TIMOPTIC IN OCUDOSE- timolol maleate solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Bausch Health US LLC

INN (Algemene Internationale Benaming):

TIMOLOL MALEATE

Samenstelling:

TIMOLOL ANHYDROUS 3.4 mg in 1 mL

Toedieningsweg:

OPHTHALMIC

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Preservative-free TIMOPTIC in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free TIMOPTIC in OCUDOSE may be used when a patient is sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable. Preservative-free TIMOPTIC in OCUDOSE 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.

Product samenvatting:

Preservative-free Sterile Ophthalmic Solution TIMOPTIC® in OCUDOSE® is a clear, colorless to light yellow solution. Preservative-free TIMOPTIC, 0.25% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 0187-1498-25; 60 Individual Unit Doses. Preservative-free TIMOPTIC, 0.5% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 0187-1496-05; 60 Individual Unit Doses. 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 container and prolonged exposure to direct light can modify the product, the unit dose container should be kept in the protective foil overwrap and used within one month after the foil package has been opened. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Laboratoire Unither Zl de la Guérie F-50211 Coutances Cedex France ® /™ are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2020 Bausch & Lomb Incorporated or its affiliates Revised: 01/2020 65NOT8556/C 9390303

Autorisatie-status:

New Drug Application

Productkenmerken

TIMOPTIC IN OCUDOSE- TIMOLOL MALEATE SOLUTION
BAUSCH HEALTH US LLC
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TIMOPTIC IN OCUDOSE 0.25% AND 0.5%
(TIMOLOL MALEATE OPHTHALMIC SOLUTION)
PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION IN A STERILE OPHTHALMIC
UNIT
DOSE DISPENSER
DESCRIPTION
Timolol maleate 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:
Ophthalmic Solution TIMOPTIC
(timolol maleate ophthalmic solution), which contains the preservative
benzalkonium chloride; and
Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution),
the preservative-free
formulation.
Preservative-free Ophthalmic Solution TIMOPTIC is supplied in OCUDOSE
, a unit dose container,
as a sterile, isotonic, buffered, aqueous solution of timolol maleate
in two dosage strengths: Each mL
of Preservative-free TIMOPTIC in OCUDOSE 0.25% contains 2.5 mg of
timolol (3.4 mg of timolol
maleate). The pH of the solution is approximately 7.0, and the
osmolarity is 252-328 mOsm. Each mL of
Preservative-free TIMOPTIC in OCUDOSE 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
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_Mechanism of Action_
Timolol maleate is a beta and beta
(non-selective) adrenergic receptor blocking agent that does not
have signif