CROTAN Lotion (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Marnel Pharmaceuticals, Inc.

Λέξεις κλειδιά

0682-0051

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1. Description

CROTAN (crotamiton USP 10%) is a scabicidal and antipruritic agent as a lotion for topical use only. Crotamiton is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible ...

2. Clinical Pharmacology

CROTAN lotion has scabicial and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application ...

3. Indications and Usage

For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.

4. Contraindications

CROTAN lotion should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.

5. Warnings

If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.

6.1. General

CROTAN lotion should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until acute inflammation has subsided. ...

6.2. Information for Patients

Directions for patients with scrabies: Take a routine bath or shower. Thoroughly massage CROTAN lotion into the skin from the chin to the toes including folds and creases. Put CROTAN lotion under ...

6.4. Drug Interactions

None known.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals have not been conducted.

6.7. Pregnancy

Pregnancy (Category C). Animal reproduction studies have not been conducted with CROTAN (crotamiton USP) lotion. It is also not known whether CROTAN can cause fetal harm when applied to a pregnant woman ...

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

6.11. Geriatric Use

Clinical studies with CROTAN (crotamiton USP) lotion did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported ...

7. Adverse Reactions

Primary inrritation reactions such as dermititis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients.

9. Overdosage

There is no specific informaton on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed. Accidental oral ingestion may be accompanied ...

10. Dosage and Administration

Shake well before use. In Scabies: Thoroughly massage into the skin of the whole body, from the chin down, paying particular attention to all folds and creases. A second application is advisable ...

11. How Supplied

CROTAN (crotamitan USP) lotion, 10% is available in: 2 fl oz ( NDC 0682-0051-20) 8 fl oz ( NDC 0682-0051-10) 16 lf oz ( NDC 0682-0051-30) KEEP OUT OF REACH OF CHILDREN.

12. Storage and Handling

Store 20° to 25°C (68°-77°F). Excursions allowed between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature].