Ala Quin Cream

Name: Ala Quin Cream

Ala Quin Cream - Clinical Pharmacology

Iodochlorhydroxyquin is a broad-spectrum antibacterial and antifungal. Its precise mechanism of action is unknown. Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Precautions

General

Staining of skin and fabrics may occur. Additionally, there are rare reports of discoloration (yellowing) of hair and nails. Iodochlorhydroxyquin-Hydrocortisone may prove irritating to sensitized skin in rare cases. If irritation occurs, discontinue therapy. Check with physician if no improvement within 1 to 2 weeks.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Signs and symptoms of systemic toxicity, electrolyte imbalance, or adrenal suppression have not been reported with Iodochlorhydroxyquin-Hydrocortisone. Nevertheless, the possibility of suppression of the HPA axis during therapy should be kept in mind, especially when the drug is used under occlusive dressings, for a prolonged period, or for treating extensive cutaneous areas since significant absorption of corticosteroid may occur under these conditions, particularly in children and infants.

Patients receiving a large dose of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.

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 systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS – Pediatric Use)

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

Iodochlorhydroxyquin may be absorbed through the skin and interfere with thyroid function test.

Iodochlorhydroxyquin may cause significant elevation of protein-bound iodine (PBI) or butanol-extractable iodine (BEI) and a decrease in radioactive iodine (RAI) uptake. If such tests are contemplated, wait at least one month between discontinuation of therapy and performance of these tests.

Prolonged use may result in overgrowth of nonsusceptible organisms requiring appropriate therapy. In the presence of systemic infections, appropriate systemic antibiotics should be used.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

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

Nursing Mothers

It is not known whether topical administration of this drug 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 this class of drug is administered to a nursing woman.

Pediatric Use

Use is not recommended for infants or children up to 2 years of age.

Iodochlorhydroxyquin may produce false-positive ferric chloride test results for phenylketonuria (PKU) if iodochlorhydroxyquin is present in the neonate’s diaper or urine.

Special care must be exercised in using this drug in a pediatric patient. It is recommended that only low-potency topical corticosteroids that are not fluorinated and that have a free 17-hydroxyl group be used in children unless there is a very specific indication for one or the other topical corticosteroids. 

As a general rule, pediatric therapy continuing for longer than 2 weeks and consisting of doses in excess of 2 daily applications (with low-potency corticosteroids) should be carefully evaluated by the physician. This is especially important if medication is applied to more than 5-10% of the body surface or if an occlusive dressing is used. A tight-fitting diaper or one covered with plastic pants may constitute an occlusive dressing.

Administration of topical corticosteroids to children 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.

Grams Label

NDC 0316-0123-80

Rx Only

ALA-QUIN ®

Hydrocortisone 0.5%

Iodochlorhydroxyquin 3% Cream

80 grams

WARNING: Keep out of reach of children.

For external use only. Not for ophthalmic use.

See crimp of tube for Lot Number and Expiration Date.

Each gram contains: 5 mg Hydrocortisone USP and 30 mg Iodochlorhydroxyquin USP in a cream base consisting of purified water, glycerin, cetyl alcohol, polysorbate 80, stearyl alcohol, sodium lauryl sulfate, cetyl palmitate and sorbic acid.

Usual Dosage: Apply as a thin film to the affected areas 2 to 4 times daily or as directed by physician. See package insert for full prescribing information.

TO OPEN: Use cap to puncture seal.

IMPORTANT: Do not use if seal has been punctured or is not visible.

Store at 20o-25 oC (68 o-77 oF) [See USP Controlled Room Temperature].

Protect from freezing.

Manufactured and Distributed by:

Crown Laboratories, Inc.

Johnson City, TN 37604

P4763.00

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