TIMOLOL MALEATE solution/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

REMEDYREPACK INC.

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Timolol Maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol Maleate 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.

Produkt oppsummering:

Timolol Maleate ophthalmic solution, USP is a clear, colorless to light yellow solution. Timolol Maleate ophthalmic solution, 0.25% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: Timolol Maleate ophthalmic solution, 0.5% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: Storage: Store at 15°-25°C (59°-77°F). Protect from freezing. Protect from light. Revised: 04/2017 © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Irvine, CA 92612 Made in the U.S.A. PHARMACIST - DETACH AND GIVE INSTRUCTIONS TO PATIENT Please detach at the perforation to separate the patient information.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
REMEDYREPACK INC.
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TIMOLOL MALEATE
OPHTHALMIC SOLUTION, USP 0.25% AND 0.5%
S TERILE
DESCRIPTION
Timolol Maleate ophthalmic solution 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 nominal 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 432.50. It is a white,
odorless, crystalline powder which is
soluble in water, methanol, and alcohol. Timolol Maleate ophthalmic
solution is stable at room
temperature.
Timolol Maleate ophthalmic solution is supplied as a sterile,
isotonic, buffered, aqueous solution of
Timolol Maleate in two dosage strengths: Each mL, for ophthalmic
administration, of 0.25% solution
contains 2.5 mg of timolol (3.4 mg of Timolol Maleate). The pH of the
solution is approximately 7.0.
Each mL, for ophthalmic administration, of 0.5% solution contains 5 mg
of timolol (6.8 mg of Timolol
Maleate). Inactive ingredients: monobasic and dibasic sodium
phosphate; hydrochloric acid and/or
sodium hydroxide to adjust pH; and purified water. Benzalkonium
chloride 0.01% is added as
preservative.
CLINICAL PHARMACOLOGY
Mechanism of Action: Timolol Maleate is a beta
and beta
(non-selective) adrenergic receptor
blocking agent that does not have significant intrinsic
sympathomimetic, direct myocardial depressant, or
local anesthetic (membrane-stabilizing) activity.
13
24
4
3
4
4
4
1
2
Beta-adrenergic receptor blockade reduces cardiac output in both
healthy subjects and patients with
heart disease. In patients with severe impairment of myocardial
function, beta-adrenergic receptor
blockade may inhibit the stimulatory effect of the sympathetic nervous
system necessary to maintain
adequate cardiac function.
Beta-ad