Prostin E2 Vaginal Gel 1 mg and 2 mg

Prostin E2 Vaginal Gel 1 mg/ 2 mg

Dinoprostone

Pharmacia Logo

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, midwife or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, midwife or pharmacist.

In this leaflet:

• 1. What Prostin E2 Vaginal gel is and what it is used for


• 2. Before you are given Prostin E2 Vaginal gel


• 3. How Prostin E2 Vaginal gel is given to you


• 4. Possible side effects


• 5. How to store Prostin E2 Vaginal gel


• 6. Further information

What Prostin E2 Vaginal Gel is and what it is used for

Prostin E2 Vaginal Gel contain the prostaglandin dinoprostone and is used to "induce" labour. This means that the medicine will help your uterus (womb) to start contracting and you will go into labour. Dinoprostone is similar to the natural ‘E2’, type of prostaglandins which are made in your body when labour starts. Your doctor would have satisfied himself/herself that there are no conditions making the induction unsafe. It will only be given to you in a hospital or clinic which has an obstetric and maternity unit.

Before you are given Prostin E2 Vaginal Gel

Most women can be treated with Prostin E2 Vaginal Gel. Some women may need extra checks during treatment and for some women a different treatment may be better. Your doctor or midwife will ask you questions before giving you Prostin E2 Vaginal Gel to make sure it is safe for you. If you do not understand any of the questions, ask your doctor or midwife to explain.

Do not use Prostin E2 Vaginal gel:

• If you have had an allergic reaction (e.g.wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin) to dinoprostone or any other prostaglandin or any of the other ingredients in the gel, which are listed in Section 6 below.

Your doctor or midwife will not use Prostin E2 to start or strengthen your labour in certain circumstances if:

• you have heart, lung, kidney or liver disease


• you have had a Caesarean section or any major surgery to your womb.


• the size of your baby’s head means there may be a problem with the delivery.


• there has been or there is suspected fetal distress (your baby is short of oxygen).


• you had a difficult labour or traumatic delivery in a previous pregnancy.


• you have already had six or more full-term pregnancies.


• your waters have broken.


• you have a past history or existing infection of your womb, ovaries or tubes (pelvic inflammatory disease) unless you are receiving treatment for these, or if you have ever had such an infection in the past.


• you have been told that you have or might have placenta praevia (where the placenta lies across the entrance to the womb, rather than being high up and out of the way during birth). This causes bleeding from the vagina during pregnancy and may require that your baby is delivered by Caesarean section.


• during your pregnancy you have had bleeding from the vagina and the cause of the bleeding is not known.


• your baby is not lying with his or her head down.

Take special care with Prostin E2:

Tell your doctor or midwife if you have or have had in the past any of the following conditions as they may want to monitor you more closely.

• heart, lung, kidney or liver disease.


• glaucoma (raised pressure in the eye)


• epilepsy


• suffered from asthma


• hypertension (high blood pressure) at any time, including during this or any previous pregnancy


• been told you had abnormally strong contractions of your womb during a previous labour


• scarring of your womb from a previous operation

Your doctor or midwife will ask you questions before giving you Prostin E2 Vaginal Gel to make sure they are safe for you.

If you do not understand any of the questions, ask your doctor or midwife to explain.

Taking other medicines:

Prostin E2 Vaginal Gel can make you more sensitive to another medicine called oxytocin which is used to strengthen contractions. Medical staff will normally try not to use this medicine at the same time as Prostin E2 Vaginal gel. If you need this medicine, your doctor or midwife will make sure they are not given to you close together and will watch over the contractions very carefully.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Pregnancy

Prostin E2 Vaginal gel will only be given to you in the late stages of pregnancy to induce labour.

Breastfeeding

Although prostaglandins are present in breast milk they will not harm your baby and you may breastfeed as normal after delivery.

Driving and using machinery

No effect on your ability to drive or use machinery is expected after being given Prostin E2 Vaginal gel

How Prostin E2 Vaginal gel is given to you

Prostin E2 Vaginal Gel can only be used in a hospital or a clinic with a specialist obstetric unit. Before you are given this medicine, you will be examined by your doctor or midwife. They need to know the position of your baby’s head and how dilated (wide) your cervix (neck of the womb) is.

You will be given a numbered score after you have been examined. This is known as the Bishop score. The lower your Bishop score, the less ready you are to go into labour without any help. In this case, a higher dose of Prostin E2 Vaginal Gel is given.

Prostin E2 Vaginal Gel will be inserted into the posterior fornix (an area high up in your vagina) while you are lying down. You will then be asked to stay lying down for at least 30 minutes.

The usual dose is 1 mg. If you this is your first pregnancy and you have a low Bishop score, you will be given 2 mg.

Your doctor or midwife may decide to give you a second dose of gel if you do not start having contractions or if you are only having weak contractions. Because this treatment can take a long time to have an effect in some women, your doctor or midwife will not give you a second dose until they are sure that this is needed. You should not have a second dose for at least six hours and many doctors and midwives will wait much longer than this. This means that you could even have your second dose the following day. You should not be given more than 4 mg.

Your doctor or midwife should be keeping a very close eye on you during your treatment. They should be able to act quickly if you have side-effects or if your womb reacts too strongly to the dose you are given.

Your doctor or midwife will do internal checks to make sure that your cervix is opening enough. They will also check your contractions (to make sure that they are not too strong) and your baby (to make sure he or she does not get distressed).

Possible side effects

Like all medicines Prostin E2 Vaginal gel can cause side effects, although not everybody gets them.

If you have asthma, Prostin E2 Vaginal gel could cause you to have an asthmatic attack. You must tell your doctor or midwife if you suffer from asthma or if you have difficulty breathing.

Rare side effects

Rare but serious side effects which can sometimes happen include the following:

• tearing or bursting of the wall of your womb (uterine rupture)


• heart attack


• allergic reactions (symptoms may include wheezing, breathlessness, swelling of the hands, face, itchy rash or redness of the skin).

If you get any of these symptoms please tell your doctor or midwife straight away.

Common side effects

• vomiting (being sick)


• nausea (feeling sick)


• diarrhoea.

These have seldom been bad enough for the woman to stop the treatment.

Other side effects

As prostaglandins make the body go into labour in the same way as it would happen naturally, anything that can happen in a natural labour can also happen if you have been given Prostin E2 Gel. Talk to your midwife or doctor about this if you want to know more, as they will be able to give you the information that you need.

• sudden blockage of a blood vessel with amniotic fluid (the fluid which surrounds the baby) or by a blood clot in the lungs. This could cause chest pain and shortness of breath.


• placenta becoming detached


• stillbirth or death of the newborn baby


• abnormally strong, frequent or long contractions of the womb, slowing or quickening of the baby’s heart rate and distress in the baby


• itching, soreness or rash of the vaginal area


• high blood pressure in the mother


• very quick opening of the cervix


• running a high temperature


• backache


• rash


• baby born with an Apgar score lower than seven. (The Apgar score, which is measured on a scale of one to ten, is used to describe the baby’s condition at birth. A low Apgar Score means that the baby’s heart or lungs are not working properly.)

Studies have shown proliferation (thickening) of bone in new-born infants who have been treated with prostaglandins for a long time. There is no evidence that this occurs following short-term treatment with Prostin E2 Vaginal Gel.

If you think you may be having any of the above side effects, or you are worried about anything unusual happening during your labour, please tell your doctor or midwife.

How to store Prostin E2 Vaginal gel

The medicine will be kept out of the reach and sight of children.

Prostin E2 Vaginal gel will not be given to you after the expiry date. The expiry date refers to the last day of that month.

Your hospital pharmacist will store this medicine in a refrigerator at 2 to 8 °C before use.

Further information

What Prostin E2 Vaginal Gel contains:

The active substance is called dinoprostone.

The other ingredients are Triacetin and colloidal silicon dioxide.

What Prostin E2 Vaginal gel looks like and contents of the pack

Prostin E2 Vaginal gel is packed in syringes that contain 1 mg or 2 mg of dinoprostone in 3 grams of gel. Each pack contains one pre-filled syringe and the syringes are for single use only.

Marketing Authorisation Holder:

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UK

Manufacturer:

Pfizer Manufacturing Belgium NV

Rijksweg 12

B-2870 Puurs

Belgium

For further information on this medicine, please contact Pfizer Medical Information on: 01304 616161.

This leaflet was last updated in July2008.

Ref: PR 1_1

mycophenolate mofetil

mye-koe-FEN-oh-late MOE-fe-til

Oral route(Capsule;Tablet;Powder for Suspension)

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe, and they should have complete information requisite for the follow-up of the patient. Female contraception must be used due to increased risk of congenital malformations and pregnancy loss .

Commonly used brand name(s)

In the U.S.

• Cellcept

Available Dosage Forms:

• Powder for Suspension


• Capsule


• Tablet

Therapeutic Class: Immune Suppressant

Uses For mycophenolate mofetil

Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity in patients who receive organ transplants (e.g., kidney, heart, or liver).

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate prevents the white blood cells from rejecting the transplanted organ.

mycophenolate mofetil is available only with your doctor's prescription.

Before Using mycophenolate mofetil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mycophenolate mofetil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mycophenolate mofetil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate in children receiving kidney transplants. However, safety and efficacy have not been established in infants younger than 3 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of mycophenolate in children receiving heart or liver transplants. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mycophenolate in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving mycophenolate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking mycophenolate mofetil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using mycophenolate mofetil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Activated Charcoal


• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Azathioprine


• Bacillus of Calmette and Guerin Vaccine, Live


• Cholestyramine


• Colesevelam


• Colestipol


• Dexlansoprazole


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Esomeprazole


• Influenza Virus Vaccine, Live


• Lansoprazole


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Measles Virus Vaccine, Live


• Metronidazole


• Mumps Virus Vaccine, Live


• Norfloxacin


• Omeprazole


• Pantoprazole


• Poliovirus Vaccine, Live


• Rabeprazole


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using mycophenolate mofetil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ciprofloxacin


• Cyclosporine


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Iron


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Sevelamer


• Valacyclovir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of mycophenolate mofetil. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (e.g., neutropenia) or


• Stomach ulcers or bleeding—Use with caution. May make these conditions worse.

• Infection—May decrease your ability to fight an infection.

• Kelley-Seegmiller syndrome (rare genetic disease) or


• Lesch-Nyhan syndrome (rare genetic disease)—Should not be used in patients with these conditions.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The oral suspension contains aspartame (phenylalanine), which can make this condition worse.

Proper Use of mycophenolate mofetil

Take mycophenolate mofetil exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

mycophenolate mofetil should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take mycophenolate mofetil on an empty stomach, either one hour before or 2 hours after meals, unless your doctor tells you otherwise.

Mycophenolate capsules and tablets should be swallowed whole. Do not break, crush, open, or chew them.

It is important that you handle mycophenolate mofetil with care. Avoid inhaling the powder from the capsule or allowing the powder or the oral liquid to touch your skin or eyes. If the medicine gets on your skin, wash it thoroughly with soap and water. If the medicine gets in your eyes, wash them with plain water. Should a spill occur, wipe it up using paper towels wetted with water to remove the powder or liquid.

You should use the oral dispenser from the pharmacist to measure the correct amount of suspension. If you have any questions about this, ask your doctor or pharmacist.

Use only the brand of mycophenolate tablets that your doctor ordered. Different brands may not work the same way.

If you are also using antacids that contain aluminum or magnesium (such as Maalox® or Mylanta®), do not use them at the same time as mycophenolate. Use them 1 hour before or 2 hours after your dose. If you have questions, talk with your doctor about the best times to use your medicines.

Dosing

The dose of mycophenolate mofetil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of mycophenolate mofetil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, suspension, or tablets):
  
  • For heart transplants:
    
    • Adults—1.5 grams two times a day.
    
    
    • Older adults—1.5 grams two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For kidney transplants:
    
    • Adults—1 gram two times a day.
    
    
    • Older adults—1 gram two times a day.
    
    
    • Teenagers and children above 3 months of age—Dose is based on body size as determined by the doctor. The suspension dose is 600 milligrams (mg) per square meter [m(2)] two times a day. The capsules and tablets are given as 750 mg to 1 gram two times a day.
    
    
    • Infants younger than 3 months of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For liver transplants:
    
    • Adults—1.5 grams two times a day.
    
    
    • Older adults—1.5 grams two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of mycophenolate mofetil, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The oral suspension can also be kept in the refrigerator. Throw away any unused suspension after 60 days.

Precautions While Using mycophenolate mofetil

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using mycophenolate mofetil while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using mycophenolate mofetil to make sure you are not pregnant. Your birth control pills may not work as well while you are using mycophenolate mofetil. You must use two forms of birth control together for 1 month before starting mycophenolate mofetil, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of mycophenolate mofetil. Use birth control pills together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using mycophenolate mofetil may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

Mycophenolate can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

mycophenolate mofetil may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

mycophenolate mofetil may increase your risk of developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

While you are receiving mycophenolate, and after you stop, do not have any immunizations (vaccinations) without your doctor's approval. Mycophenolate will lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Do not stop taking mycophenolate mofetil without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take mycophenolate mofetil.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

mycophenolate mofetil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach cramps or pain


