TIMOPTIC IN OCUDOSE- timolol maleate solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

זמין מ:

Amring Pharmaceuticals Inc.

מסלול נתינה (של תרופות):

OPHTHALMIC

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution USP, benzalkonium chloride, or when use of a preservative-free topical medication is advisable. Preservative-free timolol maleate ophthalmic solution USP in the unit dose vial is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.

leaflet_short:

Preservative-free Timolol Maleate Ophthalmic Solution USP is a clear, colorless to light yellow solution. Preservative-free Timolol Maleate Ophthalmic Solution USP, 0.25% timolol equivalent, is supplied in a clear low density polyethylene vial. Each individual unit contains 0.3 mL of solution, and is available in 2 blocks of 5 vials in a sealed aluminum pouch; six pouches per carton. NDC 69918-602-60; 0.3 mL Single-dose vials in a carton of 60. Preservative-free Timolol Maleate Ophthalmic Solution, 0.5% timolol equivalent, is supplied in a clear low density polyethylene vial. Each individual unit contains 0.3 mL of solution, and is available in 2 blocks of 5 vials in a sealed aluminum pouch; six pouches per carton. NDC 69918-601-60; 0.3 mL Single-dose vials in a carton of 60. Storage Store at room temperature, 15 to 30°C (59 to 86°F). Protect from freezing. Protect from light. Because evaporation can occur through the unprotected polyethylene unit dose vial and prolonged exposure to direct light can modify the product, the unit dose vial should be kept in the protective foil overwrap and used within one month after the foil package has been opened. Keep out of Reach of Children. Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312 www.amringusa.com The Amring Logo and the “A” Logo are trademarks of Amring Pharmaceuticals Inc. Manufactured by: Holopack Verpackungstechnik GmbH, Bahnhofstrasse 18, 74429 Sulzbach-Laufen, Germany Origin Germany Rev. 11/2021 006-00423

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TIMOPTIC IN OCUDOSE- TIMOLOL MALEATE SOLUTION
AMRING PHARMACEUTICALS INC.
----------
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
0.25% AND 0.5%
PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION in a Sterile Ophthalmic
Single-Dose Vial
DESCRIPTION
Timolol maleate USP is a non-selective beta-adrenergic receptor
blocking agent. Its
chemical name is
(-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-
propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric
carbon atom in
its structure and is provided as the levo-isomer. The optical rotation
of timolol maleate is:
[α]
25°
405 nm
in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -
12.5°)
Its molecular formula is C
H
N O S•C H O and its structural formula is:
Timolol maleate has a molecular weight of 432.50. It is a white,
odorless, crystalline
powder which is soluble in water, methanol, and alcohol. Timolol
maleate is stable at
room temperature.
Timolol maleate ophthalmic solution is supplied in two formulations:
timolol maleate
ophthalmic solution, which contains the preservative benzalkonium
chloride; and timolol
maleate ophthalmic solution, the preservative-free formulation.
Preservative-free timolol maleate ophthalmic solution, USP is supplied
in a single-dose
vial, as a sterile, isotonic, buffered, aqueous solution of timolol
maleate in two dosage
strengths: Each mL of preservative-free timolol maleate ophthalmic
solution USP 0.25%
contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the
solution is
13
24
4
3
4
4
4
approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of
Preservative-free
timolol maleate ophthalmic solution USP 0.5% contains 5 mg of timolol
(6.8 mg of timolol
maleate). Inactive ingredients: monobasic and dibasic sodium
phosphate, sodium
hydroxide to adjust pH, and water for injection.
CLINICAL PHARMACOLOGY
_Mechanism of Action_
Timolol maleate USP is a beta and beta (non-selective) adrenergic
receptor blocking
agent that does not have significant intrinsic sympathomimetic, direct
myocardial
depressant,