TIMOLOL MALEATE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pacific Pharma, Inc.

INN (International Name):

TIMOLOL MALEATE

Composition:

TIMOLOL ANHYDROUS 2.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Timolol Maleate ophthalmic solution, USP is a clear, colorless to light yellow solution. Timolol Maleate ophthalmic solution, 0.25% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: Timolol Maleate ophthalmic solution, 0.5% timolol equivalent, is supplied sterile in opaque white LDPE plastic bottles with droppers with yellow high impact polystyrene (HIPS) caps as follows: Storage: Store at 15˚-25˚C (59˚-77˚F). Protect from freezing. Protect from light. Revised: 0 1/2024 Distributed for: AbbVie Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company. PHARMACIST - DETACH AND GIVE INSTRUCTIONS TO PATIENT Please detach at the perforation to separate the patient information.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
PACIFIC PHARMA, INC.
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TIMOLOL MALEATE
OPHTHALMIC SOLUTION, USP 0.25% AND 0.5%
STERILE
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 nominal
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 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, for
ophthalmic
administration, of 0.25% solution contains 2.5 mg of timolol (3.4 mg
of Timolol Maleate).
The pH of the solution is approximately 7.0. Each mL, for ophthalmic
administration, of
0.5% solution contains 5 mg of timolol (6.8 mg of Timolol Maleate).
Inactive ingredients:
monobasic and dibasic sodium phosphate; hydrochloric acid and/or
sodium hydroxide
to adjust pH; and purified water. 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.
13
24
4
3
4
4
4
1
2
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-