• black, tarry stools


• bladder pain


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• bloody or cloudy urine


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• confusion


• convulsions


• cough or hoarseness


• decreased urine


• difficult or labored breathing


• difficult, burning, or painful urination


• dizziness


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• drowsiness


• dry mouth


• fainting


• fast, slow, pounding, or irregular heartbeat or pulse


• fever or chills


• flushed, dry skin


• frequent urge to urinate


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• irregular heartbeats


• irregular pulse


• irritability


• lightheadedness


• loss of appetite


• lower back or side pain


• mood changes


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle pain or cramps


• muscle spasms (tetany) or twitching


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• rapid weight gain


• rapid, shallow breathing


• seizures


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stomach pain and bloating


• sweating


• swollen glands


• tightness in the chest


• tingling of the hands or feet


• trembling


• tremor


• troubled breathing


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• weakness or heaviness of the legs


• wheezing

Incidence not known

• Back pain


• bloating


• constipation


• convulsions


• coughing or spitting up blood


• darkened urine


• general feeling of illness


• indigestion


• night sweats


• pain


• pains in the stomach, side, or abdomen, possibly radiating to the back


• severe headache


• sudden high fever or low-grade fever for months


• tenderness


• watery or bloody diarrhea


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• fear or nervousness


• heartburn


• lack or loss of strength


• rash


• sleeplessness


• unable to sleep


• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: mycophenolate mofetil side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More mycophenolate mofetil resources

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

• Mycophenolate Mofetil Prescribing Information (FDA)


• Mycophenolate Mofetil MedFacts Consumer Leaflet (Wolters Kluwer)


• CellCept Prescribing Information (FDA)


• Cellcept Consumer Overview

Compare mycophenolate mofetil with other medications

• Autoimmune Hepatitis
• Bullous Pemphigoid
• Cogan's Syndrome
• Crohn's Disease
• Dermatomyositis
• Evan's Syndrome
• Graft-versus-host disease
• High Cholesterol
• Inflammatory Bowel Disease
• Multiple Sclerosis
• Myasthenia Gravis
• Nephrotic Syndrome
• Organ Transplant, Rejection Prophylaxis
• Pemphigoid
• Pemphigus
• Psoriatic Arthritis
• Pulmonary Fibrosis
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Ulcerative Colitis
• Uveitis

Nacon Sustained-Release Tablets

Pronunciation: KAR-bin-OX-a-meen/METH-skoe-POL-a-meen/SOO-doe-e-FED-rin
Generic Name: Carbinoxamine/Methscopolamine/Pseudoephedrine
Brand Name: Examples include Nacon and Pannaz

Nacon Sustained-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Nacon Sustained-Release Tablets are an antihistamine, decongestant, and anticholinergic combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Nacon Sustained-Release Tablets if:

• you are allergic to any ingredient in Nacon Sustained-Release Tablets


• you are pregnant or breast-feeding


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you have severe heart blood vessel disease; severe high blood pressure; narrow-angle glaucoma; severe bleeding; severe irritation of the esophagus or other serious problems with the esophagus (eg, esophageal achalasia); peptic ulcer; a blockage of your stomach, bowel, or bladder; bowel motility problems; severe bowel inflammation (eg, ulcerative colitis); certain muscle problems (eg, myasthenia gravis); or uncontrolled bleeding


• you are unable to urinate or are having an asthma attack

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

Before using Nacon Sustained-Release Tablets:

Some medical conditions may interact with Nacon Sustained-Release Tablets. 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 a history of diabetes, an enlarged prostate or other prostate problems, bladder or kidney problems, severe bowel problems, high blood pressure, diarrhea, asthma, nerve problems, heart problems, blood vessel problems, blood clots, trouble urinating, a hiatal hernia, an adrenal gland tumor, glaucoma, breathing problems during sleep, stroke, seizures, myasthenia gravis (muscle weakness), or an overactive thyroid

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

• Alpha-blockers (eg, guanethidine, methyldopa, prazosin), beta-blockers (eg, atenolol), diuretics (eg, furosemide, hydrochlorothiazide), furazolidone, or MAOIs (eg, phenelzine) because the risk of high or low blood pressure may be increased


• Alkalizers (eg, calcium or magnesium antacids), anticholinergics (eg, atropine, benztropine, dicyclomine), carbonic anhydrase inhibitors (eg, acetazolamide), ergotamine, sodium bicarbonate, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Nacon Sustained-Release Tablets's side effects


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, potassium chloride, or sodium oxybate (GHB) because the risk of their side effects may be increased by Nacon Sustained-Release Tablets


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Nacon Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nacon Sustained-Release Tablets 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 Nacon Sustained-Release Tablets:

Use Nacon Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Nacon Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Do not take Nacon Sustained-Release Tablets at the same time as an antacid, certain medicines for diarrhea (eg, attapulgite, bismuth, kaolin, pectin), or ketoconazole. Take these medicines 2 or 3 hours before or after taking Nacon Sustained-Release Tablets.


• Swallow Nacon Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Nacon Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of Nacon Sustained-Release Tablets 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 Nacon Sustained-Release Tablets.

Important safety information:

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


• If your symptoms do not get better within 7 days or if they get worse or you develop a high fever or persistent headache, check with your doctor.


• Nacon Sustained-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.


• Nacon Sustained-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Nacon Sustained-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Do not take diet or appetite control medicines while you are taking Nacon Sustained-Release Tablets without checking with your doctor.


• Nacon Sustained-Release Tablets has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Nacon Sustained-Release Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Nacon Sustained-Release Tablets for a few days before the tests.


• If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Nacon Sustained-Release Tablets.


• Nacon Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you are taking Nacon Sustained-Release Tablets.


• Tell your doctor or dentist that you take Nacon Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


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


• Use Nacon Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Nacon Sustained-Release Tablets in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: It is not known if Nacon Sustained-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nacon Sustained-Release Tablets while you are pregnant. Nacon Sustained-Release Tablets are found in breast milk. Do not breast-feed while taking Nacon Sustained-Release Tablets.

Possible side effects of Nacon Sustained-Release Tablets:

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; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe dizziness, light-headedness, or headache; tremor; vision changes.

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: Nacon 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 deep sleep or loss of consciousness; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing.

Proper storage of Nacon Sustained-Release Tablets:

Store Nacon Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nacon Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Nacon Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Nacon Sustained-Release Tablets 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 Nacon Sustained-Release Tablets. 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 Nacon resources

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

Compare Nacon with other medications

• Rhinitis

Physiolyte

Dosage Form: Irrigating Solution

Balanced Electrolyte Solution for Irrigation.

For All General Irrigation, Washing, and Rinsing Purposes.

Not for Injection by Usual Parenteral Route.

Physiolyte Description

Physiolyte is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing, and rinsing purposes.

Each 100 mL contains:

Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g

Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride

USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g

Water for Injection USP qs

Glacial Acetic Acid USP has been added to adjust the pH

pH: 6.8 (6.3–7.3)

Calculated Osmolarity: The solution is isotonic (295 mOsmol/liter)

Concentration of Electrolytes (mEq/liter): Sodium 140

Potassium 5; Magnesium 3; Chloride 98; Acetate (CH3COO−) 27

Gluconate (HOCH2(CHOH)4COO−) 23

It contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded.

Physiolyte may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle.

The formulas of the active ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Sodium Chloride USP	NaCl	58.44
Sodium Acetate Trihydrate USP	CH3COONa•3H2O	136.08
Potassium Chloride USP	KCl	74.55
Magnesium Chloride Hexahydrate USP	MgCl2•6H2O	203.30
Sodium Gluconate USP		218.14

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Physiolyte - Clinical Pharmacology

Physiolyte exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a vehicle for drugs used for irrigation or other pharmaceutical preparations.

Physiolyte provides an isotonic calcium-free balanced electrolyte irrigation with the same ionic composition as Isolyte® S (Multi-Electrolyte Solution) a multiple electrolyte solution for IV replacement of acute extracellular fluid losses.

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis, and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Magnesium, a principal cation of soft tissue, is primarily involved in enzyme activity associated with the metabolism of carbohydrates and protein. Magnesium is also involved in neuromuscular and cardiac conduction and irritability.

Gluconate and acetate are organic ions which are hydrogen ion acceptors and contribute bicarbonate during their metabolism to carbon dioxide and water, and serve as alkalinizing agents.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Physiolyte

Physiolyte® (A Physiological Irrigating Solution) is indicated for all general irrigation, washing, and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Contraindications

Physiolyte is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations.

Do not warm above 150°F (66°C).

After opening container, it's contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Precautions

General

Use aseptic technique when preparing and administering sterile irrigation solutions for irrigating body cavities, wounds and urethral catheters or for wetting dressings that come in contact with the body tissues.

