HOMATROPINE HYDROBROMIDE OPHTHALMIC- homatropine hydrobromide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HOMATROPINE HYDROBROMIDE (UNII: BEW7469QZ0) (HOMATROPINE - UNII:8QS6WCL55Z)

Available from:

Altaire Pharmaceuticals Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A moderately long-acting mydriatic and cycloplegic for cycloplegic refraction and in the treatment of inflammatory conditions of the uveal tract. For pre and postoperative states when mydriasis is required. Use as an optical aid in some cases of axial lens opacities. Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g. narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.

Product summary:

5mL size in a white plastic bottle 5mL - NDC 59390-192-05 Store at 15° - 30°C (59°- 86°F). Caution: Federal (USA) law prohibits dispensing without prescription. Mfd. by: Altaire Pharmaceuticals, Inc Aquebogue, NY 11931                                                                   R05/13 F# 16545

Authorization status:

unapproved drug other

Summary of Product characteristics

HOMATROPINE HYDROBROMIDE OPHTHALMIC- HOMATROPINE
HYDROBROMIDE SOLUTION
ALTAIRE PHARMACEUTICALS INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HOMATROPINE HYDROBROMIDE OPHTHALMIC SOLUTION, USP
HOMATROPINE HYDROBROMIDE
OPHTHALMIC SOLUTION, USP
RX ONLY
ESTABLISHED NAME:
Homatropine Hydrobromide
CHEMICAL NAME:
Benzeneacetic acid, ɑ-hydroxy-, 8-methyl-8-azabicyclo
[3.2.1]-oct-3-yl ester,
hydrobromide, _endo_-(±)-. The active ingredient is represented by
the chemical
structure:
Each mL contains: Active: Homatropine Hydrobromide 5.0%. Preservative:
Benzalkonium Chloride 0.005%. Inactive: Boric Acid, Edetate Disodium,
Potassium
Chloride, Water for Injection. Boric Acid or Sodium Carbonate may be
added to adjust
the pH.
INDICATIONS AND USAGE:
A moderately long-acting mydriatic and cycloplegic for cycloplegic
refraction and in the
treatment of inflammatory conditions of the uveal tract. For pre and
postoperative
states when mydriasis is required. Use as an optical aid in some cases
of axial lens
opacities.
DOSAGE AND ADMINISTRATION:
For refraction, instill one or two drops topically in the eye(s). May
be repeated in five or
ten minutes if necessary. For uveitis, instill one or two drops
topically up to every three
to four hours. Individuals with heavily pigmented irides may require
larger doses.
CONTRAINDICATIONS:
Contraindicated in persons with primary glaucoma or a tendency toward
glaucoma, e.g.
narrow anterior chamber angle, and in those persons showing
hypersensitivity to any
component of this preparation.
WARNING:
For topical use only – not for injection. Risk-benefit should be
considered when the
following medical problems exist: keratoconus (Homatropine may produce
fixed dilated
pupil); Down’s syndrome, children with brain damage and the elderly
(increased
susceptibility). In infants and small children, use with extreme
caution. Excessive use in
pediatric