Vioform (Clioquinol)

VIOFORM®

Novartis Pharmaceuticals

Clioquinol

Antibacterial – Antifungal

Action And Clinical Pharmacology: Clioquinol is active against a broad spectrum of pathogenic microorganisms, including fungi (e.g., Candida, Microsporum, Trichophyton) and gram-positive bacteria (e.g., Staphylococci). Clioquinol has only a slight inhibitory effect on gram-negative bacteria. Clioquinol exerts a bacteriostatic, rather than a bactericidal action.

The antibacterial and antifungal properties of clioquinol have long been clinically established. Topically, clioquinol has demonstrated effectiveness in secondary skin infections and is compatible with many drugs commonly prescribed in the treatment of skin disorders.

Indications And Clinical Uses: Antimycotic and/or antibacterial treatment for nonextensive superficial dermatomycoses, infected forms of eczema, pyoderma, and mild burns.

The ointment is indicated for dry, crusted lesions.

In serious skin infections, the use of concomitant systemic antibacterial or antifungal agents may be indicated.

Contra-Indications: Known hypersensitivity to hydroxyquinolines, clioquinol, or other quinoline derivatives, iodine, as well as to any other components of the preparation (see Supplied).

Children: Clioquinol should not be used in children under 2 years of age.

Manufacturers’ Warnings In Clinical States: Pregnancy and Lactation: As in the case of any form of drug therapy, clioquinol should be used with caution during pregnancy, especially during the first 3 months.

It is not known whether the active substance passes into the breast milk when applied topically. The potential benefit of using this medication during pregnancy or lactation must be weighed against the possible hazard to the fetus or nursing infant.

Precautions: Application of clioquinol to relatively large and/or eroded areas of skin, treatment for longer than 1 week, as well as use under occlusive dressings may lead to a marked increase in protein-bound iodine (PBI) and should be avoided (see Overdose: Symptoms and Treatment).

If no improvement occurs within 1 week, the therapy should be discontinued; it is then advisable to identify and treat the causative pathogens.

Clioquinol should not be allowed to come into contact with the conjunctiva.

In patients suffering from hepatic and/or renal failure, caution is indicated.

Clioquinol may turn yellow when exposed to air and may stain fabric, hair, skin or nails.

Interactions : Topical use of clioquinol, as well as other iodine-containing compounds, may increase the amount of protein-bound iodine (PBI) in patients with normal thyroid function and therefore may interfere with some thyroid function tests (such as PBI, radioactive iodine and butanol-extractable iodine). These tests should not be performed within a period shorter than 1 month following the use of clioquinol. Other thyroid function tests, such as the T3 resin sponge test or the T4 determination, are unaffected by clioquinol.

The ferric chloride test for phenylketonuria may yield a false positive test when trace amounts of clioquinol are present in the urine.

Adverse Reactions: In rare cases, clioquinol may prove irritating to sensitized skins. If an exacerbation or allergic type reaction occurs, treatment should be discontinued.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Application to extensive or eroded areas of skin may lead to increased PBI values within 1 week. Elevated PBI values may also occur where relatively small areas of skin are treated for more than 1 week. If signs and symptoms resembling those of thyrotoxicosis occur, the preparation should be withdrawn at once. tag_DosageDosage

Dosage And Administration: Apply clioquinol to the affected area in a thin layer 2 to 3 times daily.

Use of clioquinol under occlusive dressings is not recommended in view of the presence of skin infection and also the possibility of an increase in PBI.

Availability And Storage: Each tube of off-white ointment contains: clioquinol 3%. Nonmedicinal ingredients: petrolatum and sorbitan esters. Bisulfite- and tartrazine-free. Tubes of 30 g. Protect from heat (store between 15 and 30°C). May turn yellow when exposed to air and may cause staining of the skin, nails, hair or fabrics.

VIOFORM® Novartis Pharmaceuticals Clioquinol Antibacterial – Antifungal

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