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APPETITE SUPPRESSANTS, SYMPATHOMIMETIC (Systemic)

Some commonly used brand names are:

In the U.S.—

• Adipex-P ⁵
• Adipost ⁴
• Bontril PDM ⁴
• Bontril Slow-Release ⁴
• Didrex ¹
• Fastin ⁵
• Ionamin ⁵
• Mazanor ³
• Melfiat ⁴
• Obenix ⁵
• Obezine ⁴
• Phendiet ⁴
• Phendiet-105 ⁴
• Phentercot ⁵
• Phentride ⁵
• Plegine ⁴
• Prelu-2 ⁴
• Pro-Fast ⁵
• PT 105 ⁴
• Sanorex ³
• Tenuate ²
• Tenuate Dospan ²
• Tepanil Ten-Tab ²
• Teramine ⁵
• Zantryl ⁵

In Canada—

• Ionamin ⁵
• Sanorex ³
• Tenuate ²
• Tenuate Dospan ²

Other commonly used names are:

• Amfepramone
• Benzfetamine

Category

• Appetite suppressant—Benzphetamine; Diethylpropion; Mazindol; Phendimetrazine; Phentermine

Description

Sympathomimetic appetite suppressants are used in the short-term treatment of obesity. Their appetite-reducing effect tends to decrease after a few weeks. Because of this, these medicines are useful only during the first few weeks of a weight-loss program. The sympathomimetic appetite suppressants can help you to lose weight while you are learning new ways to eat and to exercise. Changes in eating habits and activity level must be developed and continued long-term in order for you to continue losing weight and to keep the lost weight from returning.

These medicines are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Benzphetamine
  • Tablets (U.S.)
• Diethylpropion
  • Tablets (U.S. and Canada)
  • Extended-release tablets (U.S. and Canada)
• Mazindol
  • Tablets (U.S. and Canada)
• Phendimetrazine
  • Extended-release capsules (U.S.)
  • Tablets (U.S.)
• Phentermine
  • Capsules (U.S.)
  • Resin capsules (U.S. and Canada)
  • Tablets (U.S.)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or amphetamine, dextroamphetamine, ephedrine, epinephrine, isoproterenol, metaproterenol, methamphetamine, norepinephrine, phenylephrine, phenylpropanolamine, pseudoephedrine, terbutaline, or other appetite suppressants. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—You must follow a reduced-calorie diet while using an appetite suppressant in order to lose weight. Also, in order to keep the lost weight from returning, changes in diet and exercise must be continued after the weight has been lost.

Pregnancy—If a pregnant woman takes this medicine in high doses or more often than the doctor has directed, it may cause withdrawal symptoms in the newborn baby. Also, medicines similar to sympathomimetic appetite suppressants can cause birth defects in the newborn baby if a pregnant woman takes them in high doses. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Diethylpropion and benzphetamine pass into breast milk. It is not known if other sympathomimetic appetite suppressants pass into breast milk. However, use of sympathomimetic appetite suppressants during breast-feeding is not recommended, because it may cause unwanted effects in nursing babies.

Children—Studies on these medicines have been done only in adult patients, and there is no specific information comparing use of sympathomimetic appetite suppressants in children with use in other age groups. The use of these medicines by children younger than 16 years of age is not recommended.

Older adults—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 or if they cause different side effects or problems in older people. There is no specific information comparing use of appetite suppressants in the elderly with use in other age groups.

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 appetite suppressants, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines or
• Caffeine (e.g., NoDoz) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, or hay fever or other allergies (including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Pemoline (e.g., Cylert)—Using these medicines with sympathomimetic appetite suppressants may increase the central nervous system (CNS) stimulant effects, such as irritability, nervousness, trembling or shaking, or trouble in sleeping

• Appetite suppressants (diet pills), other or
• Selective serotonin reuptake inhibitors (citalopram [e.g., Celexa], fluoxetine [e.g., Prozac], fluvoxamine [e.g., Luvox], paroxetine [e.g., Paxil], sertraline [e.g., Zoloft])—It is not known whether using two different appetite suppressants together or using a sympathomimetic appetite suppressant with a selective serotonin reuptake inhibitor is safe and effective. There have been some serious unwanted effects on the hearts of people who used two different appetite suppressants together

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Do not take an appetite suppressant while you are taking or less than 14 days after taking a monoamine oxidase (MAO) inhibitor . If you do, you may develop sudden extremely high blood pressure

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Using these medicines with sympathomimetic appetite suppressants may cause high blood pressure or irregular heartbeat

Other medical problems—The presence of other medical problems may affect the use of appetite suppressants. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on appetite suppressants may be more likely to develop

• Type 2 diabetes mellitus—The amount of insulin or oral antidiabetic medicine that you need to take may change

• Epilepsy—Diethylpropion may increase the risk of having seizures

• Family history of mental illness—Mental depression or other mental illness may be more likely to occur

• Glaucoma or
• Heart or blood vessel disease or
• High blood pressure or
• Mental illness or
• Overactive thyroid—Appetite suppressants may make the condition worse

• Kidney disease—Higher blood levels of the appetite suppressant may occur, increasing the chance of serious side effects

Proper Use of This Medicine

In order to prevent trouble in sleeping, if you are taking:

• One dose of this medicine a day, take it about 10 to 14 hours before bedtime.
• More than one dose of this medicine a day, take the last dose of the day about 4 to 6 hours before bedtime.

