Sibutramine

PRODUCT DESCRIPTION

Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain. Neurotransmitters are chemicals that are produced and released by nerves in order to communicate with other nerves. Released neurotransmitters may attach to other nerves or they may be taken up again by the nerves that release them, a process termed reuptake. Sibutramine blocks the reuptake of the neurotransmitters dopamine, norepinephrine, and serotonin. Blocking the reuptake of neurotransmitters alters the balance of neurotransmitters within the nerve cells and thereby affect nerve function and interaction.

Patients taking sibutramine may achieve a 5-10% reduction from their baseline weight. Additionally, sibutramine-assisted weight loss has been accompanied by improvement in blood lipids (e.g, cholesterol). Sibutramine was approved by the FDA in 1997.

Sibutramine affects chemicals in the brain that affect weight maintenance.

Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.

Sibutramine may also be used for other purposes not listed in this medication guide.

DOSAGE METHOD

Usual Adult Dose for Obesity:

It was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Initial Dose: 10 mg orally once a day.

Usual Geriatric Dose for Obesity:

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. It is contraindicated in this group of patients.

Usual Pediatric Dose for Obesity:

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Based on one study (n=60)

14 to 17 years:

Initial Dose: 10 mg orally once a day.

What other drugs will affect sibutramine?

Before using sibutramine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by sibutramine.

Ask your doctor before taking any decongestants, cough medicine, or other diet pills.

The following drugs can interact with sibutramine. Tell your doctor if you are using any of these:

lithium (Lithobid, Eskalith, and others);

tryptophan or L-tryptophan;

ketoconazole (Nizoral);

an antibiotic such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

NEGATIVE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:

fast, pounding, or uneven heartbeats;

new or worsening shortness of breath;

agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;

very stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out;

easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure);

constipation, stomach pain;

Disclaimer

While every effort has been taken to ensure that the information provided is accurate, up-to-date and complete, Prime Medical Pharma cannot guarantee its accuracy. Please note that the drug information contained herein may be time-sensitive and should not be relied upon beyond the date hereof. This material is intended as a reference resource and should not be used as a substitute for the expertise, skill, knowledge, and judgment of healthcare practitioners in patient care. It is important to note that the absence of a warning for a given drug or combination thereof does not imply safety, effectiveness, or appropriateness for any particular patient. This material does not endorse drugs, diagnose patients, or recommend therapy.