Betason

Betason may be available in the countries listed below.

Ingredient matches for Betason

Betamethasone

Betamethasone is reported as an ingredient of Betason in the following countries:

• Indonesia

International Drug Name Search

Dorzolamide/Timolol Drops

Pronunciation: dor-ZOLE-a-mide/TIM-oh-lol
Generic Name: Dorzolamide/Timolol
Brand Name: Cosopt

Dorzolamide/Timolol Drops are used for:

Treating increased pressure in the eye (ocular hypertension) and open-angle glaucoma in patients who do not respond to other medicine.

Dorzolamide/Timolol Drops are a carbonic anhydrase inhibitor and beta-blocker combination. It works by decreasing fluid production and pressure inside the eye.

Do NOT use Dorzolamide/Timolol Drops if:

• you are allergic to any ingredient in Dorzolamide/Timolol Drops


• you have severe chronic obstructive pulmonary disease (COPD) or a history of asthma


• you have heart block, heart failure, or an unusually slow heartbeat


• you are in shock caused by severe heart problems


• you have severe kidney problems


• you are taking an oral carbonic anhydrase inhibitor (eg, acetazolamide)


• you are using another beta-blocker eye drop (eg, betaxolol)

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

Before using Dorzolamide/Timolol Drops:

Some medical conditions may interact with Dorzolamide/Timolol 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have a history of lung or breathing problems (eg, bronchitis, COPD, emphysema), diabetes, low blood sugar, heart problems, liver or kidney problems, certain muscle problems (eg, myasthenia gravis), blood vessel problems, or an overactive thyroid


• if you have narrow-angle glaucoma, double vision, a drooping eyelid, or other eye problems

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

• Bupivacaine, calcium blockers (eg, verapamil), certain antiarrhythmics (eg, disopyramide, flecainide, quinidine), cimetidine, digoxin, ketanserin, reserpine, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because serious heart problems (eg, conduction problems, heart failure, slow heartbeat) or low blood pressure may occur


• Clonidine because increased blood pressure may occur


• Insulin or oral antidiabetics (eg, glyburide, repaglinide) because the risk of low blood sugar (eg, hunger, shakiness or weakness, dizziness, headache, sweating) or slow heart rate may be increased. Dorzolamide/Timolol Drops may also hide certain signs of low blood sugar


• Salicylates (eg, aspirin) because the risk of their side effects may be increased or their effectiveness may be decreased by Dorzolamide/Timolol Drops


• Alpha-blockers (eg, alfuzosin, prazosin), oral beta-blockers (eg, propranolol), other beta-blocker eye drops (eg, betaxolol), or oral carbonic anhydrase inhibitors (eg, acetazolamide) because the risk of their side effects may be increased by Dorzolamide/Timolol Drops


• Certain sympathomimetics (eg, albuterol, salmeterol), epinephrine, or theophylline because their effectiveness may be decreased by Dorzolamide/Timolol Drops

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

How to use Dorzolamide/Timolol Drops:

Use Dorzolamide/Timolol Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Dorzolamide/Timolol Drops. Talk to your pharmacist if you have questions about this information.


• Dorzolamide/Timolol Drops are only for the eye. Do not get it in your nose or mouth.


• Soft contact lenses may absorb a chemical in Dorzolamide/Timolol Drops. Remove contact lenses before you use Dorzolamide/Timolol Drops; lenses may be placed back in the eyes 15 minutes after use of Dorzolamide/Timolol Drops.


• To use Dorzolamide/Timolol Drops in the eye, 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, dry 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 the eye. Keep the container tightly closed.


• Do NOT overtighten the cap on the bottle. This may damage the bottle or cap.


• Do NOT try to make the hole of the medicine dropper larger.


• Use Dorzolamide/Timolol Drops at least 10 minutes apart from any other medicine that you put in your eye.


• Using Dorzolamide/Timolol Drops at the same time each day will help you remember to use it.


• Continue to use Dorzolamide/Timolol Drops even if you feel well. Do not miss any doses.


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

Ask your health care provider any questions you may have about how to use Dorzolamide/Timolol Drops.

Important safety information:

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


• Tell your doctor or dentist that you take Dorzolamide/Timolol Drops before you receive any medical or dental care, emergency care, or surgery.


• Contact your doctor if you have an eye injury or infection, or if you will be having eye surgery.


• Diabetes patients - Dorzolamide/Timolol Drops may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk for an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are using Dorzolamide/Timolol Drops.


• Dorzolamide/Timolol Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Lab tests, including eye pressure, may be performed while you use Dorzolamide/Timolol Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Dorzolamide/Timolol Drops should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dorzolamide/Timolol Drops while you are pregnant. Dorzolamide/Timolol Drops are found in breast milk. Do not breast-feed while taking Dorzolamide/Timolol Drops.

Possible side effects of Dorzolamide/Timolol 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:

Back pain; bloodshot eyes; blurred vision; cough; dizziness; dry eyes; eyelid discomfort; feeling that something is in your eye; headache; increased tear production; minor burning, itching, or stinging of the eye; nausea; sore throat; stomach pain or upset; taste changes.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; chills; confusion; dark urine; eye irritation, swelling, pain, or discharge; eyelid pain, redness, scaling, drooping, or swelling; fainting; fever; pain, numbness, weakness, or tingling of an arm or leg; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; slow or irregular heartbeat; swelling of the hands, ankles, or feet; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.

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

See also: Dorzolamide/Timolol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; difficulty breathing or shortness of breath; severe or persistent dizziness or headache; slow or irregular heartbeat.

Proper storage of Dorzolamide/Timolol Drops:

Store Dorzolamide/Timolol 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 Dorzolamide/Timolol Drops out of the reach of children and away from pets.

General information:

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


• Dorzolamide/Timolol 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 Dorzolamide/Timolol 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 Dorzolamide/Timolol resources

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

Compare Dorzolamide/Timolol with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Leukoprol

Leukoprol may be available in the countries listed below.

Ingredient matches for Leukoprol

Mirimostim

Mirimostim is reported as an ingredient of Leukoprol in the following countries:

• Japan

International Drug Name Search

Apritone

Apritone may be available in the countries listed below.

Ingredient matches for Apritone

Aprindine

Aprindine hydrochloride (a derivative of Aprindine) is reported as an ingredient of Apritone in the following countries:

• Japan

International Drug Name Search

Nife-CT Retardtabletten

Nife-CT Retardtabletten may be available in the countries listed below.

Ingredient matches for Nife-CT Retardtabletten

Nifedipine

Nifedipine is reported as an ingredient of Nife-CT Retardtabletten in the following countries:

• Germany

International Drug Name Search

Benzoyl Peroxide Foam

Pronunciation: BEN-zoe-il per-OX-ide
Generic Name: Benzoyl Peroxide
Brand Name: BenzEFoam

Benzoyl Peroxide Foam is used for:

Treating acne

Benzoyl Peroxide Foam is a keratolytic agent with antibacterial actions. It works by causing mild drying and peeling of the skin, and by killing sensitive bacteria.

Do NOT use Benzoyl Peroxide Foam if:

• you are allergic to any ingredient in Benzoyl Peroxide Foam

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

Before using Benzoyl Peroxide Foam:

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

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


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


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

Some MEDICINES MAY INTERACT with Benzoyl Peroxide Foam. However, no specific interactions with Benzoyl Peroxide Foam are known at this time.

Ask your health care provider if Benzoyl Peroxide Foam 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 Benzoyl Peroxide Foam:

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

• An extra patient leaflet is available with Benzoyl Peroxide Foam. Talk to your pharmacist if you have questions about this information.


• Prime the container before the first use. To prime the container, shake well. Gently tap the bottom of the can 3 times on the palm of your hand or another solid surface. Remove the cap. Hold the can upright over the sink. Press down on the actuator for 1 to 3 seconds, until the tab breaks and foam appears. If foam does not appear within 3 seconds, repeat the entire process.


• Gently wash the affected area with mild soap and water, rinse with warm water, and pat dry before each use.


• Shake well and tap the bottom of the container 3 times on the palm of your hand or another solid surface before each use.


• To use Benzoyl Peroxide Foam, hold the can upright. If you are treating face acne, spray an amount the size of a marble into your hand. If you are treating back or chest acne, spray an amount the size of a walnut into your hand.


• Apply the foam to the affected area as directed by your doctor. Rub in completely.


• Wipe any excess foam off of the can after each use.


• Wash your hands with soap and water after each use.


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

Ask your health care provider any questions you may have about how to use Benzoyl Peroxide Foam.

Important safety information:

• Benzoyl Peroxide Foam is for external use only. Do not get Benzoyl Peroxide Foam in your eyes, on the inside of your nose or mouth, or on your lips. If you get it in any of these areas, rinse right away with cool water.


• Do not apply Benzoyl Peroxide Foam to skin that is inflamed, damaged, irritated, or sunburned. Do not apply it to an open wound.