Use only if solution is clear and container and seal are intact.

Do not use for irrigation that may result in absorption of large amounts into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.

When used as a "pour" irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the plastic irrigation container. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Physiolyte® (A Physiological Irrigating Solution) have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Physiolyte (A Physiological Irrigating Solution). It is also not known whether Physiolyte (A Physiological Irrigating Solution) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Physiolyte (A Physiological Irrigating Solution) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when Physiolyte is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Physiolyte in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use

Clinical studies of Physiolyte (A Physiological Irrigating Solution) have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Use in Patients with Renal Insufficiency/Failure

Clinical studies of Physiolyte (a Physiological Irrigation Solution) have not been performed to determine whether patients with renal failure respond differently from those with normal renal function. Given the potential for systemic absorption, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Increased caution should be exercised when administering Physiolyte to patients with impaired fluid and electrolyte homeostasis.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Physiolyte Dosage and Administration

As required for irrigation.

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a vehicle for other drugs, the directions of the additive's manufacturer should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

How is Physiolyte Supplied

Physiolyte® (A Physiological Irrigating Solution) is supplied sterile and nonpyrogenic in 1000 mL PIC™ (Plastic Irrigation Containers) packaged 16 per case.

NDC	Cat. No.	Size
Physiolyte (A Physiological Irrigating Solution)
0264-2205-00	R5510-01	1000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Rx only

Issued: July 2003

Physiolyte and Isolyte S are registered trademarks and PIC is a trademark of B. Braun Medical Inc.

Made in USA

Directions For Use of PIC Containers

Not for injection.

Aseptic technique is required.

1. Caution – Before use, perform the following checks:
   

   (a)

   
   

   Read the label. Ensure solution is the one ordered and is within the expiration date.

   
   

   (b)

   
   

   Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.

   
   

Use only if solution is clear and container and seal are intact.

Single unit container. Discard unused portion.

2.

Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.

3.

Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour.

4.

Do not warm above 150°F to assure minimal bottle distortion. Keep bottles upright.

B. Braun Medical Inc.

Irvine, CA USA 92614-5895

©2003 B. Braun Medical Inc.

Y36-002-478

Physiolyte  sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0264-2205 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Sodium Chloride (Sodium Chloride) Active 0.53 GRAM  In 100 MILLILITER Sodium Gluconate (Sodium Gluconate) Active 0.5 GRAM  In 100 MILLILITER Sodium Acetate (Sodium Acetate) Active 0.37 GRAM  In 100 MILLILITER Potassium Chloride (Potassium Chloride) Active 0.037 GRAM  In 100 MILLILITER Magnesium Chloride (Magnesium Chloride) Active 0.03 GRAM  In 100 MILLILITER Water Inactive   Glacial Acetic Acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0264-2205-00 16 CONTAINER In 1 CASE contains a CONTAINER 1 1000 mL (MILLILITER) In 1 CONTAINER This package is contained within the CASE (0264-2205-00)

Revised: 10/2008B. Braun Medical Inc.

More Physiolyte resources

• Physiolyte Side Effects (in more detail)
• Physiolyte Dosage
• Physiolyte Support Group
• 0 Reviews · Be the first to review/rate this drug

Lotrisone Cream

Pronunciation: kloe-TRIM-a-zole/BAY-ta-METH-a-sone
Generic Name: Clotrimazole/Betamethasone
Brand Name: Lotrisone

Lotrisone Cream is used for:

Treating certain fungal skin infections, including ringworm, athlete's foot, and jock itch. It also relieves redness, swelling, and itching associated with infection.

Lotrisone Cream is an antifungal and corticosteroid combination. It works by weakening the cell membrane of certain fungi. It also acts as an anti-inflammatory and anti-itching agent.

Do NOT use Lotrisone Cream if:

• you are allergic to any ingredient in Lotrisone Cream


• you are taking pimozide or an ergot alkaloid (eg, ergotamine)

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

Before using Lotrisone Cream:

Some medical conditions may interact with Lotrisone Cream. 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 or other substances


• if you have diaper rash, eczema, measles, tuberculosis (TB) or a positive TB skin test, chickenpox, shingles, or thinning of the skin


• if you have recently received a vaccination

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

• Clarithromycin because the risk of certain side effects may be increased


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Lotrisone Cream's effectiveness


• Ergot alkaloids (eg, ergotamine), imatinib, live vaccines, macrolide immunosuppressants (eg, tacrolimus), pimozide, or ritodrine because their actions and the risk of their side effects may be increased by Lotrisone Cream


• Hydantoins (eg, phenytoin) or interleukin-2 because their effectiveness may be decreased by Lotrisone Cream

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

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

• Wash your hands before and after applying Lotrisone Cream.


