entecavir

en-TEK-a-vir

Oral route(Tablet;Solution)

Severe acute exacerbations of hepatitis B have been reported upon discontinuation of anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months in patients who discontinue therapy and reinitiation of anti-hepatitis B therapy may be warranted. Entecavir is not recommended in HIV/HBV co-infected patients not treated with highly active antiretroviral therapy because there is potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues .

Commonly used brand name(s)

In the U.S.

• Baraclude

Available Dosage Forms:

• Solution


• Tablet

Therapeutic Class: Antiviral

Chemical Class: Guanosine Nucleoside Analog

Uses For entecavir

Entecavir belongs to the family of medicines called antivirals. Antivirals are used to treat infections that are caused by viruses. Entecavir is used to treat the liver infection caused by hepatitis B virus. entecavir will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage.

entecavir is available only with your doctor's prescription.

Before Using entecavir

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 entecavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to entecavir 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 have not been performed on the relationship of age to the effects of entecavir in children and teenagers younger than 16 years of age. 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 entecavir in the elderly. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving entecavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

• Liver disease—May increase chance for serious side effects.

Proper Use of entecavir

Take entecavir exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. When your supply of entecavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of entecavir. Also, do not stop taking entecavir without checking with your doctor first.

Take entecavir on an empty stomach (at least two hours after a meal and two hours before the next meal).

Read and follow carefully the patient information leaflet before starting entecavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.

Measure the oral solution correctly using the marked measuring spoon that comes with the package. Rinse the dosing spoon with water after each use.

Dosing

The dose of entecavir 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 entecavir. 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 chronic hepatitis B infection:
  
  • For oral dosage form (solution or tablets):
    
    • Adults and teenagers above 16 years of age—0.5 to 1 milligram (mg) or 10 to 20 milliliters (mL) once per day.
    
    
    • Children and teenagers below 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of entecavir, 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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Do not throw any unused medicine in the trash. Flush it down the toilet or take it to a community take-back program when available.

Precautions While Using entecavir

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking entecavir.

If you have or get HIV (human immunodeficiency virus) infection, be sure to discuss your treatment with your doctor. If you are taking entecavir to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. Your doctor may need you to get an HIV test before you start taking entecavir and anytime after that when there is a chance you were exposed to HIV. entecavir will not help your HIV infection.

Two rare but serious reactions to entecavir are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child feel tired, weak, dizzy, or nauseated, if you vomit or have stomach pain, dark urine, light-colored stools, unusual muscle pains, or trouble with breathing, or if your skin or eyes turn yellow.

Liver disease may become worse if treatment with entecavir is stopped. Do not stop taking entecavir unless your doctor tells you to stop.

Treatment with entecavir has not been shown to decrease the chance of giving hepatitis B virus infection to other people through sexual contact or blood contamination.

entecavir 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:

Incidence not known

• Abdominal or stomach discomfort


• decreased appetite


• diarrhea


• fast, shallow breathing


• general feeling of discomfort


• muscle pain or cramping


• nausea


• rash


• right upper abdominal or stomach pain and fullness


• shortness of breath


• sleepiness


• unusual tiredness or weakness

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:

Less common

• Headache

Rare

• Acid or sour stomach


• belching


• dizziness


• heartburn


• indigestion


• sleepiness or unusual drowsiness


• sleeplessness


• stomach discomfort, upset, or pain


• trouble sleeping


• vomiting

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: entecavir 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 entecavir resources

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

• Entecavir Professional Patient Advice (Wolters Kluwer)


• Entecavir Monograph (AHFS DI)


• Entecavir MedFacts Consumer Leaflet (Wolters Kluwer)


• Baraclude Prescribing Information (FDA)


• Baraclude Consumer Overview

Compare entecavir with other medications

• Hepatitis B

Domperidone 1mg / ml Suspension

DOMPERIDONE 1MG/ML ORAL SUSPENSION

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 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.

In this leaflet:

• 1. What domperidone is and what it is used for


• 2. Before you take domperidone


• 3. How to take domperidone


• 4. Possible side effects


• 5. How to store domperidone


• 6. Further information

What Domperidone Is And What It Is Used For

The name of your medicine is Domperidone 1mg/ml Oral Suspension (called domperidone in this leaflet). The active ingredient in this medicine is called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’.

