Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Lifestar Pharma LLC.
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 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 /amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of
Lansoprazole delayed-release capsules, USP are available as: • 15 mg capsules are white to off white, spherical to oval pellets filled in hard gelatin capsule shells of size 3 with " " imprinted in grey ink on green opaque colored cap and "806" imprinted in black ink on white opaque colored body. Bottles of 30: NDC 70756-806- 30 • 30 mg capsules are white to off white spherical to oval pellets filled in hard gelatin capsule shells of size 1 with " " imprinted in white ink on black opaque colored cap and "807" imprinted in black ink on white opaque colored body. Bottles of 30: NDC 70756-807- 30 Bottles of 90: NDC 70756-807- 90 Bottles of 500: NDC 70756-807-51 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LANSOPRAZOLE- lansoprazole capsule, delayed release Lifestar Pharma LLC. ---------- MEDICATION GUIDE Lansoprazole (lan-SO-pruh-zole) 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 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 c Lue koko asiakirja
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE LIFESTAR PHARMA LLC. ---------- 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, Severe Cutaneous Adverse Reactions ( 5.5) 03/2022 Hypomagnesemia and Mineral Metabolism ( 5.8) 03/2022 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 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 FORMS AND STRENGTHS Delayed-release capsules: 15 mg and 30 mg. ( 3) CONTRAINDICATIONS • Contraindicated in patients with known hypersensitivity to any component of the lansoprazole delayed- release capsules formulation. ( 4) •Patients receiving rilpivirine-containing products. ( 4, 7) WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response with lansoprazole delayed-release capsule does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing . ( 5.1) Acute Tubulointerstitial Nephritis: Discontinue tr Lue koko asiakirja