TIMOLOL MALEATE solution/ drops

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

H.J. Harkins Company, Inc.

Tuyến hành chính:

OPHTHALMIC

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 shock; or (8) hypersensitivity to any component of this product. STERILE OPHTHALMIC SOLUTION TIMOLOL MALEATE OPHTHALMIC SOLUTION USP 0.25% AND 0.5% INSTRUCTIONS FOR USE Please follow these instructions carefully when using Timolol Maleate Ophthalmic Solution. Use Timolol Maleate Ophthalmic Solution as prescribed by your doctor. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after the use of Timolol Maleate Ophthalmic Solution. 2. Wash hands before eac

Tóm tắt sản phẩm:

Sterile ophthalmic solution of timolol maleate is a clear, colorless solution. Timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in a labeled translucent LDPE bottle with insert cap assembly comprising of a yellow colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust- cover sealing the bottle cap. NDC 76519-1163-0, 5 mL in a 5 mL bottle Storage Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F)[See USP controlled room temperature] Protect from freezing. Protect from light.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
H.J. HARKINS COMPANY, INC.
----------
1163 TIMOLOL MALEATE
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 C13H24N4O3S•C4H4O4 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.
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 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-adrenergic receptor blockade in the bronchi and bronchioles
results in increased airway resistanc