AllerDur

Generic Name: dexchlorpheniramine and pseudoephedrine (dex klor fen EER a meen and soo doe e FED rin)

Brand Names: AllerDur, Duotan PD, Tanafed DP

What is AllerDur (dexchlorpheniramine and pseudoephedrine)?

Dexchlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of dexchlorpheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dexchlorpheniramine and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about AllerDur (dexchlorpheniramine and pseudoephedrine)?

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Dexchlorpheniramine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking AllerDur (dexchlorpheniramine and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to dexchlorpheniramine, or pseudoephedrine, or if you have:

• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may not be able to use dexchlorpheniramine and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Dexchlorpheniramine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take AllerDur (dexchlorpheniramine and pseudoephedrine)?

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 use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

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

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take 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.

Symptoms of an overdose may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking AllerDur (dexchlorpheniramine and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by dexchlorpheniramine and pseudoephedrine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

AllerDur (dexchlorpheniramine and pseudoephedrine) side effects

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

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Keep taking the medication and talk to your doctor if you have any of these less serious side effects:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  mild loss of appetite, stomach upset;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  ringing in your ears.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AllerDur (dexchlorpheniramine and pseudoephedrine)?

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

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

If you are using any of these drugs, you may not be able to use dexchlorpheniramine and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect dexchlorpheniramine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More AllerDur resources

• AllerDur Use in Pregnancy & Breastfeeding
• AllerDur Drug Interactions
• AllerDur Support Group
• 0 Reviews for AllerDur - Add your own review/rating

• Duotan PD Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare AllerDur with other medications

• Nasal Congestion

Where can I get more information?

• Your pharmacist has information about dexchlorpheniramine and pseudoephedrine written for health professionals that you may read.

Murine Tears Plus Drops

Pronunciation: te-tra-hye-DROZ-oh-leen
Generic Name: Tetrahydrozoline
Brand Name: Examples include Eye Moisturizing Relief and Murine Tears

Murine Tears Plus Drops are used for:

Temporarily relieving redness, burning, and irritation caused by dry eyes. It may also be used for other conditions as determined by your doctor.

Murine Tears Plus Drops are an eye decongestant and lubricant. It works by constricting the blood vessels in the eye and coating the eye, which relieves redness and dryness.

Do NOT use Murine Tears Plus Drops if:

• you are allergic to any ingredient in Murine Tears Plus Drops


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days

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

Before using Murine Tears Plus Drops:

Some medical conditions may interact with Murine Tears Plus Drops. 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 glaucoma, high blood pressure, diabetes, heart problems, or thyroid problems, or you are taking medicine for high blood pressure

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

• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Murine Tears Plus Drops's effectiveness


• Cocaine, furazolidone, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Murine Tears Plus Drops's side effects, such as headache, fever, and high blood pressure


• Bromocriptine or cocaine because their actions and side effects may be increased by Murine Tears Plus Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Murine Tears Plus Drops 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 Murine Tears Plus Drops:

Use Murine Tears Plus Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Murine Tears Plus Drops are for use in the eye only. Avoid contact with the nose, mouth, or other mucous membranes.


• To use Murine Tears Plus Drops, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.


• If you miss a dose of Murine Tears Plus Drops and you are using it regularly, 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 Murine Tears Plus Drops.

Important safety information:

• Remove contact lenses before using Murine Tears Plus Drops.


• Do not use Murine Tears Plus Drops if it becomes cloudy or changes color.


• Contact your doctor if you experience changes in your vision, eye pain, irritation, soreness, or continued redness, or if your condition does not improve after 3 days.


• Use Murine Tears Plus Drops with caution in CHILDREN because they may be more sensitive to its effects.


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

Possible side effects of Murine Tears Plus Drops:

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:

Blurred vision; minor stinging when the medicine is dropped into the eye.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; eye pain; worsening or persistent eye irritation or redness.

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.

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. Murine Tears Plus Drops may be harmful if swallowed, especially in children.

Proper storage of Murine Tears Plus Drops:

Store Murine Tears Plus Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Murine Tears Plus Drops out of the reach of children and away from pets.

