TIMOLOL MALEATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Bryant Ranch Prepack

DCI (Dénomination commune internationale):

TIMOLOL MALEATE

Composition:

TIMOLOL ANHYDROUS 10 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Timolol maleate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Timolol is indicated in patients who have survived the acute phase of myocardial infarction, and are clinically stable, to reduce cardiovascular mortality and the risk of reinfarction. Timolol is indicated for the prophylaxis of migraine headache. Timolol maleate is contraindicated in patients with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS); sinus bradycardia; second- and third-degree atrioventricular block; overt cardiac failure (see WARNINGS); cardiogenic shock; hypersensitivity to this product.

Descriptif du produit:

Product: 63629-7167 NDC: 63629-7167-1 30 TABLET in a BOTTLE NDC: 63629-7167-2 120 TABLET in a BOTTLE NDC: 63629-7167-3 18 TABLET in a BOTTLE NDC: 63629-7167-4 180 TABLET in a BOTTLE

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TIMOLOL MALEATE- TIMOLOL MALEATE TABLET
BRYANT RANCH PREPACK
----------
DESCRIPTION
Timolol maleate is a nonselective beta-adrenergic receptor blocking
agent. The chemical name for
timolol maleate is
(_S_)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-
propanol (_Z_)-2-butenedioate (1:1) salt. It possesses an asymmetric
carbon atom in its structure and is
provided as the levo isomer. 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 supplied as tablets containing 5 mg, 10 mg and 20
mg timolol maleate for oral
administration. Inactive ingredients are: colloidal silicon dioxide,
croscarmellose sodium, magnesium
stearate, microcrystalline cellulose, pregelatinized starch (corn),
sodium lauryl sulfate, FD&C Blue
No. 2 aluminum lake, and D&C Yellow No. 10 aluminum lake.
CLINICAL PHARMACOLOGY
Timolol maleate is a beta and beta (nonselective) adrenergic receptor
blocking agent that does not
have significant intrinsic sympathomimetic, direct myocardial
depressant, or local anesthetic activity.
PHARMACODYNAMICS
Clinical pharmacology studies have confirmed the beta-adrenergic
blocking activity as shown by (1)
changes in resting heart rate and response of heart rate to changes in
posture; (2) inhibition of
isoproterenol-induced tachycardia; (3) alteration of the response to
the Valsalva maneuver and amyl
nitrite administration; and (4) reduction of heart rate and blood
pressure changes on exercise.
Timolol decreases the positive chronotropic, positive inotropic,
bronchodilator, and vasodilator
responses caused by beta-adrenergic receptor agonists. The magnitude
of this decreased response is
proportional to the existing sympathetic tone and the concentration of
timolol at receptor sites.
In normal volunteers, the reduction in heart rate response to a
standard exercise was dose dependent
over the test range o