Take the medication exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Take the medication with food or milk if it upsets your stomach.

Do not suddenly stop taking hydralazine/hydrochlorothiazide/reserpine. Stopping suddenly could make your condition much worse or cause very serious side effects. Talk to your doctor before you stop taking this medication.


Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of an overdose include low blood pressure (fainting, dizziness, weakness), slow pulse or an irregular heartbeat, low body temperature, diarrhea, increased urination, vomiting, headache, flushing of the skin, and slow breathing.


What should I avoid while taking Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine)?


Use caution when driving, operating machinery, or performing other hazardous activities. This medicine may cause dizziness. If you experience dizziness, avoid these activities. Avoid alcohol while taking hydralazine/hydrochlorothiazide/reserpine. Alcohol may increase the drowsiness caused by this medication and may increase dizziness. Use caution even with small amounts of alcohol. Use caution when rising from a sitting or lying position, especially first thing in the morning. You may become dizzy while taking hydralazine/hydrochlorothiazide/reserpine, and you may fall and injure yourself.

Do not let yourself become overheated in hot weather or during exercise, and use caution if you have a fever. Dehydration may increase the effects of hydralazine/hydrochlorothiazide/reserpine, and you may become very dizzy.


Avoid prolonged exposure to sunlight. Hydrochlorothiazide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine) side effects


If you experience any of the following serious side effects, stop taking hydralazine/hydrochlorothiazide/reserpine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing, closing of your throat, swelling of your lips, tongue or face, hives);




  • irregular or fast heartbeats or a fluttering feeling in your chest;




  • new or worsening chest pain;




  • heart failure (shortness of breath, swelling of ankles or legs, sudden weight gain of 2 pounds in one day or 5 pounds in one week);




  • unusual fatigue or confusion;




  • abnormal bleeding or bruising;




  • yellow skin or eyes;




  • blood in your urine or stools;




  • little or no urine;




  • numbness, tingling, pain, or weakness of your arms or legs; or




  • fainting.



Other, less serious side effects are more likely to occur. Continue to take hydralazine/hydrochlorothiazide/reserpine and talk to your doctor if you experience



  • mild fatigue, drowsiness, or dizziness;




  • headache;




  • water retention (swelling of the hands, feet, or ankles);




  • anxiety, depression, or nightmares;




  • diarrhea, nausea, vomiting , abdominal pain;




  • stuffy nose or a dry mouth;




  • muscle weakness or cramps;




  • increased hunger, thirst, or urination;




  • a rash;




  • sensitivity to sunlight; or



  • impotence or difficulty ejaculating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Hydrap-ES (hydralazine/hydrochlorothiazide/reserpine)?


Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI), such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate), in the last 14 days.


Before taking this medication, tell your doctor if you are taking any of the following drugs:



  • digoxin (Lanoxin, Lanoxicaps);




  • quinidine (Cardioquin, others);




  • lithium (Lithobid, Eskalith, others);



  • a tricyclic antidepressant such as amitriptyline (Elavil, Endep), imipramine (Tofranil), nortriptyline (Pamelor), doxepin (Sinequan), and others;

  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), and others;


  • an antidiabetic medicine such as glipizide (Glucotrol), glyburide (Micronase, Glynase, Diabeta), and others; or




  • a steroid medicine such as prednisone (Orasone, Deltasone), prednisolone (Delta Cortef, Prelone), methylprednisolone (Medrol), and others.



You may not be able to take hydralazine/hydrochlorothiazide/reserpine, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.


Also, before taking hydralazine/hydrochlorothiazide/reserpine, tell your doctor if you are taking any medicine to treat high blood pressure, water retention, heart problems, prostate problems, or another condition. Some medicines used to treat these conditions may interact with hydralazine/hydrochlorothiazide/reserpine, and the interaction may increase the effects on your heart.


Hydralazine/hydrochlorothiazide/reserpine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your doctor approves.


Drugs other than those listed here may also interact with hydralazine/hydrochlorothiazide/reserpine or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More Hydrap-ES resources


  • Hydrap-ES Side Effects (in more detail)
  • Hydrap-ES Use in Pregnancy & Breastfeeding
  • Hydrap-ES Drug Interactions
  • Hydrap-ES Support Group
  • 0 Reviews for Hydrap-ES - Add your own review/rating


  • Ser-Ap-Es Prescribing Information (FDA)



Compare Hydrap-ES with other medications


  • High Blood Pressure


Where can I get more information?


  • Your pharmacist has additional information about hydralazine/hydrochlorothiazide/reserpine written for health professionals that you may read.

What does my medication look like?


Hydralazine/hydrochlorothiazide/reserpine is available with a prescription under the brand name Ser-Ap-Es. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.


Hydralazine/hydrochlorothiazide/reserpine strengths are as follows:



  • Ser-Ap-Es (25 mg/15 mg/0.1mg)--round, salmon-pink, dry-coated tablets



See also: Hydrap-ES side effects (in more detail)


Percodan


Pronunciation: OX-i-KOE-done/AS-pir-in
Generic Name: Oxycodone/Aspirin
Brand Name: Examples include Endodan and Percodan


Percodan is used for:

Treating moderate to moderately severe pain.


Percodan is a narcotic pain reliever and salicylate combination. The narcotic works in the brain to reduce pain. The salicylate works by blocking certain chemicals in the body that cause pain and inflammation.


Do NOT use Percodan if:


  • you are allergic to any ingredient in Percodan or to a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

  • you have had asthma symptoms (eg, shortness of breath, wheezing), nasal swelling, or growths in the nose caused by aspirin

  • you have moderate to severe breathing problems, severe asthma, or you are having an asthma attack

  • you have a history of certain bleeding problems (eg, hemophilia, von Willebrand disease), low blood platelet levels, stomach ulcers, or you have severe bleeding

  • you have known or suspected bowel blockage (paralytic ileus) or you have severe or persistent diarrhea caused by antibiotics

  • the patient is a child with a viral infection (eg, chickenpox, flu symptoms)

  • you are taking sodium oxybate (GHB) or ketorolac

Contact your doctor or health care provider right away if any of these apply to you.



Before using Percodan:


Some medical conditions may interact with Percodan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you are allergic to other narcotic pain relievers (eg, morphine, codeine, hydromorphone)

  • if you have a history of constipation, lung or breathing problems (eg, asthma, emphysema, bronchitis, chronic obstructive pulmonary disease [COPD]), sleep apnea (you stop breathing when you sleep), curvature of the spine (eg, kyphoscoliosis), heart problems (eg, cor pulmonale), low blood pressure, dehydration, low blood volume, or shock caused by heart problems

  • if you have a history of recent head injury, growths in the brain (eg, tumors, lesions), an enlarged blood vessel in the brain (eg, aneurysm), increased pressure in the brain, stroke, or seizures (eg, epilepsy)

  • if you have blood problems (eg, porphyria), bleeding or clotting problems, low levels of vitamin K in the blood, chickenpox or flu symptoms, hives, Kawasaki syndrome, a rheumatic condition, or severe drowsiness

  • if you have a history of kidney or liver problems, thyroid problems, stomach or bowel problems (eg, ulcers, inflammation, recent surgery), pancreas or gallbladder problems, adrenal problems (Addison disease), an enlarged prostate, blockage of your bladder, or trouble urinating

  • if you have a history of mood or mental problems (eg, depression, hallucinations), suicidal thoughts or behavior, alcohol or other substance abuse, regular alcohol use, or if you are in alcohol withdrawal

  • if you are in poor health or will be having surgery

Some MEDICINES MAY INTERACT with Percodan. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, heparin, warfarin, enoxaparin), clopidogrel, dabigatran, desirudin, NSAIDs (eg, ibuprofen, ketorolac), rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram) because the risk of bleeding or ulcers may be increased

  • Certain antinausea medicines (eg, metoclopramide), azole antifungals (eg, ketoconazole), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, clarithromycin), muscle relaxants (eg, cyclobenzaprine), narcotic pain relievers (eg, codeine), nefazodone, phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or telithromycin because the risk of serious side effects, such as severe drowsiness or slow or difficult breathing, may be increased

  • Mixed narcotic agonists/antagonists (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), naltrexone, or rifamycins (eg, rifampin) because they may decrease Percodan's effectiveness

  • Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, methotrexate, oral diabetes medicines (eg, glyburide, repaglinide), phenytoin, or valproic acid because the risk of their side effects may be increased by Percodan

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), diuretics (eg, furosemide, hydrochlorothiazide), probenecid, or sulfinpyrazone because their effectiveness may be decreased by Percodan

This may not be a complete list of all interactions that may occur. Ask your health care provider if Percodan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Percodan:


Use Percodan as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Percodan by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

  • Do not change your dose or suddenly stop taking Percodan without first checking with your doctor.

  • If Percodan is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Percodan properly.

  • If you miss a dose of Percodan and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Percodan.



Important safety information:


  • Percodan may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Percodan with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Percodan; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Percodan may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • The risk of serious breathing problems may be greater if you take Percodan in high doses. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Percodan may cause stomach bleeding. Your risk may be greater if you drink alcohol while you are using Percodan.

  • Percodan may cause or worsen constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while taking Percodan, talk with your doctor or pharmacist. A stool softener or fiber laxative may be required.

  • Talk to your doctor before you take Percodan if you drink 3 or more drinks with alcohol per day.

  • Percodan may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Aspirin has been linked to a serious illness called Reye syndrome. Do not give Percodan to a child or teenager who has the flu, chickenpox, or a viral infection. Do not give Percodan to a child or teenager who has recently received a flu or chickenpox vaccine. Contact your doctor with any questions or concerns.

  • Tell your doctor or dentist that you take Percodan before you receive any medical or dental care, emergency care, or surgery.

  • Percodan has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin or another salicylate in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • If you are taking aspirin prescribed by your doctor to prevent heart attack or stroke, check with your doctor to see whether you should continue to take it with Percodan

  • Diabetes patients - Percodan may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Percodan may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Percodan.

  • Use Percodan with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.

  • Percodan should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Percodan has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Percodan while you are pregnant. Avoid using Percodan during the last 3 months of pregnancy. Percodan is found in breast milk. Do not breast-feed while taking Percodan.

When used for long periods of time or at high doses, Percodan may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Percodan stops working well. Do not take more than prescribed.


Some people who use Percodan for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.


If you suddenly stop taking Percodan, you may have WITHDRAWAL symptoms. These may include anxiety, backache, chills, diarrhea, enlarged pupils, fast breathing, fast heartbeat, increased tearing, irritability, joint pain, loss of appetite, muscle pain, nausea, restlessness, runny nose, stomach cramps, sweating, trouble sleeping, vomiting, weakness, or yawning.



Possible side effects of Percodan:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; heartburn; lightheadedness; nausea; stomach upset; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or black stools; confusion; dark urine; decreased or difficult urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucination; hearing loss; mood or mental changes; muscle pain, weakness, or cramps; one-sided weakness; ringing in the ears; seizures; severe dizziness, drowsiness, headache, or lightheadedness; severe or persistent constipation, heartburn, or stomach pain; shortness of breath; slow or shallow breathing; trouble swallowing; unusual bruising or bleeding; vision or speech problems; vomit that looks like coffee grounds; wheezing; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Percodan side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; cold and clammy skin; coma; confusion; dehydration; depression; enlarged or decreased pupil size; fever; loss of consciousness; ringing in the ears or trouble hearing; severe drowsiness, dizziness, lightheadedness, nausea, vomiting, or diarrhea; severe weakness; slow, shallow, or difficult breathing; slow heartbeat.


Proper storage of Percodan:

Store Percodan at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Percodan out of the reach of children and away from pets.


General information:


  • If you have any questions about Percodan, please talk with your doctor, pharmacist, or other health care provider.

  • Percodan is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Percodan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Percodan resources


  • Percodan Side Effects (in more detail)
  • Percodan Use in Pregnancy & Breastfeeding
  • Drug Images
  • Percodan Drug Interactions
  • Percodan Support Group
  • 4 Reviews for Percodan - Add your own review/rating


  • Percodan Prescribing Information (FDA)

  • Percodan Advanced Consumer (Micromedex) - Includes Dosage Information

  • Percodan Consumer Overview

  • Endodan Prescribing Information (FDA)



Compare Percodan with other medications


  • Pain

Wednesday, August 29, 2012

Norwich Aspirin


Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin


What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.


Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.


Aspirin may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about aspirin?


There are many brands and forms of aspirin available and not all brands are listed on this leaflet.


Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.


Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.


What should I discuss with my healthcare provider before taking aspirin?


Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, or if you have:

  • a recent history of stomach or intestinal bleeding;




  • a bleeding disorder such as hemophilia; or




  • an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.



If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:



  • asthma or seasonal allergies;




  • stomach ulcers;



  • liver disease;

  • kidney disease;


  • a bleeding or blood clotting disorder;




  • heart disease, high blood pressure, or congestive heart failure;




  • gout; or




  • nasal polyps.




If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?


Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.


Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.


Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.


If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.


Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?


Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.


What should I avoid while taking aspirin?


Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.


Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;




  • coughing up blood or vomit that looks like coffee grounds;




  • severe nausea, vomiting, or stomach pain;




  • fever lasting longer than 3 days;




  • swelling, or pain lasting longer than 10 days; or




  • hearing problems, ringing in your ears.



Less serious side effects may include:



  • upset stomach, heartburn;




  • drowsiness; or




  • headache.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect aspirin?


Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.


Before taking aspirin, tell your doctor if you are using any of the following drugs:



  • a blood thinner such as warfarin (Coumadin); or




  • another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).



