Zinc Undecylenate Powder

Pronunciation: zink un-deh-sil-EN-ate
Generic Name: Zinc Undecylenate
Brand Name: Blis-To-Sol

Zinc Undecylenate Powder is used for:

Treating athlete's foot, jock itch, and ringworm. It may also be used for other conditions as determined by your doctor.

Zinc Undecylenate Powder is an antifungal. It works by preventing fungal growth.

Do NOT use Zinc Undecylenate Powder if:

• you are allergic to any ingredient in Zinc Undecylenate Powder

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

Before using Zinc Undecylenate Powder:

Some medical conditions may interact with Zinc Undecylenate Powder. 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 have diabetes or blood vessel problems in your arms or legs

Some MEDICINES MAY INTERACT with Zinc Undecylenate Powder. Because little, if any, of Zinc Undecylenate Powder is absorbed into the blood, the risk of interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zinc Undecylenate Powder 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 Zinc Undecylenate Powder:

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

• Zinc Undecylenate Powder is for external use only. Do not get Zinc Undecylenate Powder in your eyes, nose, or mouth. If you get Zinc Undecylenate Powder in your eyes, rinse immediately with cool tap water.


• Wash your hands immediately before and after using Zinc Undecylenate Powder.


• Wash and completely dry the affected area.


• Shake a thin layer of medicine over the entire affected area. For athlete's foot, pay special attention to the spaces between the toes.


• Do not cover with a bandage or dressing unless directed otherwise by your doctor.


• If you miss a dose of Zinc Undecylenate Powder, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Zinc Undecylenate Powder.

Important safety information:

• If your symptoms do not improve within 4 weeks for athlete's foot or ringworm or 2 weeks for jock itch, or if they become worse, check with your doctor.


• For athlete's foot, it may be helpful to wear well-fitting, well-ventilated shoes and to change shoes and socks at least once daily.


• Do not use Zinc Undecylenate Powder on the scalp or the nails. It is not effective on these areas.


• Do not use Zinc Undecylenate Powder on blistered or oozing skin or over deep puncture wounds.


• It is important to use Zinc Undecylenate Powder for the full course of treatment. Failure to do so may decrease the effectiveness of Zinc Undecylenate Powder and may increase the risk that the fungus will no longer be sensitive to Zinc Undecylenate Powder and will not be able to be treated by this or certain other antifungals in the future.


• Overuse of topical products may worsen your condition.


• Zinc Undecylenate Powder may be harmful if swallowed. If you or someone you know may have taken Zinc Undecylenate Powder by mouth, contact your local poison control center or emergency room immediately.


• Supervise CHILDREN younger than 12 years of age who are using Zinc Undecylenate Powder.


• Zinc Undecylenate Powder is not recommended for use in CHILDREN younger than 2 years of age without first checking with your doctor. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Zinc Undecylenate Powder during pregnancy. It is unknown if Zinc Undecylenate Powder is excreted in breast milk. If you are or will be breast-feeding while you are using Zinc Undecylenate Powder, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Zinc Undecylenate Powder:

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:

Mild stinging.

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); blistering, burning, itching, peeling, swelling, or reddening of your skin not present when you began using Zinc Undecylenate Powder.

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: Zinc Undecylenate 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. Zinc Undecylenate Powder may be harmful if swallowed.

Proper storage of Zinc Undecylenate Powder:

Store Zinc Undecylenate Powder at room temperature, between 68 and 77 degrees F (20 and 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 Zinc Undecylenate Powder out of the reach of children and away from pets.

General information:

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


• Zinc Undecylenate Powder 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 Zinc Undecylenate Powder. 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 Zinc Undecylenate resources

• Zinc Undecylenate Side Effects (in more detail)
• Zinc Undecylenate Use in Pregnancy & Breastfeeding
• Zinc Undecylenate Support Group
• 1 Review for Zinc Undecylenate - Add your own review/rating

Compare Zinc Undecylenate with other medications

• Onychomycosis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Travatan

Generic Name: travoprost ophthalmic (TRA voe prost off THAL mik)

Brand Names: Travatan, Travatan Z

What is travoprost ophthalmic?

Travoprost ophthalmic (for the eye) reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Travoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

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

What is the most important information I should know about travoprost ophthalmic?

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

After using this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

What should I discuss with my health care provider before using travoprost ophthalmic?

Do not use this medication if you are allergic to travoprost.

Before using travoprost, tell your doctor if you are allergic to any drugs, or if you have swelling or infection of your eye.

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether travoprost is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether travoprost passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use travoprost ophthalmic?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using the eye drops.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

  
  


• 
  

  If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop. Also wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

  
  

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. At any time during your use of travoprost ophthalmic, tell your doctor at once if you have an eye injury, if you develop an eye infection, or if you plan to have eye surgery. Do not use the eye drops if the liquid changes colors or has particles in it. Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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.

An overdose of travoprost ophthalmic used in the eyes is not expected to produce life-threatening symptoms.

What should I avoid while using travoprost ophthalmic?

Avoid using too much of this medication, which can actually make it less effective in lowering the pressure inside the eye.

Avoid using any eyedrop medicine that has not been prescribed by your doctor.

Travoprost ophthalmic 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 travoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

• 
  

  redness, swelling, itching, or pain in or around your eye;

  
  


• 
  

  oozing or discharge from your eye;

  
  


• 
  

  increased sensitivity to light;

  
  


• 
  

  vision changes; or

  
  


• 
  

  chest pain.

  
  

Less serious side effects may include:

• 
  

  mild eye discomfort;

  
  


• 
  

  headache;

  
  


• 
  

  feeling like something is in your eye;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry or watery eyes; or

  
  


• 
  

  stinging or burning of the eyes after using the drops.

  
  

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 travoprost ophthalmic?

There may be other drugs that can affect travoprost ophthalmic. 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 Travatan resources

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

• Travatan Advanced Consumer (Micromedex) - Includes Dosage Information


• Travatan Consumer Overview


• Travatan Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Travatan Prescribing Information (FDA)


• Travatan Monograph (AHFS DI)


• Travatan Z Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Travatan Z Consumer Overview

Compare Travatan with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Where can I get more information?

• Your pharmacist can provide more information about travoprost ophthalmic.

See also: Travatan side effects (in more detail)

Trelstar Depot

Generic Name: triptorelin (TRIP toe REL in)

Brand Names: Trelstar Depot, Trelstar Depot Mixject, Trelstar LA, Trelstar LA Mixject

What is Trelstar Depot (triptorelin)?

Triptorelin is a man-made form of a hormone that regulates many processes in the body. Triptorelin overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily.

Triptorelin is used to treat the symptoms of prostate cancer. Triptorelin treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

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

What is the most important information I should know about Trelstar Depot (triptorelin)?

You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

Before using triptorelin, tell your doctor if you have any type of cancer that has spread to your spine, a bladder obstruction or problems with urination, diabetes, heart disease, high blood pressure, high cholesterol, a history of stroke or heart attack, or if you smoke.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin. Some of the side effects of triptorelin are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels. Call your doctor at once if you have pain or burning when you urinate, blood in your urine, bone pain, numbness, tingling, muscle weakness, or loss of movement in any part of your body. Although triptorelin is not for use by women, this medication can cause birth defects and should not be used by a woman who is pregnant or who may become pregnant.

What should I discuss with my healthcare provider before using Trelstar Depot (triptorelin)?

You should not use this medication if you are allergic to triptorelin or similar drugs such as leuprolide (Lupron, Viadur, Eligard) or goserelin (Zoladex).

If you have any of these other conditions, you may need a triptorelin dose adjustment or special tests:

• 
  

  any type of cancer that has spread to your spine;

  
  


• 
  

  a bladder obstruction or problems with urination;

  
  


• 
  

  diabetes, heart disease, high blood pressure, recent weight gain, high cholesterol (especially in men);

  
  


• 
  

  heart disease, high blood pressure, high cholesterol;

  
  


• 
  

  a history of heart attack or stroke; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category X. Although triptorelin is not for use by women, this medication can harm an unborn baby or cause birth defects. Triptorelin should not be used by a woman who is pregnant or who may become pregnant. It is not known whether triptorelin passes into breast milk or if it could harm a nursing baby. Although triptorelin is not for use by women, this medication should not be used while breast-feeding a baby.

How should I use Trelstar Depot (triptorelin)?

Triptorelin is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

This medication comes with a vial (bottle) of powder medicine and a prefilled syringe of sterile water. The powder must be mixed with the sterile water before using the medicine. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not save the mixture for later use. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Triptorelin is usually given once every 4, 12, or 24 weeks. Your dose schedule will depend on the strength of triptorelin you are using. Follow your doctor's dosing instructions very carefully.

After your injection, your prostate cancer symptoms may get worse for a short time because triptorelin raises your testosterone levels. These side effects should get better within 3 or 4 weeks. Call your doctor if your symptoms do not improve, or if they get worse while using triptorelin.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store vials and prefilled syringes at room temperature away from moisture, heat, and light. Do not freeze.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of triptorelin.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Trelstar Depot (triptorelin)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Trelstar Depot (triptorelin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect. Some of these side effects are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels:

• 
  

  painful or difficult urination, burning when you urinate, blood in the urine;

  
  


• 
  

  bone pain;

  
  


• 
  

  numbness, tingling, or muscle weakness (especially in your legs and feet);

  
  


• 
  

  loss of movement in any part of your body;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech; or

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  
  

Less serious side effects may include:

• 
  

  hot flashes;

  
  


• 
  

  back pain, pain or swelling in your legs;

  
  


• 
  

  headache, dizziness, tired feeling;

  
  


• 
  

  decreased interest in sex, impotence, trouble having an orgasm;

  
  


• 
  

  nausea, vomiting, diarrhea, upset stomach;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  breast pain or swelling; or

  
  


• 
  

  pain where the medicine was injected.

  
  

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 Trelstar Depot (triptorelin)?

There may be other drugs that can interact with triptorelin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Trelstar Depot resources

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

• Trelstar Depot Prescribing Information (FDA)


• Trelstar Depot MedFacts Consumer Leaflet (Wolters Kluwer)


• Trelstar Depot Advanced Consumer (Micromedex) - Includes Dosage Information


• Trelstar LA Prescribing Information (FDA)


• Triptorelin Pamoate Monograph (AHFS DI)

Compare Trelstar Depot with other medications

• Prostate Cancer

Where can I get more information?

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

See also: Trelstar Depot side effects (in more detail)

Nutropin AQ Vials

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Refrigerated)
Brand Name: Nutropin AQ

Nutropin AQ Vials are used for:

Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or other conditions (eg, chronic kidney problems, idiopathic short stature). It may also be used for other conditions as determined by your doctor.

Nutropin AQ Vials are a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.

