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Clodan Kit

Clodan Kit Recall

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FDA Labeling Changes

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Uses

Clodan™ is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older (see PRECAUTIONS). Treatment should be limited to four consecutive weeks because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. The total dosage should not exceed 50g (50 mL or 1.75 fl. oz.) per week (see DOSAGE and ADMINISTRATION).

Patients should be instructed to use Clodan™, for the minimum time period necessary to achieve the desired results (see PRECAUTIONS).

Use in patients younger than 18 years of age is not recommended due to numerically high rates of HPA axis suppression (see PRECAUTIONS, Pediatric Use).

There were insufficient numbers of non-Caucasian patients to determine whether they responded differently than Caucasian patients with regards to efficacy and safety.

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History

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Other Information

Clodan™ (clobetasol propionate) Shampoo, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate.

Chemical Structure

Clobetasol propionate

Clobetasol propionate has a molecular weight of 466.97 (CAS Registry Number 25122-46-7). The molecular formula is C25H32CIFO5. Clobetasol propionate is a white to practically white crystalline, odorless powder insoluble in water.

Each mL of Clodan™ contains clobetasol propionate, 0.05%, in a shampoo base consisting of alcohol, coco-betaine, hydrochloric acid, polyquaternium-10, purified water, and sodium laureth sulfate.

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Clodan Kit Manufacturers

  • Medimetriks Pharmaceuticals
    Clodan Kit | Medimetriks Pharmaceuticals
    No Recall

    Clodan Kit | Medimetriks Pharmaceuticals

    Clodan Kit | Medimetriks Pharmaceuticals

    Clodan™ should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing.

    Move the hair away from the scalp so that one of the affected areas is exposed. Position the bottle over the lesion. Apply a small amount of the shampoo directly onto the lesion, letting the product naturally flow from the bottle (gently squeeze the bottle), avoiding any contact of the product with the facial skin, eyes or lips. In case of contact, rinse thoroughly with water. Spread the product so that the entire lesion is covered with a thin uniform film. Massage gently into the lesion and repeat for additional lesion(s). Wash your hands after applying Clodan™.

    Leave the shampoo in place for 15 minutes, then add water, lather and rinse thoroughly all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck and shoulders). Avoid contact with eyes and lips. Minimize contact to non-affected areas of the body. Although no additional shampoo is necessary to cleanse your hair, you may use a non-medicated shampoo if desired.

    Treatment should be limited to 4 consecutive weeks. As with other corticosteroids, therapy should be discontinued when control is achieved. If complete disease control is not achieved after four weeks of treatment with Clodan™, treatment with a less potent topical steroid may be substituted. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

    Clodan™ should not be used with occlusive dressings unless directed by a physician.

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