This list is not complete and there may be other drugs that can interact with aspirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Norwich Aspirin resources


  • Norwich Aspirin Side Effects (in more detail)
  • Norwich Aspirin Use in Pregnancy & Breastfeeding
  • Norwich Aspirin Drug Interactions
  • Norwich Aspirin Support Group
  • 0 Reviews for Norwich Aspirin - Add your own review/rating


  • Aspirin Monograph (AHFS DI)

  • Aspirin Prescribing Information (FDA)

  • Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information

  • ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Norwich Aspirin with other medications


  • Angina
  • Angina Pectoris Prophylaxis
  • Ankylosing Spondylitis
  • Antiphospholipid Syndrome
  • Aseptic Necrosis
  • Back Pain
  • Fever
  • Heart Attack
  • Ischemic Stroke
  • Ischemic Stroke, Prophylaxis
  • Juvenile Rheumatoid Arthritis
  • Kawasaki Disease
  • Myocardial Infarction, Prophylaxis
  • Niacin Flush
  • Osteoarthritis
  • Pain
  • Prevention of Thromboembolism in Atrial Fibrillation
  • Prosthetic Heart Valves
  • Prosthetic Heart Valves, Mechanical Valves
  • Revascularization Procedures, Prophylaxis
  • Rheumatic Fever
  • Rheumatoid Arthritis
  • Sciatica
  • Systemic Lupus Erythematosus
  • Thromboembolic Stroke Prophylaxis
  • Transient Ischemic Attack


Where can I get more information?


  • Your pharmacist can provide more information about aspirin.

See also: Norwich Aspirin side effects (in more detail)


Tuesday, August 28, 2012

MiraLax Powder Packets for Oral Solution



Pronunciation: pol-ee-ETH-il-een GLYE-col
Generic Name: Polyethylene Glycol-3350
Brand Name: Examples include GlycoLax and MiraLax


MiraLax Powder Packets for Oral Solution is used for:

Treating occasional constipation.


MiraLax Powder Packets for Oral Solution is a laxative. It works by softening the stool and increasing the frequency of bowel movements by retaining water in the stool.


Do NOT use MiraLax Powder Packets for Oral Solution if:


  • you are allergic to any ingredient in MiraLax Powder Packets for Oral Solution

  • you have blockage of the stomach or intestine (nausea, vomiting, stomach pain, or bloating); loss of strength in the intestinal muscles; chronic inflammation and ulceration of the bowel; holes in the intestine; or an enlarged colon

Contact your doctor or health care provider right away if any of these apply to you.



Before using MiraLax Powder Packets for Oral Solution:


Some medical conditions may interact with MiraLax Powder Packets for Oral Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with MiraLax Powder Packets for Oral Solution. However, no specific interactions with MiraLax Powder Packets for Oral Solution are known at this time.


Ask your health care provider if MiraLax Powder Packets for Oral Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use MiraLax Powder Packets for Oral Solution:


Use MiraLax Powder Packets for Oral Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Dissolve contents of 1 packet (unless directed otherwise by your doctor) in 8 oz (240 mL) of water, juice, soda, coffee, or tea before administering.

  • Do not use MiraLax Powder Packets for Oral Solution for more than 2 weeks unless directed to do so by your doctor.

  • If you miss a dose of MiraLax Powder Packets for Oral Solution and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use MiraLax Powder Packets for Oral Solution.



Important safety information:


  • It may take 2 to 4 days for MiraLax Powder Packets for Oral Solution to work.

  • Follow the diet and exercise program given to you by your health care provider to produce more regular bowel habits.

  • The risk of abnormal blood electrolyte levels and dependence on laxatives may be greater if you take MiraLax Powder Packets for Oral Solution in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than 2 weeks without checking with your doctor.

  • Do not take MiraLax Powder Packets for Oral Solution with other laxatives or stool softeners, unless directed by your doctor.

  • MiraLax Powder Packets for Oral Solution should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using MiraLax Powder Packets for Oral Solution while you are pregnant. It is not known if MiraLax Powder Packets for Oral Solution is found in breast milk. If you are or will be breast-feeding while you use MiraLax Powder Packets for Oral Solution, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of MiraLax Powder Packets for Oral Solution:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Cramps; diarrhea; excessive or frequent bowel movements; gas; nausea; stomach bloating.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: MiraLax side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include severe or prolonged stomach cramps or diarrhea.


Proper storage of MiraLax Powder Packets for Oral Solution:

Store MiraLax Powder Packets for Oral Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep MiraLax Powder Packets for Oral Solution out of the reach of children and away from pets.


General information:


  • If you have any questions about MiraLax Powder Packets for Oral Solution, please talk with your doctor, pharmacist, or other health care provider.

  • MiraLax Powder Packets for Oral Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about MiraLax Powder Packets for Oral Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More MiraLax resources


  • MiraLax Side Effects (in more detail)
  • MiraLax Use in Pregnancy & Breastfeeding
  • MiraLax Drug Interactions
  • MiraLax Support Group
  • 27 Reviews for MiraLax - Add your own review/rating


Compare MiraLax with other medications


  • Bowel Preparation
  • Constipation
  • Constipation, Acute

Sunday, August 26, 2012

Melphalan Tablets


Pronunciation: MEL-fa-lan
Generic Name: Melphalan
Brand Name: Alkeran

Melphalan should only be used under the supervision of a doctor experienced with the use of cancer medicines. Melphalan may cause a decrease in the body's blood cells (bone marrow suppression), which could cause bleeding problems or infection. It may also cause a certain type of blood cell cancer (leukemia). Notify your doctor immediately if you develop unusual bleeding or bruising, unusual fatigue, or signs of an infection (eg, fever, chills, persistent sore throat).





Melphalan is used for:

Treating symptoms of certain types of cancer (multiple myeloma, ovarian cancer). It may also be used for other conditions as determined by your doctor.


Melphalan is an alkylating agent. It works by destroying resting and rapidly dividing tumor cells in certain types of cancer.


Do NOT use Melphalan if:


  • you are allergic to any ingredient in Melphalan

  • you have used Melphalan before and it did not work

  • you have taken or will be taking palifermin within 24 hours before or after taking Melphalan

  • you are taking nalidixic acid

Contact your doctor or health care provider right away if any of these apply to you.



Before using Melphalan:


Some medical conditions may interact with Melphalan. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are able to become pregnant

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have bone marrow problems, low white blood cell count, low platelet count, an infection, kidney problems, shingles, or chickenpox

  • if you have had chemotherapy or radiation treatment

  • if you have recently had or are scheduled to have a vaccine

Some MEDICINES MAY INTERACT with Melphalan. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Cisplatin because the risk of Melphalan's side effects may be increased

  • Carmustine (BCNU), cyclosporine, or nalidixic acid because serious lung, kidney, or bowel problems may occur

  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer

This may not be a complete list of all interactions that may occur. Ask your health care provider if Melphalan may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Melphalan:


Use Melphalan as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Melphalan on an empty stomach at least 1 hour before or 2 hours after eating.

  • Check with your pharmacist about how to dispose of unused medicine.

  • If you miss a dose of Melphalan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Melphalan.



Important safety information:


  • Melphalan may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Melphalan. Talk with your doctor before you receive any vaccine.

  • Melphalan may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur.

  • If loss of appetite, nausea, or vomiting occurs, ask your doctor, nurse, or pharmacist for ways to lessen these effects.

