TIMOLOL MALEATE solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

REMEDYREPACK INC.

Toedieningsweg:

OPHTHALMIC

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Timolol maleate ophthalmic solution USP 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. The DROP-TAINER® bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER bottle, read the complete instructions carefully. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Timolol Maleate Ophthalmic Solution. 2. Wash hands before each use. 3. Before using the medication for the first time, be sure the Safety Seal on th

Product samenvatting:

Sterile timolol maleate ophthalmic solution USP is a clear, colorless solution. Timolol maleate ophthalmic solution, 0.25% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-226-05 5 mL NDC 61314-226-10 10 mL NDC 61314-226-15 15 mL Timolol maleate ophthalmic solution, 0.5% timolol equivalent, is supplied in a white, opaque, plastic ophthalmic dispenser with a controlled drop tip as follows: NDC 61314-227-05 5 mL NDC 61314-227-10 10 mL NDC 61314-227-15 15 mL Storage : Store at room temperature 15° - 30°C (59° - 86°F). Protect from freezing. Protect from light. * BLOCADREN is a registered trademark of Merck & Co., Inc. Rx Only 340048-0604 Revised: June 2004  

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
REMEDYREPACK INC.
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TIMOLOL MALEATE
OPHTHALMIC SOLUTION USP
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 optical rotation of timolol maleate
is:
[α] 25° 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 ophthalmic
solution USP is stable at room
temperature.
Timolol maleate ophthalmic solution is supplied as a sterile,
isotonic, buffered, aqueous solution of
timolol maleate in two do sage strengths: Each mL of timolol maleate
ophthalmic solution 0.25%
contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of
timolol maleate ophthalmic solution
0.5% contains 5.0 mg of timolol (6.8 mg of timolol maleate). Inactive
ingredients: monobasic and
dibasic sodium phosphate, sodium hydroxide to adjust pH (6.5 to 7.5),
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.
Beta-adrenergic receptor blockade reduces cardiac output in both
healthy subjects and patients with
13
24
4
3
4
4
4
1
2
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 blockad