Tenuate is a stimulant similar to an amphetamine. Diethylpropion is an appetite suppressant that affects the central nervous system.

Tenuate is used as together with diet and exercise to treat obesity in people who have a body mass index (BMI) of at least 30 kilograms per square meter.

Tenuate is usually given after diet and exercise have been tried without success.

You should not take Tenuate if you are in an agitated state, or if you have pulmonary hypertension, severe coronary artery disease, overactive thyroid, glaucoma, severe high blood pressure, or a history of drug abuse.

Do not use this medicine if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not take Tenuate together with any other diet pills unless your doctor tells you to.

Tenuate may cause blurred vision and may impair your thinking or reactions. Diethylpropion may also cause restless feelings that can hide the symptoms of extreme tiredness. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Tenuate may be habit-forming and should be used only by the person it was prescribed for. Keep this medicine in a secure place where others cannot get to it.

Do not stop using Tenuate suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine.

Before taking this medicine

Do not use Tenuate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use Tenuate if you are allergic to diethylpropion, or if you have:

• pulmonary hypertension;

• severe coronary artery disease;

• severe high blood pressure;

• an overactive thyroid;

• a history of drug abuse;

• glaucoma; or

• if you are in an agitated state.

Do not take Tenuate with any other diet pills unless your doctor tells you to. Taking diethylpropion in combination with other diet pills or appetite suppressants can cause a rare fatal lung disorder called pulmonary hypertension.

To make sure Tenuate is safe for you, tell your doctor if you have ever had:

• kidney disease;

• high blood pressure;

• a heart valve disorder or heart rhythm disorder;

• seizures or epilepsy; or

• if you have taken any other diet pills within the past 12 months.

It is not known whether this medicine will harm an unborn baby. If you use Tenuate while you are pregnant, your baby could become dependent on the drug. This can cause withdrawal symptoms in the baby after it is born. Tell your doctor if you are pregnant or plan to become pregnant.

Diethylpropion can pass into breast milk and may affect the nursing baby. Tell your doctor if you are breast-feeding.

Tenuate is not approved for use by anyone younger than 16 years old.

Take Tenuate exactly as prescribed. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Diethylpropion may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

The immediate-release Tenuate tablet is usually taken three times a day before meals.

The extended-release Tenuate Dospan tablet is usually taken once a day midmorning.

Tell your doctor if you do not lose at least 4 pounds after taking the medicine for 4 weeks along with a low calorie diet.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

If you need surgery, tell the surgeon ahead of time that you are using Tenuate. You may need to stop using the medicine for a short time.

Do not stop using Tenuate suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Diethylpropion is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Usual Adult Dose for Obesity:

IMMEDIATE-RELEASE: 25 mg orally 3 times a day, 1 hour before meals, and in mid-evening if desired to overcome night hunger.

CONTROLLED-RELEASE: 75 mg orally once a day in mid-morning, swallowed whole.

Comments:
-Indicated for monotherapy use only.
-Treatment should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds or as determined by the physician and patient).
-Discontinue treatment if tolerance develops; do not exceed the recommended dose in an attempt to increase the effect.

Use: Management of exogenous obesity as a short-term adjunct (a few weeks) on a regimen of weight reduction based on caloric restriction in patients with an initial BMI of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Usual Pediatric Dose for Obesity:

Over 16 years of age:
IMMEDIATE-RELEASE: 25 mg orally 3 times a day, 1 hour before meals, and in mid-evening if desired to overcome night hunger.

CONTROLLED-RELEASE: 75 mg orally once a day in mid-morning, swallowed whole.

Comments:
-Indicated for monotherapy use only.
-Treatment should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds or as determined by the physician and patient).
-Discontinue treatment if tolerance develops; do not exceed the recommended dose in an attempt to increase the effect.

Use: Management of exogenous obesity as a short-term adjunct (a few weeks) on a regimen of weight reduction based on caloric restriction in patients with an initial BMI of 30 kg/m2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone.

Do not use Tenuate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use Tenuate if you are allergic to diethylpropion, or if you have:

• pulmonary hypertension;

• severe coronary artery disease;

• severe high blood pressure;

• an overactive thyroid;

• a history of drug abuse;

• glaucoma; or

• if you are in an agitated state.

Do not take Tenuate with any other diet pills unless your doctor tells you to. Taking diethylpropion in combination with other diet pills or appetite suppressants can cause a rare fatal lung disorder called pulmonary hypertension.

To make sure Tenuate is safe for you, tell your doctor if you have ever had:

• kidney disease;

• high blood pressure;

• a heart valve disorder or heart rhythm disorder;

• seizures or epilepsy; or

• if you have taken any other diet pills within the past 12 months.

It is not known whether this medicine will harm an unborn baby. If you use Tenuate while you are pregnant, your baby could become dependent on the drug. This can cause withdrawal symptoms in the baby after it is born. Tell your doctor if you are pregnant or plan to become pregnant.

Diethylpropion can pass into breast milk and may affect the nursing baby. Tell your doctor if you are breast-feeding.

Tenuate is not approved for use by anyone younger than 16 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include restlessness, tremors, overactive reflexes, rapid breathing, confusion, hallucinations, dilated pupils, panic, aggression, or seizure.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

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

Call your doctor at once if you have:

• chest pain, feeling short of breath (especially with exertion);

• swelling in your ankles or feet;

• anxiety, feeling nervous or jittery;

• muscle twitches;

• feelings of extreme happiness or sadness;

• fast or pounding heartbeats, fluttering in your chest; or

• a light-headed feeling, like you might pass out.

Common Tenuate side effects may include:

• nausea, vomiting, diarrhea, upset stomach, constipation;

• headache, blurred vision;

• sleep problems (insomnia);

• dizziness, drowsiness, tired feeling;

• depressed mood;

• dry mouth, unpleasant taste in your mouth;

• decreased sex drive; or

• redness, bruising, or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• insulin or oral diabetes medicines;

• blood pressure medicine; or

• medicine to treat mental illness.

This list is not complete. Other drugs may interact with diethylpropion, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.