Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 BOTOL @ 6 TABLET SALUT ENTERIK
2022-09-24
Page 1 of 8 Lylian ® Ilaprazole PRODUCT NAME Generic name: Ilaprazole Enteric-coated Tablets DESCRIPTION Ilaprazole is an enteric-coated tablet and is white or off-white when the coating is removed. COMPOSITION Each tablet contain: Ilaprazole 5 mg Chemical name: 5 - (1H - pyrrole - 1 - base) – 2 - [[(4 - methoxy - 3 - methyl) - 2 – pyridyl] - methyl] - sulfinyl - 1H - benzimidazole Chemical formula: Molecular formula: C 19 H 18 N 4 O 2 S Molecular weight: 366.43 EXCIPIENTS Eudragit L30D, Magnesium Stearate, Titanium Dioxide, Sunset Yellow Aluminum Lake etc. INDICATIONS It is indicated for the treatment of duodenal ulcer and reflux esophagitis. DOSAGE AND ADMINISTRATION Ilaprazole is used for the treatment of duodenal ulcer and reflux esophagitis in adults. Swallow Ilaprazole Enteric-coated Tablets with water in every morning before meal; do not chew. 1. For the treatment of duodenal ulcer: 10 mg once daily for consecutive 4 weeks, or use it as directed by your doctor. 2. For the treatment of reflux esophagitis: DISETUJUI OLEH BPOM : 05/09/2022 EREG10028912100050 Page 2 of 8 10 mg once daily for consecutive 4 weeks. If not healed, patients are recommended to take an additional 4-week treatment; if healed but still have persistent symptoms, patients are recommended to adjust the dosage to 5 mg daily for additional 4-week, or take the drug as directed by the doctor. CONTRAINDICATIONS It is contraindicated in patients with known hypersensitivity to any component of the formulation. It is contraindicated in patients with known hypersensitivity to Ilaprazole and other benzimidazoles. PRECAUTIONS 1. Swallow Ilaprazole Enteric-coated tablet whole. Do not chew or crush the tablets. 2. It is not recommended to treat general peptic ulcer by large dosage and/or long-term usage of Ilaprazole due to its strong inhibiting effect on gastric acid secretion. 3. Malignant lesions of stomach and esophagus should be excluded before using the product, so as not to delay the diagnosis due to symptomatic relief. 4. Use with caution Les hele dokumentet