FDA Notification: On March 30, 2007, the FDA notified healthcare professionals and patients that Novartis had agreed to discontinue marketing tegaserod (Zelnorm) for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years of age with chronic constipation.
This medication is a selective serotonin receptor agonist, prescribed for irritable bowel syndrome (IBS) in women who have constipation as their main symptom. It is also used for treating certain men and women (younger than 65 years) who have a type of chronic constipation.
Contraindicated to patients with severe kidney or moderate to severe liver impairment; history of bowel obstruction or symptomatic gallbladder disease; suspected sphincter of Oddi (muscle that controls the flow of bile and pancreatic juice into the intestine) dysfunction or abdominal adhesions; known hypersensitivity. Patients currently experiencing or who frequently experience diarrhea, lactation.
The recommended dose is 12mg/day, for four to six weeks; for a maximum of 12 weeks.
It comes as a tablet to take by mouth. It is usually taken twice a day on an empty stomach.
• The drug may cause loose motions, pain in abdomen or bleeding through the rectum. Stop the drug immediately if these symptoms occur.
• Caution should be exercised during pregnancy and breast feeding, children less than 18 years.
Abdominal pain, nausea,vomiting, bile duct stone, stomach upset, fecal incontinence, gangrenous bowel, stomach inflammation, rectal pain, rectal bleeding, GI reflux, diarrhea, flatulence, abdominal distension, bleeding, ischemic colitis( inflammation and injury of the large intestine result from inadequate blood supply), mesenteric ischemia, stomach discomfort, suspected sphincter of Oddi spasm.
• Heart: Fatigue, bundle branch block (this condition blocks the impulse flow in the heart, so it is enough to say abnormal heart rhythm), flushing, low blood pressure, chest pain, abnormal heart rhythm, fainting.
• Central Nervous System: Headaches, increased appetite, restlessness, sleep disorder, dizziness, sleeplessness, depression.
• Skin: Itching, skin rash.
• Eye and ENT: Visual disturbance.
• Blood: Increased eosinophil count, low neutrophil count.
• Genitourinary: Painful menstruation, urinary tract infection, breast cancer, irregular period, miscarriage.
• Liver: Gall stone, elevated liver enzyme.
• Metabolic: Electrolyte disorders, decreased blood volume, increased creatine phosphokinase, peripheral swelling.
• Musculoskeletal: Back pain, joint disease, muscle pain.
• Respiratory: Upper respiratory tract infection, paranasal inflammation, inflammation of pharynx, nasal congestion, difficulty in breathing.
• Miscellaneous: Accidental trauma, fungal infection, leg pain, chest pain, hypersensitivity, pain.
Do not start or stop any medicine without doctor approval.
Oral: Store at 25°C. Store it at room temperature and in an airtight container.
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