Do NOT use Nutropin AQ Vials if:

• you are allergic to any ingredient in Nutropin AQ Vials


• you have been or are being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing


• you have premature epiphyseal closure (your bone growth is complete) or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)


• you have certain eye problems caused by diabetes (eg, diabetic retinopathy)


• you have Prader-Willi syndrome and are severely overweight or have severe breathing problems

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

Before using Nutropin AQ Vials:

Some medical conditions may interact with Nutropin AQ Vials. 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 have endocrine problems including pituitary or adrenal gland problems, diabetes or a family history of diabetes, eye problems caused by diabetes, or an underactive thyroid


• if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer


• if you have curvature of the spine (scoliosis), kidney or liver problems, ear or hearing problems (eg, repeated ear infection), Prader-Willi syndrome, are severely overweight, or have had recent major surgery or trauma

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

• Corticosteroids (eg, prednisone) because they may decrease Nutropin AQ Vials's effectiveness


• Anticonvulsants (eg, phenytoin, carbamazepine) or cyclosporine because the risk of their side effects may be increased or their effectiveness may be decreased by Nutropin AQ Vials

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nutropin AQ Vials 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 Nutropin AQ Vials:

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

• Nutropin AQ Vials are given as an injection. A health care provider will teach you how to use it. Be sure you understand how to use Nutropin AQ Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Allow Nutropin AQ Vials to come to room temperature before you use it.


• Wash your hands before and immediately after using Nutropin AQ Vials.


• Use a new needle each time you inject Nutropin AQ Vials. Do not reuse needles.


• Do not use Nutropin AQ Vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.


• Always rotate injection sites each time you use Nutropin AQ Vials.


• Do not shake Nutropin AQ Vials. Swirl gently to mix it.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Nutropin AQ Vials, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Nutropin AQ Vials.

Important safety information:

• Nutropin AQ Vials may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Nutropin AQ Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Rare, sometimes fatal, lung and breathing problems may be caused by Nutropin AQ Vials in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Nutropin AQ Vials, contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Nutropin AQ Vials. Nutropin AQ Vials may need to be stopped.


• Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Nutropin AQ Vials. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.


• Rarely, children using Nutropin AQ Vials have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.


• Nutropin AQ Vials may have benzyl alcohol, metacresol, or glycerin in it. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol, metacresol, or glycerin.


• Diabetes patients - Nutropin AQ Vials may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine or your diet.


• Lab tests, including blood sugar levels and thyroid function, may be performed while you use Nutropin AQ Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nutropin AQ Vials with caution in the ELDERLY; they may be more sensitive to its effects.


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

Possible side effects of Nutropin AQ Vials:

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:

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

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); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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: Nutropin AQ 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 excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Nutropin AQ Vials:

Before mixing, store Nutropin AQ Vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from heat, moisture, and light. Do not use Nutropin AQ Vials past the expiration date on the product label. After mixing, store Nutropin AQ Vials according to the product label. Contact your pharmacist if you have any questions about the proper storage of Nutropin AQ Vials. Keep Nutropin AQ Vials, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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


• Nutropin AQ Vials are 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 Nutropin AQ Vials. 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 Nutropin AQ resources

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

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NTZ Long Acting Nasal

Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen)

Brand Names: Afrin, Afrin Nasal Sinus, Allerest 12 Hour Nasal Spray, Duramist Plus, Duration, Four-Way Nasal Spray, Genasal, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, NTZ Long Acting Nasal, Oxyfrin, Oxymeta-12, Sinarest Nasal, Sinex Long-Acting, Twice-A-Day

What is NTZ Long Acting Nasal (oxymetazoline nasal)?

Oxymetazoline is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. The nasal formulation acts directly on the blood vessels in your nasal tissues. Constriction of the blood vessels in your nose and sinuses leads to drainage of these areas and a decrease in congestion.

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

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

What is the most important information I should know about NTZ Long Acting Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use NTZ Long Acting Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This could cause a very dangerous drug interaction with serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  high blood pressure;

  
  


• 
  

  any type of heart disease, hardening of the arteries, or irregular heart beats;

  
  


• 
  

  thyroid problems;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  an enlarged prostate or difficulty urinating; or

  
  


• 
  

  liver or kidney disease.

  
  

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether oxymetazoline nasal will harm an unborn baby. Do not use oxymetazoline nasal without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of oxymetazoline nasal. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. If you over 60 years of age, you may be more likely to experience side effects from oxymetazoline nasal. You may require a lower dose of this medication.

How should I use NTZ Long Acting Nasal (oxymetazoline nasal)?

Use oxymetazoline nasal exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful. Oxymetazoline nasal should not be used more often than twice a day (every 12 hours).

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking NTZ Long Acting Nasal (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

NTZ Long Acting Nasal (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

• 
  

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

  
  


• 
  

  seizures;

  
  


• 
  

  unusual behavior or hallucinations; or

  
  


• 
  

  an irregular or fast heartbeat.

  
  

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect NTZ Long Acting Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

• 
  

  furazolidone (Furoxone);

  
  


• 
  

  guanethidine (Ismelin);

  
  


• 
  

  indomethacin (Indocin);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  bromocriptine (Parlodel);

  
  


• 
  

  caffeine in cola, tea, coffee, chocolate and other products;

  
  


• 
  

  theophylline (Theo-Dur, Theochron, Theolair, others);

  
  


• tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);


• other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);


• phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and


• other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More NTZ Long Acting Nasal resources

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

• Afrin Advanced Consumer (Micromedex) - Includes Dosage Information


• Afrin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare NTZ Long Acting Nasal with other medications

• Nasal Congestion

Where can I get more information?

• Your pharmacist has additional information about oxymetazoline nasal written for health professionals that you may read.

See also: NTZ Long Acting Nasal side effects (in more detail)

Cefuroxime Sodium Injection

1. Name Of The Medicinal Product

Cefuroxime sodium for injection 250mg, cefuroxime sodium for injection 750mg and cefuroxime sodium for injection 1.5g.

