TIMOLOL MALEATE- timolol solution/ drops

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Timolol (UNII: 817W3C6175) (Timolol Anhydrous - UNII:5JKY92S7BR)

Beschikbaar vanaf:

Akorn

Toedieningsweg:

OPHTHALMIC

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

Preservative-Free Timolol Maleate Ophthalmic Solution USP, 0.5% 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 17478-189-24        0.3 mL Single-dose vials in package 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. AKORN Manufactured for: Akorn, Inc. Lake Forest, IL 60045 Made in France TMO00N       Rev. 04/19

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TIMOLOL MALEATE- TIMOLOL SOLUTION/ DROPS
AKORN
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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 is supplied in two formulations:
timolol maleate
ophthalmic solution, which contains the preservative benzalkonium
chloride; and timolol
maleate ophthalmic solution, 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: 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
sodium phosphate monohydrate and dibasic sodium phosphate anhydrous,
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
13
24
4
3
4
4
4
1
2
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