BIMATOPROST solution/ drops

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Akorn

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 recommended

製品概要:

Bimatoprost Ophthalmic Solution, 0.03% is supplied sterile in white low density polyethylene ophthalmic dispenser bottles and tips with turquoise caps in the following sizes: 2.5 mL fill in 6 mL container - NDC 50383-908-02 5 mL fill in 10 mL container - NDC 50383-908-05 7.5 mL fill in 10 mL container - NDC 50383-908-07 Storage: Bimatoprost ophthalmic solution should be stored in the original container at 2º to 25ºC (36º to 77ºF). Bimatoprost ophthalmic solution can be used until the expiration date stamped on the bottle.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

BIMATOPROST- BIMATOPROST SOLUTION/ DROPS
AKORN
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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, 0.03% is a prostaglandin analog
indicated for the reduction of elevated
intraocular pressure in patients with open angle glaucoma or ocular
hypertension. (1) (1)
DOSAGE AND ADMINISTRATION
One drop in the affected eye(s) once daily in the evening. (2) (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 0.3 mg/mL bimatoprost (3) (3)
CONTRAINDICATIONS
Hypersensitivity (4) (4)
WARNINGS AND PRECAUTIONS
•
Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes
can occur. Iris pigmentation is likely to be
(5)
permanent. (5.1) (5)
•
Gradual change to eyelashes including increased length, thickness and
number of lashes. Usually
reversible. (5)
(5.2) (5)
ADVERSE REACTIONS
Most common adverse reaction is conjunctival hyperemia (45%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AKORN OPERATING COMPANY
LLC AT 1-
800-932-5676 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) (7)
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
Pigmentation.
Eyelash Changes.
5.4 Macular Edema
5.5 Bacterial Keratitis
5.6 Contact Lenses Use
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATI