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:

Sandoz Inc

Via de administração:

OPHTHALMIC

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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. Read this Instructions for Use that comes with timolol maleate ophthalmic solution before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Important information about timolol maleate ophthalmic solution: How should I use timolol maleate ophthalmic solution? The bottle is designed to assure the delivery of a precise dose of medication. Before

Resumo do produto:

Timolol maleate ophthalmic solution, USP is a clear, colorless solution. Timolol maleate ophthalmic solution, USP 0.25% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-226-05 5 mL NDC 61314-226-10 10 mL NDC 61314-226-15 15 mL Timolol maleate ophthalmic solution, USP 0.5% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-227-05 5 mL NDC 61314-227-10 10 mL NDC 61314-227-15 15 mL Storage Store at room temperature 15° to 30°C (59° to 86°F). Protect from freezing. Protect from light. After opening, timolol maleate ophthalmic solution can be used until the expiration date on the bottle.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
SANDOZ INC
----------
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
0.25% AND 0.5%
STERILE
RX ONLY
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:
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, USP is stable at room temperature.
Timolol maleate ophthalmic solution, USP is supplied as a sterile,
isotonic, buffered,
aqueous solution of timolol maleate in two dosage strengths. Each mL
of timolol maleate
ophthalmic solution 0.25% contains 2.5 mg of timolol (3.4 mg of
timolol maleate). The pH
of the solution is 6.5 to 7.5, and the osmolality is 280 to 320
mOsm/kg. Each mL of
timolol maleate ophthalmic solution 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 purified water. Benzalkonium chloride
0.01% is added as
preservative.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
25°
[α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°)
405 nm
13
24
4
3
4
4
4
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.
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 m