CARTEOLOL HYDROCHLORIDE solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

CARTEOLOL HYDROCHLORIDE (UNII: 4797W6I0T4) (CARTEOLOL - UNII:8NF31401XG)

Предлага се от:

Sandoz Inc

Начин на приложение:

OPHTHALMIC

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications. Carteolol is contraindicated in those individuals with bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease (see WARNINGS ); sinus bradycardia; second- and third-degree atrioventricular block; overt cardiac failure (see WARNINGS ); cardiogenic shock; or hypersensivity to any component of this product.

Каталог на резюме:

Carteolol Hydrochloride Ophthalmic Solution USP, 1% is supplied as a sterile ophthalmic solution in plastic dispenser bottles of 5 mL (NDC 61314-238-05), 10 mL (NDC 61314-238-10) and 15 mL (NDC 61314-238-15). Store at 15° to 25°C (59° to 77°F) (room temperature) and protect from light.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CARTEOLOL HYDROCHLORIDE- CARTEOLOL HYDROCHLORIDE SOLUTION
SANDOZ INC
----------
CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION USP, 1%
RX ONLY
STERILE
DESCRIPTION
Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective
beta-
adrenoceptor blocking agent for ophthalmic use.
The chemical name for carteolol hydrochloride is
(±)-5-[3-[(1,1-dimethylethyl) amino]-2-
hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The
structural
formula is as follows:
C
H
N O •HCI Mol. Wt. 328.84
Each mL of sterile solution contains ACTIVE: carteolol hydrochloride
10 mg (1%).
PRESERVATIVE: benzalkonium chloride 0.05 mg (0.005%). INACTIVES:
sodium chloride,
monobasic and dibasic sodium phosphate, sodium hydroxide and/or
hydrochloric acid
(to adjust pH to 6.0 - 8.0) and purified water.
CLINICAL PHARMACOLOGY
Carteolol is a nonselective beta-adrenergic blocking agent with
associated intrinsic
sympathomimetic activity and without significant membrane-stabilizing
activity.
Carteolol Hydrochloride reduces normal and elevated intraocular
pressure (IOP) whether
or not accompanied by glaucoma. The exact mechanism of the ocular
hypotensive
effect of beta-blockers has not been definitely demonstrated.
In general, beta-adrenergic blockers reduce cardiac output in patients
in good and poor
cardiovascular health. In patients with severe impairment of
myocardial function, beta-
blockers may inhibit the sympathetic stimulation necessary to maintain
adequate cardiac
16
24
2
3
function. Beta-adrenergic blockers may also increase airway resistance
in the bronchi
and bronchioles due to unopposed parasympathetic activity.
Given topically twice daily in controlled domestic clinical trials
ranging from 1.5 to 3
months, Carteolol Hydrochloride produced a median percent reduction of
IOP 22% to
25%. No significant effects were noted on corneal sensitivity, tear
secretion, or pupil
size.
INDICATIONS AND USAGE
Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be
effective in
lowering intraocular pressure and may be used