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OtiRx Ear Drops

Generic Name: hydrocortisone, pramoxine hydrochloride, and chloroxylenol
Dosage Form: ear drops

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

OtiRx
Ear Drops

OtiRx Ear Drops Description

OtiRx™ Ear Drops is an anti-inflammatory, antimicrobial and local anesthetic solution for use in the external ear only.

Each 1 mL contains:

Hydrocortisone 10 mg
Pramoxine Hydrochloride 10 mg
Chloroxylenol 1 mg

Inactive Ingredients: Propylene Glycol and Isopropyl Alcohol.

Hydrocortisone (Cortisol)(Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-,(11β)–.) is an anti-inflammatory and antipruritic agent. Pramoxine (Morpholine, 4-[3-(4-butoxyphenoxy) propyl]-,hydrochloride), is a topical anesthetic. Chloroxylenol (4-Chloro-3,5-xylenol) is a wide spectrum antimicrobial agent.

OtiRx Ear Drops - Clinical Pharmacology

Hydrocortisone is a corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory action of topical corticosteroids is unclear. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically-administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pramoxine hydrochloride is a topical anesthetic which is chemically unrelated to procaine and the other "caines". It provides temporary relief from itching and pain by stabilizing the neuronal membranes of nerve endings with which it comes into contact.

Chloroxylenol in low concentrations is a germicide that may be used to treat bacterial and fungal infections. It is a halogenated phenol, non-toxic, non-corrosive, non-staining with a high phenol coefficient. It may be applied directly to a wound and shows no chemical reactivity toward blood.

Indications and Usage for OtiRx Ear Drops

For the treatment of superficial infections of the external ear caused by microbes, and to control the accompanying inflammation and itching.

Contraindications

Topical corticosteroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the components of this preparation. OtiRx™ Ear Drops should not be applied in the external auditory canal where there is a perforated eardrum or when this medication can reach the middle ear. This medication should not be used on a child who has an ear tube(s) in place.

Warnings

This product should be used with care in cases of long-standing otitis media because of the possible perforation of the eardrum concomitant with the external ear use of this product. This preparation is not intended for ophthalmic or oral use.

If irritation or sensitization occurs, promptly discontinue use of this preparation and institute other measures.

Precautions

General

Treatment should not be continued for longer than ten days and the source of infection and/or inflammation evaluated to determine whether therapy should be changed.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestation of Cushing's syndrome, hyperglycemia and glycosuria in some patients. Conditions which augment systemic absorption include the application of more potent steroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see Pediatric Use section below).

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

  1. The medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
  2. Do not use this medication for any disorder other than for which it has been prescribed. Check with your physician before using this medication for future ear problems.
  3. Report any signs of local adverse reactions to your physician.
  4. Keep this and all medication out of the reach of children.
  5. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
  6. Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect of topical corticosteroids on fertility. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate, and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically-administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface to body weight ratio. Cushing's syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestation of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regime. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, allergic contact dermatitis, skin atrophy, striae and miliaria.

Overdosage

Topically-applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. Treatment of overdosage should be symptomatic and supportive.

OtiRx Ear Drops Dosage and Administration

The external ear, that is the auricle and the auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. Four (4) to 5 drops of OtiRx™ Ear Drops should be instilled into the affected ear 3 or 4 times daily. The patient should lie with the affected ear upward to instill the drops and this position maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary for the opposite affected ear.

If preferred, a gauze ear plug or a wick may be inserted into the ear canal prior to applying OtiRx™ drops. When using a wick, a few drops of sterile water should be applied directly to the wick following insertion to facilitate hydration. It should then be saturated with OtiRx™. The patient should be instructed to add a few drops of OtiRx™ to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of OtiRx™ should continue to be instilled 3 or 4 times daily thereafter. When using a gauze is inserted into the ear canal to contain the medication. The gauze ear plug or expanded ear wick are easily removed using fingers, forceps or tweezers.

OtiRx™ may be used in the unaffected ear 3 times daily as a preventive.

How is OtiRx Ear Drops Supplied

OtiRx™, Ear Drops is supplied in plastic dropper bottles of 10 mL NDC# 51991-671-71.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage

Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature.

Protect from freezing. Protect from light.

Pharmacist: Dispense in original container.

Rx ONLY

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

Manufactured by:
Deltex Pharmaceuticals, Inc.
Rosenberg, TX 77471

MG #18719

ISS. 6/03
Rev. 01/09

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

Breckenridge
Pharmaceutical, Inc.

NDC 51991-671-71

OtiRx
Ear Drops

Hydrocortisone - Pramoxine
Chloroxylenol

Rx Only

10 mL Multi Dose

OTI RX 
hydrocortisone, pramoxine hydrochloride, and chloroxylenol liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-671
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (Hydrocortisone) Hydrocortisone 10 mg  in 1 mL
Pramoxine Hydrochloride (Pramoxine) Pramoxine Hydrochloride 10 mg  in 1 mL
Chloroxylenol (Chloroxylenol) Chloroxylenol 1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Propylene Glycol  
Isopropyl Alcohol  
Product Characteristics
Color WHITE (Clear) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-671-71 10 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2003 01/31/2012
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Deltex Pharmaceuticals 019851778 MANUFACTURE
Revised: 01/2011
 
Breckenridge Pharmaceutical, Inc.

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