Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
tegaserod (UNII: 458VC51857) (tegaserod - UNII:458VC51857)
US WorldMeds, LLC
ORAL
PRESCRIPTION DRUG
ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). Limitations of Use - The safety and effectiveness of ZELNORM in men with IBS-C have not been established [see Clinical Studies (14)] . ZELNORM is contraindicated in patients with: - A history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), or angina [see Warnings and Precautions (5.1)] - A history of ischemic colitis or other forms of intestinal ischemia [see Warnings and Precautions (5.2)] - Severe renal impairment (eGFR< 15 mL/min/1.73 m2 ) or end-stage renal disease [see Use in Specific Populations (8.6)] - Moderate and severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations (8.7)] - A history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions [see Adverse Reactions (6.2)] - Hypersensitivity to tegaserod [see Adverse Reactions (6.2)] Risk Summary Availabl
ZELNORM is supplied as 6 mg tegaserod whitish to slightly yellowish, round flat tablets with a beveled edge engraved with "ZEL" and "6" . Unit Dose (blister pack) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Protect from moisture.
New Drug Application
US WorldMeds, LLC ---------- Medication Guide ZELNORM™ (ZEL-norm) (tegaserod) tablets, for oral use What is the most important information I should know about ZELNORM? ZELNORM can cause serious side effects, including: • Major heart (cardiovascular) events. Major cardiovascular events such as stroke, heart attack, and death from stroke or heart attack have happened in adults taking ZELNORM who had an increased risk of having a cardiovascular event. Risk factors that increase your risk of a major cardiovascular event include: • currently smoke • high blood pressure or your blood pressure is controlled with medicine that lowers your blood pressure • high blood cholesterol levels or your blood cholesterol levels are controlled with medicine that lowers your blood cholesterol levels • have or have had diabetes mellitus • age 55 years or older • obesity Talk to your healthcare provider about risk factors you may have for a major cardiovascular event before you start taking ZELNORM. Get emergency medical help right away if you have signs or symptoms of a heart attack, stroke, mini stroke (transient ischemic attack or TIA) or angina (chest pain that happens because your heart is not getting enough oxygen), including: • chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen) • feeling sweaty • shortness of breath • feeling sick or vomiting • sudden numbness or weakness, especially on one side of the body • severe headache or confusion • problems with vision, speech, or balance Tell your healthcare provider right away if you are told that you have narrowing in the blood vessels that carry blood to your heart (coronary artery disease). • Inflammation and injury of the intestines caused by reduced blood flow to the intestines (ischemic colitis). Ischemic colitis and other problems of the intestines caused by reduced blood flow to the intestines, that sometimes required hospitalization, have happened in some people taking ZELNORM. Stop taking ZELNORM and call your he read_full_document
ZELNORM- TEGASEROD TABLET US WORLDMEDS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZELNORM™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZELNORM™. ZELNORM™ (TEGASEROD) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2002 RECENT MAJOR CHANGES Indications and Usage (1) 03/2019 Contraindications (4) 03/2019 Warnings and Precautions (5.1, 5.4) 03/2019 INDICATIONS AND USAGE ZELNORM is a serotonin-4 (5-HT ) receptor agonist indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). (1) Limitations of Use: The safety and effectiveness of ZELNORM in men with IBS-C have not been established. (1) DOSAGE AND ADMINISTRATION The recommended dosage in adult women less than 65 years of age is 6 mg taken twice daily orally at least 30 minutes before meals. Discontinue ZELNORM in patients who have not had adequate control of symptoms after 4 to 6 weeks of treatment. (2) DOSAGE FORMS AND STRENGTHS Tablets: 6 mg tegaserod. (3) CONTRAINDICATIONS ZELNORM is contraindicated in patients with: A history of myocardial infarction, stroke, transient ischemic attack, or angina. (4, 5.1) A history of ischemic colitis or other forms of intestinal ischemia. (4, 5.2) Severe renal impairment (eGFR< 15 mL/min/1.73 m ) or end-stage renal disease. (4, 8.6) Moderate or severe hepatic impairment (Child-Pugh B or C). (4, 8.7) A history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions. (4) Hypersensitivity to tegaserod. (4) WARNINGS AND PRECAUTIONS Cardiovascular Ischemic Events, Including Major Adverse Cardiovascular Events (MACE): The potential risks of treatment must be balanced with expectations in improvements in symptoms of IBS-C. Discontinue ZELNORM treatment in patients who experience a myocardial infarction, stroke, transient ischemic attack or angina. (4) Evaluate the risks and benefits of continued treatment in pa read_full_document