The following information is a summary about
REDUCTIL. It is not
intended to replace a doctor's instructions.
(sibutramine hydrochloride monohydrate - ORAL)
USES
Reductil is a weight-control medicine that acts as an appetite suppressant helping you maintain a lower calorie diet. Patients treated with Reductil while on a reduced calorie diet showed a significant weight loss during the first 6 months of treatment, and significant weight loss was maintained for one year. In one 12-month study, the average weight loss in patients taking Reductil, 10 mg daily, was about 10 lbs. and in those taking 15 mg daily was about 14 lbs. The average weight loss in persons on only a reduced calorie diet was 3 1/2 lbs.
Reductil works by affecting appetite control centers in the brain. In medical studies in overweight people, Reductil, along with a reduced calorie diet, produced significant reductions in body weight. Reductil should be used as part of a comprehensive weight loss program supervised by your doctor, that includes a reduced calorie diet and appropriate physical activity.
DIRECTIONS
The recommended starting dose of REDUCTIL is one 10mg capsule administered once daily with or without food. If there is inadequate weight loss (ie less than 2kg) after 4 weeks, the dose may be increased to one 15mg capsule once daily provided 10mg was well tolerated. Blood pressure and heart rate changes should be taken into account when deciding to increase the dose. Doses above 15mg daily are not recommended. In most of the clinical trials, REDUCTIL was given in the morning.
SIDE EFFECTS
Reductil, like all medications, may cause side effects. In studies the most common side effects were: dry mouth, constipation, and insomnia (inability to fall asleep). Other side effects that may occur include: headache, increased sweating, an increase in blood pressure, and an increase in heart rate. These side effects are generally mild, and have usually not caused people to stop taking Reductil. If you develop a symptom that you think might be a side effect, stop taking Reductil and notify your doctor immediately so he or she can advise you on what to do.
Certain weight loss drugs have been associated with pulmonary hypertension (PPH), a rare but sometimes fatal disease. In clinical studies, no cases of PPH have been reported with Reductil. Because this disease is so rare, however, it is not known whether or not Reductil may cause this disease.
The first symptom of PPH is usually shortness of breath. If you experience new or worsening shortness of breath, or if you experience chest pain, fainting, or swelling of your feet, ankles, or legs, stop taking Reductil and notify your doctor immediately.
