BIMATOPROST- bimatoprost solution/ drops

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Micro Labs Limited

Az alkalmazás módja:

OPHTHALMIC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 organogenesis, 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 clinical dose. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure at the recommended clinical dose (based on blood AUC levels).  No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure at the recommended clinical dose (based on blood AUC levels). Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure at the recommended human ophthalmic dose [RHOD], based on AUC). The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure at the RHOD, based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure at the RHOD, based on AUC). The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure at the RHOD, based on AUC). No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure at the RHOD, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day. These effects were observed at exposures at least 41 times the human systemic exposure at the RHOD, based on AUC. The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at 14 times the human systemic exposure at the RHOD, based on AUC). Risk Summary It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the RHOD (on a m 2 g/m basis), however no animal data is available at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bimatoprost ophthalmic solution, 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution, 0.03%. 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. No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Bimatoprost Ophthalmic Solution 0.03% Before you use Bimatoprost Ophthalmic Solution 0.03% for the first time: 1. Check to make sure that the tamper evident ring between the bottle and the cap is not broken (See Figure A). If the tamper evident ring is broken or missing, contact your pharmacist. 2. Tear off the tamper evident ring (See Figure B). 3. To open the bottle, remove the cap by turning it in the counterclockwise direction (See Figure C). This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: Micro Labs Limited Bangalore-560099, INDIA. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873 Rev.01/2024

Termék összefoglaló:

Bimatoprost ophthalmic solution 0.03% is supplied sterile in white low density polyethylene 3 piece open nozzle container with cone shape, turquoise color TSTR- TEAR OFF caps available in following packs: 2.5 mL fill in 5 mL    NDC 42571-128-35 5 mL fill in 10 mL     NDC 42571-128-21 7.5 mL fill in 10 mL  NDC 42571-128-28 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 printed on the bottle.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BIMATOPROST - BIMATOPROST SOLUTION/ DROPS
MICRO LABS LIMITED
----------
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)
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 MICRO LABS LIMITED AT
1-855-839-8195
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: 1/2024
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 Lactati