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and either approve or decline your prescription. If you are declined there will
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How to take this medication
The recommended starting dose of Reductil™ is 15 mg administered once daily with
or without food. Blood pressure and heart rate changes should be taken into
account when making decisions regarding dosage. Doses above 15 mg are not
recommended. In most of the clinical trials, Reductil™ was given in the morning.
Analysis of numerous variables has indicated that approximately 60% of patients
who lose at least 4 pounds in the first 4 weeks of treatment with Reductil™ in combination
with a reduced-calorie diet lost at least 5% (placebo-subtracted) of their initial
body weight by the end of 6 months to 1 year of treatment on that dose of Reductil™.
Conversely, approximately 80% of patients who do not lose at least 4 pounds in the
first 4 weeks of treatment with a given dose of Reductil™ do not lose at least 5%
(placebo-subtracted) of their initial body weight by the end of 6 months to 1 year
of treatment. If a patient has not lost at least 4 pounds in the first 4 weeks
of treatment, the physician should consider re-evaluation of therapy which may include
increasing the dose or discontinuation of Reductil™.
The safety and effectiveness of Reductil™, as demonstrated in double-blind, placebo-controlled
trials, have not been determined beyond 2 years at this time.
Side Effects
The most common side effects when taking Reductil™ are headache, dry mouth, constipation,
anorexia and insomnia. Other side effects that may occur include increased
sweating, an increase in blood pressure and an increase in heart rate.
Precautions
Do not take Reductil™ if you are receiving monoamine oxidase inhibitors (MAOI's).
Do not take Reductil™ if you are hypersensitive to sibutramine or any of the inactive
ingredients of Reductil™. Reductil™ should not be taken by patients who have
a major eating disorder (anorexia nervosa or bulimia nervosa). Do not take
Reductil™ while taking any other weight loss drugs.
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.
Reductil™ may increase the sedative effects of alcohol. It is important that you
let your doctor know how often, and what type of alcoholic beverages you drink.
Your doctor can advise you best as to whether you should drink alcoholic beverages
while on Reductil™.
Reductil™ can be safely taken with moderate use of coffee, tea or caffeinated beverages.
You should check with your doctor to make sure that you do not have a medical condition
that can be aggravated by these beverages independent of being on Reductil™. You
should check with your doctor if you consume a great deal of caffeinated beverages
or use over-the-counter pills that contain caffeine.
Reductil™ was associated with mean increases in systolic and diastolic blood pressure
of approximately 1 to 3 mm Hg relative to placebo. Blood pressure and pulse should
be measured prior to starting therapy with Reductil™ and should be monitored at
regular intervals thereafter. For patients who experience sustained increase
in blood pressure or pulse rate while taking Reductil™, either dose reduction or
discontinuation should be considered.
Reductil™ should not be taken by patients with a history of hypertension or by patients
with uncontrolled or poorly controlled hypertension.
Drug Interactions
Inform your doctor about all the medicines you take with and without a prescription.
Reductil™ should not be taken by patients using Manoamine Oxidase Inhibitors (MAOI's).
Missed Dose
If you miss a dose, skip the missed dose and resume your usual dosing schedule.
Do not "double-up" the amount to catch up.
Storage
Store at room temperature away from sunlight. Keep this and all medications out
of the reach of children.
Notes
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE
THIS MEDICINE for other health conditions. KEEP THIS PRODUCT out of the reach of
children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain repeat prescription
before your supply runs out.
