Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Preferred Pharmaceuticals, Inc.
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 delayed-release capsules/amoxicillin/clarithromycin Lansoprazole delayed-release capsules 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 capsules/amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (
Lansoprazole Delayed-Release Capsules USP are available as follows: 15 mg - hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with “93” and “7350”, filled with off-white to beige pellets, in bottles of; Bottles of 14 - 68788-9677-1 Bottles of 30 - 68788-9677-3 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Lansoprazole (lan-SOH-prə-zohl) Delayed-Release Capsules, for oral use 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 interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release capsules, may develop a kidney problem called acute interstitial 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 ch Izlasiet visu dokumentu
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PREFERRED 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. LANSOPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Dosage and Administration Recommended Pediatric Dosage (2.2) 06/2018 Contraindications (4) 07/2017 Warnings and Precautions Interactions with Investigations for Neuroendocrine Tumors (5.8) 07/2017 Fundic Gland Polyps (5.11) 06/2018 INDICATIONS AND USAGE Lansoprazole delayed-release capsules 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 non-steroidal 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: • Administration Instructions (2.4) _Lansoprazole delayed-release capsules_ • See full prescribing information for alternative administration options. DOSAGE FORMS AND STRENGTHS Capsules: 15 mg and 30 mg. (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • See full prescribing information for complete dosing information for lansoprazole delayed-release capsules b Izlasiet visu dokumentu