Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOTRIMAZOLE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
CLOTRIMAZOLE
15 ml
GLENMARK PHARMACEUTICALS LTD
Consumer Medication Information Leaflet (RiMUP) 1 CANDID EAR DROPS Clotrimazole USP 1% w/v WHAT IS IN THIS LEAFLET 1. What Candid Ear Drops is used for 2. How Candid Ear Drops works 3. Before you use Candid Ear Drops 4. How to use Candid Ear Drops 5. While you are using it 6. Side effects 7. Storage and Disposal of Candid Ear Drops 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CANDID EAR DROPS IS USED FOR The active substance in Candid 1% Ear Drops is clotrimazole. Clotrimazole belongs to a group of medicines called imidazoles and is an antifungal agent which fights the cause of fungal ear infections. HOW CANDID EAR DROPS WORKS Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc. Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062- 8.0 µg/ml substrate. The mode of action of clotrimazole is primarily fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive. In addition to its antimycotic action, clotrimazole also acts on gram-positive microorganisms (Streptococci / Staphylococci / Gardnerella vaginalis), and gram-negative microorganisms (Bacteroides). In vitro clotrimazole inhibits the multiplication of Corynebacteria and gram- positive cocci - with the exception of Enterococci - in concentrations of 0.5-10 µg/ml substrate. Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions. BEFORE YOU USE CANDID EAR DROPS _When you must not use it _ If you are Izlasiet visu dokumentu
PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE: PE 19364 PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: Clotrimazole also has antibacterial action and some strains of Staphylococcus aureus and Streptococcus pyogenes have been reported to be sensitive. Clotrimazole is believed to exert its activity on the cell membrane of the fungus. It appears that the drug inhibits protein synthesis and so influences the utilisation and the incorporation of the acylated amino acids essential for fungi. PHARMACOKINETICS Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites. Following topical and vaginal administration, however, Clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive Clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of Clotrimazole varied from 3 3 100 mcg / cm in the stratum corneum to 0.5 to 1 mcg / cm in 3 the stratum reticulare, and 0.1 mcg / cm in the subcutis. No measurable amount of radioactivity ( £ 0.001 mcg/ml) was found in the serum within 48 hours after application under occlusive dressing of 0.5 ml of the solution or 0.8 g of the cream. Only 0.5% or less of the applied radioactivity was excreted in the urine. INDICATIONS lOtomycosis. lConcomitant therapy with Antibiotic and Corticosteroid Ear Drops. lProphylaxis for swimmers. CONTRAINDICATIONS Except for possible hypersensitivity reactions, there are no contraindications to CANDID Ear Drops. SIDE EFFECTS / ADVERSE REACTIONS The local tolerance of CANDID Ear Drops is excellent and no systemic effects are seen with topical use. Rarely patients may experience local irritation.This generally disappears on continuing the therapy. PE00000 MY SAME SIZE ARTWORK LEAFLET SIZE: 130 mm x 100 mm DRUG INTERACTIONS None reported. PRECAUTIONS / WARNINGS When the ear drum is perforated, CANDID Ear Drops should be used with caution. This in accordance with the general directions for the use of all ear drops. This Izlasiet visu dokumentu