TIMOLOL MALEATE solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

Timolol Maleate (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR)

Beszerezhető a:

Bausch & Lomb Incorporated

Az alkalmazás módja:

OPHTHALMIC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Timolol Maleate Sterile Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol Maleate Ophthalmic Gel Forming Solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see WARNINGS, Obstructive Pulmonary Disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure [see WARNINGS, Cardiac Failure ]; (7) cardiogenic shock; or (8) hypersensitivity to any component of this product. Timolol Maleate Ophthalmic Gel Forming Solution 0.25% and 0.5% Read this Instructions for Use that comes with Timolol Maleate Ophthalmic Gel Forming Solution 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 Timol

Termék összefoglaló:

Timolol Maleate Ophthalmic Gel Forming Solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous solution. Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% timolol equivalent, is supplied in a white low density polyethylene (LDPE) dispenser with a controlled drop tip and a yellow polypropylene cap as follows: NDC 24208-818-25 , 5 mL in a 7.5 mL capacity bottle. Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% timolol equivalent, is supplied in a white low density polyethylene (LDPE) dispenser with a controlled drop tip and a yellow polypropylene cap as follows: NDC 24208-819-05 , 5 mL in a 7.5 mL capacity bottle. Storage Store at 15° to 25°C (59° to 77°F). Avoid Freezing. Protect from light. Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2021 Bausch & Lomb Incorporated or its affiliates Revised: 02/2021 9753400

Engedélyezési státusz:

New Drug Application Authorized Generic

Termékjellemzők

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
BAUSCH & LOMB INCORPORATED
----------
STERILE OPHTHALMIC GEL FORMING SOLUTION
TIMOLOL MALEATE OPHTHALMIC
GEL FORMING SOLUTION
0.25% AND 0.5%
TIMOLOL MALEATE OPHTHALMIC
GEL FORMING SOLUTION
0.25% AND 0.5%
DESCRIPTION
Timolol Maleate Ophthalmic Gel Forming 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:
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 Sterile Ophthalmic Gel Forming Solution is supplied as
a sterile, isotonic,
buffered, aqueous solution of timolol maleate in two dosage strengths.
The pH of the
solution is approximately 7.0, and the osmolarity is 260-330 mOsm.
Each mL of Timolol
Maleate Ophthalmic Gel Forming Solution 0.25% contains 2.5 mg of
timolol (3.4 mg of
timolol maleate). Each mL of Timolol Maleate Ophthalmic Gel Forming
Solution 0.5%
contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive
ingredients: gellan gum,
tromethamine, mannitol, and water for injection. Preservative:
benzododecinium bromide
0.012%.
The gel forming solution contains a purified anionic
heteropolysaccharide derived from
13
24
4
3
4
4
4
gellan gum. An aqueous solution of gellan gum, in the presence of a
cation, has the
ability to gel. Upon contact with the precorneal tear film, Timolol
Maleate Ophthalmic Gel
Forming Solution forms a gel that is subsequently removed by the flow
of tears.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Timolol maleate is a beta and beta (non-selective) adrenergic receptor
blocking agent
that does not have sig