TIMOPTIC- timolol maleate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bausch & Lomb Incorporated

INN (International Name):

Timolol Maleate

Composition:

Timolol Anhydrous 2.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TIMOPTIC Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. TIMOPTIC 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. TIMOPTIC ® (tim-op´tik) (timolol maleate ophthalmic solution) 0.25% and 0.5% Read this Instructions for Use that comes with TIMOPTIC 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 TIMOPTIC: • Use TIMOPTIC exactly as your doctor tells you to use it. Your doctor will tell you how much TIMOPTIC to use and when to use it. • If

Product summary:

TIMOPTIC® (timolol maleate ophthalmic solution) is a clear, colorless to light yellow solution. TIMOPTIC 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 24208-812-05: 5 mL in a 7.5 mL capacity bottle TIMOPTIC 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 24208-813-05: 5 mL in a 7.5 mL capacity bottle NDC 24208-813-10: 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, TIMOPTIC can be used until the expiration date on the bottle. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA TIMOPTIC is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates Revised: 04/2022 9667803 (L-500346) 9667903 (L-500347)

Authorization status:

New Drug Application

Summary of Product characteristics

TIMOPTIC- TIMOLOL MALEATE SOLUTION
BAUSCH & LOMB INCORPORATED
----------
TIMOPTIC
0.25% AND 0.5%
(TIMOLOL MALEATE OPHTHALMIC SOLUTION)
DESCRIPTION
TIMOPTIC (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. TIMOPTIC is stable at room
temperature.
TIMOPTIC Ophthalmic Solution is supplied as a sterile, isotonic,
buffered, aqueous
solution of timolol maleate in two dosage strengths. Each mL of
TIMOPTIC 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
TIMOPTIC 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.
CLINICAL PHARMACOLOGY
®
®
13
24
4
3
4
4
4
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 to maintain adequate cardiac function.
Beta-adrenergic receptor blo