Product Details: Zelnorm (Tegaserod)

Customers must provide prescriptions dated after 30th March 2007 to order this product. We are only able to supply the generic version of this drug. Please note the statement from the manufacturer of the branded version of this drug below.

Generic Options

What are Generics? A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, how it is taken, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name and works the same way in the body in the same amount of time.

The only differences between generics and their brand-name counterparts is the generics are less expensive and may look slightly different (e.g. different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to invent a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name drug and sell it at substantial discounts.

Description

Zelnorm is indicated for the treatment of patients (men and women) less than 65 years of age with chronic idiopathic constipation. Zelnorm is a medicine for the short-term treatment of women who have Irritable Bowel Syndrome (IBS) with constipation as their main bowel problem. Zelnorm does not work for all women and has not been shown to work in men with IBS with constipation.
April 2, 2008:
Following the US marketing suspension of Zelnorm® (tegaserod maleate) Novartis initiated a restricted access program called a treatment IND in collaboration with the Food & Drug Administration (FDA) in July 2007, so that patients in need of this medicine can be considered for treatment. On April 2, 2008, after more than eight months of availability, the company has re-assessed the program and has made a decision to close it. Novartis is in the process of communicating this decision to physicians participating in the program. Patients who had access to Zelnorm via this program are instructed to discuss alternative treatment options with their physicians.
FDA has noted that for patients who have an emergency situation, defined as one that is immediately life-threatening or serious enough to qualify for hospitalization, there may be an alternative (an emergency IND) option. Physicians may inquire about this potential access option by contacting the FDA CDER Division of Drug Information at 301-796-3400 or www.fda.gov/cder.

Directions

Follow the directions for using this medicine provided by your doctor. THIS MEDICINE COMES WITH A PATIENT INFORMATION LEAFLET. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medicine on an empty stomach. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.

Cautions

DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. IT MAY TAKE UP TO 4 WEEKS for this medicine to work. If you experience different or suddenly worsening stomach pain compared to your regular IBS symptoms, stop taking this medicine and call your doctor immediately. DO NOT EXCEED THE RECOMMENDED DOSE without checking with your doctor. IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.

Side Effects

Headache or joint pain may occur. If any of these effects persist or worsen, notify your doctor promptly. Remember that your doctor has prescribed this medication because he/she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. If diarrhea occurs, it may be only temporary during the first week of treatment. If it occurs, your doctor may recommend that you drink plenty of liquids to avoid becoming dehydrated. If the diarrhea does not resolve on its own after 2 days or if you feel very weak, have severe cramping, dizziness/lightheadedness/fainting, or irregular heartbeats, stop tegaserod and tell your doctor immediately. If you experience different or suddenly worsening stomach/abdominal pain compared to your regular IBS symptoms, with or without bloody stools, stop taking this medication and tell your doctor immediately. This could be a sign of a rare but serious intestinal problem (ischemic colitis). Seek immediate medical attention if the following rare but very serious side effects occur: chest/jaw pain or discomfort, weakness on one side of your body, slurred speech, confusion. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Active Ingredients

Tegaserod