TIMOPTIC IN OCUDOSE- timolol maleate solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Bausch & Lomb Incorporated

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

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 24208-498-34; 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 24208-499-68; 60 Individual Unit Doses. Storage Store at room temperature, 15°C to 30°C (59°F 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 Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Laboratoire Unither 1 rue de l’Arquerie 50200 Coutances France TIMOPTIC and OCUDOSE are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates Revised: 01/2022 65NOT8556/D 9390305

Status de autorização:

New Drug Application

Características técnicas

TIMOPTIC IN OCUDOSE- TIMOLOL MALEATE SOLUTION
BAUSCH & LOMB INCORPORATED
----------
TIMOPTIC IN OCUDOSE
(TIMOLOL MALEATE OPHTHALMIC SOLUTION)
0.25% AND 0.5%
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:
Its molecular formula is C
H
N O S•C H O , and its structural formula is:
Timolol maleate has a molecular weight of 432.49. It is a white,
odorless, crystalline
powder which is soluble in water; sparingly soluble in ethanol;
slightly soluble in
chloroform; practically insoluble in ether. 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
®
®
13
24
4
3
4
4
4
®
®
®
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
_Mechanism of Action_
Timolol maleate is a beta and beta (non-selective) adrenergic receptor
blocking agent
that does not have significant intri