Domperidone works by helping to move food faster through your food pipe (oesophagus), stomach and gut. This is so that it does not stay in the same place for too long. It also helps stop food flowing the wrong way back up your food pipe.

Domperidone can be used for the following:

Adults

• To stop or prevent you feeling sick (nausea) or being sick (vomiting).


• To stop or prevent the feeling of fullness during or shortly after a meal.


• To treat stomach discomfort, or heartburn caused by the flow of the stomach contents back into your food pipe.

Children

• To stop or prevent children feeling sick (nausea) or being sick (vomiting).

Before You Take Domperidone

Do not take Domperidone if:

• You are allergic (hypersensitive) to domperidone or any of the other ingredients of Domperidone 1mg/ml Oral Suspension (listed in section 6: Further information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.


• You have a tumour of the pituitary gland (prolactinoma).


• You have a blockage or tear in your intestines.


• You have black, tarry bowel motions (stools) or notice blood in your bowel motions. This could be a sign of bleeding in the stomach or intestines.

Do not take domperidone if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking domperidone.

Take special care with domperidone and check with your doctor or pharmacist before taking this medicine if:

• You have any kidney problems. If you take domperidone over a long period, your doctor may want to lower the amount you use.
  This will depend on how severe your kidney problems are.


• You have liver problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking domperidone. Do this even if they have applied in the past.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you can buy without a prescription, including herbal medicines. This is because domperidone can affect the way some other medicines work. Also, some medicines can affect the way domperidone works.

In particular, tell your doctor if you are taking any of the following:

• Ketoconazole tablets or liquid for fungal infections.


• Antibiotics for infections (such as erythromycin).


• Medicines for HIV (such as ritonavir).

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before taking domperidone if:

• You are pregnant, might become pregnant or think you may be pregnant.


• You are breast-feeding. It is best not to take domperidone if you are breast-feeding. This is because small amounts may pass into the mother’s milk.

Driving and using machines:

You may feel sleepy, confused or have less control over your movements while taking domperidone. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Domperidone Oral Suspension:

This medicine contains sorbitol. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking domperidone.

How To Take Domperidone

Always take Domperidone Oral Suspension exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth.


• Take your medicine using the plastic measuring cup provided with Domperidone Oral Suspension.


• This cup is marked in ml (millilitres) to help you measure out the correct amount of this medicine.


• Take your medicine 15 to 30 minutes before a meal and, if needed, before you go to bed.

The usual dose is:

• 
  Adults and teenagers (over 12 years of age and who weigh more than 35kg)
  Take 10ml to 20ml of the suspension, three or four times each day.
  Do not take more than 80ml of Domperidone Oral Suspension a day.


• 
  Babies and children
  
  Your doctor will work out the dose. This will depend on the weight of your child. Do not give your child any more than 80 ml of Domperidone Oral Suspension a day.

People with kidney problems

Your doctor may tell you to take a lower dose or to take the medicine less often.

How long can I take this medicine for?

Your doctor will decide how long you will need to take this medicine.

If you take domperidone for more than 4 weeks your doctor may wish to see you again. This is to check if you need to keep taking the treatment.

If you take more domperidone than you should:

• If you have taken more domperidone than you should, talk to a doctor or go to the nearest hospital casualty department straight away. Take the carton and bottle containing any remaining medicine with you. This is so the doctors know what you have taken.


• The signs of taking more than you should include feeling sleepy, confused, uncontrolled movements (especially in children) which include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted neck).

If you forget to take domperidone:

• If you forget to take domperidone, take it as soon as you remember.


• However if it is time for the next dose, skip the missed dose.


• Do not take a double dose to make up for a forgotten dose.

Possible Side Effects

Like all medicines, domperidone can have side effects, although not everybody gets them.

Stop taking domperidone and see your doctor or go to a hospital straightaway if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to domperidone.


• You notice any uncontrolled movements. These include irregular eye movements, unusual movements of the tongue, and abnormal posture such as a twisted neck, trembling and muscle stiffness. This is more likely to happen in children. These symptoms should stop once you stop taking domperidone.

Other side effects include:

Rare (affects less than 1 in 1,000 people)

• Unusual production of breast milk in men and women.


