TIMOLOL MALEATE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Armas Pharmaceuticals, Inc.

Njia ya uendeshaji:

OPHTHALMIC

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable. Preservative-free 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.

Bidhaa muhtasari:

Preservative-free sterile timolol maleate ophthalmic solution USP is a clear, colorless to light yellow solution. Preservative-free timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in single-dose vial, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 72485-602-60; 0.3 mL Single-dose vials in a carton of 60. Storage Store at room temperature, 15° to 30°C (59° to 86°F). Protect from freezing. Protect from light. Because evaporation can occur through the unprotected polyethylene unit dose container and prolonged exposure to direct light can modify the product, the unit dose container should be kept in the protective foil overwrap and used within one month after the foil package has been opened. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 USA Manufactured by: Holopack Verpackungstechnik GmbH, Bahnhofstrasse 18, Sulzbach-Laufen, Germany 74429 for Sentiss Origin Germany Rev. 01/2023

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
ARMAS PHARMACEUTICALS, INC.
----------
TIMOLOL MALEATE OPHTHALMIC SOLUTION USP, 0.5%
PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION in a Sterile Ophthalmic
Single-
Dose Vial
DESCRIPTION
Timolol maleate 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:
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 is stable at
room temperature.
Timolol maleate ophthalmic solution USP is supplied as the
preservative-free formulation.
Preservative-free timolol maleate ophthalmic solution USP is supplied
in a single-dose vial,
as a sterile, isotonic, buffered, aqueous solution of timolol maleate
in one dosage
strength. The pH of the solution is approximately 7.0, and the
osmolarity is 252-328
mOsm. Each mL of preservative-free timolol maleate ophthalmic solution
USP, 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 water for
injection.
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
13
24
4
3
4
4
4
1
2
patients with heart disease. In patients with severe impairment of
myocardial function,
beta-adrenergic receptor blockade may inhibit the stimulatory effe