Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
DEXLANSOPRAZOLE (UNII: UYE4T5I70X) (DEXLANSOPRAZOLE - UNII:UYE4T5I70X)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
DEXILANT is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. DEXILANT is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. DEXILANT is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks. - DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)] . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)] . - PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)] . Risk Summary There are no studies with dexlansoprazole us
Product: 50090-4374 NDC: 50090-4374-0 90 CAPSULE, DELAYED RELEASE in a BOTTLE
New Drug Application
A-S Medication Solutions ---------- Revised: 11/2020 MEDICATION GUIDE DEXILANT (decks-i-launt) (dexlansoprazole) delayed-release capsules, for oral use Read this Medication Guide before you start taking DEXILANT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information that I should know about DEXILANT? DEXILANT may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. DEXILANT can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including DEXILANT, may develop a kidney problem called acute tubulointerstitial nephritis, that can happen at any time during treatment with PPI medicines. 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. DEXILANT may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take DEXILANT exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take DEXILANT. • 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 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 Belgenin tamamını okuyun
DEXILANT- DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DEXILANT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXILANT. DEXILANT (DEXLANSOPRAZOLE) DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 (LANSOPRAZOLE) RECENT MAJOR CHANGES Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2) 11/2020 Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age (5.11) 9/2020 INDICATIONS AND USAGE DEXILANT is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). (1.1) Maintenance of healed EE and relief of heartburn. (1.2) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). (1.3) DOSAGE AND ADMINISTRATION Recommended dosage in patients 12 years of age and older: See full prescribing information for complete dosing information for DEXILANT by indication and age group and dosage adjustment in patients with hepatic impairment. (2.1, 2.2) Administration Instructions (2.3): Take without regard to food. Swallow whole; do not chew. See full prescribing information for alternative administration options. DOSAGE FORMS AND STRENGTHS Delayed-release capsules: 30 mg and 60 mg. (3) CONTRAINDICATIONS Patients with known hypersensitivity to any component of the formulation. (4) Patients receiving rilpivirine-containing products. (4, 7) WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1) Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2) _Clostridium difficile_-Associated Diarrhea: PPI therapy may be associated with increased risk. (5.3) Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosi Belgenin tamamını okuyun