• Several weeks may pass before you see improvement in your acne. Continue to use Benzoyl Peroxide Foam for the full time recommended by your doctor. If your acne does not get better or if it gets worse, check with your doctor.


• Do NOT use more than the recommended dose without checking with your doctor.


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


• Do not use Benzoyl Peroxide Foam for other conditions at a later time.


• Benzoyl Peroxide Foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Benzoyl Peroxide Foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Benzoyl Peroxide Foam may cause bleaching. Avoid contact with hair, fabrics, or carpeting.


• Benzoyl Peroxide Foam should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Benzoyl Peroxide Foam:

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

Dry skin; mild irritation, itching, peeling, redness, or stinging.

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

Severe allergic reactions (rash; hives; itching; dizziness; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent burning, irritation, itching, peeling, redness, or tenderness of the skin; swelling of the skin; very dry skin.

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

See also: Benzoyl Peroxide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include flushing or excessive scaling, redness, or swelling.

Proper storage of Benzoyl Peroxide Foam:

Store Benzoyl Peroxide Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Avoid temperatures above 120 degrees F (49 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister, even if it appears to be empty. Keep Benzoyl Peroxide Foam out of the reach of children and away from pets.

General information:

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


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


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


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

This information is a summary only. It does not contain all information about Benzoyl Peroxide Foam. 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 Benzoyl Peroxide resources

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

Compare Benzoyl Peroxide with other medications

• Acne
• Perioral Dermatitis

Aerobin

Aerobin may be available in the countries listed below.

Ingredient matches for Aerobin

Theophylline

Theophylline is reported as an ingredient of Aerobin in the following countries:

• Germany

International Drug Name Search

Protamine Sulphate

Protamine Sulphate may be available in the countries listed below.

UK matches:

• Protamine Sulphate Injection BP 1% (Sovereign Medical) (SPC)

Ingredient matches for Protamine Sulphate

Protamine

Protamine Sulphate (BAN) is known as Protamine in the US.

International Drug Name Search

Glossary

BAN	British Approved Name
SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Amocasin

Amocasin may be available in the countries listed below.

Ingredient matches for Amocasin

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Amocasin in the following countries:

• Argentina

International Drug Name Search

Amlodipine Besylate Soho

Amlodipine Besylate Soho may be available in the countries listed below.

Ingredient matches for Amlodipine Besylate Soho

Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipine Besylate Soho in the following countries:

• Indonesia

International Drug Name Search

Oxygen Carbon Dioxide Mix

Dosage Form: gas
carbon dioxide oxygen mix

COMPRESSED GAS, OXIDIZING, N.O.S.

(95% OXYGEN USP, 5% CARBON DIOXIDE USP)    

 UN3156

NON-FLAMMABLE 2     OXIDIZER 5.1

83670 (R 03/05)

Rx only.

CAUTION: Federal law prohibits dispensing without a prescription. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken.


WARNING: HIGH PRESSURE OXIDIZING LIQUID GAS. VIGOROUSLY ACCELERATES COMBUSTION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52oC(125oF). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).

    

 FIRST AID:   IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.     OXYGEN CAS: 7782-44-7  CARBON DIOXIDE  CAS: 124-38-9

DO NOT REMOVE THIS PRODUCT LABEL.   



AIRGAS PURITAN MEDICAL Distributed By:  Airgas West, Inc. Lakewood, CA 90712 (562) 497-1991

COMPRESSED GAS, OXIDIZING, N.O.S.

(% OXYGEN USP, % CARBON DIOXIDE USP)    

 UN3156

NON-FLAMMABLE 2     OXIDIZER 5.1

83670 (R 03/05)

Rx only.

CAUTION: Federal law prohibits dispensing without a prescription. WARNING: Administration of this gas mixture may be hazardous or contraindicated. For use by or under the supervision of a licensed practitioner who is experienced in the use and administration of gas mixtures and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken.


WARNING: HIGH PRESSURE OXIDIZING LIQUID GAS. VIGOROUSLY ACCELERATES COMBUSTION. MIXTURES CONTAINING CARBON DIOXIDE CAN INCREASE RESPIRATION AND HEART RATE. Keep oil and grease away. Open valve slowly. Store and use with adequate ventilation. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Use a back flow preventive device in the piping. Cylinder temperature should not exceed 52oC(125oF). Close valve after each use and when empty. Use in accordance with the Material Safety Data Sheet (MSDS).

    

 FIRST AID:   IF INHALED, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.     OXYGEN CAS: 7782-44-7  CARBON DIOXIDE  CAS: 124-38-9

DO NOT REMOVE THIS PRODUCT LABEL.   



