দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Teva Pharmaceuticals USA, Inc.
LANSOPRAZOLE
LANSOPRAZOLE 15 mg
ORAL
PRESCRIPTION DRUG
Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1)] . Triple Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults 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 (14.2)] . Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is
Lansoprazole Delayed-Release Orally Disintegrating Tablets are available as follows: 15 mg – white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "15" on one side of the tablet and plain on the other side. Packaged in unit dose cartons of 100 tablets (10 blister cards x 10 tablets), NDC 0093-3008-93. 30 mg – white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "30" on one side of the tablet and plain on the other side. Packaged in unit dose cartons of 100 tablets (10 blister cards x 10 tablets), NDC 0093-3009-93. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
Teva Pharmaceuticals USA, Inc. ---------- Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE Lansoprazole (lan-soe'-pra-zole) Delayed-Release Orally Disintegrating Tablets What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets? You should take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Lansoprazole delayed-release orally disintegrating tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release orally disintegrating tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release orally disintegrating tablets. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including lansoprazole delayed-release orally disintegrating tablets, may সম্পূর্ণ নথি পড়ুন
LANSOPRAZOLE- LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS. LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions, Severe Cutaneous Adverse Reactions (5.5) 3/2022 Hypomagnesemia and Mineral Metabolism (5.8) 3/2022 INDICATIONS AND USAGE Lansoprazole delayed-release orally disintegrating tablets are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults. (1.1) Eradication of _H. pylori_ to reduce the risk of duodenal ulcer recurrence in adults. (1.2) Maintenance of healed duodenal ulcers in adults. (1.3) Treatment of active benign gastric ulcer in adults. (1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5) Risk reduction of NSAID-associated gastric ulcer in adults. (1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8) Maintenance of healing of EE in adults. (1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10) DOSAGE AND ADMINISTRATION Recommended Dosage: See full prescribing information for complete dosing information for lansoprazole delayed-release orally disintegrating tablets by indication and age group and dosage adjustment in patients with severe hepatic impairment. (2.1, 2.2, 2.3) Administration Instructions (2.4) _Lansoprazole delayed-release orally disintegrating tablets_ Should not be broken or cut. Should not be chewed. Place the tablet on the tongue and allow it to disint সম্পূর্ণ নথি পড়ুন