Pramoxine-HC

Ascend Laboratories, LLC

FULL PRESCRIBING INFORMATION

DESCRIPTION:
Each 1 mL for otic administration contains:
Hydrocortisone ......................................10 mg
Chloroxylenol ...........................................1 mg
Pramoxine HCl .......................................10 mg

Inactive ingredients: In an aqueous vehicle containing Isopropyl Alcohol and Propylene Glycol.
Hydrocortisone (cortisol) (11ß, 17,21-trihydroxy pregn-4-ene-3,20-dione) is an anti-inflammatory and antipruritic agent. Chloroxylenol is a broad spectrum bactericidal agent which occurs as white crystals with a phenolic odor. It is soluble in alcohol, ether and alkali hydroxides. Chemically it is (4-chloro-3,5-dimethyl phenol or meta-chloroxylenol). Pramoxine (4-[3-(butoxyphenoxy)propyl-]morpholine), used as the hydrochloride salt, is a topical anesthetic.

CLINICAL PHARMACOLOGY:
This product is effective as both an antibacterial and antifungal agent. Hydrocortisone is a corticosteroid which has anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory action of topical corticosteroids is not clear. 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 the systemically-administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Metabolized primarily in the liver, corticosteroids are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

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

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

Uses

INDICATIONS AND USAGE:
For the treatment of superficial infections of the external ear caused by microbes and to control the accompanying itching.

CONTRAINDICATIONS:
Topical corticosteroids are contraindicated in varicella, vaccinia and in patients sensitive to any of the ingredients. This medication should not be applied in the external auditory canal if there is a perforated eardrum or when this medication can reach the middle ear.

WARNINGS:
The 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 product is not intended for ophthalmic or oral use. If irritation or sensitization occurs, promptly discontinue use of this otic solution and institute other measures.

PRECAUTION:
Treatment should not be continued for longer than ten days and the source of infection and/or inflammation or sensitization 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 discontinuing 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 this medication should be advised of the following:

• This medication is to be used as directed by a physician.
• Do not use this medication for any disorder other than for which it was prescribed. Check with your physician before using this medication for future ear problems.
• Report any signs of local adverse reactions to your physician.
• Keep this and all medications out of the reach of children. In case of accidental overdose or ingestion, seek professional assistance or contact a poison control center immediately.
• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been performed to evaluate the carcinogenic or mutagenic potential of this product.

Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be used when topical corticosteroids are administered to nursing women.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of 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 regimen. 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 millaria.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:
The external ear and the ear canal should be thoroughly cleaned and dried. Four (4) to five (5) drops of Pramoxine-HC Otic Drops should be administered into the affected ear, 3 to 4 times daily. For infants and small children, three (3) drops are suggested because of the smaller ear canal. The patient should lie with the affected ear upward to administer the drops and remain in this position for at least 5 minutes to help the drops flow into the ear canal. Repeat in the opposite affected ear, if necessary. A gauze ear plug may be used, if preferred. Drops of Pramoxine-HC Otic Drops may be added to the gauze ear plug 3 or 4 times daily to keep the ear plug moist. The ear plug should be removed after one day of use.

The gauze ear plug should be easily removed using fingers, forceps or tweezers.

HOW SUPPLIED:
Pramoxine-HC Otic Drops are supplied as a clear liquid in 10 mL plastic dropper bottles, NDC 67877-269-11.

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

STORAGE: Protect from light, dispense in original container. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Manufactured for:
Ascend Laboratories, LLC
Montvale, NJ 07645

Rev. 08/11

ASCEND
Laboratories, LLC

NDC 67877-269-11       Rx Only

Pramoxine-HC
Otic Drops

Hydrocortisone ...............................10 mg
Chloroxylenol ....................................1 mg
Pramoxine HCl ................................10 mg

10 mL