AIRGAS PURITAN MEDICAL Distributed By:  Airgas West, Inc. Lakewood, CA 90712 (562) 497-1991

Oxygen Carbon Dioxide Mix  Oxygen Carbon Dioxide Mix  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10678-008 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxygen (Oxygen) Oxygen 950 mL  in 1 L Carbon Dioxide (Carbon Dioxide) Carbon Dioxide 50 mL  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10678-008-01 3539 L In 1 CYLINDER None 2 10678-008-02 5663 L In 1 CYLINDER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		05/23/1947

Labeler - Airgas-West, Inc. (805645793)

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		959837287	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		807025564	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		059820498	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		869324756	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		182365809	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		026366021	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		834717514	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		879945632	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		017427142	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		170564608	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		603878740	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		802299169	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		156072928	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		949045181	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		006136793	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		786280862	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		119883507	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		832997998	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		806715392	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		033485566	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		152936519	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		927773168	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		103079992	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		156216350	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		832997881	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		832997782	manufacture

Establishment
Name	Address	ID/FEI	Operations
Airgas-West, Inc.		959935354	manufacture

Revised: 04/2010Airgas-West, Inc.

Clotrazil

Clotrazil may be available in the countries listed below.

Ingredient matches for Clotrazil

Clotrimazole

Clotrimazole is reported as an ingredient of Clotrazil in the following countries:

• Ecuador

International Drug Name Search

Pantecta

Pantecta may be available in the countries listed below.

Ingredient matches for Pantecta

Pantoprazole

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantecta in the following countries:

• Italy


• Spain

International Drug Name Search

Alprazolam Alter

Alprazolam Alter may be available in the countries listed below.

Ingredient matches for Alprazolam Alter

Alprazolam

Alprazolam is reported as an ingredient of Alprazolam Alter in the following countries:

• France


• Italy

International Drug Name Search

Cefpodoxime Teva

Cefpodoxime Teva may be available in the countries listed below.

Ingredient matches for Cefpodoxime Teva

Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Cefpodoxime Teva in the following countries:

• France

International Drug Name Search

Faktor IX "SSI"

Faktor IX "SSI" may be available in the countries listed below.

Ingredient matches for Faktor IX "SSI"

Coagulation Factor IX, Human

Coagulation Factor IX, Human is reported as an ingredient of Faktor IX "SSI" in the following countries:

• Iceland

International Drug Name Search

Foliumzuur ratiopharm

Foliumzuur ratiopharm may be available in the countries listed below.

Ingredient matches for Foliumzuur ratiopharm

Folic Acid

Folic Acid is reported as an ingredient of Foliumzuur ratiopharm in the following countries:

• Netherlands

International Drug Name Search

Sulpirid

Sulpirid may be available in the countries listed below.

Ingredient matches for Sulpirid

Sulpiride

Sulpiride is reported as an ingredient of Sulpirid in the following countries:

• Bosnia & Herzegowina


• Croatia (Hrvatska)


• Serbia


• Slovenia


• Vietnam

International Drug Name Search

Dialon-T

Dialon-T may be available in the countries listed below.

Ingredient matches for Dialon-T

Buflomedil

Buflomedil hydrochloride (a derivative of Buflomedil) is reported as an ingredient of Dialon-T in the following countries:

• Georgia


• Greece

International Drug Name Search

Xet

Xet may be available in the countries listed below.

Ingredient matches for Xet

Paroxetine

Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Xet in the following countries:

• India


• Myanmar

International Drug Name Search

Schericur

Schericur may be available in the countries listed below.

Ingredient matches for Schericur

Hydrocortisone

Hydrocortisone is reported as an ingredient of Schericur in the following countries:

• Spain

International Drug Name Search

Ulinastatin

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0009010-53-1

Therapeutic Category

Enzyme inhibitor, protease

Chemical Name

Glycoprotein of molecular weight about 67,000 isolated from human urine, inhibiting mainly proteolytic enzymes

Foreign Names

• Ulinastatinum (Latin)
• Ulinastatin (German)
• Ulinastatine (French)
• Ulinastatina (Spanish)

Generic Names

• Ulinastatin (OS: JAN)
• Urinastatin (IS)
• Ulinastatin (PH: JP XIV)

Brand Names

• Bradol
  Takata Seiyaku, Japan



• Estotin
  Sawai Seiyaku, Japan



• Gokumisin
  Nipro GenephaNipurojenefa, Japan



• Miraclid
  Mochida, Japan

International Drug Name Search

Glossary

IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Ferrlecit

In the US, Ferrlecit (sodium ferric gluconate complex systemic) is a member of the drug class iron products and is used to treat Anemia Associated with Chronic Renal Failure.

US matches:

• Ferrlecit

Ingredient matches for Ferrlecit

Ferrous Succinate

Ferrous Succinate is reported as an ingredient of Ferrlecit in the following countries:

• Germany

International Drug Name Search

Noscapine HCl Sandoz

Noscapine HCl Sandoz may be available in the countries listed below.

Ingredient matches for Noscapine HCl Sandoz

Noscapine

Noscapine hydrochloride (a derivative of Noscapine) is reported as an ingredient of Noscapine HCl Sandoz in the following countries:

• Netherlands

International Drug Name Search

Noventron

Noventron may be available in the countries listed below.

Ingredient matches for Noventron

Ondansetron

Ondansetron is reported as an ingredient of Noventron in the following countries:

• Slovakia

International Drug Name Search

Xilopar

Xilopar may be available in the countries listed below.

Ingredient matches for Xilopar

Ribavirin

Ribavirin is reported as an ingredient of Xilopar in the following countries:

• Argentina

Selegiline

Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Xilopar in the following countries:

• Austria


• Germany


• Italy


• Portugal

International Drug Name Search

Nurasel

Nurasel may be available in the countries listed below.

Ingredient matches for Nurasel

Fluconazole

Fluconazole is reported as an ingredient of Nurasel in the following countries:

• Dominican Republic

International Drug Name Search

Norbet

Norbet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Norbet

Betamethasone

Betamethasone is reported as an ingredient of Norbet in the following countries:

• United Kingdom

International Drug Name Search

Pyoderma Gangrenosum Medications

Definition of Pyoderma Gangrenosum: An ulcerating condition of skin resulting in heaped borders with a typical appearance. Pyoderma gangrenosum appears to be mediated by the immune system, but the exact cause is unknown. The lesion

Drugs associated with Pyoderma Gangrenosum

The following drugs and medications are in some way related to, or used in the treatment of Pyoderma Gangrenosum. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Remicade

Calfspan

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Calfspan

Sulfadimidine

Sulfadimidine is reported as an ingredient of Calfspan in the following countries:

• United States

International Drug Name Search

oxiconazole topical

Generic Name: oxiconazole topical (ox ee CON a zole)

Brand Names: Oxistat

What is oxiconazole topical?

Oxiconazole topical is an antifungal medication. Oxiconazole topical prevents fungus from growing on your skin.

Oxiconazole topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm.

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

What is the most important information I should know about oxiconazole topical?

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use oxiconazole topical?

Do not use oxiconazole topical if you have had an allergic reaction to it in the past.

Oxiconazole topical is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not use oxiconazole topical without first talking to your doctor if you are pregnant. It is not known whether oxiconazole passes into breast milk. Do not use oxiconazole topical without first talking to your doctor if you are breast-feeding a baby.

How should I use oxiconazole topical?

Use oxiconazole topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream or lotion once or twice daily as directed for 2 to 4 weeks.

Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store oxiconazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of oxiconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of oxiconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used, or that oxiconazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using oxiconazole topical?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Oxiconazole topical side effects

Serious side effects of oxiconazole topical use are not expected. Stop using oxiconazole and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

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.

Oxiconazole topical Dosing Information

Usual Adult Dose for Tinea Versicolor:

Apply cream to affected areas once a day. Oxiconazole lotion should not be used to treat tinea versicolor.

Treatment should continue for 2 weeks. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Adult Dose for Tinea Corporis:

Apply lotion or cream to affected areas once or twice a day.

Tinea corporis, tinea cruris: Treatment should continue for 2 weeks.
Tinea pedis: Treatment should continue for 1 month to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Adult Dose for Tinea Cruris:

Apply lotion or cream to affected areas once or twice a day.

Tinea corporis, tinea cruris: Treatment should continue for 2 weeks.
Tinea pedis: Treatment should continue for 1 month to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Adult Dose for Tinea Pedis:

Apply lotion or cream to affected areas once or twice a day.

Tinea corporis, tinea cruris: Treatment should continue for 2 weeks.
Tinea pedis: Treatment should continue for 1 month to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Pediatric Dose for Tinea Versicolor:

Apply cream to affected areas once a day. Oxiconazole lotion should not be used to treat tinea versicolor.

Treatment should continue for 2 weeks. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Pediatric Dose for Tinea Corporis:

Apply lotion or cream to affected areas once or twice a day.

