BIMATOPROST solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

BIMATOPROST

Composition:

BIMATOPROST 0.3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 observed at 2.6 time

Product summary:

Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low-density polyethylene dispenser bottles and tips with turquoise polystyrene caps accompanied by sterile, disposable applicators: 3 mL in a 4 mL bottle with 70 applicators - NDC 0781-6206-93 5 mL in a 8 mL bottle with 140 applicators - NDC 0781-6206-75 Storage: Store at 2° to 25°C (36° to 77°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BIMATOPROST- BIMATOPROST SOLUTION/ DROPS
SANDOZ INC
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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, 0.03%, FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Bimatoprost ophthalmic solution 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
•
•
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 SANDOZ INC. AT
1-800-525-8747 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 5/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Effects on Intraocular Pressure
5.2 Iris Pigmentation
5.3 Lid Pigmentation
5.4 Hair Growth Outside the Treatment Area
5.5 Intraocular Inflammation
5.6 Macular Edema
5.7 Contamination of Bimatoprost Ophthalmic Solution or Applicators
5.8 Use With Contact Lenses
Concurrent administration of bimatoprost ophthalmic solution and
intraocular pressure (IOP)-lowering
prostaglandin analogs in ocular hypertensive patients may decrease