Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Zydus Pharmaceuticals USA Inc.
LANSOPRAZOLE
LANSOPRAZOLE 15 mg
ORAL
PRESCRIPTION DRUG
Lansoprazole delayed-release capsules 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/amoxicillin/clarithromycin Lansoprazole 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/amoxicillin Lansoprazole in combination with amoxicillin as dual 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) who are either allergic or intolerant to clarithro
Lansoprazole Delayed-release Capsules USP, 15 mg are enteric-coated pellets filled in size '3' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -50" in black ink and white opaque body printed with "15mg" in black ink and are supplied as follows: NDC 68382-543-06 in bottle of 30 capsules NDC 68382-543-10 in bottle of 1000 capsules NDC 68382-543-77 in cartons of 100 capsules (10 x 10 unit-dose) Lansoprazole Delayed-release Capsules USP, 30 mg are enteric-coated pellets filled in size '1' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -51" in black ink and white opaque body printed with "30 mg" in black ink and are supplied as follows: NDC 68382-544-06 in bottle of 30 capsules NDC 68382-544-16 in bottle of 90 capsules NDC 68382-544-01 in bottle of 100 capsules NDC 68382-544-10 in bottle of 1000 capsules NDC 68382-544-77 in cartons of 100 capsules (10 x 10 unit-dose) Storage Store at 20ο to 25ο C (68ο to 77ο F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Abbreviated New Drug Application
Zydus Pharmaceuticals USA Inc. ---------- MEDICATION GUIDE Lansoprazole (lan soe' pra zole) Delayed-release Capsules, USP What is the most important information that I should know about lansoprazole delayed- release capsules? You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed. 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: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis, that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release capsules. 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 capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to y Prečítajte si celý dokument
LANSOPRAZOLE - LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS ZYDUS PHARMACEUTICALS USA 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. LANSOPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2) 11/2020 Risk of Heart Valve Thickening in Pediatric Patients Less than One Years of Age (5.12)9/2020 INDICATIONS AND USAGE Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) 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 capsules 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 capsules_ Should be swallowed whole. See full prescribing information for alternative administration options. DOSAGE FORMS AND STRENGTHS Capsules: 15 mg and 30 mg. (3) CONTRAINDICATIONS Patients r Prečítajte si celý dokument