General information:

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


• Murine Tears Plus Drops 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 Murine Tears Plus Drops. 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 Murine Tears Plus resources

• Murine Tears Plus Use in Pregnancy & Breastfeeding
• Murine Tears Plus Drug Interactions
• Murine Tears Plus Support Group
• 1 Review for Murine Tears Plus - Add your own review/rating

Compare Murine Tears Plus with other medications

• Eye Dryness/Redness

Flolan

Generic Name: epoprostenol (EE poe PROST en ol)

Brand Names: Flolan, Veletri

What is Flolan (epoprostenol)?

Epoprostenol is a prostaglandin (a hormone-like substance that occurs naturally in the body). Prostaglandins help to control functions in the body such as blood pressure and muscle contractions.

Epoprostenol is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise.

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

What is the most important information I should know about Flolan (epoprostenol)?

You should not use this medication if you are allergic to epoprostenol, if you have breathing problems when you first start using epoprostenol, or if you have congestive heart failure caused by a decrease in your heart's ability to pump blood back into the body.

Before using epoprostenol, tell your doctor if you have a bleeding or blood clotting disorder, heart disease, liver or kidney disease, or high blood pressure.

Epoprostenol is injected into a vein using an infusion pump, usually through a permanent central intravenous (IV) catheter placed into a large vein (such as in your chest). You may need to use this medication for many years.

You may be shown how to use an infusion pump at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

You will receive your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur. Your blood pressure and heart rate may also need to be monitored whenever your dose is changed.

Tell your doctor about all other drugs you use, especially medicines to prevent blood clots.

Do not stop using epoprostenol without first talking to your doctor, even if you feel fine or have no symptoms. Even short breaks in the flow of your medication through the IV can cause the treatment to stop working. Missing doses or stopping suddenly may make your condition worse and you may have symptoms such as dizziness, weakness, or trouble breathing. Call your doctor if your symptoms do not improve, or if they get worse while using epoprostenol.

What should I discuss with my healthcare provider before using Flolan (epoprostenol)?

You should not use this medication if you are allergic to epoprostenol, if you have breathing problems when you first start using epoprostenol, or if you have congestive heart failure caused by a decrease in your heart's ability to pump blood back into the body.

To make sure you can safely use epoprostenol, tell your doctor if you have any of these other conditions:

• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  liver disease.

  
  

FDA pregnancy category B. Epoprostenol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether epoprostenol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Flolan (epoprostenol)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. You may need to use this medication for many years.

Epoprostenol is injected into a vein using a computerized, portable infusion pump to control the rate of medication you receive. Because epoprostenol must be used long-term, it is usually given through a permanent central intravenous (IV) catheter placed into a large vein (such as in your chest).

You may be shown how to use an infusion pump at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

You will receive your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur. Your blood pressure and heart rate may also need to be monitored whenever your dose is changed.

You may be given other medications to prevent blood clots while you are receiving epoprostenol.

Epoprostenol is a powder medicine that must be mixed with a liquid (diluent) before using it. Use only the diluent provided with your medication and do not mix epoprostenol with any other medications or diluents not approved by your doctor.

If you are using the injections at home, be sure you understand how to properly mix and store the medicine. These directions are different for the Flolan and Veletri brands of this medication. Be sure you understand all mixing and storage directions for the specific brand of epoprostenol you are using.

After mixing Flolan with the diluent, store in the refrigerator and use within 48 hours. After mixing Veletri with the diluent, store in the refrigerator ans use within 5 days. The Veletri and diluent mixture may also be stored at room temperature but you must use it within 48 hours after it was mixed. Protect the mixed medicine from light and do not freeze. Throw away any epoprostenol and diluent mixture that has become frozen, has changed colors, or has any particles in it. Call your doctor for a new prescription. The epoprostenol and diluent mixture must be protected from light at all times, whether it is in storage or in use. Do not stop using epoprostenol without first talking to your doctor, even if you feel fine or have no symptoms. Missing doses or stopping suddenly may make your condition worse and you may have symptoms such as dizziness, weakness, or trouble breathing.

Even short breaks in the flow of your medication through the IV can cause the treatment to stop working. To make sure there is no interruption in your treatment, you may need to have a back-up infusion pump in case your first pump fails to work properly. Also keep replacement batteries and extra IV infusion sets on hand at all times. Get your prescription refilled before you run out of medicine completely.

