Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Advanced Rx Pharmacy of Tennessee, LLC
ORAL
PRESCRIPTION DRUG
1.1 Healing of Erosive Esophagitis (EE) Adults Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 1.2 Maintenance of Healing of EE Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 1.3 Treatment of Symptomatic GERD Adults Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GE
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40 mg, are size 3 capsule with pink opaque cap imprinted with 'RB67' and pink opaque body imprinted with '40 mg' in black ink containing off-white to brownish colored beads. They are supplied as follows: Bottles of 30 Capsules NDC: 80425-0183-01 For bottle of 30's Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature.] This package is child-resistant. Keep out of reach of children. Keep esomeprazole magnesium delayed-release capsules, USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP product package is subdivided.
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE Advanced Rx Pharmacy of Tennessee, LLC ---------- MEDICATION GUIDE Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um) Delayed-Release Capsules, USP Rx only What is the most important information I should know about esomeprazole magnesium delayed-release capsules, USP? Esomeprazole magnesium delayed-release capsules, USP may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole magnesium delayed-release capsules, USP can cause serious side effects, including: •A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, USP, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules, USP. 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 esomeprazole magnesium delayed-release capsules, USP, 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 Přečtěte si celý dokument
ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE ADVANCED RX PHARMACY OF TENNESSEE, LLC ---------- ESOMEPRAZOLE MAGNESIUM DR 40MG CAPSULES 1. INDICATIONS AND USAGE 1.1 Healing of Erosive Esophagitis (EE) Adults Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed- release capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 1.2 Maintenance of Healing of EE Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 1.3 Treatment of Symptomatic GERD Adults Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age. 1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. 1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradicatio Přečtěte si celý dokument