Bepotastine besilate

What is Bepotastine besilate?

• Bepotastine besilate (Bepreve) is a histamine H1 receptor antagonist used for the treatment of itching associated with allergic conjunctivitis.

Bepotastine

Bepotastine

What are the uses of this medicine?

• Bepotastine besilate (Bepreve) is used for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

How does this medicine work?

• Bepotastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Bepreve.

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• Instill one drop of Bepreve™ into the affected eye(s) twice a day (BID).

Administration:

• For topical ophthalmic administration only.
• Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
• Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Bepreve™ should not be used to treat contact lens-related irritation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Solution containing bepotastine besilate, 1.5%

This medicine is available in fallowing brand namesː

• Bepreve

What side effects can this medication cause?

The most common side effects of this medicine include:

• mild taste following instillation
• eye irritation
• headache
• nasopharyngitis

What special precautions should I follow?

• To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.
• Patients should be advised not to wear a contact lens if their eye is red. Bepreve™ should not be used to treat contact lens-related irritation.
• Bepreve™ should not be instilled while wearing contact lenses.
• Remove contact lenses prior to instillation of Bepreve™.
• The preservative in Bepreve™, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bepreve™.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of bepotastine besilate in pregnant women.
• Because animal reproduction studies are not always predictive of human response, Bepreve™ (bepotastine besilate ophthalmic solution) 1.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and efficacy of Bepreve™ (bepotastine besilate ophthalmic solution) 1.5% have not been established in pediatric patients under 2 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BEPOTASTINE

Inactive ingredients:

• SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
• SODIUM CHLORIDE
• SODIUM HYDROXIDE
• WATER
• BENZALKONIUM CHLORIDE

Who manufactures and distributes this medicine?

Manufactured for:

• ISTA Pharmaceuticals, Inc.
• Irvine, CA 92618

By:

• Bausch & Lomb Incorporated
• Tampa, FL 33637

Under license from:

• Senju Pharmaceutical Co., Ltd.
• Osaka, Japan 541-004

What should I know about storage and disposal of this medication?

• Store at 15º – 25ºC (59º – 77ºF).

• Dailymed label info on Bepotastine besilate
• FDA Bepotastine besilate

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• Cyclizine
• Cyproheptadine
• Dexbrompheniramine
• Dexchlorpheniramine
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Second Generation Antihistamines

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• Loratadine
• Desloratadine