|
| Zelnorm Description:
Zelnorm is a medicine used for the short-term treatment of women who have irritable bowel syndrome (IBS) with constipation (hard stools or difficulty passing stools) as their main bowel problem. IBS is a disorder that interferes with the normal functions of the large intestine (colon). Symptoms may include cramps, abdominal pain, bloating, constipation, and/or diarrhea. The cause of IBS is not known.
Zelnorm works by increasing the movement of stools through the bowels. For those patients who are helped, Zelnorm reduces pain and discomfort in the abdominal area, bloating, and constipation.
Zelnorm is not a cure for IBS and does not work for all women who use it. FDA does not have evidence that Zelnorm is effective in men with IBS. |
Product Notes:
. What new changes are being made to the Zelnorm label?
The major changes to the Zelnorm label include a new warning about serious consequences of diarrhea, a new precaution about ischemic colitis and other forms of intestinal ischemia, and updated labeling for patients that includes information about these potential side effects and advises that patients should stop taking Zelnorm and contact their doctor.
4. 4. What are serious consequences of diarrhea?
Serious consequences that can occur when patients experience large amounts of diarrhea include dehydration, low blood pressure, and fainting. In some of the reported cases in patients taking Zelnorm, these complications have required hospitalization for rehydration.
5. What is ischemic colitis?
Ischemic colitis is a condition resulting from reduced blood flow to the intestines, which in some cases can cause serious intestinal damage, and rarely death. Some of the signs and symptoms of ischemic colitis are new or worsening abdominal pain, fever, vomiting, bloody diarrhea, rectal bleeding, and low back pain.
Sometimes ischemic colitis is mild and may resolve by itself. However, other times ischemic colitis can lead to serious problems requiring surgery and in rare cases can lead to death.
FDA has received 20 reports of ischemic colitis in people taking Zelnorm, however, at this time we are not able to determine whether these events were caused by Zelnorm. It is possible that these events were not caused by Zelnorm, but rather by some other cause including other diseases that the patient may have or other drugs the patient was taking.
6. What is intestinal ischemia?
Intestinal ischemia is a condition resulting from reduced blood flow to the intestines that can lead to ischemic colitis or to more severe forms of intestinal damage that may require surgery or result in death.
7. Who should not use Zelnorm?
Patients should not start taking Zelnorm if they have:
diarrhea now or have diarrhea often
bad kidney or liver disease
ever had bowel obstruction (intestinal blockage), symptomatic gallbladder disease, or abdominal adhesions causing pain and/or intestinal blockage.
8. How should Zelnorm be taken?
The recommended dosage of Zelnorm is 6 mg taken twice daily orally before meals for 4 to 6 weeks. For those patients who respond to therapy at 4-6 weeks, an additional 4-6 week course can be considered. Side Effects:
The most common side effects of Zelnorm include:
Headache
Abdominal pain
Diarrhea
Nausea
Dizziness
These are not all the possible side effects of Zelnorm. Doctors or pharmacists can provide patients with additional information on the side effects of Zelnorm. Manufacturer link or canadian Pharmacy drug sources: na
|