Tinea corporis, tinea cruris: Treatment should continue for 2 weeks.
Tinea pedis: Treatment should continue for 1 month to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Pediatric Dose for Tinea Cruris:

Apply lotion or cream to affected areas once or twice a day.

Tinea corporis, tinea cruris: Treatment should continue for 2 weeks.
Tinea pedis: Treatment should continue for 1 month to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

Usual Pediatric Dose for Tinea Pedis:

Apply lotion or cream to affected areas once or twice a day.

Tinea corporis, tinea cruris: Treatment should continue for 2 weeks.
Tinea pedis: Treatment should continue for 1 month to reduce the possibility of recurrence.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed and alternate etiology considered.

What other drugs will affect oxiconazole topical?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of oxiconazole topical.

More oxiconazole topical resources

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

• Oxistat Prescribing Information (FDA)


• Oxistat Monograph (AHFS DI)


• Oxistat Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Oxistat Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare oxiconazole topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

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

See also: oxiconazole side effects (in more detail)

Sertralin Genericon

Sertralin Genericon may be available in the countries listed below.

Ingredient matches for Sertralin Genericon

Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralin Genericon in the following countries:

• Austria


• Estonia


• Latvia


• Slovakia

International Drug Name Search

Enanton Depot Set

Enanton Depot Set may be available in the countries listed below.

Ingredient matches for Enanton Depot Set

Leuprorelin

Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Enanton Depot Set in the following countries:

• Sweden

International Drug Name Search

Dientamoeba fragilis Medications

Definition of Dientamoeba fragilis:

A species of small amoeba-like flagellates, formerly considered a true amoeba, now recognised as an amebo-flagellate related to Trichomonas.

They are parasitic in the large intestine of humans and certain monkeys, and although usually nonpathogenic, they are believed to be capable causing low-grade inflammation with mucous diarrhoea and gastrointestinal disturbance in humans.

See: Histomonas meleagridis.

Drugs associated with Dientamoeba fragilis

The following drugs and medications are in some way related to, or used in the treatment of Dientamoeba fragilis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Diquinol

Humatin

Paromycin

Yodoxin

Phenolphthalein

In some countries, this medicine may only be approved for veterinary use.

In the US, Phenolphthalein is a member of the drug class laxatives.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A06AB04

CAS registry number (Chemical Abstracts Service)

0000077-09-8

Chemical Formula

C20-H14-O4

Molecular Weight

318

Therapeutic Category

Stimulant laxative

Chemical Name

1(3H)-Isobenzofuranone, 3,3-bis(4-hydroxyphenyl)-

Foreign Names

• Phenolphthaleinum (Latin)
• Phenolphthalein (German)
• Phénolphtaléine (French)
• Fenolftaleina (Spanish)

Generic Names

• Fenolftaleina (OS: DCIT)
• Phénolphtaléine (OS: DCF)
• Phenolphthalein (OS: BAN)
• Laxane (IS)
• Laxiline (IS)
• Phénolphtaléine (PH: Ph. Eur. 6)
• Phenolphthalein (PH: BP 2010, USP 30, Ph. Eur. 6)
• Phenolphthaleinum (PH: Ph. Eur. 6)

Brand Names

• Agarol
  Pfizer, Ghana; Pfizer, India; Pfizer, Kenya; Pfizer, Liberia; Pfizer, Malawi; Pfizer, Nigeria; Pfizer, Sudan; Pfizer, Sierra Leone



• Alin
  Münir Sahin, Turkey



• Easylax
  Sam-On, Israel



• Fenolftaleina
  Valma, Chile



• Fructines
  Fucus, Argentina



• Laksafenol
  Liba, Turkey



• Laxative Tablets (veterinary use)
  Bob Martin, United Kingdom



• Musilaks
  Günsa, Turkey



• Phenolphtaleinum
  Valeant, Hungary



• Phenolphthalein Guilin Pharma
  Guilin, China

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Koncentrovani

Koncentrovani may be available in the countries listed below.

