TRAVOPROST OPHTHALMIC SOLUTION 0.004%- travoprost solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRAVOPROST (UNII: WJ68R08KX9) (TRAVOPROST - UNII:WJ68R08KX9)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

TRAVOPROST

Composition:

TRAVOPROST 0.04 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. None Pregnancy Category C Teratogenic effects: Travoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses >3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses >0.3 mcg/kg/day (7.5 times the MRHOD). In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lacta

Product summary:

Travoprost Ophthalmic Solution 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL) Travoprost ophthalmic solution is supplied as a 2.5 mL and a 5 mL solution, each in a 5 mL natural translucent polypropylene dispenser bottle with a natural translucent low density polyethylene dropper tip and a turquoise polyethylene overcap with a tamper evident locking ring. 2.5 mL fill NDC 49884-044-48 5 mL fill NDC 49884-044-63 Storage Store at 2º to 25ºC (36º to 77ºF).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAVOPROST OPHTHALMIC SOLUTION 0.004%- TRAVOPROST SOLUTION
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAVOPROST OPHTHALMIC SOLUTION USP,
0.004% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRAVOPROST OPHTHALMIC SOLUTION USP,
0 .0 0 4 %.
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Travoprost Ophthalmic Solution USP, 0.004% 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 0.04 mg/mL travoprost ophthalmic solution. ( 3)
WARNINGS AND PRECAUTIONS
•
•
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: 9/2016
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
6.1 CLINICAL STUDIES EXPERIENCE
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy Section
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic and Renal Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
Pigmentation. Pigmentation of the iris, periorbital tissue (eyelid)
and eyelashes can occur. Iris pigmentation likely to
be permanent. (5.1)
Eyelash Changes. Gradual change to eyelashes including increased
length, thickness and number of lashes. Usually
reversible. (5.2)
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis and Mutagenesis and Impair