Oticin HC Ear Drops is an anti-inflammatory, antimicrobial and local anesthetic solution for use in the external ear only.
Each 10 mL for otic administration contains:
Hydrocortisone ……………….. 0.100 gm
Parachlorometaxylenol …..….. 0.010 gm
Proxazocain HCl …………..…. 0.100 gm
Hydrocortisone (11β, 17, 21-trihydroxy pregn-4-ene-3, 20-dione) is an anti-inflammatory and antipruritic agent.
Parachlorometaxylenol (4-chloro-3,5-xylenol) is a wide spectrum antimicrobial agent.
Proxazocain (p-butoxyphenyl γ-morpholinopropyl ether), used as the hydrochloride salt, is a topical anesthetic.
INACTIVE INGREDIENT
In a non aqueous vehicle containing edetate disodium EDTA, Poloxamer 188, propylene glycol, propylene glycol diacetate, propylgallate, and purified water.
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.
Parachlorometaxylenol 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.
Proxazocain HCl 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.
INDICATIONS AND USAGE
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. This medication should not be applied in the external auditory canal where there is a perforated eardrum or when this medication can reach the middle ear.
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 opthalmic 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 hypothalmic-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).
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
The medication is to be used as directed by the physician. It is for external use only. Avoid contact with eyes.
Do not use this medication for any disorder other than 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 medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Store at 15(- 30(C (59(- 86(F).
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
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-administration cortical steroids 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 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. Manifestations 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 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 amount to produce systemic effects. Treatment of overdosage should be symptomatic and supportive.
DOSAGE AND ADMINISTRATION
The external ear, that is the auricle and the auditory canal should be thoroughly cleansed and dried. Four (4) to 5 drops of Oticin HC Ear Drops should be instilled into the affected ear 3 or 4 times daily. For infants and small children, 3 drops are suggested because of the smaller capacity of the ear canal. 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 Oticin HC Ear 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 Oticin HC Ear Drops. The patient should be instructed to add a few drops of Oticin HC Ear Drops to the wick every four hours, and to remove the wick after 24 hours. Five (5) drops of Oticin HC Ear Drops should be instilled 3 or 4 times daily thereafter. When using a gauze ear plug, the external ear canal is first treated with drops of Oticin HC Ear Drops. Next, the gauze is inserted into the ear canal to contain the medication. The gauze ear plug or the expanded wick are easily removed using fingers, forceps, or tweezers.
This product may be used in the unaffected ear 3 times daily as a preventative.
HOW SUPPLIED
Oticin HC Ear Drops are supplied in plastic dropper bottles of 10 mL, NDC 68436-110-10.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Storage and Handling
Storage: Store at 15(- 30(C (59(- 86(F).
Pharmacist: Protect from light. Dispense in this container.
Rx Only
Manufactured for:
Teral, Inc.
Ponce, P.R. 00716
500387 Iss. 05/09
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Figure 1
Figure 2: Oticin HC Container Label
| OTICIN HC EAR DROPS pramoxine hcl / hydrocortisone / chloroxylenol solution/ drops | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 11/12/2009 | ||
| Labeler - Teral, Inc. (186958810) |
| Registrant - Teral, Inc. (186958810) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sovereign Pharmaceuticals, Ltd. | 623168267 | MANUFACTURE | |
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