Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Appetite Suppressant, Centrally Acting
Pharmacologic Class: Serotonin/Norepinephrine Reuptake Inhibitor
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. sibutramine is approved for use only in people who are very overweight.
sibutramine is available only with your doctor's prescription.
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 sibutramine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to sibutramine 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.
Studies on sibutramine have been done only in adult patients, and there is no specific information comparing use of sibutramine in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of sibutramine in the elderly with use in other age groups, sibutramine is not expected to cause different side effects or problems in older people than it does in younger adults.
|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.|
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.
Using sibutramine 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.
Using sibutramine 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.
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.
The presence of other medical problems may affect the use of sibutramine. Make sure you tell your doctor if you have any other medical problems, especially:
Take sibutramine only as directed. 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 effects, such as high blood pressure.
Follow a reduced-calorie diet while taking sibutramine, as directed by your doctor.
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.
You must follow a reduced-calorie diet while taking sibutramine in order to lose weight and keep the lost weight from returning.
The dose of sibutramine 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 sibutramine. 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.
If you miss a dose of sibutramine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
It is important that your doctor check your progress at regular visits. Sibutramine may increase blood pressure or heart rate and your doctor will check for these effects. Your doctor may need to adjust your dose.
If sibutramine does not seem to be working well, do not increase your dosage. Check with your doctor.
Do not take sibutramine while you are taking or within 2 weeks of taking medicines with monoamine oxidase (MAO) inhibitor activity , such as isocarboxazid (e.g., Marplan), phenelzine (e.g., Nardil), procarbazine (e.g., Matulane), selegiline (e.g., Eldepryl), or tranylcypromine (e.g., Parnate). 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 the serotonin syndrome.
Do not drink excess alcohol while taking sibutramine.
Notify your doctor as soon as possible if you develop a skin rash, hives, or other allergic symptoms.
Sibutramine may cause dizziness, drowsiness, or poor judgment. Be sure you know how you react to sibutramine before you drive, operate machinery, or do other things that could be dangerous if you are not alert and able to think clearly.
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.
Along with its needed effects, a medicine may cause some unwanted effects. Some of these effects, such as high blood pressure, may not have signs or symptoms that you can see or feel. While you are taking sibutramine, your doctor will check your blood pressure and heart rate at regular visits.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:Less common
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
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.
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