TIMOLOL MALEATE solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Timolol Maleate (UNII: P8Y54F701R) (Timolol Anhydrous - UNII:5JKY92S7BR)

Dostępny od:

Bausch & Lomb Americas Inc.

Droga podania:

OPHTHALMIC

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. Timolol Maleate Ophthalmic Solution 0.25% and 0.5% 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? Step 1. Wash

Podsumowanie produktu:

Timolol Maleate Ophthalmic Solution is a clear, colorless to light yellow solution. Timolol Maleate Ophthalmic Solution 0.25% timolol equivalent is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow polypropylene cap as follows: NDC 82260-812-05: 5 mL in a 7.5 mL capacity bottle Timolol Maleate Ophthalmic Solution 0.5% timolol equivalent is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow polypropylene cap as follows: NDC 82260-813-05: 5 mL in a 7.5 mL capacity bottle NDC 82260-813-10: 10 mL in a 10 mL capacity bottle Storage Store at 15°C to 25°C (59°F to 77°F). Protect from freezing. Protect from light. After opening, Timolol Maleate Ophthalmic Solution can be used until the expiration date on the bottle. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: 04/2022 9779400 (L-500346) 9779500 (L-500347)

Status autoryzacji:

New Drug Application Authorized Generic

Charakterystyka produktu

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
BAUSCH & LOMB AMERICAS INC.
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TIMOLOL MALEATE OPHTHALMIC SOLUTION
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, sparingly soluble in ethanol;
slightly soluble in
chloroform; practically insoluble in ether. 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. 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, and the osmolality is 260-340
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.
13
24
4
3
4
4
4
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.
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