Ingredient matches for Koncentrovani

Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Koncentrovani in the following countries:

• Serbia

International Drug Name Search

Halazone

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0000080-13-7

Chemical Formula

C7-H5-Cl2-N-O4-S

Molecular Weight

270

Therapeutic Categories

Antiseptic

Disinfectant

Chemical Name

Benzoic acid, 4-[(dichloroamino)sulfonyl]-

Foreign Names

• Halazonum (Latin)
• Halazon (German)
• Halazone (French)
• Halazona (Spanish)

Generic Names

• Halazone (OS: DCF)
• Aseptamide (IS)
• Pantocid (IS)
• Sulfochloramin (IS)
• Halazone (PH: USP 32)

Brand Names

• Oro-Dezenfektan
  Oro, Turkey



• Pure
  Globe, Bangladesh

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Neupogen

In the US, Neupogen (filgrastim systemic) is a member of the drug class colony stimulating factors and is used to treat Aplastic Anemia, Bone Marrow Transplantation, Myelodysplastic Syndrome, Neutropenia, Neutropenia Associated with AIDS or Zidovudine, Neutropenia Associated with Chemotherapy, Peripheral Progenitor Cell Transplantation and Sepsis.

US matches:

• Neupogen


• Neupogen SingleJect

UK matches:

• Neupogen Singleject Syringes
• Neupogen Vials
• Neupogen 30 MU (0.3 mg/ml) and 48 MU (0.3 mg/ml). Solution for injection (SPC)
• Neupogen Singleject 30 MU (0.6 mg/ml) (SPC)
• Neupogen Singleject 48 MU (0.96 mg/ml) (SPC)

Ingredient matches for Neupogen

Filgrastim

Filgrastim is reported as an ingredient of Neupogen in the following countries:

• Algeria


• Argentina


• Aruba


• Australia


• Austria


• Azerbaijan


• Bahrain


• Bangladesh


• Belarus


• Belgium


• Bolivia


• Bosnia & Herzegowina


• Botswana


• Brazil


• Canada


• Chile


• Colombia


• Cote D'ivoire


• Croatia (Hrvatska)


• Cuba


• Czech Republic


• Denmark


• Dominican Republic


• Ecuador


• Egypt


• Estonia


• Finland


• France


• Georgia


• Germany


• Ghana


• Hong Kong


• Hungary


• Iceland


• India


• Indonesia


• Iran


• Ireland


• Israel


• Italy


• Jamaica


• Jordan


• Kazakhstan


• Kenya


• Kuwait


• Latvia


• Lebanon


• Libya


• Lithuania


• Luxembourg


• Macedonia


• Malawi


• Malaysia


• Malta


• Mauritius


• Mexico


• Morocco


• Namibia


• Nepal


• Netherlands


• New Zealand


• Nigeria


• Norway


• Oman


• Pakistan


• Paraguay


• Peru


• Philippines


• Poland


• Portugal


• Qatar


• Romania


• Russian Federation


• Saudi Arabia


• Serbia


• Singapore


• Slovakia


• Slovenia


• South Africa


• Spain


• Sri Lanka


• Sudan


• Sweden


• Switzerland


• Tanzania


• Thailand


• Trinidad & Tobago


• Tunisia


• Turkey


• Uganda


• Ukraine


• United Arab Emirates


• United Kingdom


• United States


• Uruguay


• Uzbekistan


• Venezuela


• Vietnam


• Zambia


• Zimbabwe

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Lactulose Generis

Lactulose Generis may be available in the countries listed below.

Ingredient matches for Lactulose Generis

Lactulose

Lactulose is reported as an ingredient of Lactulose Generis in the following countries:

• Portugal

International Drug Name Search

Cetirizinhydrochlorid Stada

Cetirizinhydrochlorid Stada may be available in the countries listed below.

Ingredient matches for Cetirizinhydrochlorid Stada

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetirizinhydrochlorid Stada in the following countries:

• Germany

International Drug Name Search

Nifedipina-ratiopharm

Nifedipina-ratiopharm may be available in the countries listed below.

Ingredient matches for Nifedipina-ratiopharm

Nifedipine

Nifedipine is reported as an ingredient of Nifedipina-ratiopharm in the following countries:

• Italy

International Drug Name Search

Brompheniramine and Pseudoephedrine Drops

Dosage Form: liquid
Brompheniramine Maleate 1 mg Pseudoephedrine HCl 7.5 mg Drops

Brompheniramine and Pseudoephedrine Drops Description

Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops is an antihistaminic drop for oral administration containing the following amounts of active ingredients in each 1 mL dropperful:

Brompheniramine Maleate, USP …….........................…………………. 1 mg

Pseudoephedrine HCl …….........................…….............……………. 7.5 mg


Inactive Ingredients: Citric Acid, Cotton Candy Flavor, Glycerin, Propylene Glycol, Purified Water, Saccharin Sodium, Sodium Benzoate, Sorbitol, and Xanthan Gum.


Brompheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, -[4-bromophenyl)-N,N-dimethyl-,(±)-,[Z]-2-butenedioate (1:1) with the following chemical structure:

Pseudoephedrine Hydrochloride is a nasal decongestant with the chemical name, Benzenemethanol,-[1-(methylamino)ethyl]-,[S-(R*,R*)],hydrochloride. Its structure is as follows:

Brompheniramine and Pseudoephedrine Drops - Clinical Pharmacology

Brompheniramine Maleate

Brompheniramine Maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilatation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.


Pseudoephedrine Hydrochloride

Pseudoephedrine Hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. Serum half-life for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered dose is excreted in the urine.

Indications and Usage for Brompheniramine and Pseudoephedrine Drops

Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops is indicated for symptomatic relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Do not use in newborn infants, premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heart disease, or in those receiving monoamine oxidase (MAO) inhibitors. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack. Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Antihistamines may diminish mental alertness, and may cause hyperexcitability especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Use with caution in patients with hypertension, ischemic heart disease, and persons older than 60 years old. Do not give this product to children who have a chronic pulmonary disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives or tranquilizers without first consulting with a doctor. Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. Do not exceed the recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

Precautions

General

Because Brompheniramine Maleate 1 mg and Pseudoephrdrine HCl 7.5 mg Drops contain an antihistamine, it should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Due to its sympathomimetic component, Brompheniramine Maleate 1 mg Drops should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.


Information for Patients (or Parents)

Patients (or parents) should be warned about engaging in activities requiring mental alertness. In mild cases or in particularly sensitive patients, less frequent doses may be adequate.


Drug Interactions

Do not use this medication in a child who is taking a prescription monoamineoxidase (MAO) inhibitor (certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAO inhibitor. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines and may enhance the effect of pseudoephedrine HCl. Sympathomimetic agents may reduce the effects of anti-hypertensive drugs. Antihistamines have additive effects with alcohol and other CNS (central nervous system) depressants (hypnotics, sedatives, tranquilizers, anti-anxiety agents, etc.)


Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed to assess the carcinogenic and mutual potential of Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops or its effects on fertility.


Pregnancy, Teratogenic Effects – Pregnancy Category C

Animal reproductive studies have not been performed with Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops. It is also not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Brompheniramine Maleate 1 mg Drops should be given to a pregnant women only if clearly needed.


Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops is contraindicated in nursing mothers.


Geriatric Use

The elderly (60 years of age or older) are more likely to experience adverse reactions. Caution should be taken when prescribing this drug to the elderly.

Adverse Reactions

The most frequent adverse reactions to Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops include: sedation, dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness.


Other adverse reactions may include:

Dermatologic- urticaria, drug rash, photosensitivity, pruritus

Cardiovascular System- hypotension, hypertension, cardiac arrhythmias, palpitations

Central Nervous System (CNS)- disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.

G.U. System- urinary frequency, difficult urination.

G.I. System- epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System- tightness of chest and wheezing, shortness of breath.

Hematologic System- hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSE

Signs and Symptoms

Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may also occur. Overdosage of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension and cardiac arhythmias, signs of CNS depression may occasionally be seen.


Treatment

Include emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, but in some cases tracheotomy may be needed prior to lavage. For CNS hyperactivity or convulsive seizures, intravenous shortacting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids and other supportive measures should be used as indicated.

Brompheniramine and Pseudoephedrine Drops Dosage and Administration

Take by mouth only.

Do not exceed 4 doses during a 24-hour period.

*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

How is Brompheniramine and Pseudoephedrine Drops Supplied

Brompheniramine Maleate 1 mg and Pseudoephedrine HCl 7.5 mg Drops is a cotton candy-flavored, sugar free, alcohol free, dye free liquid packaged in 1 fl oz (30 mL) bottles for dropper dosage, NDC 68032-325-21. Calibrated, shatterproof dropper enclosed in each carton.


Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Dispense in a tight, light resistant container as defined is the USP/NF- with a child resistant cap. Dispense in the original container. Avoid exposure to excessive heat. Keep tightly closed.


Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.


WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


Manufactured for:

River's Edge Pharmaceuticals, LLC.

Suwanee, GA 30024

Iss. 06/08 325-11

PACKAGING

Label

Carton

BROMPHENIRAMINE MALEATE PSEUDOEPHEDRINE HCL  brompheniramine maleate pseudoephedrine hcl  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-325 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (DEXBROMPHENIRAMINE) DEXBROMPHENIRAMINE MALEATE 1 mg  in 1 mL PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE 7.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor COTTON CANDY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68032-325-21 30 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2008

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2009River's Edge Pharmaceuticals, LLC

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