TIMOLOL MALEATE solution/ drops

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Lifestar Pharma LLC

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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, USP 0.25% and 0.5% (tim oh lol mal ee ate) 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: - Use timolol maleate ophthalmic solution ex

Produkt oversigt:

Timolol maleate ophthalmic solution, USP is a clear, colorless solution. Timolol maleate ophthalmic solution 0.25% timolol equivalent is supplied in a Natural LDPE bottle with a Natural LDPE controlled drop tip and a Yellow HDPE cap as follows: NDC 70756-654-15                5 mL in a 5 mL capacity bottle NDC 70756-655-30                10 mL in a 10 mL capacity bottle Timolol maleate ophthalmic solution 0.5% timolol equivalent is supplied in a Natural LDPE bottle with a Natural LDPE controlled drop tip and a Yellow HDPE cap as follows: NDC 70756-656-15                5 mL in a 5 mL capacity bottle NDC 70756-657-30                10 mL in a 10 mL capacity bottle Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Protect from light. After opening, timolol maleate ophthalmic solution can be used until the expiration date on the bottle. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Germany Revised: May 2023, V-02

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
LIFESTAR PHARMA LLC
----------
STERILE OPHTHALMIC SOLUTION
TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.25% AND 0.5%
RX ONLY
DESCRIPTION
Timolol maleate ophthalmic solution, USP 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,
USP 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 to
almost white crystalline
powder which is soluble in water; sparingly soluble in ethanol;
slightly soluble in
chloroform; practically insoluble in ether. Timolol maleate ophthalmic
solution is stable at
room temperature.
Timolol maleate ophthalmic solution, USP 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 osmolality is 270-330
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
chloride, sodium hydroxide to adjust pH, and water for injection.
Benzalkonium chloride
0.01% is added as preservative.
CLINICAL PHARMACOLOGY
13
24
4
3
4
4
4
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 s