• Breast enlargement in men.


• Lowering of sexual drive (libido) in men.


• In women, menstrual periods may be irregular or stop.

Very rare (affects less than 1 in 10,000 people)

• Mild stomach cramps.


• An itchy, lumpy rash.

Talk to your doctor or pharmacist if any of the side effects get serious or last longer than a few days, or if you notice any side effects not listed in this leaflet.

How To Store Domperidone

• Keep out of the reach and sight of children.


• Do not take Domperidone Oral Suspension after the expiry date stated on the pack.


• Ask your pharmacist how to dispose of medicines you no longer need. Do not dispose of medicines by flushing down a toilet or sink, or by throwing them out with your normal household rubbish. This will help to protect the environment.

Further Information

What Domperidone 1mg/ml Oral Suspension contains

Domperidone 1mg/ml Oral Suspension contains domperidone (the active ingredient). It also contains sorbitol, microcrystalline cellulose and carmellose sodium, methylhydroxybenzoate, propylhydroxybenzoate, sodium saccharin, polysorbate 20, sodium hydroxide and water.

What Domperidone 1mg/ml Oral Suspension looks like and contents of the pack

Each pack contains a 200 millilitre bottle of a white coloured liquid suspension.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

Winthrop Pharmaceuticals

PO Box 611

GU1 4YS

UK

Manufacturer is:

Sofarimex - Industria Quimica e Farmacêutica Lda

Av. das Industrias - Alto do Colaride

Agualva 2735-213 Cacém

Portugal

This leaflet was last revised in: September 2008

‘Winthrop’ is a registered trademark. ©2008 Winthrop Pharmaceuticals.

2020635.06

collagenase clostridium histolyticum Injection

KOL-a-jen-ase klos-TRID-ee-um his-toe-LIT-ik-um

Commonly used brand name(s)

In the U.S.

• Xiaflex

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Collagenase

Uses For collagenase clostridium histolyticum

Collagenase clostridium histolyticum injection is used to treat Dupuytren's contracture with a palpable cord in adults.

collagenase clostridium histolyticum is to be administered only by or under the supervision of your doctor.

Before Using collagenase clostridium histolyticum

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 collagenase clostridium histolyticum, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to collagenase clostridium histolyticum 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 have not been performed on the relationship of age to the effects of collagenase clostridium histolyticum injection in the pediatric population. 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 collagenase clostridium histolyticum injection in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 collagenase clostridium histolyticum. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting disorders—Use with caution. May make these conditions worse.

Proper Use of collagenase clostridium histolyticum

A nurse or other trained health professional will give you collagenase clostridium histolyticum in a hospital. collagenase clostridium histolyticum is given through a needle placed into the cord of the contracture of your hand.

Precautions While Using collagenase clostridium histolyticum

It is very important that you return to your doctor the next day. This will allow your doctor to see the injected hand, and to do a possible finger extension procedure to disrupt the cord.

collagenase clostridium histolyticum may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have itching, rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive collagenase clostridium histolyticum.

Using collagenase clostridium histolyticum may cause injury to the blood vessels, tendons, or ligaments of the hand. Tell your doctor right away if you have pain or numbness in your hand or arm, trouble bending the finger after the swelling goes down, or bleeding at the injection site.

collagenase clostridium histolyticum may cause infection. Tell your doctor right away if you have a fever, chills, or increasing redness or swelling of your hand.

It is very important that you elevate the fingers of the injected hand until bedtime to prevent swelling. Do not try to move or massage the cord, bend, or extend the fingers of the injected hand, or do heavy activity using your hand to prevent more injury.

Your doctor may put a splint on your hand after giving collagenase clostridium histolyticum. Wear the splint at bedtime for up to 4 months. Do finger bending and extending exercises as instructed by your doctor.

collagenase clostridium histolyticum 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 or nurse immediately if any of the following side effects occur:

More common

• Bruising or bleeding at the injection site


• swelling of the hands


• tearing of the skin

Incidence not known

• Bone pain


• lower back or side pain


• painful, swollen joints

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

• Blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, lumps, numbness, rash, scarring, stinging, tingling, or ulceration at the injection site


• bruise


• flushing, redness of the skin or unusually warm skin at the injection site


• itching, pain, swelling, or tenderness at the injection site


• swollen, painful, or tender lymph glands in the neck or armpit

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: collagenase clostridium histolyticum Injection 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 collagenase clostridium histolyticum Injection resources

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

Compare collagenase clostridium histolyticum Injection with other medications

• Dupuytren's contracture

Nadostine Sucrose-Free

Generic Name: nystatin (Oral route)

nye-STAT-in

Commonly used brand name(s)

In the U.S.

• Bio-Statin

In Canada

• Mycostatin Suspension


• Nadostine


• Nadostine Sucrose-Free


• Nilstat Drops


• Nilstat Powder


• Nyaderm


• Pms-Nystatin

Available Dosage Forms:

• Capsule


• Tablet


• Suspension

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For Nadostine Sucrose-Free

Nystatin belongs to the group of medicines called antifungals. The dry powder, lozenge (pastille), and liquid forms of this medicine are used to treat fungus infections in the mouth.

Nystatin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, nystatin is used in certain patients with the following medical condition:

• Candidiasis, oral (fungus infection of the mouth) (prevention)

Before Using Nadostine Sucrose-Free

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

This medicine has been tested in children and has not been reported to cause different side effects or problems in children than it does in adults. However, since children up to 5 years of age may be too young to use the lozenges (pastilles) or tablets safely, the oral suspension dosage form is best for this age group.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of oral nystatin in the elderly with use in other age groups.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of nystatin

This section provides information on the proper use of a number of products that contain nystatin. It may not be specific to Nadostine Sucrose-Free. Please read with care.

For patients taking the dry powder form of nystatin:

• Add about ⅛ teaspoonful of dry powder to about 4 ounces of water immediately before taking. Stir well.


• After it is mixed, take this medicine by dividing the whole amount (4 ounces) into several portions. Hold each portion of the medicine in your mouth or swish it around in your mouth for as long as possible, gargle, and swallow. Be sure to use all the liquid to get the full dose of medicine.

For patients taking the lozenge (pastille) form of nystatin:

• Nystatin lozenges (pastilles) should be held in the mouth and allowed to dissolve slowly and completely. This may take 15 to 30 minutes. Also, the saliva should be swallowed during this time. Do not chew or swallow the lozenges whole.


• Do not give nystatin lozenges (pastilles) to infants or children up to 5 years of age. They may be too young to use the lozenges safely.

For patients taking the oral liquid form of nystatin :

• This medicine is to be taken by mouth even if it comes in a dropper bottle. If it does come in a dropper bottle, use the specially marked dropper to measure each dose accurately.


• Take this medicine by placing one-half of the dose in each side of your mouth. Hold the medicine in your mouth or swish it around in your mouth for as long as possible, then gargle and swallow.

Patients with full or partial dentures may need to soak their dentures nightly in nystatin for oral suspension to eliminate the fungus from the dentures. In rare cases when this does not eliminate the fungus, it may be necessary to have new dentures made.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of this medicine 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 this medicine. 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 the lozenge (pastille) and tablet dosage forms:
  
  • Adults and children 5 years of age and older: 1 or 2 lozenges or tablets three to five times a day for up to fourteen days.
  
  
  • Children up to 5 years of age: Children this young may not be able to use the lozenges or tablets safely. The oral suspension is better for this age group.
  
  


• For the suspension dosage form:
  
  • Adults and children 5 years of age and older: 4 to 6 milliliters (mL) (about 1 teaspoonful) four times a day.
  
  
  • For older infants: 2 mL four times a day.
  
  
  • For premature and low-birth-weight infants: 1 mL four times a day.
  
  

Missed Dose

If you miss a dose of this medicine, 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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the lozenge (pastille) form in the refrigerator.

Nadostine Sucrose-Free 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.

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:

Less common

• Diarrhea


• nausea or vomiting


• stomach pain

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.

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 Nadostine Sucrose-Free resources

• Nadostine Sucrose-Free Use in Pregnancy & Breastfeeding
• Drug Images
• Nadostine Sucrose-Free Drug Interactions
• Nadostine Sucrose-Free Support Group
• 3 Reviews for Nadostine Sucrose-Free - Add your own review/rating

Compare Nadostine Sucrose-Free with other medications

• Gastrointestinal Candidiasis
• Oral Thrush

Halaven

Generic Name: eribulin (Intravenous route)

er-i-BUE-lin MES-i-late

Commonly used brand name(s)

In the U.S.