Call your doctor if your symptoms do not improve, or if they get worse while using epoprostenol. Store unopened vials of epoprostenol and its diluent at cool room temperature (below 77 degrees F), away from moisture, heat, and light. Keep in the original carton.

What happens if I miss a dose?

Because this medication is given around the clock, you should not miss a dose if you use the medication properly. Call your doctor right away if your epoprostenol therapy is interrupted for any reason.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while using Flolan (epoprostenol)?

Avoid using any infusion pump that has not been approved for use by your doctor.

Flolan (epoprostenol) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  fever, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;

  
  


• 
  

  chest pain, trouble breathing;

  
  


• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  blood in your urine or stools;

  
  


• 
  

  coughing up blood;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  numbness or increased sensitivity anywhere in your body.

  
  

Less serious side effects may include:

• 
  

  flushing (warmth, redness, or tingly feeling);

  
  


• 
  

  nausea, vomiting, diarrhea, stomach pain;

  
  


• 
  

  headache or jaw pain;

  
  


• 
  

  joint or muscle pain;

  
  


• 
  

  dizziness, sweating; or

  
  


• 
  

  feeling anxious, nervous, or agitated.

  
  

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 Flolan (epoprostenol)?

Epoprostenol can increase your risk of bleeding. This effect is increased when you also use medicines to prevent blood clots, such as:

• 
  

  heparin or warfarin (Coumadin, Jantoven);

  
  


• 
  

  alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

  
  


• 
  

  dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra), tinzaparin (Innohep); or

  
  


• 
  

  abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

  
  

Tell your doctor about all other medications you use, especially:

• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  aspirin or an NSAID (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with epoprostenol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Flolan resources

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

• Flolan Prescribing Information (FDA)


• Flolan MedFacts Consumer Leaflet (Wolters Kluwer)


• Flolan Monograph (AHFS DI)


• Flolan Advanced Consumer (Micromedex) - Includes Dosage Information


• Epoprostenol Prescribing Information (FDA)


• Veletri Prescribing Information (FDA)

Compare Flolan with other medications

• Pulmonary Arterial Hypertension

Where can I get more information?

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

See also: Flolan side effects (in more detail)

Amoclan

Generic Name: amoxicillin and clavulanate (Oral route)

a-mox-i-SIL-in, KLAV-ue-la-nate poe-TAS-ee-um

Commonly used brand name(s)

In the U.S.

• Amoclan


• Augmentin


• Augmentin ES-600


• Augmentin XR

In Canada

• Alti-Amoxi Clav


• Apo-Amoxi Clav


• Novo-Clavamoxin 125


• Novo-Clavamoxin 250


• Ratio-Amoxi Clav 250f

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Powder for Suspension


• Tablet, Chewable

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Uses For Amoclan

Amoxicillin and clavulanate combination is used to treat bacterial infections in many different parts of the body.

Amoxicillin and clavulanate combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Amoclan

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate chewable tablets and oral suspension in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate tablets in children weighing 40 kilograms (kg) or more. However, safety and efficacy have not been established in children weighing less than 40 kg.

Appropriate studies have not been performed on the relationship of age to the effects of amoxicillin and clavulanate extended-release tablets in teenagers and children 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 amoxicillin and clavulanate combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving amoxicillin and clavulanate combination.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this medicine, 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 this medicine 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.

• Methotrexate


• Venlafaxine

Using this medicine 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.

• Acenocoumarol


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Khat


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Probenecid


• Warfarin

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:

• Diarrhea or


• Liver disease—Use with caution. May make these conditions worse.

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

• Kidney disease, severe—The extended-release tablets should not be used in patients with this condition.

• Liver disease, history of with amoxicillin and clavulanate combination or


• Mononucleosis ("mono")—Should not be used in patients with these conditions.

• Phenylketonuria (PKU)—The chewable tablet and oral suspension contain phenylalanine, which can make this condition worse.

Proper Use of amoxicillin and clavulanate

This section provides information on the proper use of a number of products that contain amoxicillin and clavulanate. It may not be specific to Amoclan. Please read with care.

