Homatropine Hydrobromide Ophthalmic
Homatropine Hydrobromide
Altaire Pharmaceuticals Inc.
Human Prescription Drug
NDC 59390-192Homatropine Hydrobromide Ophthalmic also known as Homatropine Hydrobromide is a human prescription drug labeled by 'Altaire Pharmaceuticals Inc.'. National Drug Code (NDC) number for Homatropine Hydrobromide Ophthalmic is 59390-192. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Homatropine Hydrobromide Ophthalmic drug includes Homatropine Hydrobromide - 50 mg/mL . The currest status of Homatropine Hydrobromide Ophthalmic drug is Active.
Drug Information:
| Drug NDC: | 59390-192 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Homatropine Hydrobromide Ophthalmic |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Homatropine Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Altaire Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HOMATROPINE HYDROBROMIDE - 50 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jun, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Altaire Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 992757
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | BEW7469QZ0
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Cholinergic Muscarinic Antagonist [EPC]
Cholinergic Muscarinic Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 59390-192-05 | 5 mL in 1 BOTTLE, PLASTIC (59390-192-05) | 01 Jun, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Homatropine hydrobromide ophthalmic homatropine hydrobromide homatropine hydrobromide homatropine benzalkonium chloride boric acid edetate disodium potassium chloride water sodium carbonate
Indications and 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.
Warnings:
Warning: for topical use only â not for injection. risk-benefit should be considered when the following medical problems exist: keratoconus (homatropine may produce fixed dilated pupil); downâs 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 ).
General 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.
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.
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.
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
Read more... 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.
Use in Pregnancy:
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.
Pediatric Use:
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.
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.
Description:
Description: homatropine hydrobromide is an anticholinergic prepared as a sterile topical ophthalmic solution.
Clinical Pharmacology:
Clinical pharmacology: 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). carcinogenesis, mutagenesis, impairment of fertility: there have been no long-term studies done using homatropine hydrobromide in animals to evaluate carcinogenic potential.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility: there have been no long-term studies done using homatropine hydrobromide in animals to evaluate carcinogenic potential.
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
Information for Patients:
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 childâs mouth and to wash their own hands and the childâs hands following administration. do not touch dropper tip to any surface, as this may contaminate the solution.
Package Label Principal Display Panel:
Principal display panel ndc 59390-192-05 homatropaire homatropine hydrobromide ophthalmic solution, usp 5% 5 ml- sterile rx only ndc 59390-192-05 homatropaire homatropine hydrobromide ophthalmic solution, usp 5% 5 ml- sterile rx only