  • Use of Melphalan may increase your risk of developing another type of cancer. The risk may be greater if you use higher doses of Melphalan or if you use it for a longer period of time. Discuss any questions or concerns with your doctor.

  • Melphalan may affect the ovaries. This may cause irregular or absent menstrual periods and decreased fertility in some women. Discuss any questions or concerns with your doctor.

  • Melphalan may affect the testicles and cause decreased fertility in some men. This may be permanent in some patients. Discuss any questions or concerns with your doctor.

  • Lab tests, including complete blood cell counts, may be performed while you use Melphalan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Melphalan with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Melphalan has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Melphalan. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Melphalan while you are pregnant. It is not known if Melphalan is found in breast milk. Do not breast-feed while taking Melphalan.


Possible side effects of Melphalan:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Diarrhea; hair loss; loss of appetite; nausea; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine or stools; chest pain; dark urine; fainting; fever or chills; irregular or absent menstrual periods; numbness of an arm or leg; pale stools; persistent cough; persistent loss of appetite; severe or persistent diarrhea, nausea, or vomiting; shortness of breath; sore throat; sores on the mouth, tongue, or lips; stomach pain; sudden, severe headache; swelling of hands, ankles, or feet; unusual bruising or bleeding; unusual lumps or growths; unusual tiredness or weakness; weight loss; yellowing eyes and skin.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Melphalan side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; severe nausea and vomiting; sores on the mouth, tongue, or lips; symptoms of stomach or bowel bleeding (eg, black, tarry, or bloody stools; vomit that looks like coffee grounds).


Proper storage of Melphalan:

Store Melphalan in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Melphalan out of the reach of children and away from pets.


General information:


  • If you have any questions about Melphalan, please talk with your doctor, pharmacist, or other health care provider.

  • Melphalan is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Melphalan. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Melphalan resources


  • Melphalan Side Effects (in more detail)
  • Melphalan Dosage
  • Melphalan Use in Pregnancy & Breastfeeding
  • Melphalan Drug Interactions
  • Melphalan Support Group
  • 0 Reviews for Melphalan - Add your own review/rating


Compare Melphalan with other medications


  • Multiple Myeloma
  • Ovarian Cancer

Thursday, August 23, 2012

Vecuronium Bromide


Generic Name: vecuronium (VEK ue ROE nee um)

Brand Names: Vecuronium Bromide


What is Vecuronium Bromide (vecuronium)?

Vecuronium is used to relax the muscles. It works by blocking the signals between your nerves and your muscles.


Vecuronium is given before general anesthesia in preparing you for surgery. Vecuronium helps keep your body still during surgery. It also relaxes your throat so a breathing tube can be more easily inserted before the surgery.


Vecuronium may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Vecuronium Bromide (vecuronium)?


Before receiving vecuronium, tell your doctor if you are allergic to any drugs, or if you have kidney disease, heart disease or congestive heart failure, problems with circulation, or a nerve-muscle disorder such as ALS (Lou Gehrig's disease), MS (multiple sclerosis), or muscular dystrophy.


Tell your doctor if you are pregnant or breast-feeding.


It may take you longer to recover from the effects of vecuronium if you have cirrhosis or other liver disease.


Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.


What should I discuss with my health care provider before receiving Vecuronium Bromide (vecuronium)?


You should not receive this medication if you are allergic to vecuronium.

Before receiving vecuronium, tell your doctor if you are allergic to any drugs, or if you have:



  • myasthenia gravis;




  • cirrhosis or other liver disease;




  • a history of kidney disease;




  • heart disease or congestive heart failure;




  • problems with circulation; or




  • a nerve-muscle disorder such as ALS (Lou Gehrig's disease), MS (multiple sclerosis), or muscular dystrophy.



If you have any of these conditions, you may not be able to receive vecuronium, or you may need dosage adjustments or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Before receiving vecuronium, tell your doctor if you are breast-feeding a baby.

How is vecuronium given?


Vecuronium is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a hospital or surgical setting.


Your caregivers will monitor your heart function, blood pressure, and breathing while you are under the effects of vecuronium.


It may take you longer to recover from the effects of vecuronium if you have cirrhosis or other liver disease.


What happens if I miss a dose?


Since vecuronium is usually given just for anesthesia, you are not likely to be on a dosing schedule.


What happens if I overdose?


An overdose of vecuronium is unlikely to occur since the medication is given by a doctor. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.


What should I avoid after receiving Vecuronium Bromide (vecuronium)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.


Vecuronium Bromide (vecuronium) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers right away if you have any of these serious side effects:

  • trouble breathing;




  • ongoing muscle weakness; or




  • inability to move your muscles.



Less serious side effects may include:



  • feeling light-headed; or




  • itching.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Vecuronium Bromide (vecuronium)?


There may be other drugs that can interact with vecuronium. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors.



More Vecuronium Bromide resources


  • Vecuronium Bromide Side Effects (in more detail)
  • Vecuronium Bromide Use in Pregnancy & Breastfeeding
  • Vecuronium Bromide Drug Interactions
  • Vecuronium Bromide Support Group
  • 0 Reviews for Vecuronium Bromide - Add your own review/rating


  • Vecuronium Bromide Professional Patient Advice (Wolters Kluwer)

  • Vecuronium Bromide Monograph (AHFS DI)

  • Vecuronium Prescribing Information (FDA)

  • Vecuronium MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Vecuronium Bromide with other medications


  • Anesthesia


Where can I get more information?


  • Your doctor or pharmacist can provide more information about vecuronium.

See also: Vecuronium Bromide side effects (in more detail)


Friday, August 17, 2012

Boots Ibuprofen 10% gel





1. Name Of The Medicinal Product



Fenbid Forte 10% Gel



AAH Pharmaceutical's Ibuprofen pain relief gel maximum strength 10% w/w



Tesco's Ibuprofen pain relief gel maximum strength 10% w/w



Boots Ibuprofen 10% gel



Lloydspharmacy's Maximum strength Ibuprofen 10% gel



Ibuprofen 10% gel



Numark's Ibuprofen Pain Relief Gel Maximum Strength 10% w/w



Morrison's Ibuprofen Pain Relief Gel Maximum Strength 10% w/w



Thornton &Ross's Ibuprofen 10% gel



Phorpain gel maximum strength



Boots Ibuprofen Max Strength 10% Gel


2. Qualitative And Quantitative Composition



Ibuprofen Ph. Eur. 10% Gel



3. Pharmaceutical Form



Gel for topical application



4. Clinical Particulars



4.1 Therapeutic Indications



Prescription Only indication



For the relief of pain and inflammation associated with backache, mild to moderate arthritic conditions, rheumatic and muscular pain, sprains, strains, sports injuries and neuralgia.



Pharmacy Only indication



For the relief of pain and inflammation associated with backache, rheumatic and muscular pain, strains, sprains, neuralgia and sports injuries. For the relief of pain of non-serious arthritic conditions.



4.2 Posology And Method Of Administration



Method of administration



For topical application to the skin.



