TIMOLOL MALEATE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Ascend Laboratories, LLC

Mode d'administration:

OPHTHALMIC

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.      Timolol Maleate Ophthalmic Solution 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 shook; or (8) hypersensitivity to any component of this product. Pediatric Use      Safety and effectiveness in pediatric patients have not been established. Geriatric Use      No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Descriptif du produit:

     Sterile ophthalmic solution of timolol maleate is a clear, colorless solution.      Timolol maleate ophthalmic solution USP, 0.25% timolol equivalent, is supplied in a translucent LDPE plastic ophthalmic dispenser with a yellow polystyrene cap NDC 67877-228-55 5 mL in a 5 mL bottle NDC 67877-228-11 10 mL in a 10 mL bottle NDC 67877-228-15 15 mL in a 15 mL bottle Timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in a translucent LDPE plastic ophthalmic dispenser with a yellow polystyrene cap NDC 67877-229-55 5 mL in a 5 mL bottle NDC 67877-229-11 10 mL in a 10 mL bottle NDC 67877-229-15 15 mL in 15 mL bottle

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
ASCEND LABORATORIES, LLC
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STERILE
OPHTHALMIC SOLUTION
TIMOLOL MALEATE
OPHTHALMIC SOLUTION
USP 0.25% AND 0.5%
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 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 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 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 approximately 7.0,
and the osmolarity is 274-328 mOsm. 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 chloride, sodium hydroxide to adjust pH, and water
for injection. 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.
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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 functi