TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% solution/ drops TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% so

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Alembic Pharmaceuticals Inc.

Laluan pentadbiran:

OPHTHALMIC

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Timolol maleate 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 Timolol malea

Ringkasan produk:

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) screw neck bottle with a white low density polyethylene (LDPE) nozzle and high density polyethylene (HDPE) yellow screw cap as follows: NDC 62332-545-05, 5 mL in a 5 mL capacity bottle. Timolol maleate ophthalmic gel forming solution 0.5% timolol equivalent, is supplied in a white low density polyethylene (LDPE) screw neck bottle with a white low density polyethylene (LDPE) nozzle and high density polyethylene (HDPE) yellow screw cap as follows: NDC 62332-546-05, 5 mL in a 5 mL capacity bottle. Storage Store at 15° to 25°C (59° to 77°F). Avoid Freezing. Protect from light. TIMOPTIC is trademark of Bausch & Lomb Incorporated or its affiliates. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA. Made in India. Manufactured by: Gland Pharma Limited Hyderabad-500 043, INDIA. Revised: 06/2021.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% - TIMOLOL
MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.25% SOLUTION/ DROPS
TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% - TIMOLOL
MALEATE OPHTHALMIC GEL FORMING SOLUTION, 0.5% SOLUTION/ DROPS
ALEMBIC PHARMACEUTICALS INC.
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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 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
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