LUMIGAN- bimatoprost solution/ drops

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Allergan, Inc.

INN (nemzetközi neve):

bimatoprost

Összetétel:

bimatoprost 0.1 mg in 1 mL

Az alkalmazás módja:

OPHTHALMIC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

LUMIGAN ®   (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. LUMIGAN ®   0.01% 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 LUMIGAN ®   (bimatoprost ophthalmic solution) 0.01% 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 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 to bimatoprost 0.03% dosed bilaterally once daily (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 huma

Termék összefoglaló:

LUMIGAN ®   (bimatoprost ophthalmic solution) 0.01% is supplied sterile in opaque white low density polyethylene ophthalmic dispenser bottles and tips with turquoise polystyrene caps in the following sizes: 2.5 mL fill in a 5 mL container - NDC 0023-3205-03 5 mL fill in a 10 mL container - NDC 0023-3205-05 7.5 mL fill in a 10 mL container - NDC 0023-3205-08 Storage: Store at 2°C to 25°C (36°F to 77°F). After opening, LUMIGAN ®   0.01% can be used until the expiration date on the bottle.

Engedélyezési státusz:

New Drug Application

Termékjellemzők

LUMIGAN- BIMATOPROST SOLUTION/ DROPS
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUMIGAN 0.01% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LUMIGAN 0.01%.
LUMIGAN (BIMATOPROST OPHTHALMIC SOLUTION) 0.01%, FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
LUMIGAN 0.01% 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 0.1 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 (31%) is conjunctival hyperemia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-678-1605 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: 3/2022
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 LACTATION
8.4 PEDIATRIC USE
8.5 GERIATRIC USE
10 OVERDOSAGE
11 DESCRIPTIO