TIMOLOL MALEATE- timolol maleate solution/ drops

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

NuCare Pharmaceuticals,Inc.

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

Timolol Maleate Ophthalmic Solution, 0.5% timolol equivalent, is supplied in a white opaque, plastic ophthalmic bottle with a controlled drop tip as follows: 2.5 mL, 5 mL, 10 mL and 15 mL. NDC 68071-1563-5 Bottle 5mL Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Protect from light. AKORN Manufactured By: Akorn, Inc. Lake Forest, IL 60045 TL00NS       Rev. 08/16

授权状态:

Abbreviated New Drug Application

产品特点

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
NUCARE PHARMACEUTICALS,INC.
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TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
Rx only
DESCRIPTION
Timolol maleate ophthalmic solution 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 nominal optical rotation of timolol
maleate is:
25°
[α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°)
405 nm
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:
TIMOLOL MALEATE OPHTHALMIC SOLUTION, 0.25%
EACH ML CONTAINS: ACTIVE: timolol maleate 3.4 mg, equivalent to 2.5 mg
timolol (0.25%). INACTIVES:
dibasic sodium phosphate, monobasic sodium phosphate, sodium hydroxide
to adjust pH and Water for
Injection, USP. The pH of the solution is approximately 7.0, and the
osmolarity is 274-328 mOsm.
PRESERVATIVE: benzalkonium chloride 0.1 mg (0.01%).
TIMOLOL MALEATE OPHTHALMIC SOLUTION, 0.5%
EACH ML CONTAINS: ACTIVE: timolol maleate 6.8 mg, equivalent to 5 mg
timolol (0.5%). INACTIVES:
dibasic sodium phosphate, monobasic sodium phosphate, sodium hydroxide
to adjust pH and Water for
Injection, USP. PRESERVATIVE: benzalkonium chloride 0.1 mg (0.01%).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Timolol maleate is a beta1 and beta2 (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 outpu