Warnings & Recalls for Lotronex
FDA and Lotronex
In February of 2000, Lotronex was
removed from the market due to adverse reactions involving serious and even fatal gastrointestinal side effects. By June 2002, the
U.S. Food and Drug Administration approved Lotronex for limited use among women with severe irritable bowel syndrome who had been unsuccessfully treated with other medications.
Lotronex and Pregnancy
Lotronex has been classified as an
FDA pregnancy Category B medicationand is not known to cause harm to the fetus when taken by a woman during pregnancy. Studies do not confirm if Lotronex may pass through breast-milk or harm a nursing infant. Consult your doctor before taking Lotronex if you are breastfeeding or pregnant.
General Warnings
Lotronex
should not be used as a treatment for IBS in anyone who:
- is allergic to alosetron hydrochloride
- has liver disease
- is constipated, has ever had severe, persistent constipation, or has a blockage or perforation (hole) along the pathway of the intestines
- blood clot or circulatory disorders involving the intestines
- Chron's disease (a type of inflammatory bowel disease or IBD)
- ulcerative colitis (inflamed intestines) or diverticulitis (swollen sacs along the walls of the intestines which may become infected)
- currently uses Luvox as a treatment for obsessive-compulsive disorder (OCD)
Lotronex may cause adverse reactions such as
ischemic colitis (a blockage of the intestines which causes a restriction of blood flow). Lotronex may be dangerous for
elderly patients as it may increase the risk of serious side effects from severe constipation
Lotronex Interactions
Lotronex may
interact with other medicines. Be sure to tell your doctor about any other drugs you are taking, particularly:
- cimetidine (a treatment for gastroesophageal reflux disease)
- antifungals such as ketoconazole, itraconazole or voriconazole
- antibiotics including ciproflaxin, clarithromycin, levofloxacin, moxiflaxin, norfloxacin, ofloxacin, or telithromycin
- isoniazid (a drug for treating tuberculosis)
- medications for high blood pressure such as hydralazine
- medicines for treating arrhythmia including procainamide
- any HIV (human immunodeficiency virus) treatments
Lotronex Treatment and Use
Lotronex | Alosetron hydrochloride is a serotonin receptor antagonist marketed by Prometheus Laboratories for treating severe cases of chronic irritable bowel syndrome (IBS) in women who have previously and unsuccessfully attempted to treat their condition. Lotronex should not be used by men.
Due to serious risks which may be posed by the medication, Lotronex is available to patients through only the Prometheus Prescribing Program.
Lotronex should not be taken by anyone under 18 years of age.
How Does Lotronex Work?
Lotronex prevents serotonin functions, causing stools to travel more slowly throughout the intestines. Lotronex simultaneously blocks sensations of pain by interfering with nerve receptors.
Lotronex Dosage Information
Lotronex comes in tablet form to be taken by mouth with a full glass of water. The general starting dose of Lotronex is 0.5 mg twice each day. Take Lotronex exactly as prescribed to you by your doctor. End your use of Lotronex if your symptoms of IBS have not been reduced within 28 days.
