ZELNORM Tablet (2020)
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Alfasigma USA, Inc.
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1. Indications and Usage
ZELNORM is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C). <u>Limitations of Use:</u> The safety and effectiveness of ZELNORM ...
2. Dosage and Administration
The recommended dosage of ZELNORM in adult women less than 65 years of age is 6 mg taken twice daily orally at least 30 minutes before meals <em>[see Clinical Pharmacology (12.3)]</em>. Discontinue ZELNORM ...
3. Dosage Forms and Strengths
ZELNORM Tablets: 6 mg tegaserod; supplied as whitish to slightly yellowish, round flat tablet with a beveled edge engraved with ZEL and 6.
4. Contraindications
ZELNORM is contraindicated in patients with: A history of myocardial infarction (MI), stroke, transient ischemic attack (TIA), or angina <em>[see Warnings and Precautions (5.1)]</em> A history of ischemic ...
5. Warnings and Precautions
5.1 Cardiovascular Ischemic Events, Including Major Adverse Cardiovascular Events (MACE) Stroke, MI, and cardiovascular death (major adverse cardiovascular events [MACE]) have been reported in adults taking ...
6. Adverse Reactions
The following adverse reactions are discussed in more detail elsewhere in the labeling: Cardiovascular Ischemic Events, including MACE <em>[see Warnings and Precautions (5.1)]</em> Ischemic Colitis <em> ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ZELNORM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
8.1. Pregnancy
Risk Summary Available data from case reports with ZELNORM use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In ...
8.2. Lactation
Risk Summary There are no data regarding the presence of tegaserod in human milk, the effects on the breastfed infant, or the effects on milk production. Tegaserod and its metabolites are present in rat ...
8.4. Pediatric Use
Safety and effectiveness of ZELNORM in pediatric patients have not been established.
8.5. Geriatric Use
ZELNORM is not indicated in patients 65 years of age and older.
8.6. Renal Impairment
ZELNORM is contraindicated in patients with severe renal impairment (eGFR <15 mL/min/1.73 m²) or end stage renal disease <em>[see Contraindications (4)]</em>. The C<sub>max</sub> and AUC of the tegaserod ...
8.7. Hepatic Impairment
ZELNORM is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) <em>[see Contraindications (4)]</em>. No dosage adjustment is necessary in patients with mild hepatic ...
10. Overdosage
Single oral doses of 120 mg (20 times the recommended dose) of ZELNORM were administered to three healthy subjects in one study. All three subjects developed diarrhea and headache. Two of these subjects ...
11. Description
ZELNORM oral tablets contain tegaserod, a serotonin-4 (5-HT<sub>4</sub>) receptor agonist, as the hydrogen maleate salt. As the maleate salt, tegaserod is chemically designated as 3-(5-methoxy-1H-indol-3-ylmethylene)-N-pentylcarbazimidamide ...
12.1. Mechanism of Action
Tegaserod is an agonist of serotonin type-4 (5-HT<sub>4</sub>) receptors that stimulates the peristaltic reflex and intestinal secretion, inhibits visceral sensitivity, enhances basal motor activity, and ...
12.2. Pharmacodynamics
Cardiac Electrophysiology Centrally analyzed ECGs were recorded in 4,605 male and female patients receiving ZELNORM 6 mg twice daily or placebo for IBS-C and other related motility disorders. No subject ...
12.3. Pharmacokinetics
The pharmacokinetics of tegaserod in IBS-C patients are comparable to those in healthy subjects. The mean (±SD) peak tegaserod concentration (C<sub>max</sub>) was 2.9 (±1.1) ng/mL, and mean (±SD) AUC was ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Tegaserod was not carcinogenic in rats given oral dietary doses up to 180 mg/kg/day (approximately 93 to 111 times the recommended dose based on AUC) for 110 to 124 weeks. In mice, dietary administration ...
13.2. Animal Toxicology and/or Pharmacology
Inhibition of the hERG (human Ether-a-go-go-Related Gene) channel was evident only in the micromolar concentration range with an IC<sub>50</sub> of 13 micromolar (approximately 1300 times the C<sub>max ...
14. Clinical Studies
Results in Women ZELNORM is not recommended in females 65 years of age and older with IBS-C <em>[see Indications and Dosage (1)]</em>. In three multicenter, double-blind, placebo-controlled trials, 2,470 ...
16.1. How Supplied
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) Box of 60 (strips of 10) NDC 0525-0971-60 ...
16.2. Storage and Handling
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.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Cardiovascular Ischemic Events, Including MACE Inform patients that stroke, myocardial infarction, and cardiovascular death ...