LUMIGAN- bimatoprost solution/ drops

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

bimatoprost (UNII: QXS94885MZ) (bimatoprost - UNII:QXS94885MZ)

Tillgänglig från:

Physicians Total Care, Inc.

INN (International namn):

bimatoprost

Sammansättning:

bimatoprost 0.1 mg in 1 mL

Administreringssätt:

OPHTHALMIC

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

LUMIGAN ® 0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. None Pregnancy Category C Teratogenic effects: In embryo/fetal developmental studies in pregnant mice and rats, abortion was observed at oral doses of bimatoprost which achieved at least 33 or 97 times, respectively, the maximum intended human exposure based on blood AUC levels. At doses at least 41 times the maximum intended human exposure based on blood AUC levels, the gestation length was reduced in the dams, the incidence of dead fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup body weights were reduced. There are no adequate and well-controlled studies of LUMIGAN ® 0.01% and 0.03% (bimatoprost ophthalmic solution) administration in pregnant women. Because animal reproductive studies are not always predictive of human response LUMIGAN ® should be administered during pregnancy only if th

Produktsammanfattning:

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: 5 mL fill - NDC 54868-6304-0 LUMIGAN ® (bimatoprost ophthalmic solution) 0.03% 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 - NDC 54868-4575-2 5 mL fill - NDC 54868-4575-0 7.5 mL fill - NDC 54868-4575-1 Storage: LUMIGAN ® 0.01% and 0.03% should be stored at 2° to 25°C (36° to 77°F).

Bemyndigande status:

New Drug Application

Produktens egenskaper

LUMIGAN - BIMATOPROST SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LUMIGAN 0.01% AND 0.03% (BIMATOPROST
OPHTHALMIC SOLUTION) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LUMIGAN .
LUMIGAN 0.01% AND 0.03% (BIMATOPROST OPHTHALMIC SOLUTION)
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
LUMIGAN 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
Solution containing 0.1 mg/mL bimatoprost (LUMIGAN 0.01%) or
containing 0.3 mg/mL bimatoprost (LUMIGAN
0.03%). (3)
WARNINGS AND PRECAUTIONS
Pigme ntation.
Eyelash Changes.
ADVERSE REACTIONS
Most common adverse reaction (range 25% - 45%) is conjunctival
hyperemia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-433-8871 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: 9/2011
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 Angle-closure, Inflammatory, or Neovascular Glaucoma
5.6 Bacterial Keratitis
5.7 Use with Contact Lenses
6 ADVERSE REACTIONS
6.1 Clinical Studies Experience
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Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes
can occur. Iris pigmentation is likely to be
permanent (5.1).
Gradual change to eyelashes including increased length, thickness and
number of lashes. Usually reversible. (5.2)
8 USE IN SPECIFIC