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Updated On: 18-11-2024

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Bepotastine Besilate - Bepreive - @- Ophthalmic agent (Sept 2009)

Drug Name:
Bepotastine Besilate - Bepreive - @- Ophthalmic agent (Sept 2009)

List Of Brands:

BEPREIVE *

Indication Type Description:

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation

Indication:

Proprietary Name- Bepreive

Established Name - Bepotasine Mesylate- Histamine H2 Receptor

Applicant- Ista Pharmaceuticals

Indication-

Itching Associated with allergic Conjuntivitis

Approved by FDA 8-9- 2009 (Ref- FDA approved List- 2009)

LIST OF NEW DRUG APPROVED FROM 01-01-2016 To TILL DATE

BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA

Sr.No Name of Drug Indication Date of Issue

7. Bepotastine Besilate Bulk & 08-06-2016

Bepotastine Besilate 1.5% w/v

Ophthalmic solution

For the treatment of itching associated with allergic

conjunctivitis

Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2016 To Till Date)

Adverse Reaction:

The most common adverse reaction occurring in approximately 25%

of patients was a mild taste following instillation. Other adverse reactions

which occurred in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.

Contra-Indications:

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Contamination of Tip and Solution

To minimize contaminating the dropper tip and eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

Contact Lens 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.

Dosages/ Overdosage Etc:

INDICATIONS AND USAGE

Bepreve is a histamine H1 receptor antagonist indicated for the treatment

of itching associated with allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

Instill one drop into the affected eye(s) twice a day. (BID).

DOSAGE FORMS AND STRENGTHS

Solution containing bepotastine besilate, 1.5%.

Patient Information:

For topical ophthalmic administration only.

Pharmacology/ Pharmacokinetics:

Mechanism of Action

Bepotastine is a topically active, direct H1receptor antagonist and an inhibitor

of the release of histamine from mast cells.

Absorption: The extent of systemic exposure to bepotastine following topical

ophthalmic administration of bepotastine besilate 1% and 1.5% ophthalmic

solutions was evaluated in 12 healthy adults. Following one drop of 1% or

1.5% bepotastine besilate ophthalmic solution to both eyes four time daily

(QID) for seven days, bepotastine plasma concentrations peaked at

approximately one to two hours post-instillation.

Excretion: The main route of elimination of bepotastine besilate is

urinary excretion (with approximately 75-90% excreted unchanged in urine).

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Teratogenicity studies have been performed in animals.

Bepotamine besilate was not found to be teratogenic in rats

Nursing mothers

It is not known if bepotastine besilate is excreted in human milk. Caution should be

exercised when it is administered to a nursing woman.

Pediatric Use

Safety and efficacy of Bepreve (bepotastine besilate ophthalmic solution) 1.5%

have not been established in pediatric patients under 2 years of age.

Efficacy in pediatric patients under 10 years of age was extrapolated from

clinical trials conducted in pediatric patients greater than 10 years of age and from adults.

Geriatric Use

No overall difference in safety or effectiveness has been observed between elderly

and younger patients

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Disclaimer: Every effort has been made to ensure that the information provided in this Database is authentic and accurate. Commissions or omissions in the database, if any, are purely inadvertent and the site owner shall not accept any liability whatsoever for any adverse consequences of any nature arising to any individual or third party, as a result of usage of this information.