2. Qualitative And Quantitative Composition

Each vial contains, as the active ingredient, cefuroxime sodium for injection equivalent to 250mg, 750mg or 1.5g of cefuroxime.

3. Pharmaceutical Form

Vials containing an off-white to slightly yellow sterile powder for solution for injection or infusion.

4. Clinical Particulars

4.1 Therapeutic Indications

Cefuroxime sodium for injection is indicated for the treatment of infections caused by susceptible strains of the designated micro-organisms, or before the infecting organism has been identified, in the diseases listed below.

Respiratory tract infections, for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and postoperative chest infections.

Ear, nose and throat infections, for example, sinusitis, tonsillitis and pharyngitis.

Urinary tract infections, for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria.

Soft tissue infections, for example, cellulitis, erysipelas, peritonitis and wound infections.

Bone and joint infections, for example, osteomyelitis and septic arthritis.

Obstetric and gynaecological infections, pelvic inflammatory disease.

Gonorrhoea, particularly if penicillin is unsuitable.

Other infections, including septicaemia and meningitis.

Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection.

Consideration should be given to official local guidance (eg, national recommendations) on the appropriate use of antibacterial agents.

Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.

4.2 Posology And Method Of Administration

Usually cefuroxime is effective when administered alone, but when appropriate it may be used in combination with metronidazole or an aminoglycoside.

General Dosage

Adults: Many infections will respond to 750mg three times daily by intramuscular or intravenous injection. For more severe infections this dose should be increased to 1.5g three times daily intravenously. The frequency of dosage may be increased to six-hourly injections, intramuscular or intravenous, giving total daily doses of 3g to 6g.

Infants and children: Doses of 30 to 100mg/kg/day given in three or four divided doses. A dose of 60mg/kg/day will be appropriate for most infections.

Neonates: Doses of 30 to 100mg/kg/day given in two or three divided doses. In the first weeks of life the serum half-life of cefuroxime can be three to five times that in adults.

Gonorrhoea

1.5g should be given as a single dose or as two 750mg injections into different sites, eg, each buttock.

Meningitis

Cefuroxime therapy is suitable for sole therapy of bacterial meningitis due to sensitive strains.

Infants and children: 200 to 240mg/kg/day intravenously in three or four divided doses. This dosage may be reduced to 100mg/kg/day after three days or when clinical improvement occurs.

Neonates: The initial dosage should be 100mg/kg/day intravenously. This dosage may be reduced to 50mg/kg/day after three days or when clinical improvement occurs.

Adults: 3g intravenously every eight hours. No data is currently available to recommend a dose for intrathecal administration.

Prophylaxis

The usual dose is 1.5g intravenously with induction of anaesthesia. For orthopaedic, pelvic and abdominal operations this may be followed with two 750mg doses 8 and 16 hours later. For vascular, cardiac, oesophageal and pulmonary operations this may be supplemented with 750mg intramuscularly three times a day for a further 24 to 48 hours.

In total joint replacement, 1.5g cefuroxime powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.

Dosage in Impaired Renal Function

As cefuroxime is excreted by the kidneys, the dosage should be reduced to allow for slower excretion in patients with impaired renal function, once creatinine clearance falls below 20ml/min, as follows:

Marked impairment (creatinine clearance 10 to 20ml/min)	750mg twice daily
Severe impairment (creatinine clearance of less than 10ml/min)*	750mg once daily
Continuous peritoneal dialysis	750mg twice daily
Renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units	750mg twice daily
Low-flux haemofiltration	As for impaired renal function
*For patients on haemodialysis, a further 750mg should be given at the end of each dialysis session.

4.3 Contraindications

Contra-indicated in patients hypersensitive to the cephalosporin group of antibiotics.

4.4 Special Warnings And Precautions For Use

Cephalosporin antibiotics may, in general, be given safely to patients who are hypersensitive to penicillins, although cross-reactions have been reported. Special care is indicated in patients who have experienced an anaphylactic reaction to penicillin.

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics or aminoglycosides, as these combinations are suspected of adversely affecting renal function. Clinical experience has shown that this is not likely to be a problem at the recommended dose levels.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent administration of probenecid prolongs the excretion of cefuroxime and produces an elevated peak serum level.

Concurrent administration of potent diuretics, aminoglycosides may adversely affect renal function (see section 4.4).

Interference with Laboratory Tests

Slight interference may occur with the copper reduction methods (Fehling's, Benedict's) but this should not lead to false-positive results. Cefuroxime does not interfere with the enzyme based tests for glycosuria, or with the alkaline picrate method for creatinine. It is recommended that either the hexokinase or glucose oxidase methods are used for determination of blood/plasma glucose levels.

4.6 Pregnancy And Lactation

Studies in animals revealed no evidence of embryopathic or teratogenic effects due to cefuroxime, but, as with all drugs, it should be used with caution during pregnancy.

Since cefuroxime is excreted in human milk, caution should be exercised when administering this antibiotic to a nursing mother.

4.7 Effects On Ability To Drive And Use Machines

Cefuroxime is not known to affect the ability to drive or use machines.

4.8 Undesirable Effects

Hypersensitivity reactions: Including skin rashes (maculopapular and urticarial), interstitial nephritis, drug fever and, very rarely, anaphylaxis. As with any antibiotic, prolonged use may lead to overgrowth of non-susceptible organisms, eg, Candida.

As with other cephalosporins, there have been rare reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Gastro-intestinal disturbance: Including, very rarely, pseudomembranous colitis, which has been reported with most broad spectrum antibiotics.