Dosage



Adults, the elderly and children over 14 years: Squeeze 50 to 125mg (2 to 5cm) of the gel from the tube and lightly rub into the affected area until absorbed.



The dose should not be repeated more frequently than every four hours and no more than 4 times in any 24 hour period.



Wash hands after each application. Do not exceed the stated dose. Review treatment after 2 weeks, especially if the symptoms worsen or persist.



Children under 14 years: Do not use on children 14 years of age, except on the advice of a doctor.



4.3 Contraindications



Hypersensitivity to any of the constituents. Hypersensitivity to aspirin, or other non-steroidal anti-inflammatory drugs, asthma, rhinitis or urticaria.



Not to be used on broken or damaged skin.



4.4 Special Warnings And Precautions For Use



Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin.



Discontinue if rash develops.



Hands should be washed immediately after use.



Not for use with occlusive dressings.



The label will state:



Do not exceed stated dose



Keep out of reach of children



For external use only



If symptoms persist consult your doctor or pharmacist.



Do not use if you are allergic to Ibuprofen or any of the ingredients, aspirin, or any other painkillers.



Consult your doctor or pharmacist before use if:



- you are taking aspirin or any other pain relieving medication



- you are pregnant



Not recommended for children under 14 years.



Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, patients with an active peptic ulcer, a history of kidney problems or asthma should seek medical advice before using Ibuprofen gel as should patients already taking other painkillers.



Patients should seek medical advice if symptoms worsen or persist.



Patients should be advised against excessive exposure to sunlight of area treated in order to avoid possibility of photosensitivity.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.



4.6 Pregnancy And Lactation



Not to be used during pregnancy or lactation.



Pregnancy:



Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and the duration of labour increased.



Lactation:



Ibuprofen appears in breast milk in very low concentrations but is unlikely to affect breast fed infants adversely.



4.7 Effects On Ability To Drive And Use Machines



None known



4.8 Undesirable Effects



Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be discontinued:



Hypersensitivity: Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis (b) respiratory tract reactivity comprising of asthma, aggravated asthma, brochospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angioedema and less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).



Gastro-intestinal: Side effects such as abdominal pain and dyspepsia have been reported.



Renal: Renal impairment can occur in patients with a history of kidney problems.



4.9 Overdose



Overdosage with a topical presentation of Fenbid Forte Gel is unlikely.



Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC code: M02A A13, Anti-inflammatory preparations, non-steroids for topical use.



The gel is for topical application. It contains the active ingredient, ibuprofen, a phenylpropionic acid derivative which exerts its anti-inflammatory and analgesic effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis. Because it is formulated in an aqueous/ alcoholic gel, the preparation also exerts a soothing and cooling effect when applied to the affected area.



5.2 Pharmacokinetic Properties



Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively (approximately 22% of a finite dose within 48 hours), achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and the synovial fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic side-effects, other than in rare individuals who are hypersensitive to ibuprofen. Furthermore, there do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion.



5.3 Preclinical Safety Data



There is no new data published on the active ingredient.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Hydroxyethyl cellulose EP



Sodium Hydroxide EP



Benzyl alcohol EP



Isopropyl alcohol BP



Purified water



6.2 Incompatibilities



None known



6.3 Shelf Life



36 months



6.4 Special Precautions For Storage



Store below 25°C



6.5 Nature And Contents Of Container



Collapsible aluminium tubes with internal protective lacquer with HDPE screw caps.



P: 30g, 50g



POM: 30, 50 & 100g



6.6 Special Precautions For Disposal And Other Handling



No special instructions



7. Marketing Authorisation Holder



Goldshield Group Limited



(trading as Goldshield Pharmaceuticals)



NLA Tower



12-16 Addiscombe Road



Croydon



Surrey



CR0 0XT



8. Marketing Authorisation Number(S)



PL 10972/0082



9. Date Of First Authorisation/Renewal Of The Authorisation



05/12/2005



10. Date Of Revision Of The Text



12/09/2011




Thursday, August 16, 2012

Trasylol


Generic Name: Aprotinin
Class: Hemostatics
VA Class: BL300
Chemical Name: Pancreatic basic trypsin inhibitor
Molecular Formula: C284H432N84O79S7
CAS Number: 9087-70-1


Special Alerts:


[UPDATE 05/14/2008] Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of aprotinin (Trasylol) from hospital pharmacies and warehouses. Under a limited use agreement, access to aprotinin is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using aprotinin in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients. For more information visit the FDA website at: , and .


[Posted 11/05/2007] FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of aprotinin injection (Trasylol), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of aprotinin injection.


Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of aprotinin injection outweigh the risks. However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to aprotinin injection. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase aprotinin injection out of the marketplace in a way that does not cause shortages of other drugs used for this purpose. For more information visit the FDA website at: , and .





  • Hypersensitivity reactions, including fatal anaphylactic or anaphylactoid reactions, reported with aprotinin treatment during surgery.1




  • Fatal reactions occurred with initial (test) dose and also in individuals who tolerated initial (test) dose.1 42




  • Risk increased in patients with prior exposure to aprotinin.1 Most cases of anaphylaxis occur within first 12 months after reexposure to aprotinin; also reported >12 months after reexposure.1 (See Contraindications under Cautions.)




  • Weigh benefits of aprotinin use in patients undergoing initial CABG against risk of anaphylaxis following any subsequent exposure to drug.1 41 42




Introduction

A naturally occurring protease inhibitor isolated from bovine lung tissue; attenuates systemic inflammatory response and bleeding associated with cardiopulmonary bypass during CABG.1 2 4 7 12


Uses for Trasylol


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Prevention of Bleeding Associated with Cardiopulmonary Bypass during CABG


Used prophylactically to reduce both perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass during CABG who are at an increased risk for blood loss and blood transfusion, including that related to thrombolytic agents.1 8 9 10 11 12 15 16 29 32 33 34 41 42 (See Sensitivity and Dermatologic Reactions under Cautions and see Boxed Warning.)


Increased risk of serious cardiovascular, cerebrovascular, hypersensitivity, and renal complications with use of aprotinin;1 35 36 37 42 consider limiting use to situations in which benefits of the drug in reducing blood loss are thought to outweigh potential risks.1 36 37 38 40


ACC and AHA state that routine use of aprotinin in patients undergoing cardiopulmonary bypass during CABG not recommended34 but may be considered in selected high-risk patients (e.g., geriatric patients ≥65 years of age, females, patients with more than one diseased coronary artery, poor left ventricular function, history of heart surgery, patients requiring urgent CABG).34


Trasylol Dosage and Administration


General


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.



  • For reduction of perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass during CABG, high-dose1 8 9 10 13 16 17 29 30 and low-dose1 10 prophylactic regimens of aprotinin have been used. No clinically important differences in efficacy between the high-dose and low-dose regimens in low-risk patients undergoing CABG;1 use either dosage at clinician’s discretion.1



Administration


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


IV Administration


For solution and drug compatibility information, see Compatibility under Stability.


