Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
NuCare Pharmaceuticals, Inc.
LANSOPRAZOLE
LANSOPRAZOLE 30 mg
ORAL
PRESCRIPTION DRUG
Lansoprazole delayed-release capsules are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. [See Clinical Studies (14)] Triple Therapy: Lansoprazole delayed-release capsules /amoxicillin /clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14) ] Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin Dual Therapy: Lansoprazole delayed-release capsules /amoxicillinLansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and
Lansoprazole delayed release capsules USP, 30 mg are white to pale yellow colored enteric coated pellets filled in size ‘1’ hard gelatin capsules with opaque pink colored cap and opaque black colored body, imprinted ‘RDY’ on cap and ‘399’ on body with white ink. They are supplied in bottles of Bottles of 30 NDC 68071-1972-3 Bottles of 60 NDC 68071-1972-6 Bottles of 7 NDC 68071-1972-7 Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].
Abbreviated New Drug Application
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE NuCare Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Lansoprazole Delayed-Release Capsules, USP Read this Medication Guide before you start taking lansoprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information that I should know about lansoprazole delayed-release capsules? Lansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Lansoprazole delayed-release capsules can cause serious side effects, including: • Diarrhea. Lansoprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take lansoprazole delayed-release capsules. Lansoprazole delayed-release capsules can have other serious side effects. See “ What are the possible side effects of lansoprazole delayed-release capsules?” What are lansoprazole delayed-release capsules? Lansoprazole delayed-release capsules are prescription medicine called a proton pump inhibitor (PPI). Lansoprazole delayed-release capsules reduces the amount of acid in your stomach. Lansoprazole delayed-release capsules are used in adults: • for 4 weeks for the healing and symptom relief of duodenal ulcers. The duodenal a Baca dokumen lengkap
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE NUCARE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANSOPRAZOLE DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANSOPRAZOLE DELAYED-RELEASE CAPSULES DELAYED-RELEASE CAPSULES LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, FOR ORAL USE FOR ORAL ADMINISTRATION INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Indications and Usage, Gastroesophageal Reflux Disease (GERD) ( 1.7) 12/2014 Dosage and Administration, Recommended Dose ( 2.1) 12/2014 Contraindications ( 4) 12/2014 Warnings and Precautions, Acute Interstitial Nephritis ( 5.2) 12/2014 Warnings and Precautions, Cyanocobalamin (vitamin B12) Deficiency ( 5.3) 12/2014 INDICATIONS AND USAGE Lansoprazole delayed-release capsule is a proton pump inhibitor (PPI) indicated for: Short-Term Treatment of Active Duodenal Ulcer ( 1.1) _H. pylori_ Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.2) Maintenance of Healed Duodenal Ulcers ( 1.3) Short-Term Treatment of Active Benign Gastric Ulcer (1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-Associated Gastric Ulcer ( 1.5) Risk Reduction of NSAID-Associated Gastric Ulcer (1.6) Gastroesophageal Reflux Disease (GERD) ( 1.7) Maintenance of Healing of Erosive Esophagitis (EE) ( 1.8) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) ( 1.9) DOSAGE AND ADMINISTRATION NDIC ATIO N DO SE FREQUENCY DUODENAL ULCERS ( 1.1,1.3) Short-Term Treatment 15 mg Once daily for 4 wks Maintenance of Healed 15 mg Once daily H. PYLORI ERADICATION TO REDUCE RECURRENCE OF DUODENAL ULCER ( 1.2) Triple Therapy: Lansoprazole delayed-release capsules Amoxicillin Clarithromycin 30 mg 1 gram 500 mg Twice daily for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules Amoxicillin 30 mg 1 gram Three times daily for 14 days BENIGN GASTRIC ULCER ( 1.4) Short-Term Treatment 30 mg Once daily up to 8 wks NSAID-ASSOCIAT Baca dokumen lengkap