Take this medicine 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.

You may take this medicine with or without meals. However, it is best to take this medicine at the start of a meal or snack to avoid an upset stomach.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

If you are using the chewable tablets, chew the tablet completely before swallowing.

There are certain flavors that can be mixed with the oral suspension to make it taste better. If you or your child do not like the taste of this medicine, ask your pharmacist about these flavorings.

Keep the oral suspension refrigerated. Shake it well before measuring the dose. Use a dosing spoon or medicine dropper to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the dosing spoon or dropper with water after each use.

Do not change brands or dosage forms of amoxicillin and clavulanate combination without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, ask your pharmacist about the change.

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 bacterial infections:
  
  • For oral dosage form (chewable tablets, suspension):
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.
    
    
    • Children and infants above 3 months of age and weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given every 8 hours, or 25 to 90 mg/kg/day, divided and given every 12 hours.
    
    
    • Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 12 hours.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—2000 milligrams (mg) every 12 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.
    
    
    • Children weighing less than 40 kilograms (kg)—Use and dose must be determined by your doctor.
    
    
  
  

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.

Store the chewable tablets, regular tablets, and extended-release tablets at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral suspension in the refrigerator. Throw away any unused portion after 10 days. Keep from freezing.

Precautions While Using Amoclan

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Amoxicillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Amoxicillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g., condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.

Before you or your child have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Amoclan 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

• Hives or welts


• itching


• itching of the vagina or genital area


• pain during sexual intercourse


• redness of the skin


• skin rash


• thick, white vaginal discharge with no odor or with a mild odor

Rare

• Bloody or cloudy urine


• fever


• greatly decreased frequency of urination or amount of urine


• seizures


• swelling of the feet or lower legs

Incidence not known

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• black, hairy tongue


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the stools


• bloody nose


• chest pain


• chills


• clay-colored stools


• cough or hoarseness


• cracks in the skin


• dark urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• difficulty with moving


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever with or without chills


• general body swelling


• general feeling of tiredness or weakness


• headache


• heavier menstrual periods


• increased thirst


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• loss of heat from the body


• lower back or side pain


• muscle stiffness


• nausea or vomiting


• pain


• pain, swelling, or redness in the joints


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• shortness of breath


• sore throat


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


• swollen glands


• tightness in the chest


• troubled breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• upper right abdominal pain


• vomiting of blood


• wheezing


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain


• bloody or cloudy urine


• diarrhea


• fever


• greatly decreased frequency of urination or amount of urine


• pain or burning while urinating


• skin rash


• sleepiness


• swelling of the feet or lower legs


• vomiting

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:

Rare

• Anxiety


• dry mouth


• hyperventilation


• irregular heartbeats


• irritability


• nervousness


• restlessness


• shaking


• sleeplessness


• tooth discoloration


• trouble sitting still


• trouble with sleeping


• unable to sleep

Incidence not known

• Burning feeling in the chest or stomach


• indigestion


• redness, swelling, or soreness of the tongue


• stomach upset


• swelling or inflammation of the mouth

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: Amoclan 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 Amoclan resources

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

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Ibuprofène Teva Conseil

Ibuprofène Teva Conseil may be available in the countries listed below.

Ingredient matches for Ibuprofène Teva Conseil

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofène Teva Conseil in the following countries:

• France

International Drug Name Search

Fluocinonide Ointment

Dosage Form: ointment, cream, gel
FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base)

FLUOCINONIDE CREAM USP, 0.05%

FLUOCINONIDE GEL USP, 0.05%

Fluocinonide Ointment USP, 0.05%

0262

0263

0264

0265

FOR TOPICAL/EXTERNAL USE ONLY

NOT FOR OPHTHALMIC USE

Rx only

Fluocinonide Ointment Description

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene) bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula:

C26H32F207 M.W. 494.54

Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg fluocinonide in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid (hydrous) and purified water.

Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid (hydrous). This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties.

In this formulation, the active ingredient is totally in solution.

Each gram of Fluocinonide Gel USP, 0.05% contains: 0.5 mg fluocinonide in a specifically formulated gel base consisting of purified water, propylene glycol, edetate disodium, carbomer 934P, and sodium hydroxide. Hydrochloric acid is added to adjust the pH. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible.

