Homatropine Hydrobromide Ophthalmic Solution, USP

Manufacturer: Altaire Pharmaceuticals Inc.
Effective date: 2022-10-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 20:44:41

Label at a glance#

ProductHOMATROPINE HYDROBROMIDE OPHTHALMIC

Active ingredientHOMATROPINE HYDROBROMIDE

Label structure12 sections

Indications and uses

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

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.

Contacts and useful links#

PhoneLabel contact(800)-258-2471

Label contents#

Full prescribing information#

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:

The chemical structure for Benzeneacetic acid.

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:

INDICATIONS & USAGE SECTION

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

CONTRAINDICATIONS:

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.

WARNING:

WARNINGS SECTION

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:

PRECAUTIONS SECTION

General.

GENERAL PRECAUTIONS SECTION

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.

INFORMATION FOR PATIENTS SECTION

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:

ADVERSE REACTIONS SECTION

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 SECTION

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.

NURSING MOTHERS SECTION

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:

PEDIATRIC USE SECTION

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 SECTION

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 SECTION

Homatropine hydrobromide is an anticholinergic prepared as a sterile topical ophthalmic solution.

CLINICAL PHARMACOLOGY:

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).

Carcinogenesis, Mutagenesis, Impairment of Fertility:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

There have been no long-term studies done using homatropine hydrobromide in animals to evaluate carcinogenic potential.

HOW SUPPLIED:

HOW SUPPLIED SECTION

5mL size in a white plastic bottle
5mL - NDC 59390-192-05

Storage:

STORAGE AND HANDLING SECTION

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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
992757	homatropine HBr 5 % Ophthalmic Solution	PSN	5
992757	homatropine hydrobromide 50 MG/ML Ophthalmic Solution	SCD	5
992757	homatropine hydrobromide 5 % Ophthalmic Solution	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HOMATROPINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20200721

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
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9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59390-192-05	HOMATROPINE HYDROBROMIDE OPHTHALMIC	5 mL in 1 BOTTLE, PLASTIC	SOLUTION	5		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59390-192	HOMATROPINE HYDROBROMIDE OPHTHALMIC (HOMATROPINE HYDROBROMIDE) SOLUTION [ALTAIRE PHARMACEUTICALS INC.]	5	Legacy NDC, 1 package rows	20221101_f3ffd601-182f-4f04-b1cc-8175bc2e32fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59390-192-05	ML - Milliliter	59390-192	3adde5d7-c07f-452b-9727-fa07a0c97558	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HOMATROPINE HYDROBROMIDE	ACTIVE INGREDIENT	BEW7469QZ0	2
HOMATROPINE	ACTIVE MOIETY	8QS6WCL55Z	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

HOMATROPINE HYDROBROMIDE OPHTHALMIC
Homatropine Hydrobromide
HOMATROPINE
BENZALKONIUM CHLORIDE
BORIC ACID
EDETATE DISODIUM
POTASSIUM CHLORIDE
WATER
SODIUM CARBONATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59390-192	59390-192-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HOMATROPINE HYDROBROMIDE	BEW7469QZ0	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
POTASSIUM CHLORIDE	660YQ98I10	IACT
WATER	059QF0KO0R	IACT
SODIUM CARBONATE	45P3261C7T	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 164 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	GUM, CHEWING / BUCCAL		720 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	SUSPENSION / ORAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	POWDER / NASAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	INJECTION, SOLUTION / INTRAVENOUS		330 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.53 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SHAMPOO / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION/ DROPS / OPHTHALMIC		48 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	TABLET / ORAL		231 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET, FILM COATED / ORAL		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOAP / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	INJECTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET, DELAYED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SOLUTION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / TOPICAL	1.3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / AURICULAR (OTIC)	0 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	660YQ98I10	SOLUTION / OPHTHALMIC	0.22 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / NASAL	40.46 mg/100ml		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CARBONATE	SODIUM CARBONATE	45P3261C7T	TABLET / SUBLINGUAL		8 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	GEL / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	SUSPENSION / AURICULAR (OTIC)	0.6 %w/v		Exact identifier — unii candidate 17 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HOMATROPINE HYDROBROMIDE OPHTHALMIC	HOMATROPINE HYDROBROMIDE	Altaire Pharmaceuticals Inc.	f3ffd601-182f-4f04-b1cc-8175bc2e32fe	2022-10-28	Warnings, Adverse reactions	Exact identifier ndc (package): 59390-192-05 ndc (product): 59390-192 ndc11 (package): 59390019205 spl id: 5190a5bc-5820-4874-bbe7-32576266a72f spl set id: f3ffd601-182f-4f04-b1cc-8175bc2e32fe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.