Sibutramine was withdrawn from the US market in October 2010.
Sibutramine affects the chemicals in the brain that affect weight maintenance.
Sibutramine is used in conjunction with diet and exercise to treat obesity, which can be associated with diabetes, high cholesterol or high blood pressure.
Sibutramine may also be used for other purposes not listed in this manual.
Do not use Sibutramine if you are taking an MAO inhibitor such as furazolidone (furoxone), isocarboxazide (Marplan), phenelzine (nardyl), rasagiline (Azilect), selegiline (eldepril, emsam) or tranylcypromine (Parnat) over the past 14 days. Serious, life-threatening side effects can occur if you use Sibutramine before the MAO inhibitor is removed from the body.
You should not take Sibutramine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), if you take diet pills or if you have a history of coronary artery disease, a stroke or heart disease.
Before taking Sibutramine, tell your doctor if you have glaucoma, high blood pressure, liver or kidney disease, depression, insufficient thyroid activity, seizures, bleeding disorder, history of gallstones, or if you are 65 years of age or younger than 16 years old.
Tell your doctor about all the medicines that you use.
Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low-calorie diet.
You should not take this medication if you are allergic to sibutramine, or if you have:
- severe or uncontrolled hypertension (high blood pressure);
- eating disorder (anorexia or bulimia);
- a history of coronary artery disease (atherosclerosis);
- history of heart disease (congestive heart failure, heart rhythm disorder);
- history of heart attack or stroke; or
- if you take pills to stimulate a diet.
If you have any of these conditions, you may need to adjust the dose of Sibutramine or special tests:
- high blood pressure;
- liver disease;
- kidney disease;
- problems with the thyroid gland;
- epilepsy or seizure disorder;
- bleeding or blood clotting disorder;
- history of gallstones; or
- if you are over 65 years of age or younger than 16 years.
It is not known whether Sibutramine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Sibutramine.
It is not known whether Sibutramine passes into breast milk and whether it can harm a breastfeeding baby. Do not use this medication without telling your doctor if you are breastfeeding.
Do not give this medicine to anyone younger than 16 years old.
Side Effects of Sibutramine
Obtain immediate medical attention if you have any of these signs of an allergic reaction: shortness of breath; swelling of the face, lips, tongue, or throat.
Stop using Sibutramine and contact your doctor immediately if you have serious side effects such as:
- rapid, pounding or irregular heartbeat;
- new or worsening shortness of breath;
- hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;
- very tight muscles, high fever, sweating, confusion, a feeling that you can disappear;
- light bruising or bleeding (nasal bleeding, bleeding gums, or any bleeding that does not stop);
- dangerously high blood pressure (severe headache, blurred vision, buzzing in the ears, anxiety, attack);
- chest pain or heavy feeling, pain spreading to the arm or shoulder, a general bad feeling; or
- sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance.
Less serious side effects may include:
- dry mouth, upset stomach;
- changes in appetite;
- constipation, stomach pain;
- headache, back pain, joint pain;
- dizziness or depression;
- flu symptoms, runny or stuffy nose, sore throat, cough;
- problems with sleep (insomnia); or
- mild rash.
This is not a complete list of side effects, and others may also occur. Ask your doctor about side effects.
Sibutramine can disrupt your thinking or reaction. Be careful if you are driving or doing something that requires attention from you.
Do not take any other prescription or over-the-counter products to reduce weight without the advice of your doctor.
Avoid drinking alcohol while taking sibutramine.
Before using Sibutramine, tell your doctor if you regularly use other medicines that force you. They can add to the drowsiness caused by Sibutramine.
The following drugs may interact with Sibutramine. Tell your doctor if you are using any of these:
- lithium (lithobid, escalite, etc.);
- tryptophan or L-tryptophan;
- ketoconazole (Nizoral);
- an antibiotic such as erythromycin (EES, EryPed, Ery-Tab, Erythrocin);
- an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor) and others;
- medicines such as dihydroergotamine (DHE 45, MigranalNasalSpray), ergonovine (ergotratus), ergotamine (Ergomar) or methylergonovine (metergin).
- from migraine headaches, such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
- narcotic painkillers such as fentanyl (Actiq, Duragesic, Fentora, Onsolis), meperidine (Demerol), pentazocine (Talwin).
This list is not complete, and other drugs may interact with Sibutramine. Tell your doctor about all the medicines that you use.
Dosage of Sibutramine
Take exactly as prescribed by your doctor. Do not take more or less, or longer than recommended. Follow the directions on the recipe label.
Sibutramine is usually taken once a day. Follow the instructions of your doctor.
Your doctor can sometimes change your dose to make sure that you get the best results.
Sibutramine can be taken with or without food.
You must lose at least 4 pounds during the first 4 weeks of taking Sibutramine and follow a low-calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks.
Your blood pressure and pulse will need to be checked often. Visit your doctor regularly.
Sibutramine should not be taken more than 2 years.
Store at room temperature away from moisture, heat and light.
Do not share Sibutramine with another person. Keep the medicine in a place where others can not reach it.
Symptoms of overdose may include headache, dizziness and a fast heart rhythm.
Take the missed dose as soon as you remember. Leave it if it’s time for the next scheduled dose. Do not take additional medication to make up for the missed dose.