देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Menthol; Methyl salicylate
IDAMAN PHARMA MANUFACTURING SDN BHD
Menthol; Methyl salicylate
30 gm; 500 gm
IDAMAN PHARMA MANUFACTURING SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ DERMASAFE DEEP RUB OINTMENT Methyl Salicylate / Menthol (25% w/w / 5% w/w) 1 WHAT IS IN THIS LEAFLET 1. What Dermasafe Deep Rub Ointment is used for 2. How Dermasafe Deep Rub Ointment works 3. Before you use Dermasafe Deep Rub Ointment 4. How to use Dermasafe Deep Rub Ointment 5. While you are using Dermasafe Deep Rub Ointment 6. Side Effects 7. Storage and Disposal of Dermasafe Deep Rub Ointment 8. Product Description 9. Product Registration Holder and Manufacturer 10. Date of Revision WHAT DERMASAFE DEEP RUB OINTMENT IS USED FOR It is used for relief of minor aches and pains associated with: • Muscular pain and stiffness in simple backache • Lower back pain • Joint pain • Rheumatic conditions such as pain, swelling, stiffness and limited movement in joints, muscles and ligaments and other related condition. HOW DERMASAFE DEEP RUB OINTMENT WORKS This ointment contains 2 active ingredients which are Methyl Salicylate and Menthol. They work together to soothe and relieve minor pains. BEFORE YOU USE DERMASAFE DEEP RUB OINTMENT _- When you must not use it_ If you are allergy (hypersensitive) to any of ingredients in Dermasafe Deep Rub Ointment. _- Before you start use it_ Do not use Dermasafe Deep Rub Ointment on: • Infants below 2 years of age. • Avoid direct application into nostrils. There have been reports of cessation of breathing especially during sleep and instant collapse in infants following the local application of menthol to their nostril. • Individuals with aspirin or salicylate habit. • Individuals taking warfarin, excessive application onto the skin for muscle or joint pains may increase the chances of bleeding. • Children suffering from flu, chickenpox, or fever should avoid using this product because salicylates may induce Reyes Syndrome. • Avoid contact with the eyes and mucous membranes. • Do not apply to open wounds or damaged skin. • Avoid excessive use during pregnancy and lactation. • Do not apply over large areas of th पूरा दस्तावेज़ पढ़ें
DERMASAFE DEEP RUB OINTMENT PRODUCT DESCRIPTION A white to pale yellow coloured ointment with a pleasant odour. Each gram contains: Methyl Salicylate 25% w/w Menthol 5% w/w ROUTE OF ADMINISTRATION Topical PHARMACODYNAMICS Methyl salicylate is a salicylic derivative. It inhibits cyclooxygenase, thereby reducing the formation of prostaglandins, and cause platelet dysfunction. Methyl salicylate is used topically as a counter-irritant. Upon application, it is absorbed through the skin and is applied for the relief of pain in rheumatic conditions and painful muscle or joints. When applied to the skin menthol dilates the blood vessels causing a sensation of coldness followed by an analgesic effect. Menthol also acts as a penetration enhancer, increasing the penetration of drugs when applied on the skin, to give a faster onset of action. PHARMACOKINETICS _Methyl salicylate _ • May be absorbed through intact skin. • The absorption of topical salicylates is proportional to the surface area involved, duration of exposure, concentration and skin integrity. • Absorption characteristics of salicylates vary with the dose, formulation and route of administration. • Percutaneous absorption is enhanced by exercise, heat, occlusion, or disruption of the integrity of the skin or application to large areas of skin. • Both the rate and extent of absorption increases after repeated application; increasing the bioavailability. • Methyl salicylate is extensively metabolized to salicylic acid in the dermal and subcutaneous tissues after topical application. • At therapeutic levels, the half-life of salicylates is 2-4 hours. As salicylate level increase into the toxic range, the half-life can be greater than 18 hours. _Menthol _ • After absorption, menthol is excreted in the urine and bile as a glucuronide. INDICATION For the relief of minor aches and pains of muscles and joints associated with simple backache, arthritis and rheumatic conditions. RECOMMENDED DOSAGE _ADULTS & CHILDREN ABOVE 2 YEARS OLD: _ Apply to the affec पूरा दस्तावेज़ पढ़ें