• Halaven

Available Dosage Forms:

• Solution

Pharmacologic Class: Eribulin

Uses For Halaven

Eribulin belongs to the group of medicines called antineoplastics (cancer medicines). It is used to treat metastatic (cancer that has already spread) breast cancer. This medicine is used in patients who have already received at least two types of cancer medicines.

Eribulin interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by this medicine, other side effects may occur. Some of these may be serious and must be reported to your doctor right away. Some unwanted effects may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.

Before you begin treatment with eribulin, you and your doctor should talk about the benefits of this medicine as well as the risks.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Halaven

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 have not been performed on the relationship of age to the effects of eribulin injection in the pediatric population. 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 eribulin injection in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., cytopenia, neutropenia) or


• Congestive heart failure or


• Heart rhythm problems (e.g., arrhythmias, QT prolongation) or


• Mineral imbalance (e.g., low magnesium or potassium in the blood) or


• Nerve problems (e.g., peripheral neuropathy)—Use with caution. May make these conditions worse. or

• Heart rhythm problem (e.g., congenital long QT syndrome)—Eribulin injection should not be given in patients with this condition.

• Kidney disease or


• Liver disease—Use with caution. You may require a lower dose of this medicine. Talk with your doctor if you have concerns about this.

Proper Use of Halaven

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine is usually given on Day 1 and Day 8 of a 21-day cycle of treatment. This 2-day treatment is given again every 21 days until your body responds to the medicine or you and your doctor decide to stop the treatment. Each treatment usually takes about 2 to 5 minutes.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using Halaven

It is very important that your doctor check your progress closely to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Eribulin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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.

Halaven 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 or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bladder pain


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


• bloody or cloudy urine


• body aches or pain


• burning, numbness, tingling, or painful sensations


• chills


• convulsions


• cough


• decreased urine


• decreased weight


• difficult or labored breathing


• difficult, burning, or painful urination


• dry mouth


• ear congestion


• fever


• frequent urge to urinate


• headache


• increased thirst


• irregular heartbeat


• loss of appetite


• loss of voice


• lower back or side pain


• mood changes


• muscle pain or cramps


• nasal congestion


• nausea or vomiting


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


• pale skin


• rapid weight gain


• runny nose


• shortness of breath


• sneezing


• sore throat


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness in the arms, hands, legs, or feet


• wheezing

Incidence not known

• Fainting


• irregular heartbeat, recurrent

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


• back pain


• belching


• bone pain


• change in taste


• cracked lips


• depression


• diarrhea


• difficulty having a bowel movement (stool)


• difficulty with moving


• difficulty with swallowing


• dizziness


• hair loss or thinning of the hair


• heartburn


• indigestion


• lack or loss of strength


• loss of taste


• muscle spasm or weakness


• muscle stiffness


• pain in the arms or legs


• pain in the joints


• rash


• sleeplessness


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• stomach discomfort, upset, or pain


• swelling or inflammation of the mouth


• trouble sleeping


• unable to sleep


• watering of the eyes


• 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: Halaven 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 Halaven resources

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

• Halaven Prescribing Information (FDA)


• Halaven MedFacts Consumer Leaflet (Wolters Kluwer)


• Halaven Consumer Overview

Compare Halaven with other medications

• Breast Cancer
• Breast Cancer, Metastatic

gentamicin Otic

jen-ta-MYE-sin

Available Dosage Forms:

• Solution

Chemical Class: Aminoglycoside

Uses For gentamicin

Gentamicin belongs to the family of medicines called antibiotics. Gentamicin otic preparations are used to treat infections of the ear canal.

Gentamicin is available only with your doctor's prescription.

Before Using gentamicin

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 gentamicin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to gentamicin 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

There is no specific information comparing use of gentamicin otic solution in children up to 6 years of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of gentamicin in the elderly with use in other age groups, gentamicin is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 gentamicin. Make sure you tell your doctor if you have any other medical problems, especially:

• Any other ear infection or problem (including punctured or absent eardrum)—Use of gentamicin otic preparations in persons with this condition may lead to systemic absorption, and increase the chance of side effects.

