Bepotastine Besilate - Bepreive - @- Ophthalmic agent (Sept 2009)
Drug Name:
Bepotastine Besilate - Bepreive - @- Ophthalmic agent (Sept 2009)
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
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
