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NDC 59390-0192-05 HOMATROPINE HYDROBROMIDE OPHTHALMIC 50 mg/mL Details
HOMATROPINE HYDROBROMIDE OPHTHALMIC 50 mg/mL
HOMATROPINE HYDROBROMIDE OPHTHALMIC is a OPHTHALMIC SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Altaire Pharmaceuticals Inc.. The primary component is HOMATROPINE HYDROBROMIDE.
Product Information
| NDC | 59390-0192 |
|---|---|
| Product ID | 59390-192_5190a5bc-5820-4874-bbe7-32576266a72f |
| Associated GPIs | 86350030102010 |
| GCN Sequence Number | 007871 |
| GCN Sequence Number Description | homatropine Hbr DROPS 5 % OPHTHALMIC |
| HIC3 | Q6J |
| HIC3 Description | MYDRIATICS |
| GCN | 33012 |
| HICL Sequence Number | 003465 |
| HICL Sequence Number Description | HOMATROPINE HBR |
| Brand/Generic | Generic |
| Proprietary Name | HOMATROPINE HYDROBROMIDE OPHTHALMIC |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Homatropine Hydrobromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | HOMATROPINE HYDROBROMIDE |
| Labeler Name | Altaire Pharmaceuticals Inc. |
| Pharmaceutical Class | Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 59390-0192-05 (59390019205)
| NDC Package Code | 59390-192-05 |
|---|---|
| Billing NDC | 59390019205 |
| Package | 5 mL in 1 BOTTLE, PLASTIC (59390-192-05) |
| Marketing Start Date | 2018-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f3ffd601-182f-4f04-b1cc-8175bc2e32fe Details
SPL UNCLASSIFIED SECTION
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:
DOSAGE AND ADMINISTRATION:
CONTRAINDICATIONS:
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).
PRECAUTIONS:
General.
To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after installation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Excessive topical use of this drug can potentially lead to a confusional state characterized by delirium, agitation, and rarely coma. This state is more apt to occur in the pediatric and geriatric age groups. The specific anti-dote for this systemic anticholinergic syndrome is injectable physostigmine salicylate.
Information to Patients.
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 tip to any surface, as this may contaminate the solution.
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.
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.
DESCRIPTION:
CLINICAL PHARMACOLOGY:
HOW SUPPLIED:
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| HOMATROPINE HYDROBROMIDE OPHTHALMIC
homatropine hydrobromide solution |
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| Labeler - Altaire Pharmaceuticals Inc. (786790378) |