BIMATOPROST solution/ drops

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

BIMATOPROST (UNII: QXS94885MZ) (BIMATOPROST - UNII:QXS94885MZ)

Tillgänglig från:

Alembic Pharmaceuticals Limited

Administreringssätt:

OPHTHALMIC

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [see Adverse Reactions 6.2) ]. Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC). These adverse effects were not observ

Produktsammanfattning:

Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low-density polyethylene round screw neck bottle and tips with high density polyethylene turquoise opaque screw cap accompanied by sterile, disposable applicators: 5 mL in a 5 mL bottle with 140 applicators NDC 46708-511-05 3 mL in a 5 mL bottle with 70 applicators NDC 46708-511-03 Storage: Store at 2° to 25°C (36° to 77°F).

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BIMATOPROST - BIMATOPROST SOLUTION/ DROPS
ALEMBIC PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BIMATOPROST
OPHTHALMIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
BIMATOPROST OPHTHALMIC SOLUTION.
BIMATOPROST OPHTHALMIC SOLUTION FOR TOPICAL OPHTHALMIC USE.
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Bimatoprost ophthalmic solution, for topical ophthalmic use is a
prostaglandin analog, indicated to treat
hypotrichosis of the eyelashes by increasing their growth including
length, thickness and darkness. (1)
DOSAGE AND ADMINISTRATION
Apply nightly directly to the skin of the upper eyelid margin at the
base of the eyelashes using the
accompanying applicators. Blot any excess solution beyond the eyelid
margin. Dispose of the applicator
after one use. Repeat for the opposite eyelid margin using a new
sterile applicator. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing bimatoprost 0.3 mg/mL. (3)
CONTRAINDICATIONS
Hypersensitivity (4)
WARNINGS AND PRECAUTIONS
Concurrent administration of Bimatoprost ophthalmic solution, for
topical ophthalmic use and intraocular
pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive
patients may decrease the IOP-
lowering effect. Patients using these products concomitantly should be
closely monitored for changes to
their IOP. (5.1)
Pigmentation of the eyelids and iris may occur. Iris pigmentation is
likely to be permanent. (5.2,5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence approximately 3% to 4%) are
eye pruritus, conjunctival
hyperemia, and skin hyperpigmentation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALEMBIC PHARMACEUTICAL
INC. AT 1-866-
210-9797 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 7/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS