HOMATROPINE HYDROBROMIDE - homatropine hydrobromide ophthalmic solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Homatropine Hydrobromide (UNII: BEW7469QZ0) (Homatropine - UNII:8QS6WCL55Z)

Available from:

OCuSOFT, 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.   Homatropine should not be used during the first three months of life due to a possible association between the cycloplegia produced and the development of amblyopia. Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child’s mouth and to wash their own hands and the child's hands following administration. Do not touch dropper

Product summary:

5 mL size in a white plastic bottle.

Authorization status:

unapproved drug other

Summary of Product characteristics

HOMATROPINE HYDROBROMIDE - HOMATROPINE HYDROBROMIDE OPHTHALMIC
SOLUTION
OCUSOFT, 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
DESCRIPTION SECTION
Homatropine hydrobromide is an anticholinergic prepared as a sterile
topical ophthalmic solution.
CHEMICAL NAME: Benzeneacetic acid, a-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 containes: 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 & USAGE SECTION
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.
CLINICAL PHARMACOLOGY SECTION
This anticholinergic preparation blocks the responses of the sphincter
muscle of the iris and the
accommodative muscle of the ciliary body to cholinergic stimulation,
producing pupillary dilation
(mydriasis) and paralysis of accommodation (cycloplegia).
CONTRAINDICATIONS SECTION
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.
PREGNANCY SECTION
Pregnancy Category C. Animal reproduction studies have not been
conducted with homatropine
hydrobromine. It is also not known whether homatropine hydrobromide
can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.
Homamtropine hydrobromide
should be given to a pregnant woman ony if clearly needed.
WARNINGS SE