Proper Use of gentamicin

To use:

• Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 1 or 2 minutes to allow the medicine to come into contact with the infection. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using gentamicin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of gentamicin 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 gentamicin. 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 ear drops dosage form:
  
  • For ear infections:
    
    • Adults and children 6 years of age and older—Place three or four drops in the infected ear three times a day.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of gentamicin, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using gentamicin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

gentamicin 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:

Less common

• Itching, redness, swelling, or other sign of irritation not present before use of gentamicin

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:

Less common

• Burning or stinging in the ear

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.

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.

Alocril

Generic Name: nedocromil (Ophthalmic route)

ne-DOK-ROE-mil

Commonly used brand name(s)

In the U.S.

• Alocril

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Mast Cell Stabilizer

Uses For Alocril

Nedocromilis used to treat the itching in your eyes that happens with allergies.

Nedocromil works by acting on certain inflammatory cells to prevent them from releasing substances that cause allergic symptom.

This medicine is available only with your doctor's prescription.

Before Using Alocril

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Nedocromil has been tested in children 3 years of age and older. In effective doses, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

No differences in safety or effectiveness have been observed between elderly and younger patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of Alocril

Dosing

The dose of this medicine 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 this medicine. 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.

Nedocromil is used to help treat the itching that occurs with allergic conjunctivitis. To use the ophthalmic solution (eye drops)form of this medicine:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Blink a few times to make sure the eye is covered with the medicine.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Missed Dose

If you miss a dose of this medicine, 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.

Precautions While Using Alocril

You should avoid wearing your contact lenses while your eyes are itching from your allergies.

Alocril Side Effects

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

• Blurred vision


• change in color vision


• cough


• difficulty breathing


• noisy breathing


• shortness of breath, tightness in chest, or wheezing


• difficulty seeing at night


• dry or itching eyes


• headache


• increased sensitivity of eyes to sunlight


• redness, pain, or swelling of eye, eyelid, or inner lining of the eye


• runny or stuffy nose


• sneezing


• stinging, irritation or burning of your eyes


• unpleasant taste


• unusual watering of eyes or discharge

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: Alocril 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 Alocril resources

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

• Alocril Prescribing Information (FDA)


• Alocril Concise Consumer Information (Cerner Multum)


• Alocril eent Monograph (AHFS DI)


• Alocril Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alocril with other medications

• Conjunctivitis, Allergic

Cortizone-5

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Cortizone-5 (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about Cortizone-5 (hydrocortisone topical)?

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

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

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Cortizone-5 (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical 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 hydrocortisone topical 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. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Cortizone-5 (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

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, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Cortizone-5 (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Cortizone-5 (hydrocortisone topical) 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 hydrocortisone topical and call your doctor at once if you have any of these serious side effects:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 Cortizone-5 (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Cortizone-5 resources

• Cortizone-5 Side Effects (in more detail)
• Cortizone-5 Use in Pregnancy & Breastfeeding
• Cortizone-5 Drug Interactions
• Cortizone-5 Support Group
• 0 Reviews for Cortizone-5 - Add your own review/rating

• Cortizone-5 Advanced Consumer (Micromedex) - Includes Dosage Information


• Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Carmol HC Prescribing Information (FDA)


• Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydrocortisone Acetate Monograph (AHFS DI)


• Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

Compare Cortizone-5 with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Cortizone-5 side effects (in more detail)

Halobetasol Cream

Dosage Form: cream
Halobetasol Propionate

Cream, 0.05%

Rx only

For Dermatological Use Only

Not for Ophthalmic Use.

Halobetasol Cream Description

Halobetasol Propionate Cream, 0.05% contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an antiinflammatory and antipruritic agent.

Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β -methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:

Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water.

Each gram of halobetasol propionate cream contains 0.5 mg/g of halobetasol propionate in a cream base of cetyl alcohol, diazolidinyl urea, glycerin, isopropyl isostearate, isopropyl palmitate, methylchloroisothiazolinone, (and) methylisothiazolinone, steareth-21 and water.

