Sibutramine is an anti-obesity agent. It affects chemicals in the body that are related to
Indication: for treatment of obesity as short-term supplement to diet and exercise
Special precautions: Do not take sibutramine without talking to your doctor if you have
the following conditions: bleeding problems; anorexia nervosa; high blood pressure;
heart disease, irregular heartbeats, congestive heart failure, or a history of stroke;
present or previous history of depression; epilepsy or another seizure disorder;
gallstones; glaucoma; liver disease; or kidney disease. You may not be able to take
sibutramine, or may require a dosage adjustment or special monitoring if you have any
of the conditions listed above.
Sibutramine is not known to harm an unborn baby (FDA pregnancy category C) and
whether it passes into breast milk. Do not take sibutramine without discussing to your
doctor if you are pregnant or could become pregnant during treatment and if you are
nursing a baby. Avoid giving sibutramine in children younger than 16 years of age
because the safety and effectiveness of this drug have not been studied in this age group.
Symptoms of a sibutramine overdose are not known. Use caution when driving,
operating machinery, or performing other hazardous activities. Sibutramine may cause
dizziness, difficulty concentrating, or restlessness.
Serious side effects that necessitates stopping intake of sibutramine and seek emergency
medical attention: an allergic reaction (difficulty breathing; closing of your throat;
swelling of your lips, tongue, or face; or hives); easy bleeding, bruising under the skin ,
bloody gums, or blood in your urine or stool; new or worsening shortness of breath;
an irregular heartbeat; high blood pressure (severe headache, blurred vision); or
Other, less serious side effects may be more likely to occur. Continue to take
sibutramine and talk to your doctor if you experience restlessness or tremor,
nervousness or anxiety, mild headache or dizziness, insomnia, dry mouth or an
unpleasant taste in your mouth, or constipation.
A dangerous drug interaction with monoamine oxidase inhibitor (MAOI) such as
isocarboxazid (Marplan), tranylcypromine (Parnate), or phenelzine (Nardil) in the last
14 days may occur.
Before taking this medication, tell your doctor if you are taking any of the following
medications: lithium (Lithobid, Eskalith, Lithonate, others); almotriptan (Axert),
naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), eletriptan (Relpax),
frovatriptan (Frova), or zolmitriptan (Zomig); venlafaxine (Effexor), duloxetine
(Cymbalta), nefazodone (Serzone), mirtazapine (Remeron), or thioridazine (Mellaril);
citalopram (Celexa), fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), or
fluvoxamine (Luvox); amitriptyline (Elavil, Endep), amoxapine (Asendin),
clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil);
dihydroergotamine (D.H.E.); an oral anticoagulant or drugs that may increase bleeding
such as warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix), pentoxifylline (Trental) , aspirin, and others; dextromethorphan (in many cough medicines); meperidine (Demerol); fentanyl (Duragesic); or pentazocine (Talacen, Talwin).
Sibutramine may interact with the medicines listed above and cause a condition called Serotonin Syndrome. This syndrome requires immediate medical attention and may include one or more of the following symptoms: anxiety, restlessness, loss of consciousness, confusion, weakness, tremor, poor coordination, fever, shivering, sweating, vomiting, a fast heartbeat, and others.
Do not take any other prescription or over-the-counter medicines without first talking to your doctor, especially other appetite suppressants or weight-loss products , tryptophan (L-tryptophan, 5-HTP), decongestants, antidepressants, cough suppressants, lithium (Eskalith, Lithobid, Lithonate, others), or migraine medicines.
Sibutramine is an orally administered agent for the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the (+) and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-a -(2-methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of C17H29Cl2NO. Its molecular weight is 334.33. Each Sibutramine capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. It also contains as inactive ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients].
Sibutramine has the following structural formula: