ocupress- carteolol hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

carteolol hydrochloride (UNII: 4797W6I0T4) (carteolol - UNII:8NF31401XG)

Available from:

Novartis Ophthalmics

INN (International Name):

carteolol hydrochloride

Pharmaceutical form:

SOLUTION

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ocupress 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. Ocupress Ophthalmic Solution 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 hypersensitivity to any component of this product.

Product summary:

Ocupress Ophthalmic Solution, 1%, is supplied as a sterile ophthalmic solution in plastic dispenser bottles of 5 mL (NDC 58768-001-01), 10 mL (NDC 58768-001-02) and 15 mL (NDC 58768-001-04). Store at 15° to 25°C (59° to 77°F) (room temperature) and protect from light. Rx Only Licensed under U.S. Patent Nos. 3910924 and 4309432. Made in Canada by: CIBA Vision Sterile Mfg., Mississauga, Ontario L5N 2X5 For: Novartis Ophthalmics, Duluth, Georgia 30097 I6138-B

Summary of Product characteristics

OCUPRESS- CARTEOLOL HYDROCHLORIDE SOLUTION
NOVARTIS OPHTHALMICS
----------
OCUPRES S
OCUPRESS
(CARTEOLOL HCL OPHTHALMIC SOLUTION)
1% STERILE
DESCRIPTION
Ocupress
(carteolol hydrochloride ophthalmic solution), 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:
Each mL contains 10 mg carteolol HCl and the inactive ingredients –
Benzalkonium chloride 0.05 mg
(0.005%) as a preservative; sodium chloride; sodium phosphate,
dibasic; sodium phosphate, monobasic;
and water for injection, USP. The product has a pH of 6.2 to 7.2
CLINICAL PHARMACOLOGY
Carteolol HCl is a nonselective beta-adrenergic blocking agent with
associated intrinsic
sympathomimetic activity and without significant membrane-stabilizing
activity.
Ocupress (carteolol HCl) 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
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, Ocupress
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
®
®
Ocupress 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 hyperte