• Wash and completely dry the affected area.


• Gently rub the medicine into the affected and surrounding areas until it is evenly distributed.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• If you are using Lotrisone Cream in the groin area, use only for 2 weeks and apply the cream sparingly. Wear loose-fitting clothing. Notify your doctor if your condition persists after 2 weeks.


• Use Lotrisone Cream on a regular schedule to get the most benefit from it.


• To clear up your infection completely, use Lotrisone Cream for the full course of treatment. Keep using it even if you feel better in a few days.


• Notify your doctor if there is no improvement of your symptoms after 1 week of treatment on the groin or body or after 2 weeks of treatment on the feet.


• If you miss a dose of Lotrisone Cream, 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.

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

Important safety information:

• Lotrisone Cream has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Lotrisone Cream is for external use only. Avoid getting Lotrisone Cream in the eyes, vagina, mouth, or nose. If Lotrisone Cream gets in the eyes, immediately wash out with cool tap water.


• Be sure to use Lotrisone Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not apply Lotrisone Cream over large areas of the body without first checking with your doctor.


• Do not use Lotrisone Cream for other skin conditions at a later time.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Do not use Lotrisone Cream for diaper rash.


• Serious side effects may occur if too much of Lotrisone Cream is absorbed through the skin. This may be more likely to occur if you use Lotrisone Cream over a large area of the body. It may also be more likely if you wrap or bandage the area after you apply Lotrisone Cream. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.


• Use Lotrisone Cream with caution in the ELDERLY; they may be more sensitive to its effects, especially thinning skin.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while using a corticosteroid.


• Lotrisone Cream should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these 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 Lotrisone Cream while you are pregnant. It is not known if Lotrisone Cream is found in breast milk. If you are or will be breast-feeding while you use Lotrisone Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lotrisone Cream:

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:

Dry skin; mild burning or stinging at the application site.

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); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; irritation, itching, peeling, redness, blistering, swelling, oozing, or severe burning at the application site; spider veins; thinning, softening, or discoloration of the skin; unusual bruising.

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: Lotrisone 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. Lotrisone Cream may be harmful if swallowed.

Proper storage of Lotrisone Cream:

Store Lotrisone Cream 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 Lotrisone Cream out of the reach of children and pets.

General information:

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


• Lotrisone Cream 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 summary only. It does not contain all information about Lotrisone Cream. 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 Lotrisone resources

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

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• Tinea Corporis
• Tinea Cruris
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Engerix-B

Pronunciation: hep-ah-TY-tiss
Generic Name: Hepatitis B Vaccine (Recombinant)
Brand Name: Examples include Engerix-B and Recombivax HB

Engerix-B is used for:

Preventing hepatitis B infection.

Engerix-B is a vaccine. It works by stimulating the body to produce antibodies against hepatitis B infection.

Do NOT use Engerix-B if:

• you are allergic to any ingredient in Engerix-B, including yeast


• you have had an allergic reaction to a hepatitis B vaccine in the past

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

Before using Engerix-B:

Tell your health care provider 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 latex


• if you have a weakened immune system, heart or lung disease, a fever, an infection, an illness, a tumor, or multiple sclerosis


• if you are on dialysis, you have or might have been recently exposed to hepatitis B, or if you have traveled to areas that are high-risk for hepatitis B


• if the patient is a premature infant

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

• Immunosuppressive therapy (eg, cyclosporine) because it may decrease Engerix-B's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Engerix-B 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 Engerix-B:

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

• Engerix-B is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.


• If you miss a dose of Engerix-B, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Engerix-B.

Important safety information:

• Engerix-B has noninfectious hepatitis B antigens in it. It cannot cause you to develop the hepatitis B infection.


• Before receiving this vaccine, tell your doctor about any illnesses you may have or if you are sick.


• For Engerix-B to be effective, you must complete all doses. It is best to begin the vaccinations 6 months before travel, if possible, if that is the reason for receiving the vaccination.


• Contact your doctor at once if you are exposed to the virus through blood, a human bite, or sexual contact.


• The length of protection against the virus from Engerix-B is not known, nor is it a guarantee that the vaccine will protect you from the hepatitis B virus.