Haematological: A decrease in haemoglobin concentration, eosinophilia, leucopenia and neutropenia have been observed. Positive Coombs' tests have been reported. As with other cephalosporins, thrombocytopenia has been reported rarely.

Hepatic: Transient rises in liver enzymes or serum bilirubin have been observed, particularly in patients with pre-existing liver disease, but there is no evidence of hepatic involvement.

Renal: There may be some variation in the results of biochemical tests of renal function, but these results do not appear to be of clinical significance.

Other: Transient pain may be experienced at the site of intramuscular injection. Occasionally thrombophlebitis may occur at the site of intravenous injection. A burning sensation may be observed after intravenous injection. Mild to moderate hearing loss has been reported in some children treated for meningitis. Dizziness and headache has been reported in patients receiving cefuroxime.

4.9 Overdose

Overdosage of cephalosporins can lead to cerebral irritation and seizures. With seizures the drug should be discontinued and appropriate anticonvulsive and supportive therapy administered. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Cefuroxime is a cephalosporin antibiotic, ATC code J01DA06 (Cephalosporins and Related Substances). All cephalosporins (β-lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis. The initial step in drug action consists of binding of the drug to cell receptors, called penicillin-binding proteins. After a β-lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked. Bacterial lysis is the end result.

Susceptibility

The following MIC breakpoints separating susceptible from intermediately susceptible organisms and intermediately susceptible from resistant organisms are used.

Table 1:Susceptibility Breakpoints

Bacterial Breakpoints	Organism
NCCLS Breakpoints S: S: S: S: S:	Enterobacteriaceae Enterococcus Haemophilus influenzae Neisseria gonorrhoeae Streptococcus pneumoniae
DIN Breakpoints S:	All bacterial isolates
BSAC Breakpoints S:   S:	Acinetobacter spp. and Enterobacteriaceae Streptococcus pneumoniae Moraxella catarrhalis Neisseria gonorrhoeae Haemophilus influenzae
NCCLS: National Committee for Clinical Laboratory Standards DIN: Deutches Institut fur Normung BSAC: British Society for Antimicrobial Chemotherapy S: Susceptible, I: Intermediately susceptible, R: Resistant

The prevalence of resistance may vary geographically and with time for selected species and local information is desirable, particularly when treating several infections. This information gives only an approximate guidance on probabilities whether organisms will be susceptible to cefuroxime or not.

Table 2:Range of Bacterial Resistance to Cefuroxime in Europe

Category	Range of Resistance in Europe
Susceptible
Gram +ve Aerobes
Staphylococcus aureus (methicillin-susceptible strains)
Staphylococcus epidermidis (methicillin-susceptible strains)	0-46%
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus viridans
Gram -ve Aerobes
Escherichia coli	2-17%
Haemophilus influenzae	0-29%
Klebsiella spp.	6-21%
Moraxella catarrhalis
Neisseria spp.	0-17%
Proteus mirabilis	0-75%
Providencia spp., including Providencia rettgeri
Providencia rettgeri only
Anaerobes
Clostridium perfringens
Intermediate
Gram -ve Aerobes
Bordetella pertussis
Citrobacter	21-52%
Enterobacter spp.	36-83%
Anaerobes
Bacteroides fragilis
Insusceptible
Gram +ve Aerobes
Enterococcus faecalis
Staphylococcus aureus (methicillin-resistant strains)
Staphylococcus epidermidis (methicillin-resistant strains)
Gram -ve Aerobes
Acinetobacter spp.
Campylobacter spp.
Legionella spp.
Pseudomonas spp.
Serratia spp.
Morganella morganii	70-94%
Proteus vulgaris	75-100%
Anaerobes
Clostridium difficile

Cross-Reactivity Between Cefuroxime and Other Antibiotics

Cross-resistance between cefuroxime and several other β-lactam antibiotics, including amoxicillin, methicillin, penicillin and ampicillin and some cephalosporins, has been recorded.

Amoxicillin-sensitive Haemophilus influenzae are more likely to be susceptible to cefuroxime than amoxicillin-resistant Haemophilus influenzae. Similarly, methicillin-sensitive Staphylococcus aureus and Staphylococcus epidermidis are usually cefuroxime-susceptible, while methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis are resistant to cefuroxime.

Resistance of Staphylococcus aureus and Staphylococcus pneumoniae to penicillin can result in an increase in the cefuroxime MIC₅₀ and MIC₉₀ values for these organisms. In addition, resistance of Escherichia coli and Haemophilus influenzae to ampicillin may result in an increase of the cefuroxime MIC₅₀ values for these organisms.

Mechanisms of Resistance to Cefuroxime

Known mechanisms of resistance in targeted pathogens are the following:

• Production of β-lactamases which are able to hydrolyse cefuroxime efficiently (eg, several of the extended-spectrum and chromosomally-mediated β-lactamases).

• Reduced affinity of penicillin-binding proteins for cefuroxime (eg, penicillin-resistant Streptococcus pneumoniae).

• Cell wall impermeability.

• Efflux pumps.

5.2 Pharmacokinetic Properties

The serum half-life after either intramuscular or intravenous administration is approximately 70 minutes. After intramuscular injection the peak serum level occurs after about 45 minutes.

The antibiotic can be found in bone, synovial fluid and aqueous humour above the minimum inhibitory levels for common pathogens. The blood-brain barrier can be passed by cefuroxime when the meninges are inflamed.

Cefuroxime is excreted approximately 50% by glomerular filtration and 50% through the renal tubules. Cefuroxime is almost completely recovered unchanged in the urine within 24 hours, most being excreted within six hours.

5.3 Preclinical Safety Data

There is no experimental evidence of embryopathic or teratogenic effects attributable to cefuroxime.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Each vial contains only the active ingredient, cefuroxime sodium.

6.2 Incompatibilities

Cefuroxime should not be mixed in the syringe with aminoglycoside antibiotics.

6.3 Shelf Life

Before reconstitution: 36 months.

In keeping with good pharmaceutical practice, freshly constituted suspensions or solutions should be used immediately. If this is not practicable then solution may be stored at 2°C-8°C (in a refrigerator) for up to 24 hours.

6.4 Special Precautions For Storage

Protect from light. Before reconstitution do not store above 25°C. After reconstitution the product may be stored at 2°C-8°C (in a refrigerator) for up to 24 hours.

6.5 Nature And Contents Of Container

Type III flint glass vial, stoppered with halobutyl closures and sealed with aluminium seals that may be combined with a polypropylene cap. Pack sizes of 1 and 10 vials. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Intramuscular injection: Add 1ml of water for injections to 250mg or 3ml of water for injections to 750mg. Shake gently to produce a suspension.

Intravenous administration: Dissolve cefuroxime in water for injections using at least 2ml for 250mg, at least 6ml for 750mg and at least 15ml for 1.5g. For short intravenous infusion, 1.5g may be dissolved in 50ml of water for injections. Reconstituted solutions may be diluted with:

5% or 10% dextrose

5% dextrose containing 0.2%, 0.225%, 0.45% or 0.9% sodium chloride injection

5% dextrose containing 20mEq potassium chloride

0.9% sodium chloride injection

M/6 sodium lactate injection

Ringer's injection

Lactated Ringer's injection

Heparin (10 and 50 units/ml) in 0.9% sodium chloride injection

10mEq potassium chloride in 0.9% sodium chloride injection

These solutions may be given directly into a vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.

7. Marketing Authorisation Holder

Flynn Pharma Ltd

Alton House

4 Herbert Street

Dublin 2

Ireland

8. Marketing Authorisation Number(S)

Cefuroxime sodium for injection 250mg: PL 13621/0017

Cefuroxime sodium for injection 750mg: PL 13621/0018

Cefuroxime sodium for injection 1.5g: PL 13621/0019

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 1^st June 2005

10. Date Of Revision Of The Text

January 2009

Legal Category

POM

Package Quantities

1.5g x 1, 20ml vial

250mg x 1, 10ml vial

750mg x 1, 10ml vial

Nicardipine

Class: Dihydropyridines
VA Class: CV200
CAS Number: 54527-84-3
Brands: Cardene

Introduction

Calcium-channel blocking agent; dihydropyridine-derivative.¹

Uses for Nicardipine

Hypertension

Oral management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 2 3 70}

Therapy with extended-release capsules is preferred because of less frequent dosing, potentially smoother blood pressure control,⁷⁰ and concerns raised by experience with short-acting (conventional, immediate-release) nifedipine.^{35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 61 70 72 73}

One of several preferred initial therapies in hypertensive patients with a high risk of developing CAD, including those with diabetes mellitus.⁹⁴

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁹⁴

IV, short-term management of hypertension when oral therapy is not feasible or desirable.¹⁸

IV management of hypertensive crises (e.g., emergencies) in adults.^{18 70}

IV, rapid reduction of BP in the management of hypertensive urgencies or emergencies in pediatric patients 1–17 years of age.†⁹⁹

Angina

Management of chronic stable angina pectoris (alone or in combination with other antianginal agents).^{1 3 25}

Nicardipine Dosage and Administration

Administration

Administer orally^{1 2 5} or by IV infusion.^{18 22 23}

Oral Administration

Conventional Capsules

Administer orally 3 times daily.¹

Extended-release Capsules

Administer orally twice daily.²

IV Administration

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

Administer by slow, continuous IV infusion.^{18 22 23}

If administered via a peripheral vein, change infusion site every 12 hours to minimize risk of venous irritation.¹⁸

Monitor BP closely during and after completion of IV administration; avoid rapid or excessive reduction in systolic or diastolic BP.^{18 70}

Dilution

Dilute each 25 mg ampule with 240 mL of a compatible IV solution (see Solution Compatibility under Stability) to provide a solution containing 0.1 mg/mL.^{18 c}

Dosage

Available as nicardipine hydrochloride; dosage is expressed in terms of the salt.^{a b c}

Pediatric Patients

Hypertensive Urgencies or Emergencies†

Rapid Reduction of BP†

IV

Children and adolescents 1–17 years of age: 1–3 mcg/kg per minute as infusion.⁹⁹

Adults

Hypertension

Conventional Capsules

Oral

Initially, 20 mg 3 times daily.^{1 5}

Adjust dosage according to patient’s peak (approximately 1–2 hours after dosing, particularly during initiation of therapy) and trough (8 hours after dosing) BP responses, but generally no more frequently than at 3-day intervals.¹

Usual dosage is 20–40 mg 3 times daily.¹

Extended-Release Capsules

Oral

Initially, 30 mg twice daily.^{2 70}

Adjust dosage according to BP response 2–4 hours after dosing as well as just prior to next dose.²

Usual dosage range is 30–60 mg twice daily.²

Switching to Extended-Release Capsules

Oral

Total daily dose of conventional tablets not a useful guide to judging effective dose of extended-release capsules.^{2 c} However, may administer the currently effective total daily dose of conventional capsules and adjust dosage according to BP response.^{2 c}

Short-term Management with IV Therapy

IV

Initially, 5 mg/hour.^{18 70}

If target BP is not achieved, increase rate by 2.5 mg/hour every 15 minutes, up to 15 mg/hour.^{18 70}

For more rapid reduction, initially, 5 mg/hour. If the target BP is not achieved, increase rate by 2.5 mg/hour every 5 minutes, up to 15 mg/hour.^{18 70}

Following achievement of desired BP response, decrease rate to 3 mg/hour;¹⁸ adjust rate as necessary to maintain desired BP reponse.¹⁸

Conversion From Oral to IV Therapy

IV

Recommended Infusion Rates for Patients Previously Maintained on Oral Therapy.

