TIMOLOL MALEATE solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Timolol Maleate (UNII: P8Y54F701R) (Timolol Anhydrous - UNII:5JKY92S7BR)

Boleh didapati daripada:

Oceanside Pharmaceuticals

Laluan pentadbiran:

OPHTHALMIC

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Timolol Maleate Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. 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. Timolol Maleate Ophthalmic Solution 0.25% and 0.5% Read this Instructions for Use that comes with Timolol Maleate Ophthalmic 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 Maleate Ophthalmic Solution: How should I use Timolol Maleate Ophthalmic Solution? Step 1. Wash

Ringkasan produk:

Timolol Maleate Ophthalmic Solution is a clear, colorless to light yellow solution. Timolol Maleate Ophthalmic Solution 0.25% timolol equivalent is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow polypropylene cap as follows: NDC 68682-812-05: 5 mL in a 7.5 mL capacity bottle Timolol Maleate Ophthalmic Solution 0.5% timolol equivalent is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow polypropylene cap as follows: NDC 68682-813-05: 5 mL in a 7.5 mL capacity bottle NDC 68682-813-10: 10 mL in a 10 mL capacity bottle Storage Store at 15° to 25°C (59° to 77°F). Protect from freezing. Protect from light. Distributed by: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA © 2019 Valeant Pharmaceuticals North America LLC Revised: 01/2019 9668400 (L-500346) 9668500 (L-500347)

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION
OCEANSIDE PHARMACEUTICALS
----------
TIMOLOL MALEATE OPHTHALMIC SOLUTION
0.25% AND 0.5%
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:
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
Solution is stable at room
temperature.
Timolol Maleate Ophthalmic Solution is supplied as a sterile,
isotonic, buffered, aqueous solution of
timolol maleate in two dosage strengths. Each mL of Timolol Maleate
Ophthalmic Solution 0.25%
contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the
solution is approximately 7.0, and
the osmolarity is 260-340 mOsm/kg. Each mL of Timolol Maleate
Ophthalmic Solution 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 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
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
adeq