Crotamiton

Brand Names: Pruradik

Drug Class: General Prescription

Overview

CLINICAL PHARMACOLOGY: Pruradik ™ 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 have not been determined.

Mechanism of Action

CLINICAL PHARMACOLOGY: Pruradik ™ 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 have not been determined.

Indications

  • Pruradik ™ (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 with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203. 28. Crotamiton is N-ethyl-N(o-methyl-phenyl) 2-butenamide and its structural formula is: Pruradik lotion contains crotamiton USP 10% (100mg/ml) in a creamy lotion base containing purified water, light mineral oil, propylene glycol, cetearyl alcohol (and) cetearth-20, cetyl...

Common Doses

  • Refer to label

Dosage

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 24 hours later. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application. In Pruritis: Massage gently into affected areas until medication is completely absorbed. Repeat as needed. DIRECTIONS FOR PATIENTS WITH SCABIES: 1. Take a routine bath or shower.

Contraindications

  • CONTRAINDICATIONS: Pruradik 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.

Side Effects

  • ADVERSE REACTIONS: Primary irritation reactions such as dermatitis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients. To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma, LLC at 1-888-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Interactions

  • Drug Interactions: None known.