Pronunciation:

si-BUE-tra-meen

Brand Names:

• Meridia

Dosage Forms:

• Capsule

Classifications:

Therapeutic

Appetite Suppressant, Centrally Acting

Pharmacologic

Serotonin/Norepinephrine Reuptake Inhibitor

Uses of This Medicine:

Sibutramine is used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning. Sibutramine is thought to work by increasing the activity of certain chemicals, called norepinephrine and serotonin, in the brain. This medicine is approved for use only in people who are very overweight.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of sibutramine in the pediatric population. Safety and efficacy have not been established.

Older adults

Use of sibutramine in elderly patients older than 65 years of age is not recommended.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amphetamine
• Brofaromine
• Clorgyline
• Dexfenfluramine
• Dextroamphetamine
• Diethylpropion
• Fenfluramine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Mazindol
• Moclobemide
• Nialamide
• Pargyline
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylpropanolamine
• Procarbazine
• Rasagiline
• Selegiline
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Almotriptan
• Citalopram
• Clovoxamine
• Desvenlafaxine
• Dextromethorphan
• Dihydroergotamine
• Droperidol
• Eletriptan
• Ergotamine
• Escitalopram
• Femoxetine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Lithium
• Meperidine
• Milnacipran
• Naratriptan
• Nefazodone
• Paroxetine
• Pentazocine
• Rasagiline
• Rizatriptan
• Sertraline
• Sumatriptan
• Tryptophan
• Venlafaxine
• Zimeldine
• Zolmitriptan

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain), history of or
• Congestive heart failure, history of or
• Coronary artery disease, history of or
• Eating disorder (e.g., anorexia nervosa or bulimia nervosa) or
• Heart attack, history of or
• Heart rhythm problems (e.g., arrhythmia), history of or
• Hypertension (high blood pressure), uncontrolled or
• Kidney disease, severe or
• Liver disease, severe or
• Peripheral arterial occlusive disease or
• Stroke, history of or
• Tachycardia (rapid heart rate) or
• Transient ischemic attack or "mini stroke", history of Should not be used in patients with these conditions.

• Bleeding problems or
• Depression, history of or
• Gallstones, history of or
• Glaucoma, narrow angle or
• Hypertension (high blood pressure), history of or
• Hypothyroidism (underactive thyroid), untreated or
• Neuroleptic malignant syndrome (NMS), history of or
• Pulmonary hypertension (high blood pressure in the lungs) or
• Seizures, history of Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease Use with caution. Higher blood levels of sibutramine may occur, increasing the chance of having unwanted side effects.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than directed by your doctor. To do so may increase the chance of developing unwanted side effects such as high blood pressure.

This medicine comes with a Medication Guide and patient information insert. Read and follow the instructions carefully. Talk to your doctor if you have any questions.

Follow your doctor's instructions carefully on a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Sibutramine may be taken with or without food, on a full or empty stomach. However, if your doctor tells you to take it in a certain way, take it as directed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For weight loss:
    • Adults At first, 10 milligrams (mg) one time per day, usually in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children Use and dose must be determined by the doctor.

Missed dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. You will need to have your blood pressure and pulse checked on a regular schedule. Keep all appointments your doctor makes for you.

If sibutramine does not seem to be working well, do not change your dose without checking first with your doctor.

Do not use sibutramine if you have taken an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan], phenelzine [Nardil], procarbazine [Matulane], selegiline [Eldepryl], or tranylcypromine [Parnate] within the past 14 days. Do not take an MAO inhibitor within 2 weeks of taking sibutramine. To do so may cause severe seizures, extremely high blood pressure, or a life-threatening adverse effect called serotonin syndrome.

Make sure your doctor knows about all the other medicines you are using. This medicine may cause serious conditions called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid [Zyvox®], lithium, tryptophan, St. John’s Wort, or some pain medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

This medicine may cause a rare and life-threatening condition that affects the blood pressure in the lungs called pulmonary hypertension. Check with your doctor right away if you have new or worsening shortness of breath.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking this medicine and check with your doctor as soon as possible.

Sibutramine may cause dizziness, drowsiness, trouble in thinking, or poor judgment. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert or able to think well.

Do not drink excess alcohol while taking this medicine.

Sibutramine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Achiness

chills

fast or irregular heartbeat

increased blood pressure

mental depression

painful menstruation

swelling of the body, feet, or ankles

Rare

Bruising or red spots or patches on the skin

convulsions (seizures)

excessive bleeding following injury

headache (severe)

rapidly changing moods

skin rash

weight gain (unusual)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Anxiety

constipation

dizziness

dryness of the mouth

headache

irritability or unusual impatience

nervousness

stuffy or runny nose

trouble with sleeping

Less common

Abdominal or stomach pain

back pain

burning, itching, prickling, or tingling of the skin

change in sense of taste

diarrhea

drowsiness

increase in appetite

increased sweating

increased thirst

indigestion

nausea

unusual warmth or flushing of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.