TIMOLOL MALEATE solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Akorn

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Timolol Maleate Ophthalmic Solution 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.

Produktu pārskats:

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 opaque, plastic ophthalmic bottle with a controlled drop tip as follows: 2.5 mL, 5 mL, 10 mL and 15 mL. Timolol Maleate Ophthalmic Solution, 0.5% timolol equivalent, is supplied in a white opaque, plastic ophthalmic bottle with a controlled drop tip as follows: 2.5 mL, 5 mL, 10 mL and 15 mL. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Protect from light. AKORN Manufactured By: Akorn, Inc. Lake Forest, IL 60045 TL00NS       Rev. 08/16

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

TIMOLOL MALEATE- TIMOLOL MALEATE SOLUTION/ DROPS
AKORN
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TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP
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
possesses an
asymmetric carbon atom in its structure and is provided as the
levo-isomer. The nominal
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:
TIMOLOL MALEATE OPHTHALMIC SOLUTION, 0.25%
EACH ML CONTAINS: ACTIVE: timolol maleate 3.4 mg, equivalent to 2.5 mg
timolol
(0.25%). INACTIVES: dibasic sodium phosphate, monobasic sodium
phosphate, sodium
hydroxide to adjust pH and Water for Injection, USP. The pH of the
solution is
approximately 7.0, and the osmolarity is 274-328 mOsm. PRESERVATIVE:
benzalkonium
chloride 0.1 mg (0.01%).
TIMOLOL MALEATE OPHTHALMIC SOLUTION, 0.5%
EACH ML CONTAINS: ACTIVE: timolol maleate 6.8 mg, equivalent to 5 mg
timolol (0.5%).
INACTIVES: dibasic sodium phosphate, monobasic sodium phosphate,
sodium hydroxide
to adjust pH and Water for Injection, USP. PRESERVATIVE: benzalkonium
chloride 0.1 mg
(0.01%).
CLINICAL PHARMACOLOGY
13
24
4
3
4
4
4
MECHANISM OF ACTION
Timolol maleate is a beta1 and beta2 (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 b