For the use only of Registered Medical Practitioners or a Hospital or a Laboratory DERMOCALM LOTION. Calamine and Light Liquid Paraffin Lotion

Transcription

1 For the use only of Registered Medical Practitioners or a Hospital or a Laboratory DERMOCALM LOTION and Light Liquid Paraffin Lotion QUALITATIVE AND QUANTITATIVE COMPOSITION * IP Light Liquid Paraffin IP in a lotion base 8.0 % w/w 10.0 % w/w * is Zinc Oxide with a small proportion of ferric oxide. PHARMACEUTICAL FORM Lotion. CLINICAL PARTICULARS Therapeutic Indications DERMOCALM LOTION is indicated for use as an anti-pruritic and smoothening agent. Posology and Method of Administration Adults For Topical/cutaneous use. Dermocalm lotion to be applied gently on the affected area of the skin. Apply on the affected zone as many times as required. Children Elderly Renal impairment Hepatic impairment 1

2 Contraindications DERMOCALM LOTION is contraindicated in hypersensitivity to any of the ingredients of this product. Special warnings and Special Precautions for Use X-ray examination: should not be applied onto the skin before an X-ray examination because it may affect the outcome of the radiograph. Light liquid paraffin should be used with caution in patients with a known hypersensitivity or allergy to light liquid paraffin or to any of the excipients in the preparation. Discontinue use, if skin irritation occurs. Avoid entry of Dermocalm lotion in the eyes or mouth. Interaction with Other Medicaments and Other Forms of Interaction Benzyl penicillin Zinc oxide is incompatible with benzyl penicillin. Fatty acids Zinc oxide reacts slowly with fatty acid in oils and fats to produce the corresponding fatty acid esters. No drug interaction studies have been conducted with cutaneous light liquid paraffin. Considering the low level of systemic absorption, drug interactions are unlikely to occur. Pregnancy and Lactation Fertility Pregnancy and Lactation The safety of DERMOCALM LOTION during pregnancy and lactation has not been established. No adverse effects have been reported with calamine. No effects of light liquid paraffin during pregnancy are anticipated, since systemic exposure to light liquid paraffin is expected to be low. It is not known if light liquid paraffin is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. 2

3 Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast feeding. Effects on Ability to Drive and Use Machines Undesirable effects Light liquid paraffin Adverse drug reactions (ADR) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common ( 1/10), common ( 1/100 to <1/10), uncommon ( 1/1,000 to <1/100), rare ( 1/10,000 to <1/1,000) and very rare (<1/10,000), including isolated reports. Post marketing data: Skin and subcutaneous Tissue Disorders Rare: Application site reactions including application site irritation, rash, erythema, pruritus. Immune System Disorders Rare: Application site hypersensitivity reactions including application site dermatitis. Overdose Symptoms and signs There are no relevant data available for calamine. The product is intended for cutaneous use only Accidental ingestion of light liquid paraffin may cause gastrointestinal irritation with nausea, vomiting and diarrhea. Treatment No special procedures or anti-dote is likely to be necessary. In case of overuse wash off with soap and hot water. In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available. PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Pharmacotherapeutic Group 3

4 : Emollients and protectives; ATC Code: D02AB. Light Liquid Paraffin: Dermatologicals, other emollients and protectives; ATC code: D02AX. Mechanism of Action/ Pharmacodynamic effects has a mild astringent antipruritic and soothing action on the skin. has astringent effects in the skin or mucous membranes by coagulating protein. The protein precipitates which forms a protective coat, allowing new tissue to regenerate underneath. It is commonly used to reduce the extent of weeping in dermatitis and to check oozing and discharge in other mild disorders. Light Liquid Paraffin Light liquid paraffin exerts an emollient effect by forming an occlusive film on the stratum corneum. Pharmacokinetic Properties is unlikely to be absorbed through the skin. Light Liquid Paraffin There have been no studies to investigate the pharmacokinetics of cutaneously applied light liquid paraffin. It is chemically and biologically inert; systemic uptake is considered to be minimal (<1%). Preclinical safety data PHARMACEUTICAL PARTICULARS List of excipients Aloe Vera gel, Glycerin, Bentonite, Brij S2-SO-(TH), Brij-S21-FL-(TH), Silicone Oil 350 cs, Dow corning 1403 fluid, Magnesium Aluminium Silicate, Perfume composition 12447, Citric Acid Monohydrate, Methylparaben, Propylparaben. Incompatibilities Shelf life 4

5 The expiry date is indicated on the label and packaging. Special Precautions for Storage Store at a temperature not exceeding 30 C. Do not freeze Keep out of reach of children. Nature and Specifications of Container Bottle in a carton. All pack presentations may not be marketed in the country. Instruction for Use/Handling: For external use only. Shake the bottle before use. There are no other special requirements for use or handling of this product. For further information please contact: GlaxoSmithKline Pharmaceuticals Limited Registered Office Dr Annie Besant Road, Worli, Mumbai India. Trade marks are owned by or licensed to the GSK group of companies Version: DER/PI/IN/2018/ 02 dated 05 Sep 2018 Adapted from NCDS v 02 dated 08-June-2012 and Light Liquid Paraffin GDS 01 dated 24-September