carbastat- Carbachol injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Carbachol (UNII: 8Y164V895Y) (Carbachol - UNII:8Y164V895Y)

Available from:

Novartis Ophthalmics

INN (International Name):

Carbachol

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

0.1 mg in 1 mL

Administration route:

INTRAOCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intraocular use for obtaining miosis during surgery. In addition, Carbastat® (Carbachol Intraocular Solution USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery. Should not be used in those persons showing hypersensitivity to any of the components of this preparation.

Product summary:

CARBASTAT (Carbachol Intraocular Solution, USP) 0.01% 1.5 mL sterile glass vials in cartons of 12 (12 x 1.5 mL) NDC 58768-735-12 Store at controlled room temperature 15°-30°C (59°-86°F). Rx only   Manufactured by OMJ Pharmaceuticals, Inc., San Germán, P.R. 00683 for Novartis Ophthalmics Duluth, GA 30097 5007-D March, 2001

Summary of Product characteristics

CARBASTAT- CARBACHOL INJECTION, SOLUTION
NOVARTIS OPHTHALMICS
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CARBAS TAT
CARBAS TAT
(CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%
DESCRIPTION
CARBASTAT (Carbachol Intraocular Solution, USP) 0.01% is a sterile
balanced salt solution of
carbachol for intraocular injection. The active ingredient is
represented by the structural formula:
Established name: Carbachol
Chemical name: Ethanaminium, 2-[(aminocarbonyl)oxy]-_N,N,N_
-trimethyl-, chloride.
Each mL contains: Active: Carbachol 0.01%.
Inactive: Sodium chloride 0.64%, potassium chloride 0.075%, calcium
chloride dihydrate 0.048%,
magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%,
sodium citrate dihydrate
0.17%, sodium hydroxide and/or hydrochloric acid to adjust pH
(5.0-7.5) and water for injection USP.
CLINICAL PHARMACOLOGY
Carbachol is a potent cholinergic (parasympathomimetic) agent which
produces constriction of the iris
and ciliary body resulting in reduction in intraocular pressure. The
exact mechanism by which
carbachol lowers intraocular pressure is not precisely known.
INDICATIONS AND USAGE
Intraocular use for obtaining miosis during surgery. In addition,
Carbastat
(Carbachol Intraocular
Solution USP) reduces the intensity of intraocular pressure elevation
in the first 24 hours after cataract
surgery.
CONTRAINDICATIONS
Should not be used in those persons showing hypersensitivity to any of
the components of this
preparation.
WARNINGS
®
®
®
®
For single-dose intraocular use only. Discard unused portion.
Intraocular carbachol 0.01% should be
used with caution in patients with acute cardiac failure, bronchial
asthma, peptic ulcer, hyperthyroidism,
G.I. spasm, urinary tract obstruction and Parkinson's disease.
PRECAUTIONS
CARCINOGENES IS
Studies in animals to evaluate the carcinogenic potential have not
been conducted.
PREGNANCY: CATEGORY C.
There are no adequate and well controlled studies in pregnant women.
Carbastat
should be used during
pregnancy only if the potential benefit justifies the potential risk
to the fetus.
NURSIN