Tenuate

DRUG DESCRIPTION

TENUATE® (diethylpropion) is available for oral administration in immediate-release tablets containing 25 mg diethylpropion hydrochloride and in controlled-release tablets containing 75 mg diethylpropion hydrochloride. The inactive ingredients in each immediate-release tablet are: corn starch, lactose, magnesium stearate, pregelatinized corn starch, talc, and tartaric acid. The inactive ingredients in each controlled-release tablet are: carbomer 934P, mannitol, povidone, tartaric acid, zinc stearate. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride. Its chemical structure is:

Tenuate (diethylpropion hydrochloride) structural formula illustration

In TENUATE DOSPAN tablets, diethylpropion hydrochloride is dispersed in a hydrophilic matrix. On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix. The result is controlled release of the anorectic agent.

What are the possible side effects of diethylpropion (Tenuate, Tenuate Dospan)?

If you experience any of the following serious side effects, stop taking diethylpropion and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular heartbeat or very high blood pressure (severe headache, blurred vision); or
  • hallucinations, abnormal behavior, or confusion.

Other, less serious side effects may be more likely to occur. Continue to take diethylpropion and...

Read All Potential Side Effects and See Pictures of Tenuate »

What are the precautions when taking diethylpropion (Tenuate)?

Before taking diethylpropion, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (e.g., decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as phentermine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using diethylpropion, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (e.g., chest pain, heart attack), mental/mood problems (e.g., severe anxiety, bipolar disorder, psychosis,...

Read All Potential Precautions of Tenuate »


Tenuate Consumer (continued)

SIDE EFFECTS: Dizziness, dry mouth, difficulty sleeping, irritability, nausea, vomiting, diarrhea, or constipation may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, mental/mood changes (e.g., agitation, uncontrolled anger, hallucinations, nervousness), uncontrolled muscle movements, change in sexual ability/interest.

Stop taking this medication and seek immediate medical attention if any of these rare but very serious side effects occur: severe headache, slurred speech, seizure, weakness on one side of the body, vision changes (e.g., blurred vision).

This drug may infrequently cause serious (sometimes fatal) lung or heart problems (pulmonary hypertension, heart valve problems). The risk increases with longer use of this medication and use of this drug along with other appetite-suppressant drugs/herbal products. If you notice any of the following unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: chest pain, difficulty breathing with exercise, decreased ability to exercise, fainting, swelling of the legs/ankles/feet.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking diethylpropion, tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines (e.g., decongestants such as pseudoephedrine, stimulants such as amphetamine, appetite suppressants such as phentermine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using diethylpropion, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, glaucoma, history of alcohol/drug abuse, vascular heart disease (e.g., chest pain, heart attack), mental/mood problems (e.g., severe anxiety, bipolar disorder, psychosis, schizophrenia), high blood pressure in the lungs (pulmonary hypertension), stroke, overactive thyroid (hyperthyroidism).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, controlled high blood pressure, other heart problems (e.g., heart murmur, fast/irregular heartbeat, heart valve problems), kidney disease, seizure problem.

This drug may make you dizzy or (rarely) drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness and high blood pressure while using this drug.

During pregnancy, this medication should be used only when clearly needed. It is not recommended for use for long periods or in high doses near the expected delivery date because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for a long time or in high doses may have withdrawal symptoms such as irritability or extreme tiredness. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Tenuate Patient Information Including Side Effects

Brand Names: Tenuate, Tenuate Dospan

Generic Name: diethylpropion (Pronunciation: dye eth ill PROE pee on)

  • What is diethylpropion (Tenuate)?
  • What are the possible side effects of diethylpropion (Tenuate)?
  • What is the most important information I should know about diethylpropion (Tenuate)?
  • What should I discuss with my healthcare provider before taking diethylpropion (Tenuate)?
  • How should I take diethylpropion (Tenuate)?
  • What happens if I miss a dose (Tenuate)?
  • What happens if I overdose (Tenuate)?
  • What should I avoid while taking diethylpropion (Tenuate)?
  • What other drugs will affect diethylpropion (Tenuate)?
  • Where can I get more information?

What is diethylpropion (Tenuate)?

Diethylpropion is a sympathomimetic amine, which is similar to an amphetamine. It is also known as an "anorectic" or an "anorexigenic" drug. Diethylpropion stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.

Diethylpropion is used as a short-term supplement to diet and exercise in the treatment of obesity.

Diethylpropion may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of diethylpropion (Tenuate)?

If you experience any of the following serious side effects, stop taking diethylpropion and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • an irregular heartbeat or very high blood pressure (severe headache, blurred vision); or
  • hallucinations, abnormal behavior, or confusion.

Other, less serious side effects may be more likely to occur. Continue to take diethylpropion and talk to your doctor if you experience

  • restlessness or tremor,
  • nervousness or anxiety,
  • headache or dizziness,
  • insomnia,
  • dry mouth or an unpleasant taste in your mouth,
  • diarrhea or constipation, or
  • impotence or changes in your sex drive.

Diethylpropion is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually.

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.

What is the most important information I should know about diethylpropion (Tenuate)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diethylpropion may cause dizziness, blurred vision, or restlessness, and it may hide the symptoms of extreme tiredness. If you experience these effects, avoid hazardous activities.

Diethylpropion is habit forming. You can become physically and psychologically dependent on this medication, and withdrawal effects may occur if you stop taking it suddenly after several weeks of continuous use. Talk to your doctor about stopping this medication gradually.

Do not crush, chew, or open any "once-daily" diethylpropion tablets or capsules. Swallow them whole.

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