BIMATOPROST solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Gland Pharma Limited

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Bimatoprost ophthalmic solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. 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 developmental studies, administration of bimatoprost in pregnant mice and rats during organogensis, resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose (based on blood area under the curve [AUC] levels). These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure at the recomm

Produkt oppsummering:

Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low density polyethylene bottle which is closed with white low density polyethylene nozzle and then with turquoise colored high density polyethylene cap in the following sizes: 2.5 mL fill in a 5 mL container - NDC 68083-295-01 5 mL fill in a 10 mL container - NDC 68083-296-01 7.5 mL fill in a 10 mL container - NDC 68083-439-01 Storage:  Store at 2° to 25°C (36° to 77°F). After opening, bimatoprost ophthalmic solution, 0.03% can be used until the expiration date stamped on the bottle.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BIMATOPROST - BIMATOPROST SOLUTION/ DROPS
GLAND PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BIMATOPROST
OPHTHALMIC SOLUTION, 0.03% SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
BIMATOPROST OPHTHALMIC SOLUTION, 0.03%.
BIMATOPROST OPHTHALMIC SOLUTION, 0.03%
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Bimatoprost ophthalmic solution, 0.03% is a prostaglandin analog
indicated for the reduction of elevated
intraocular pressure in patients with open angle glaucoma or ocular
hypertension. (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 0.3 mg/mL of bimatoprost. (3)
CONTRAINDICATIONS
Hypersensitivity. (4)
WARNINGS AND PRECAUTIONS
Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid)
and eyelashes can occur. Iris
pigmentation is likely to be permanent. (5.1)
Eyelash Changes: Gradual change to eyelashes including increased
length, thickness and number of
lashes. Usually reversible. (5.2)
ADVERSE REACTIONS
Most common adverse reaction (45%) is conjunctival hyperemia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAND PHARMA AT
864-879-9994 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Use in pediatric patients below the age of 16 years is not recommended
because of potential safety
concerns related to increased pigmentation following long-term chronic
use. (8.4)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2022
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 Pigmentation
5.2 Eyelash Changes
5.3 Intraocular Inflammation
5.4 Macular Edema
5.5 Bacterial Keratitis
5.6 Contact Lens Use
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 L