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

Possible side effects of Engerix-B:

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; dizziness; fatigue; general feeling of discomfort; headache; irritability; loss of appetite; mild fever or sore throat; nausea; pain, swelling, or redness at the injection site; runny nose; tiredness; weakness.

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); fainting; fast or irregular heartbeat; red, swollen, blistered, or peeling skin; severe or persistent dizziness; unusual bruising or bleeding.

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: Engerix-B 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.

Proper storage of Engerix-B:

Engerix-B is usually handled and stored by a health care provider. If you are using Engerix-B at home, store Engerix-B as directed by your pharmacist or health care provider. Keep Engerix-B out of the reach of children and away from pets.

General information:

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


• Engerix-B 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 Engerix-B. 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 Engerix-B resources

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

• Engerix-B Advanced Consumer (Micromedex) - Includes Dosage Information


• Engerix-B Consumer Overview

Compare Engerix-B with other medications

• Hepatitis B Prevention

Abbreviation List

Class: Front Matter

Abbreviations

AAP	American Academy of Pediatrics
ACC	American College of Cardiology
ACE	angiotensin-converting enzyme
ACLS	advanced cardiovascular life support
ACOG	American Congress of Obstetricians and Gynecologists
AHA	American Heart Association
ALT	alanine aminotransferase
ANC	absolute neutrophil count
aPTT	activated partial thromboplastin time
ARDS	acute respiratory distress syndrome
ASBMT	American Society of Bone Marrow Transplantation
ASCO	American Society of Clinical Oncology
AST	aspartate aminotransferase
ATS	American Thoracic Society
AUC	area under the serum concentration-time curve
AV	atrioventricular
BP	blood pressure
bpm	beats per minute
BUN	blood urea nitrogen
CABG	coronary artery bypass grafting
CAD	coronary artery disease
CAPD	continuous ambulatory peritoneal dialysis
CBC	complete blood count
CDC	US Centers for Disease Control and Prevention
CHD	coronary heart disease
CHF	congestive heart failure
CK	creatine kinase
Clcr	creatinine clearance
CNS	central nervous system
COX-1	cyclooxygenase-1
COPD	chronic obstructive pulmonary disease
CPK	creatine phosphokinase
CPR	cardiopulmonary resuscitation
CSF	cerebrospinal fluid
CYP	cytochrome P-450
DBP	diastolic blood pressure
DVT	deep-vein thrombosis
ECG	electrocardiogram
FDA	US Food and Drug Administration
FEV1	forced expiratory volume in 1 second
FSH	follicle-stimulating hormone
GABA	γ-amino butyric acid
GERD	gastroesophageal reflux disease
GFR	glomerular filtration rate
GI	gastrointestinal
GU	genitourinary
HBV	hepatitis B virus
HCTZ	hydrochlorothiazide
HCV	hepatitis C virus
HDL	high-density lipoprotein
HIV	human immunodeficiency virus
IDSA	Infectious Diseases Society of America
IgE	immune globulin E
IgG	immune globulin G
IgM	immune globulin M
IM	intramuscular
INR	international normalized rate
IOP	intraocular pressure
IV	intravenous
JNC 7	Joint National Committee on the Prevention, Detection, and Treatment of Hypertension
LDH	lactate dehydrogenase
LDL	low-density lipoprotein
LH	luteinizing hormone
MAO	monoamine oxidase
MI	myocardial infarction
MIC	minimum inhibitory concentration
NIH	National Institutes of Health
NSAIA	nonsteroidal anti-inflammatory agents
NYHA	New York Heart Association
OTC	over-the-counter or nonprescription
PCI	percutaneous coronary intervention
PE	pulmonary embolism
PSA	prostate-specific antigen
PT	prothrombin time
PTT	partial thromboplastin time
PVC	polyvinyl chloride
RBC	red blood cell
SA	sinoatrial
SBP	systolic blood pressure
Scr	serum creatinine concentration
SIADH	syndrome of inappropriate antidiuretic hormone secretion
SNRI	selective serotonin- and norepinephrine-reuptake inhibitor
SSRI	selective serotonin-reuptake inhibitor
Sub-Q	subcutaneous
TIA	transient ischemic attack
TSH	thyrotropin, thyroid-stimulating hormone
UGT	uridine diphosphate-glucuronosyltransferase
ULN	upper limit of normal
USPHS	US Public Health Service
VLDL	very low density lipoprotein
VF	ventricular fibrillation
VPCs	ventricular premature complexes
VT	ventricular tachycardia
WBC	white blood cell
WHO	World Health Organization

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 September 01, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.