Crotocort

Crotocort

crotamiton

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Full Prescribing Info
Contents
Crotamiton.
Description
Cream: Each gram contains: Crotamiton 100 mg.
Lotion: Each ml contains: Crotamiton 100 mg.
Excipients/Inactive Ingredients: Cream: Methyl Paraben 0.025% and Propyl Paraben 0.015% as preservatives.
Lotion: Benzyl Alcohol 0.1% as preservative.
Action
Pharmacology: Mode or Mechanisms of Action: Antipruritic and acaricide.
Crotamiton penetrates easily into the skin without leaving the greasy or shiny deposit on the surface. The lotion is preferable for application to the hairy and exposed parts of the body and for use on weeping skin.
Indications/Uses
Pruritis (itching) of varying origin; Scabies (infestation of the skin by mites).
Dosage/Direction for Use
DIRECTIONS FOR USE: Pruritus: Crotamiton cream should be rubbed into the affected parts 2-3 times a day until itching has subsided. This also applies to the refractory cases requiring more prolonged treatment, as crotamiton is well tolerated by the skin. Patients using crotamiton as self-medication should consult a doctor if the itching still persists after 5 days' treatment.
Scabies: After the patient has first taken a warm bath, the skin should be well dried and crotamiton then rubbed into the entire body surface (excluding the face and scalp) until no traces of the preparation remain visible on the surface. The application should be repeated once daily, preferably in the evening, for total of 3 to 5 days depending on the response. When applying crotamiton, special attention should be paid to sites that are particularly susceptible to infestation by the mites (interdigital space, wrist, axillae and genitalia). Areas where there is pus formation should be covered with a dressing impregnated with crotamiton. While the treatment is in progress the patient may take a bath shortly before the next application. After completion of the treatment, a cleansing bath should be taken, followed by a change of bed-linen and under-clothing. In small children, crotamiton should never be applied more than once a day.
Overdosage
Symptoms and treatment for overdose and antitdote(s): Overdosage is unlikely, if accidentally ingested, gastric lavage should be performed.
Contraindications
Hypersensitivity to the active substance or excipients.
Special Precautions
Crotamiton should not be allowed to come into contact with the conjunctiva. Where such contact occurs by accident, the eye should be bathed with water. Treatment with the cream is contraindicated in acutely inflamed, weeping skin conditions or skin wounds owing to the danger of systemic absorption.
Use in Pregnancy and Lactation: Pregnancy category C, since the risk-benefit ratio in pregnancy is inadequately documented, use of crotamiton during pregnancy, particularly during the first trimester is not advised. It is not known whether the active substance passes into the breast milk.
Nursing mothers should, in all events, avoid applying crotamiton in the area of the nipples.
Use In Pregnancy & Lactation
Pregnancy category C, since the risk-benefit ratio in pregnancy is inadequately documented, use of crotamiton during pregnancy, particularly during the first trimester is not advised. It is not known whether the active substance passes into the breast milk.
Nursing mothers should, in all events, avoid applying crotamiton in the area of the nipples.
Adverse Reactions
Crotamiton is generally well-tolerated. Only in exceptional cases is irritation of the skin or contact allergy liable to occur; in such instances the preparation should be withdrawn.
Caution For Usage
Users instructions: Keep this medicine away from mouth because it may be harmful if swallowed.
Do not use more medication than prescribed.
Avoid contact with eyes or mucous membrane.
Proper administration: Read patient's instructions carefully before using.
If bath is taken before cream is used the skin should be well dried before application.
The lotion or cream should be applied in an amount sufficient to cover the entire body surface from chin down, and rub in well, especially in the body folds and creases, hands, feet (including soles), between fingers and toes and moist area (such as under arms and groins).
Do not wash the first coat of medication.
Apply a second coat of medication 24 hours after the first one.
Take a cleansing bath after 48 hours after the second application to remove medication.
To prevent re-infestation, put freshly washed or dry-cleaned clothing and change bedding. Concurrent treatment of sexual partner, especially and all household members may be required.
Storage
Store below 30°C.
Store in a tight, light resistant container.
Protect from light.
Shelf-Life: Cream: 3 years.
Lotion: 3 years.
MIMS Class
Topical Antihistamines/Antipruritics
ATC Classification
D04AX - Other antipruritics ; Used in the treatment of pruritus.
Presentation/Packing
Form
Crotocort cream 100 mg/g
Packing/Price
15 g x 1's
Form
Crotocort lotion 100 mg/mL
Packing/Price
120 mL x 1's
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