Halobetasol Cream - Clinical Pharmacology

Like other topical corticosteroids, halobetasol propionate has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of the anti-inflammatory activity of the topical corticosteroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Human and animal studies indicate that less than 6% of the applied dose of halobetasol propionate enters the circulation within 96 hours following topical administration of the cream.

Studies performed with halobetasol propionate cream indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Halobetasol Cream

Halobetasol Propionate Cream, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Contraindications

Halobetasol propionate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free-cortisol tests. Patients receiving super potent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.

Halobetasol propionate cream produced HPA axis suppression when used in divided doses at 7 grams per day for one week in patients with psoriasis. These effects were reversible upon discontinuation of treatment.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, halobetasol propionate cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of halobetasol propionate cream should be discontinued until the infection has been adequately controlled.

Halobetasol propionate cream should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1. The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. The medication should not be used for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.


4. Patients should report to their physician any signs of local adverse reactions.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH-stimulation test; A.M. plasma cortisol test; Urinary free-cortisol test.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. Positive mutagenicity effects were observed in two genotoxicity assays. Halobetasol propionate was positive in a Chinese hamster micronucleus test, and in a mouse lymphoma gene mutation assay in vitro.

Studies in the rat following oral administration at dose levels up to 50 µg/kg/day indicated no impairment of fertility or general reproductive performance.

In other genotoxicity testing, halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the sister chromatid exchange test in somatic cells of the Chinese hamster, in chromosome aberration studies of germinal and somatic cells of rodents, and in a mammalian spot test to determine point mutations.

Pregnancy

Teratogenic effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Halobetasol propionate has been shown to be teratogenic in SPF rats and chinchilla-type rabbits when given systemically during gestation at doses of 0.04 to 0.1 mg/kg in rats and 0.01 mg/kg in rabbits. These doses are approximately 13, 33 and 3 times, respectively, the human topical dose of halobetasol propionate cream. Halobetasol propionate was embryotoxic in rabbits but not in rats.

Cleft palate was observed in both rats and rabbits. Omphalocele was seen in rats, but not in rabbits.

There are no adequate and well-controlled studies of the teratogenic potential of halobetasol propionate in pregnant women. Halobetasol propionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when halobetasol propionate cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of halobetasol propionate cream in pediatric patients have not been established and use in pediatric patients under 12 is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use

Of approximately 400 patients treated with halobetasol propionate cream in clinical studies, 25% were 61 years and over and 6% were 71 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients; and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

In controlled clinical trials, the most frequent adverse events reported for halobetasol propionate cream included stinging, burning or itching in 4.4% of the patients. Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles and rash.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as halobetasol propionate cream. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Overdosage

Topically applied halobetasol propionate cream can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Halobetasol Cream Dosage and Administration

Apply a thin layer of Halobetasol Propionate Cream, 0.05% to the affected skin once or twice daily, as directed by your physician, and rub in gently and completely.

Halobetasol propionate cream is a super-high potency topical corticosteroid; therefore, treatment should be limited to two weeks, and amounts greater than 50 g/wk should not be used. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Halobetasol propionate cream should not be used with occlusive dressings.

How is Halobetasol Cream Supplied

Halobetasol Propionate Cream, 0.05% is supplied in 15 g (NDC 51672-1321-1) and 50 g (NDC 51672-1321-3) tubes.

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Revised: July, 2005

PK-4726-0714

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

NDC 51672-1321-3

50 g

Halobetasol Propionate

Cream 0.05%

FOR DERMATOLOGICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

TARO

Keep this and all medications out of the reach of children.

HALOBETASOL PROPIONATE  halobetasol propionate  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-1321 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Halobetasol Propionate (Halobetasol) Halobetasol Propionate 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength cetyl alcohol   diazolidinyl urea   glycerin   isopropyl isostearate   isopropyl palmitate   methylchloroisothiazolinone   methylisothiazolinone   steareth-21   water

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-1321-1 1 TUBE In 1 CARTON contains a TUBE 1 15 g In 1 TUBE This package is contained within the CARTON (51672-1321-1) 2 51672-1321-3 1 TUBE In 1 CARTON contains a TUBE 2 50 g In 1 TUBE This package is contained within the CARTON (51672-1321-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077227	08/04/2005

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

Revised: 01/2012Taro Pharmaceuticals U.S.A., Inc.