Oral Dosage (as Conventional Capsules)	Equivalent IV Infusion Rates
20 mg every 8 hours	0.5 mg/hour
30 mg every 8 hours	1.2 mg/hour
40 mg every 8 hours	2.2 mg/hour

Hypertensive Emergency

IV

5–15 mg/hour; adjust according to BP response and tolerance.⁷⁰

Initially, reduce mean arterial BP by no more than 25% within minutes to 1 hour, then further reduce if stable toward 160/100 to 110 mm Hg within the next 2–6 hours, avoiding excessive declines in pressure that could precipitate renal, cerebral, or coronary ischemia.⁷⁰

If patient is stable, can further reduce BP toward normal in the next 24–48 hours.⁹⁸

Angina

Conventional Capsules

Oral

Initially, 20 mg 3 times daily.^{1 5} Adjust dosage according to patient tolerance and response at ≥3-day intervals.¹

Usual dosage range is 20–40 mg 3 times daily.¹

Prescribing Limits

Adults

Hypertension

IV

15 mg/hour.^{18 70}

Special Populations

Hepatic Impairment

Conventional capsules: Initially, 20 mg twice daily in patients with severe hepatic impairment.¹ Individualize dosage, but maintain a twice-daily dosing schedule.¹

IV infusion: Consider dosage reduction.¹⁸ Use with caution in patients with portal hypertension.¹⁸

Renal Impairment

Conventional capsules: Initially, 20 mg 3 times daily.^{1 5} Titrate dosage carefully.¹

Extended-release capsules: Initially, 30 mg twice daily.² Titrate dosage carefully.²

IV infusion: Titrate dosage carefully.¹⁸

Geriatric Patients

Cautious dosing recommended.^{a b} For conventional and extended-release capsules, initiate therapy at low end of dosage range.^{20 68}

Cautions for Nicardipine

Contraindications

• 
  

  Known hypersensitivity to nicardipine or any ingredient in the formulation.^{1 2 18}

  
  


• 
  

  Advanced aortic stenosis, since reduction in diastolic pressure may worsen myocardial oxygen balance.^{1 2 18}

  
  

Warnings/Precautions

Warnings

Increased Angina

Increased frequency, duration, and severity of angina upon initiation or dosage increase of calcium channel blockers.^{1 2 18}

CHF

Use with caution in patients with CHF or substantial left ventricular dysfunction, especially in those receiving concomitant β-adrenergic blocking agents.^{1 2 18}

β-Blocker Withdrawal

Taper dosage of β-adrenergic blocking agent, preferably over 8–10 days before initiation of nicardipine.^{1 2 18} Nicardipine is not a β-adrenergic blocking agent and offers no protection against abrupt withdrawal of these agents.^{1 2 18}

General Precautions

Hypotension

Possible symptomatic hypotension from decreased peripheral resistance.^{1 2 18} Use with caution in patients with acute cerebral infarction or hemorrhage; avoid systemic hypotension in these patients.^{1 2 18}

Monitor BP carefully, especially during initiation of therapy or upward adjustment of dosage.¹

Pheochromocytoma

Limited clinical experience in patients with hypertension associated with pheochromocytoma.¹⁸ Use with caution.¹⁸

Specific Populations

Pregnancy

Category C.^{1 2 18}

Lactation

Distributed into milk in high concentrations in rats.^{1 2 18} Use not recommended.^{1 2 18}

Pediatric Use

Safety and efficacy not established in children <18 years of age.^{1 2 18}

Use with caution for rapid reduction of BP in pediatric patients 1–17 years of age†; may cause reflex tachycardia.⁹⁹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^{a b} Select dosage with caution; initiate dosage at lower end of recommended range.^{a b}

Hepatic Impairment

Use with caution in patients with hepatic impairment or reduced hepatic blood flow; dosage adjustments recommended.^{1 2 18 24} (See Hepatic Impairment under Dosage and Administration.)

Use of extended-release capsules has not been studied in patients with severe hepatic impairment.²

Renal Impairment

Use with caution; careful dosage titration recommended.^{1 2 18} (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

With oral therapy, pedal edema, dizziness, headache, asthenia, flushing, increased angina, vasodilation, palpitation.^{a b}

With IV therapy, headache, hypotension, nausea/vomiting, tachycardia.^c

Interactions for Nicardipine

Specific Drugs

Drug	Interaction	Comments
Antacids (magnesium hydroxide)	Pharmacokinetic interaction unlikely1 2 18
β-Adrenergic blockers (e.g., propranolol)	Pharmacokinetic interaction (e.g., effect on plasma protein binding of nicardipine) unlikely1 2 18
Cimetidine	Increased plasma nicardipine concentrations1 2 18	Monitor carefully1 2 18
Cyclosporine	Increased plasma cyclosporine concentrations1 2 18	Monitor plasma cyclosporine concentrations closely and adjust dosage accordingly1 2 18
Digoxin	Potential for increased plasma digoxin concentrations1 2 18	Monitor serum digoxin concentrations1 2 18
Dipyridamole	No effect on plasma protein binding of nicardipine1 2 18
Fentanyl	Potential for severe hypotension with concomitant use of a β-adrenergic blocker and a calcium channel blocker1 2 18	Increase circulating fluid volume if hypotension occurs1 2 18
Furosemide	No effect on plasma protein binding of nicardipine1 2 18
Naproxen	No effect on plasma protein binding of nicardipine1 2 18
Quinidine	No effect on plasma protein binding of nicardipine1 2 18
Warfarin	No effect on plasma protein binding of nicardipine1 2 18

