MIOSTAT- carbachol solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBACHOL (UNII: 8Y164V895Y) (Carbamoylcholine - UNII:54Z8M50D6Q)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

CARBACHOL

Composition:

CARBACHOL 0.1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP 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. Safety and efficacy in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Product summary:

In a 2.0 mL glass vial with a 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to a carton…………………………………………………………………………..NDC 0065-0023-15 STORAGE: Store at 15° - 30°C (59° - 86°F). © 2021 Alcon Inc. Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 300048977-0621

Authorization status:

New Drug Application

Summary of Product characteristics

MIOSTAT - CARBACHOL SOLUTION
ALCON LABORATORIES, INC.
----------
MIOSTAT™
(CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%
DESCRIPTION:
MIOSTAT™ (carbachol intraocular solution, USP) 0.01% is a sterile
balanced salt solution
of carbachol for intraocular injection. The active ingredient is
represented by the
chemical structure:
ESTABLISHED NAME: CARBACHOL
CHEMICAL NAME: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,Ntrimethyl-,
chloride.
MOLECULAR FORMULA: C H
CIN O
MOLECULAR WEIGHT: 182.65
EACH ML OF MIOSTAT™ (CARBACHOL INTRAOCULAR SOLUTION, USP)
0.01%CONTAINS:
ACTIVE: carbachol 0.01%.
INACTIVES: sodium chloride 0.64%, potassium chloride 0.075%, calcium
chloride
dehydrate 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) and Water for Injection. pH range is 6.5-7.5.
CLINICAL PHARMACOLOGY:
Carbachol is a potent cholinergic (parasympathomimetic) agent which
produces
6
15
2
2
constriction of the iris and ciliary body resulting in reduction in
intraocular pressure
(IOP). The exact mechanism by which carbachol lowers IOP is not
precisely known.
INDICATIONS AND USAGE:
Intraocular use for obtaining miosis during surgery. In addition,
MIOSTAT* (carbachol
intraocular solution, USP) 0.01% reduces the intensity of IOP
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. The vial stopper contains natural rubber (latex)
which may cause
severe allergic reactions.
PRECAUTIONS:
Use only if the container is undamaged.
CARCINOGENESIS:
Studies in animals to evaluate the carcinogenic potential have not
been conducted.
P