Administered by IV injection, IV infusion through a central venous line, or by addition to the recirculating priming fluid of the cardiopulmonary bypass circuit.1


Because of the risk for hypersensitivity reactions, all patients should receive a test dose.1 Administer test and loading doses when the patient is intubated and when conditions for rapid cannulation and initiation of cardiopulmonary bypass are present.1 Standard emergency treatments for hypersensitivity or anaphylactic reactions (e.g., epinephrine, corticosteroids) should be readily available in the operating room.1


If no adverse reactions occur within 10 minutes following test dose, administer loading dose IV slowly over 20–30 minutes with patient supine.1 Avoid rapid IV administration of large (e.g., loading) doses of aprotinin because of the potential for hypotension1 and/or anaphylactoid reactions.4 Administer the loading dose after induction of anesthesia but prior to sternotomy.1 In patients with known previous exposure, administer the loading dose just prior to cannulation.1


After the loading dose, administer by continuous IV infusion until the surgical procedure is completed and the patient is removed from the operating room.1 8 9 13 16 17 29 30


Delay the addition of aprotinin into the recirculating fluid of the cardiopulmonary bypass circuit (pump-priming dose) until after the loading dose has been safely administered.1 Before initiating cardiopulmonary bypass, add the pump-prime dose to the recirculating priming fluid by replacing an aliquot of the priming fluid with the drug.1 8 9 16 17 29 30


Dosage


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Dosage and potency of aprotinin usually are expressed in terms of kallikrein inhibitor (KI) units, although expression in mg also has been used.2 12 27 Each mg of the drug has a potency of approximately 7143 units.12 28


Adults


Prevention of Bleeding Associated with CABG

Prophylactic regimens include a test dose, a loading dose, a dose added to the recirculating priming fluid of the cardiopulmonary bypass circuit (pump-priming dose), and a dose administered by continuous IV infusion.1 Observe patients for manifestations of possible sensitivity reactions.1


Test Dose

IV

Administer a test dose of 10,000 units (1.4 mg [1 mL]) by IV injection at least 10 minutes before the loading dose.1


Loading Dose

IV

After successful administration of the test dose, administer an IV loading dose of 2 million units (280 mg [200 mL]) for the high-dose regimen or 1 million units (140 mg [100 mL]) for the low-dose regimen.1 Administer loading dose over 20–30 minutes.1


After the loading dose, administer 500,000 units/hour (70 mg/hour [50 mL/hour]) by continuous IV infusion for the high-dose regimen1 8 9 13 16 17 29 30 or 250,000 units/hour (35 mg/hour [25 mL/hour]) by continuous IV infusion for the low-dose regimen.1


Pump-priming Dose

IV

For the pump-priming dose with the high-dose regimen, replace an aliquot of priming fluid with 2 million units (280 mg [200 mL]).1 For the pump-priming with the low-dose regimen, replace an aliquot of priming fluid with 1 million units (140 mg [100 mL]).1


Prescribing Limits


Adults


Total dosages exceeding 7 million units (980 mg) within a 24-hour period have not been studied in controlled trials.1 28 Dosages up to 17.5 million units (2.45 g) within a 24-hour period have been administered to patients without any apparent toxicity.1 However, maximum doses and/or dosages that can be administered safely have not been established.1


Special Populations


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Hepatic Impairment


No dosage recommendations; no data are available.


Renal Impairment


The manufacturer states that dosage adjustment is not necessary in patients with renal impairment.1 Some clinicians recommend reduced dosages of the drug in patients with renal failure.4 21 (See Special Populations under Pharmacokinetics and see Renal Effects under Cautions.)


Geriatric Patients


Dosage adjustment not necessary.1


Cautions for Trasylol


Contraindications


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.



  • Known or suspected exposure to aprotinin-containing products within the previous 12 months.1 41 42




  • Known hypersensitivity to the drug.1 Patients with a history of allergic reactions to drugs or other agents may be at greater risk of developing an allergic reaction to aprotinin.1



Warnings/Precautions


Sensitivity Reactions


Sensitivity and Dermatologic Reactions

Hypersensitivity reactions, including fatal anaphylactic or anaphylactoid reactions, reported during surgery.1 42 (See Boxed Warning.) Hypotension is most frequent sign of anaphylactic or anaphylactoid reactions and may progress to anaphylactic shock with circulatory failure.1 42 Other manifestations of hypersensitivity reactions include skin eruptions, pruritus, dyspnea, nausea, and tachycardia.1


Because of the risk for hypersensitivity reactions, all patients should receive a test dose of aprotinin.1 Obtain history of any prior aprotinin exposure, including use of fibrin sealant products (e.g., Tissucol, Tisseel) that may contain aprotinin.1 42 However, hypersensitivity reactions to subsequent therapeutic doses of drug (e.g., loading dose, pump-prime regimen) may occur despite tolerance of the test dose.1 Discontinue aprotinin immediately if a hypersensitivity reaction occurs, and institute appropriate therapy (e.g., epinephrine, corticosteroids, antihistamines).1


The incidence of hypersensitivity reactions and anaphylaxis is higher in patients reexposed to aprotinin.1 Particular caution is necessary when administering aprotinin (even in test doses) to such patients.1 Standard emergency treatments for hypersensitivity or anaphylactic reactions should be readily available in the operating room.1 Administer the test dose and loading dose of aprotinin when the patient is intubated and when the conditions for rapid cannulation (if necessary) and initiation of CABG are present.1 Delay pump priming dose of aprotinin until after the loading dose has been safely administered.1


Renal Effects

Increased risk of renal dysfunction and need for dialysis in perioperative period.1 36 Generally, postoperative renal dysfunction observed was not severe and was reversible.1 However, renal dysfunction may progress to renal failure.1 Risk may be increased particularly in patients with preexisting renal impairment or in those receiving concomitant drugs that alter renal function (e.g., aminoglycosides).1 (See Interactions.) Limited data suggest an increased risk of renal failure and/or death in patients undergoing deep hypothermic circulatory arrest during aortic arch surgery; such findings were not confirmed in a second case-control study.1 31


Careful monitoring for occurrence of ischemic toxicity to kidneys recommended in patients undergoing CABG and receiving aprotinin.38 40 Manufacturer recommends monitoring Scr regularly.1 Weigh carefully the clinical benefit of reduced blood loss against the potential risks in patients with preexisting renal dysfunction (Clcr <60 mL/minute) or other risk factors for renal dysfunction.38 40 Promptly report serious and unexpected adverse effects to manufacturer or to FDA Medwatch program at 1-800-FDA-1088 or .38 40 42


General Precautions


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Cardiovascular Effects

Increased risk of MI or heart failure during a postmarketing observational study in patients undergoing CABG and receiving aprotinin; such effects not observed in pooled analysis of premarketing clinical trials.36 38 40


FDA recommends careful monitoring for the occurrence of ischemic toxicity to the heart in patients undergoing CABG and receiving aprotinin.38 40 Reserve use to situations when the clinical benefit of reduced blood loss outweighs the potential risks.38 40 Promptly report serious and unexpected adverse effects to the manufacturer or to the FDA Medwatch program at 1-800-FDA-1088 or .38 40


