HOMATROPINE HYDROBROMIDE OPHTHALMIC
Generic: HOMATROPINE HYDROBROMIDE
Basic Information
Manufacturer
Altaire Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
f3ffd601-182f-4f04-b1cc-8175bc2e32fe
Indications & Usage
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.
For pre and postoperative states when mydriasis is required.
Use as an optical aid in some cases of axial lens opacities.
Warnings
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 patients or certain individuals with a history of susceptibility to belladonna alkaloids may produce systemic symptoms of homatropine poisoning (see overdose section ).
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 patients or certain individuals with a history of susceptibility to belladonna alkaloids may produce systemic symptoms of homatropine poisoning (see overdose section ).
Adverse Reactions
ADVERSE REACTIONS: Transient symptoms of stinging and burning may occur.
Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudates, and an eczematoid dermatitis.
Thirst or dryness of mouth, eye irritation not present before therapy, or increased sensitivity of eyes to light may occur.
To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc.
at (800)-258-2471.
Pregnancy.
Pregnancy Category C.
Animal reproduction studies have not been conducted with homatropine hydrobromide.
It is also not known whether homatropine hydrobromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Homatropine Hydrobromide should be given to a pregnant woman only if clearly needed.
Nursing Mothers.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when homatropine hydrobromide is administered to a nursing woman Pediatric Use: 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.
Safety and effectiveness in pediatric patients have not been established.
Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudates, and an eczematoid dermatitis.
Thirst or dryness of mouth, eye irritation not present before therapy, or increased sensitivity of eyes to light may occur.
To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc.
at (800)-258-2471.
Pregnancy.
Pregnancy Category C.
Animal reproduction studies have not been conducted with homatropine hydrobromide.
It is also not known whether homatropine hydrobromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Homatropine Hydrobromide should be given to a pregnant woman only if clearly needed.
Nursing Mothers.
It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when homatropine hydrobromide is administered to a nursing woman Pediatric Use: 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.
Safety and effectiveness in pediatric patients have not been established.