For patients taking a long-acting form of this medicine:

• Swallow these capsules or tablets whole. Do not break, crush, or chew before swallowing.

For patients taking mazindol :

• This medicine may be taken with food, if needed, to prevent stomach upset.

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 your doctor ordered. If too much is taken, it may cause unwanted effects or become habit-forming.

If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose . Instead, check with your doctor.

Dosing—The dose of appetite suppressants 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 appetite suppressants. If your dose is different, do not change it unless your doctor tells you to do so.

• For benzphetamine
• For oral dosage form (tablets):
  • For appetite suppression:
    • Adults—At first, 25 to 50 milligrams (mg) once a day, taken in midmorning or midafternoon. Your doctor may need to adjust your dose.
    • Children up to 16 years of age—Use is not recommended.

• For diethylpropion
• For oral dosage form (tablets):
  • For appetite suppression:
    • Adults—25 milligrams (mg) three times a day, taken one hour before meals.
    • Children up to 16 years of age—Use is not recommended.
• For long-acting oral dosage form (extended-release tablets):
  • For appetite suppression:
    • Adults—75 mg once a day, taken in midmorning.
    • Children up to 16 years of age—Use is not recommended.

• For mazindol
• For oral dosage form (tablets):
  • For appetite suppression:
    • Adults—At first, 1 milligram (mg) once a day. Your doctor may need to adjust your dose.
    • Children up to 16 years of age—Use is not recommended.

• For phendimetrazine
• For long-acting oral dosage form (extended-release capsules):
  • For appetite suppression:
    • Adults—105 mg once a day, taken thirty to sixty minutes before the morning meal.
    • Children up to 16 years of age—Use is not recommended.
• For oral dosage form (tablets):
  • For appetite suppression:
    • Adults—17.5 to 35 mg two or three times a day, taken one hour before meals.
    • Children up to 16 years of age—Use is not recommended.

• For phentermine
• For oral dosage form (capsules):
  • For appetite suppression:
    • Adults—15 to 37.5 milligrams (mg) once a day, taken before breakfast or one to two hours after breakfast.
    • Children up to 16 years of age—Use is not recommended.
• For oral dosage form (tablets):
  • For appetite suppression:
    • Adults—15 to 37.5 mg once a day, taken before breakfast or one to two hours after breakfast. Instead of taking it once a day, your doctor may tell you to take smaller doses thirty minutes before meals.
    • Children up to 16 years of age—Use is not recommended.
• For oral resin dosage form (capsules):
  • For appetite suppression:
    • Adults—15 to 30 mg once a day, taken before breakfast.
    • Children up to 16 years of age—Use is not recommended.

Missed dose—If you miss a dose of this medicine, skip the missed dose and continue with your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose . Instead, check with your doctor.

Do not take an appetite suppressant with or less than 14 days after taking a monoamine oxidase (MAO) inhibitor . If you do, you may very suddenly develop extremely high blood pressure.

Taking a sympathomimetic appetite suppressant may cause a positive result in urine screening tests for amphetamines.

Sympathomimetic appetite suppressants 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 developing dental disease, including tooth decay, gum disease, and fungus infections.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine . Taking appetite suppressants together with medicines that are used during surgery or dental or emergency treatments may cause serious side effects.

Check with your doctor immediately if you notice a decrease in your ability to exercise, if you faint, or if you have chest pain, swelling of your feet or lower legs, or trouble in breathing . These may be symptoms of very serious heart or lung problems.

If you have been taking this medicine for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor .

• Some signs of dependence on appetite suppressants are:
  • a strong desire or need to continue taking the medicine.
  • a need to increase the dose to receive the effects of the medicine.
  • withdrawal side effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) when you stop taking the medicine.

For patients with diabetes :

• This medicine may affect blood sugar levels. If you notice a change in the results of your urine or blood sugar test or if you have any questions, check with your doctor.

If you have been taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor . Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This will help prevent withdrawal side effects.

Side Effects of This Medicine

Appetite suppressants may cause some serious side effects, including heart and lung problems. You and your doctor should discuss the good this medicine may do as well as the risks of taking it.

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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

Although not all of the side effects listed above have been reported for all of these medicines, they have been reported for at least one of them. However, since all of the sympathomimetic appetite suppressants are similar, any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time check with your doctor if you notice any of the following side effects:

Extreme tiredness or weakness; mental depression; nausea or vomiting; stomach cramps or pain; trembling; trouble in sleeping or nightmares

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

Revised: 04/26/1999

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