Rapid IV administration can cause a transient fall in BP.1 Administer the IV loading dose over a period of 20–30 minutes while the patient is supine.1


Nervous System Effects

Increased risk for cerebrovascular adverse events such as stroke, encephalopathy, or coma observed in patients receiving aprotinin compared with no treatment or treatment with other antifibrinolytic agents (i.e., aminocaproic acid, tranexamic acid).36 38 39 40


FDA recommends careful monitoring for the occurrence of ischemic toxicity to the CNS in patients undergoing CABG and receiving aprotinin.38 40 Reserve use to situations when the clinical benefit of reduced blood loss outweighs the potential risks.38 40 Promptly report serious and unexpected adverse effects to the manufacturer or to the FDA Medwatch program at 1-800-FDA-1088 or .38 40


Specific Populations


Pregnancy

Category B.1


No adequate and controlled studies in pregnant women.1 Use during pregnancy only when clearly needed.1


Pediatric Use

Safety and efficacy in children younger than 18 years of age not established.1 28


Geriatric Use

No overall differences in efficacy or safety were observed between geriatric and younger patients.1


Common Adverse Effects


Atrial fibrillation,1 hypotension,1 MI,1 10 29 30 atrial flutter,1 ventricular extrasystoles,1 tachycardia,1 ventricular tachycardia,1 heart failure,1 pericarditis,1 peripheral edema,1 fever,1 infection,1 nausea,1 lung disorder,1 pleural effusion,1 atelectasis.1


Interactions for Trasylol


Nephrotoxic Drugs


Potential for increased risk of nephrotoxicity.1 a Consider risks versus benefits of concurrent perioperative use of aprotinin and other nephrotoxic drugs.1 a


Specific Drugs and Laboratory Tests


















Drug



Interaction



Comments



Aminoglycosides



Potential for increased risk of nephrotoxicity1 a



Consider risks versus benefits of concurrent perioperative use1



Captopril



Potential antagonism of hypotensive effects1



Potential clinical importance not determined28



Fibrinolytic agents



Potential inhibition of fibrinolytic activity1



Test, Activated Clotting Time (ACT)



Prolongs ACT and overestimates degree of anticoagulation with heparin1



Minimum celite or kaolin ACTs of 750 or 480 seconds, respectively, suggested to ensure adequate anticoagulation1


Alternatively, use additional heparin during extended extracorporeal circulation 1


Standard loading dose and dosage of heparin added to prime volume of cardiopulmonary bypass circuits should total ≥350 units/kg1


Administer additional heparin based on patient weight and duration of cardiopulmonary bypass1


Alternatively, use protamine titration (method not affected by aprotinin) to monitor heparin concentrations1


Trasylol Pharmacokinetics


Distribution


Extent


Distributes rapidly into the total extracellular space.1 In animals accumulates principally in the kidney and is stored in phagolysosomes.1


Elimination


Metabolism


Slowly degraded by lysosomal enzymes in the kidneys.1


Elimination Route


Excreted principally by the kidneys.1 21 Approximately 25–40% of a single, radiolabeled dose is excreted in urine over 48 hours.1


Half-life


About 150 minutes (initial half-life).1 About 10 hours (terminal elimination half-life) when determined >5 hours after dosing.1


Special Populations


Effect of hepatic impairment on pharmacokinetics not established.1


Pharmacokinetics not altered substantially by age or renal impairment.1


Stability


Storage


Parenteral


Injection

Store between 2–25°C.1 Protect from freezing.1


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Do not administer other drugs concomitantly with aprotinin in the same central IV line.1


To avoid incompatibility of heparin and aprotinin in the pump prime solution, add one agent during recirculation of the priming fluid to ensure adequate dilution prior to admixture with the other agent.1


ActionsActions



  • Inhibits contact activation of the intrinsic clotting system (i.e., contact phase of coagulation), a pathway that both initiates coagulation and promotes fibrinolysis.1 17 19 21




  • Minimizes perioperative bleeding and need for blood transfusion associated with CABG through effects on platelet and granulocyte function, coagulation, and fibrinolysis.1 4 16 17 18 19 21 24 25 May improve hemostasis during and after cardiopulmonary bypass by preserving platelet membrane receptors that maintain the adhesive and aggregative capacity of platelets.4 16 25 Attenuates fibrinolysis, inflammatory responses, and thrombin generation through inhibition of plasmin and plasma and tissue kallikreins.1 2 6 13


    Because of its effects on kallikrein,17 19 21 aprotinin inhibits activation of the intrinsic clotting system.1 17 19 21 (See Specific Drugs and Laboratory Tests under Interactions.) The relative contribution of these effects to the drug’s therapeutic action remains to be fully elucidated.1 4 6 16 17 18 19 20 21 23 24 25



Advice to Patients


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.



  • Importance of informing clinician of prior exposure to aprotinin, including use of fibrin sealant products (e.g., Tissucol, Tisseel) that may contain aprotinin.1 40 42 (See Sensitivity and Dermatologic Reactions under Cautions.)




  • Importance of informing clinician of prior allergic drug reactions.39




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and any concomitant illnesses (e.g., kidney disease) or prior heart surgery.1 39 42




  • Potential for fatal anaphylactic reaction or kidney dysfunction.42




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.39




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.













Aprotinin (Bovine)

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Injection



10,000 units/mL (1.4 mg/mL)



Trasylol



Bayer



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



1. Bayer Corporation. Trasylol (aprotinin) injection prescribing information. West Haven, CT; 2006 Dec.



2. Verstraete M. Clinical application of inhibitors of fibrinolysis. Drugs. 1985; 29:236-61. [IDIS 198903] [PubMed 2580684]



3. Hemostasis and blood coagulation. In: Guyton AC. Textbook of medical physiology. 8th ed. Philadelphia: WB Saunders; 1991:390-9.



4. Westaby S. Aprotinin in perspective. Ann Thorac Surg. 1993; 55:1033-41. [IDIS 312574] [PubMed 7682054]



5. Harker LA. Bleeding after cardiopulmonary bypass. N Engl J Med. 1986; 314:1446-8. [PubMed 3702953]



6. Woodman RC, Harker LA. Bleeding complications associated with cardiopulmonary bypass. Blood. 1990; 76:1680-97. [PubMed 2224118]



7. Hardy JF, Desroches J. Natural and synthetic antifibrinolytics in cardiac surgery. Can J Anaesth. 1992; 39:353-65. [IDIS 294811] [PubMed 1373346]



8. Royston D, Bidstrup BP, Taylor KM et al. Effect of aprotinin on the need for blood transfusion after repeat open-heart surgery. Lancet. 1987; 2:1289- 91. [IDIS 236843] [PubMed 2446091]



9. Bidstrup BP, Royston D, Sapsford RN et al. Reduction in blood loss and blood use after cardiopulmonary bypass with high dose aprotinin (Trasylol). J Thorac Cardiovasc Surg. 1989; 97:364-72. [IDIS 305131] [PubMed 2465457]



