Homatropine Hydrobromide
FDA Drug Information • Also known as: Homatropine Hydrobromide Ophthalmic
- Brand Names
- Homatropine Hydrobromide Ophthalmic
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
Description
DESCRIPTION: Homatropine hydrobromide is an anticholinergic prepared as a sterile topical ophthalmic solution.
What Is Homatropine Hydrobromide Used For?
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
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.
Side Effects (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.
Warnings and Precautions
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 ).
Contraindications
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.
Pregnancy and Breastfeeding
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
Overdosage
OVERDOSAGE: When signs and symptoms of homatropine toxicity develop (see adverse reaction section ), physostigmine should be administered parenterally (for dosage refer to Goodman & Gilman or other pharmacology reference). In infants and pediatric patients, the body surface must be kept moist.
How Supplied
HOW SUPPLIED: 5mL size in a white plastic bottle 5mL - NDC 59390-192-05 Storage: 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
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.