In this formulation, the active ingredient is totally in solution.

Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment.

In this formulation, the active ingredient is totally in solution.

Fluocinonide Ointment - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Fluocinonide Ointment

The topical corticosteriods are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

The topical corticosteriods are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. 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 steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS - Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

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

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


2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.


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


4. Patients should report any signs of local adverse reactions especially under occlusive dressing.


5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test

ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy

Teratogenic Effects.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

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

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning	Perioral dermatitis
Itching	Allergic contact dermatitis
Irritation	Maceration of the skin
Dryness	Secondary infection
Folliculitis	Skin atrophy
Hypertrichosis	Striae
Acneiform eruptions	Miliaria
Hypopigmentation

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS).

Fluocinonide Ointment Dosage and Administration

The topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is Fluocinonide Ointment Supplied

Fluocinonide Cream USP, 0.05% (Emulsified Base) is supplied in 15 gram, 30 gram, and 60 gram tubes.

Fluocinonide Cream USP, 0.05% is supplied in 15 gram, 30 gram, and 60 gram tubes.

Fluocinonide Gel USP, 0.05% is supplied in 60 gram tubes.

Fluocinonide Ointment USP, 0.05% is supplied in 15 gram, 30 gram, and 60 gram tubes.

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

Avoid excessive heat, above 40°C (104°F).

Manufactured By:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. K 3/2005

Principal Display Panel

Fluocinonide Cream USP (Emulsified Base) 0.05% 60 Grams Label Text

NDC 0093-0263-92

FLUOCINONIDE CREAM, USP

(Emulsified Base)

0.05%

FOR TOPICAL USE ONLY (Not For Ophthalmic Use)

60 GRAMS

TEVA

Principal Display Panel

Fluocinonide Cream USP 0.05% 60 Grams Label Text

NDC 0093-0262-92

FLUOCINONIDE CREAM USP

0.05%

Rx only

FOR TOPICAL USE ONLY (Not For Ophthalmic Use)

60 GRAMS

TEVA

Principal Display Panel

Fluocinonide Gel USP 0.05% 60 Grams Label Text

NDC 0093-0265-92

FLUOCINONIDE GEL USP

0.05%

Rx only

FOR TOPICAL USE ONLY (Not For Ophthalmic Use)

60 GRAMS

TEVA

Principal Display Panel

Fluocinonide Ointment USP 0.05% 60 Grams Label Text

NDC 0093-0264-92

Fluocinonide Ointment, USP

0.05%

FOR EXTERNAL USE ONLY Not For Ophthalmic Use

60 GRAMS

TEVA

FLUOCINONIDE  fluocinonide  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0093-0263 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL   CETYL ALCOHOL   MINERAL OIL   PROPYLENE GLYCOL   SORBITAN MONOSTEARATE   POLYSORBATE 60   CITRIC ACID MONOHYDRATE   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0093-0263-15 15 g In 1 TUBE None 2 0093-0263-30 30 g In 1 TUBE None 3 0093-0263-92 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072490	01/20/2011

FLUOCINONIDE  fluocinonide  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0093-0262 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL   POLYETHYLENE GLYCOL 8000   PROPYLENE GLYCOL   CITRIC ACID MONOHYDRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0093-0262-15 15 g In 1 TUBE None 2 0093-0262-30 30 g In 1 TUBE None 3 0093-0262-92 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072488	01/20/2011

FLUOCINONIDE  fluocinonide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0093-0265 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength WATER   PROPYLENE GLYCOL   EDETATE DISODIUM   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0093-0265-92 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA072537	01/20/2011

FLUOCINONIDE  fluocinonide  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0093-0264 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength PETROLATUM   CASTOR OIL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0093-0264-15 15 g In 1 TUBE None 2 0093-0264-30 30 g In 1 TUBE None 3 0093-0264-92 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA073481	01/20/2011

Labeler - TEVA Pharmaceuticals USA Inc (118234421)

Revised: 01/2011TEVA Pharmaceuticals USA Inc

More Fluocinonide Ointment resources

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

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