10. Cosgrove DM III, Heric B, Lytle BW et al. Aprotinin therapy for reoperative myocardial revascularization: a placebo-controlled study. Ann Thorac Surg. 1992; 54:1031-8. [IDIS 306242] [PubMed 1280411]



11. Hardy JF, Belisle S. Aprotinin therapy for reoperative myocardial revascularization: an opposing view. Ann Thorac Surg. 1993; 56:198. [IDIS 317350] [PubMed 7687124]



12. Royston D. High-dose aprotinin therapy: a review of the first five years’ experience. J Cardiothorac Vasc Anesth. 1992; 6:76-100. [PubMed 1371939]



13. van Oeveren W, Jansen NJG, Bidstrup BP et al. Effects of aprotinin on hemostatic mechanisms during cardiopulmonary bypass. Ann Thorac Surg. 1987; 44:640-5. [IDIS 236510] [PubMed 2446574]



14. Becker RC, Alpert JS. The impact of medical therapy on hemorrhagic complications following coronary artery bypass grafting. Arch Intern Med. 1990; 150:2016-21. [IDIS 272476] [PubMed 2222086]



15. Rossi CM, Bianchi W, Zaccarini P et al. The medical therapy of hemorrhagic complications following coronary artery bypass grafting. Arch Intern Med. 1991; 151:1458-9. [IDIS 285039] [PubMed 1712192]



16. Mohr R, Goor DA, Lusky A et al. Aprotinin prevents cardiopulmonary bypass- induced platelet dysfunction: a scanning electron microscope study. Circulation. 1992; 86(Suppl II):II405-9. [IDIS 304825] [PubMed 1385010]



17. Dietrich W, Spannagl M, Jochum M et al. Influence of high-dose aprotinin treatment on blood loss and coagulation patterns in patients undergoing myocardial revascularization. Anesthesiology. 1990; 73:1119-26. [IDIS 297661] [PubMed 1701072]



18. Allison PM, Whitten CW. What is the mechanism of action of aprotinin? Anesthesiology. 1991; 75:377-8. Letter. (IDIS 286282)



19. Dietrich W, Richter JA. What is the mechanism of action of aprotinin? Anesthesiology. 1991; 75:378-9. Reply. (IDIS 286283)



20. Merle JP, Lancon JP, Dutrillaux F et al. Effects of aprotinin on postoperative bleeding. Anesthesiology. 1991; 75:379-80. [IDIS 286284] [PubMed 1713429]



21. Hunt BJ, Yacoub M. Aprotinin and cardiac surgery: reduces perioperative blood loss. BMJ. 1991; 303:660-1. [IDIS 285811] [PubMed 1717088]



22. Bethune DW. Aprotinin and cardiac surgery. BMJ. 1991; 303:991.



23. John LCH, Rees GM, Kovacs IB. Aprotinin and cardiac surgery. BMJ. 1991; 303:991-2.



24. Hunt BJ, Yacoub M. Aprotinin and cardiac surgery. BMJ. 1991; 303:1401. [IDIS 289082] [PubMed 1722126]



25. van Oeveren W, Eijsman L, Roozendaal KJ et al. Platelet preservation by aprotinin during cardiopulmonary bypass. Lancet. 1988; I:644.



26. Food and Drug Adminstration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to December 31, 1993. Rockville, MD; 1994 January.



27. Fritz H, Wunderer G. Biochemistry and applications of aprotinin, the kallikrein inhibitor from bovine organs. Arzneimittelforschung. 1983; 33:479-94. [PubMed 6191764]



28. Miles Inc, West Haven, CT: Personal communication.



29. ons: efficacy, safety, and influence on early saphenous vein graft patency. A multicenter, randomized, double-blind, placebo-controlled study. J Thorac Cardiovasc Surg. 1994; 107:543-53. [IDIS 325391] [PubMed 7508070]



30. Murkin JM, Lux J, Shannon NA et al. Aprotinin significantly decreases bleeding and transfusion requirements in patients receiving aspirin and undergoing cardiac operations. J Thorac Cardiovasc Surg. 1994; 107:554-61. [IDIS 325392] [PubMed 7508071]



31. Sundt TM III, Kouchoukos NT, Saffitz JE et al. Renal dysfunction and intravascular coagulation with aprotinin and hypothermic circulatory arrest. Ann Thorac Surg. 1993; 55:1418-24. [IDIS 316156] [PubMed 7685587]



32. Ryan TJ, Antman EM, Brooks NH et al. ACC/AHA guidelines for the management of patients with acute myocardral infarction: 1999 update: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). From website.



33. Efstratiadis T, Munsch C, Crossman D et al. Aprotinin used in emergency coronary operation after streptokinase treatment. Ann Thorac Surg. 1991; 52:1320-1. [IDIS 291699] [PubMed 1721803]



34. Eagle KA, Guyton RA, Davidoff R et al. ACC/AHA guidelines for coronary artery bypass graft surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1991 Guidelines for Coronary Artery Bypass Graft Surgery). J Am Coll Cardiol. 1999; 34:1262-346. [IDIS 440562] [PubMed 10520819]



35. Mangano DT and the Multicenter Study of Perioperative Ischemia Research Group. Aspirin and mortality form coronary bypass surgery. N Engl J Med. 2002; 347:1309-17. [IDIS 488783] [PubMed 12397188]



36. Mangano DT, Tudor JC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006: 354:353-65.



37. Karkouti K, Beattie WS, Dattilo KM, et al. Blod conservation and transfusion alternatives: a propensity socre case-control comparison of aprotinin and tranexamic acid in high-transfusion-risk cardiac surgery. Transfusion [serial online]. January, 20, 2006. Available from website. Accessed 2006 Feb 09.



38. Anon. FDA Public Health Advisory: Aprotinin Injection (marketed as Trasylol). Rockville, MD: Food and Drug Administration; 2006 Sep 29. Available at FDA website. Accessed 2007 Jan 25.



39. Anon. FDA patient information sheet: Aprotinin injection (marketed as Trasylol). Rockville, MD: Food and Drug Administration; 2006 Feb 08. Available at the FDA website. Accessed 2006 Feb 09.



40. Anon. FDA Information for healthcare professionals: Aprotinin injection (marketed as Trasylol). Rockville, MD: Food and Drug Administration; 2006 Sep.Available at the FDA website. Accessed 2006 Sep.



41. Center for Drug Evaluation and Research, Food and Drug Administration. FDA Alert: Aprotinin injection (marketed as Trasylol) information. Rockville, MD; Food and Drug Administration; Dec 2006. Available at FDA website. Accessed 2006 Dec 15.



42. Food and Drug Administration. FDA Information for healthcare professionals: Aprotinin injection (marketed as Trasylol). Rockville, MD; Dec 2006. Available at the FDA website. Accessed 2006 Dec 15.



a. Mercieri M, Mercieri A, Tritapepe L et al. High-dose aprotinin with gentamicin-vancomycin antibiotic prophylaxis increases blood concentratiosn of creatinine and cystatin C in patients undergoing coronary artery bypass grafting. Br J Anaesth. 1999; 82:531-6. [PubMed 10472217]



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