Hydrocortisone And Iodochlorhydroxyquin (Ala Quin)

Trade Name : Ala Quin

Crown Laboratories

CREAM

Strength 530 mg/gmg/g

HYDROCORTISONE; CLIOQUINOL Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydrocortisone And Iodochlorhydroxyquin (Ala Quin) which is also known as Ala Quin and Manufactured by Crown Laboratories. It is available in strength of 5; 30 mg/g; mg/g per ml. Read more

Hydrocortisone And Iodochlorhydroxyquin (Ala Quin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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For external use only.
Not for ophthalmic use.

Iodochlorhydroxyquin (Clioquinol) is an antifungal agent and a member of a family of drugs called hydroxyquinolines. Chemically, Iodochlorhydroxyquin is 5-chloro-7-iodo-quinolin-8-ol. Its structural formula is:
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Hydrocortisone is a member of this class. Chemically hydrocortisone is pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy, (11u03b2)-. Its structural formula is:
Each gram of ALA-QUIN 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.

Iodochlorhydroxyquin is a broad-spectrum antibacterial and antifungal. Its precise mechanism of action isu00a0unknown. Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanismu00a0of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, includingu00a0vasoconstrictor assays, are used to compare and predict potencies that a recognizable correlation exists betweenu00a0vasoconstrictor potency and therapeutic efficacy in man.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or otheru00a0information, FDA has classified the indications as follows:
u201cPossiblyu201d effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; infantile eczema;u00a0endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitisu00a0externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritusu00a0(vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis,u00a0pedis); moniliasis; intertrigo.
Final classification of the less-than-effective indications requires further investigation.

Hypersensitivity to lodochlorhydroxyquin-Hydrocortisone, or any of its ingredients or related compounds: lesionsu00a0of the eye, tuberculosis of the skin; most viral skin lesions (including herpes simplex, vaccinia, and varicella).
Patients sensitive to chloroxine, iodine, or iodine-containing preparations may also be sensitive to this medication.

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 Cushingu2019s 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 n )n
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.

Patients using Iodochlorhydroxyquin-Hydrocortisone should receive the following information and instructions:
1. This medication is to be used as directed by the physician.
2. This medication is for external use only. Do not use in or around the eyes.u00a0n This product is not for ophthalmic use.
3. Patients should be advised not to use this medication for any disorder other than for which it is prescribed.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test

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

Although topical steroids have not been reported to have an adverse effect on pregnancy, the safety of their useu00a0in pregnant women has not been absolutely established. Use of large amounts or for prolonged periods of timeu00a0is not recommended since systemic absorption may occur. In laboratory animals, increases in incidence of fetalu00a0abnormalities have been associated with exposure of gestating females to topical corticosteroids, in some casesu00a0at rather low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermalu00a0application in laboratory animals. There are no adequate and well-controlled studies in pregnant women onu00a0teratogenic effects from topical applied corticosteroids. Topical corticosteroids should be used during pregnancyu00a0only if the potential benefit justifies the potential risk to the fetus.
Therefore, drugs of this class should not be used extensively on pregnant patients in large amounts or foru00a0prolonged periods of time.

It is not known whether topical administration of this drug could result in sufficient systemic absorption tou00a0produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breastu00a0milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercisedu00a0when this class of drug is administered to a nursing woman.

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) ifu00a0iodochlorhydroxyquin is present in the neonateu2019s diaper or urine.
Special care must be exercised in using this drug in a pediatric patient. It is recommended that only low-potencyu00a0topical corticosteroids that are not fluorinated and that have a free 17-hydroxyl group be used in children unlessu00a0there is a very specific indication for one or the other topical corticosteroids.u00a0
As a general rule, pediatric therapy continuing for longer than 2 weeks and consisting of doses in excess ofu00a02 daily applications (with low-potency corticosteroids) should be carefully evaluated by the physician. This isu00a0especially important if medication is applied to more than 5-10% of the body surface or if an occlusive dressing isu00a0used. 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 anu00a0effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development ofu00a0children.

There have been a few reports of rash and hypersensitivity as well as thinning of the skin with easy bruising.
The following local adverse reactions have also been reported with topical corticosteroids and iodochlorhydroxyquinu00a0especially under occlusive dressings; burning; itching; irritation; dryness; folliculitis; blistering, peeling,u00a0redness, swelling; hypertrichosis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contactu00a0dermatitis; maceration of the skin, secondary infection; skin atrophy; striae; miliaria or other signs of irritation notu00a0present before therapy.
Discontinue therapy if any untoward reaction occurs.

Apply as a thin layer to the affected areas 2 to 4 times daily or as directed by a physician.

Store at 20n - 25n C (68n - 77n F) [See USP Controlled Room Temperature].n
Protect from freezing.

ALA-QUIN (Hydrocortisone USP, 0.5% and Iodochlorhydroxyquin USP, 3%) Cream is supplied in
1 ounce tube NDC 0316-0123-01
80 grams tube NDC 0316-0123-80n n
Revised: Oct. 2015
Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, Tennessee 37604
PRINTED IN USA
P8001.04

NDC 0316-0123-01
Rx Only
ALA-QUIN n n
Hydrocortisone 0.5%
Iodochlorhydroxyquin 3% Cream
1 oz (28.4 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:
Usual Dosage:
TO OPEN:
IMPORTANT:
Store at 20n -25n C (68n -77n F) [See USP Controlled Room Temperature].n
Protect from freezing.
Manufactured and Distributed by:
Crown Laboratories, Inc.
Johnson City, TN 37604
P6501.03

NDC 0316-0123-01
Rx Only
ALA-QUINn n
Hydrocortisone 0.5%
Iodochlorhydroxyquin 3% Cream
1 oz (28.4 grams)
WARNING: Keep out of reach of children.
For external use only.
Not for ophthalmic use.
Usual Dosage:
Each gram contains:
ufeffDirections for puncturing tube seal:
Store at 20n -25n C (68n -77n F) [See USP Controlled Room Temperature]. Protect from freezing.n
See end of carton for Lot Number and Expiration Date.
Manufactured and Distributed by:
Crown Laboratories, Inc.
Johnson City, TN 37604
P9003.01

NDC 0316-0123-80
Rx Only
ALA-QUIN u00ae
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:
Usual Dosage:
TO OPEN:
IMPORTANT:
Store at 20n- Arrayn- Arrayn- Arrayn- Array
Protect from freezing.
Manufactured and Distributed by:
Crown Laboratories, Inc.
Johnson City, TN 37604
P4763.00

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.
Usual Dosage:
Each gram contains:
Directions for puncturing tube seal:
Store at 20n -25n C (68n -77n F) [See USP Controlled Room Temperature]. Protect from freezing.n
See end of carton for Lot Number and Expiration Date.
Manufactured and Distributed by:
Crown Laboratories, Inc.
Johnson City, TN 37604
P4762.00

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Hydrocortisone And Iodochlorhydroxyquin (Ala Quin)

Trade Name : Ala Quin

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Hydrocortisone And Iodochlorhydroxyquin (Ala Quin)

Trade Name : Ala Quin

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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