Nicardipine Pharmacokinetics

Absorption

Bioavailability

Completely absorbed from the GI tract following oral administration; peak plasma concentrations of conventional and extended-release capsules are attained within 0.5–2 and 1–4 hours, respectively.^{1 2}

Minimum plasma levels of equivalent doses of conventional and extended-release capsules are similar.²

Bioavailability of conventional capsules is about 35%;^{1 2} extended-release capsules have a slightly lower bioavailability, except at the highest doses.²

Food

High-fat meal decreases bioavailability of conventional and extended-release capsules.^{1 2}

Special Populations

In patients with severe hepatic impairment, peak plasma concentrations and AUC increased by 1.8 and 4-fold, respectively, and terminal half-life prolonged to 19 hours.^{1 2}

In patients with moderate renal impairment, peak plasma concentrations and AUC increased by 2- to 3-fold following administration of conventional or extended-release capsules.^{1 2}

Distribution

Extent

Distributed into milk in rats.^{1 2}

Plasma Protein Binding

>95%.^{1 2 18}

Elimination

Metabolism

Extensively metabolized in the liver.^{1 2 18}

Elimination Route

Excreted in urine (49–60%) and feces (35–43%).^{1 2 18}

Half-life

Multi-phasic; terminal elimination half-life is 8.6 and 14.4 hours following oral and IV administration, respectively.^{1 2 18}

Stability

Storage

Oral

Conventional Capsules and Extended-release Capsules

Light resistant containers at 15–30°C.^{a b}

Parenteral

Injection

20–25°C; protect from light.^c Avoid exposure to increased temperatures.^c

Compatibility

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

Parenteral

Solution Compatibility^HID

Compatible
Dextrose 5% in sodium chloride 0.45% or 0.9%
Dextrose 5% in water with potassium chloride 0.3%
Sodium chloride 0.9%
Incompatible
Sodium bicarbonate 5%
Variable
Dextrose 5% in Ringer’s injection, lactated
Dextrose 5% in water
Ringer’s injection, lactated
Sodium chloride 0.45%

Drug Compatibility^HID

Admixture Compatibility

Compatible
Potassium chloride 40 mEq

Y-Site CompatibilityHID

Compatible
Amikacin sulfate
Aminophylline
Aztreonam
Butorphanol tartrate
Calcium gluconate
Cefazolin sodium
Ceftizoxime sodium
Chloramphenicol sodium succinate
Cimetidine HCl
Clindamycin phosphate
Co-trimoxazole
Dextran 40 in dextrose 5%
Diltiazem HCl
Dobutamine HCl
Dopamine HCl
Enalaprilat
Epinephrine HCl
Erythromycin lactobionate
Esmolol HCl
Famotidine
Fenoldopam mesylate
Fentanyl citrate
Gentamicin sulfate
Hetastarch in sodium chloride 0.9%
Hydrocortisone sodium succinate
Hydromorphone HCl
Labetalol HCl
Lidocaine HCl
Linezolid
Lorazepam
Magnesium sulfate
Methylprednisolone sodium succinate
Metronidazole
Midazolam HCl
Milrinone lactate
Morphine sulfate
Nafcillin sodium
Nitroglycerin
Norepinephrine bitartrate
Normosol R
Penicillin G potassium
Plasma-Lyte A
Potassium chloride
Potassium phosphates
Ranitidine HCl
Sodium acetate
Sodium nitroprusside
Tobramycin sulfate
Vancomycin HCl
Vecuronium bromide
Incompatible
Ampicillin sodium
Ampicillin sodium-sulbactam sodium
Cefepime HCI
Furosemide
Lansoprazole
Thiopental sodium
Variable
Ceftazidime
Heparin sodium

ActionsActions

• 
  

  Inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium calcium concentrations.^{a b c}

  
  


• 
  

  Peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance (afterload) and BP.^{a b c}

  
  

Advice to Patients

• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{1 2 18}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 2 18}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 2 18} (See Cautions.)

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Nicardipine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	20 mg*	Cardene	Roche
			Nicardipine Hydrochloride	Mylan, IVAX, Par, Teva
		30 mg*	Cardene	Roche
			Nicardipine Hydrochloride	Mylan, IVAX, Par, Teva
	Capsules, extended-release	30 mg	Cardene SR	Roche
		45 mg	Cardene SR	Roche
		60 mg	Cardene SR	Roche
Parenteral	For injection, concentrate, for IV infusion	2.5 mg/mL	Cardene I.V. (with sorbitol)	PDL Biopharma

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cardene 20MG Capsules (ROCHE): 90/$69.99 or 270/$189.96

Cardene 30MG Capsules (ROCHE): 90/$99.99 or 270/$282.96

Cardene SR 30MG 12-hr Capsules (EKR THERAPEUTICS): 60/$105.99 or 180/$305.98

Cardene SR 45MG 12-hr Capsules (EKR THERAPEUTICS): 60/$169.98 or 180/$499.97

NiCARdipine HCl 20MG Capsules (MYLAN): 90/$45.99 or 270/$120.97

NiCARdipine HCl 30MG Capsules (TEVA PHARMACEUTICALS USA): 90/$32.99 or 270/$81.96

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 August 2007. 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.

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