Diethylpropion CR

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

• Diethylpropion is available under the following different brand names: Tenuate

Common side effects of Diethylpropion include:

• restlessness
• nervousness
• anxiety
• jittery feeling
• tremor
• sleep problems (insomnia)
• dizziness
• drowsiness
• tired feeling
• depression
• dry mouth
• unpleasant taste in the mouth
• nausea
• vomiting
• diarrhea
• upset stomach
• headache
• blurred vision
• changes in sex drive
• itching or rash

Serious side effects of Diethylpropion include:

• chest pain, feeling short of breath (especially with exertion)
• swelling in the ankles or feet
• anxiety, feeling nervous or jittery
• muscle twitches
• feelings of extreme happiness or sadness
• fast or pounding heartbeats
• fluttering in the chest
• lightheadedness
• fast/irregular/pounding heartbeat
• mental/mood changes (e.g., agitation, uncontrolled anger, hallucinations, nervousness), or
• uncontrolled muscle movements

Rare side effects of Diethylpropion include:

• psychotic disorder
• drug dependence

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet: Schedule IV

• 25 mg

Tablet, controlled release: Schedule IV

• 75 mg

Obesity

Adult dosage

• Immediate release
  • 25 mg orally every 6-8 hours 1 hour before meals
  • May add 1 additional 25 mg dose orally midevening to overcome night hunger
• Controlled-release
  • 75 mg orally once a day, swallowed whole, in midmorning

Pediatric dosage

• Children younger than 16 years
  • Safety & efficacy not established
• Children older than 16 years
  • Immediate release: 25 mg orally every 8 hours before meals
  • Controlled release: 75 mg orally once a day, swallowed whole, in midmorning

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Diethylpropion has severe interactions with the following drugs:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • methylphenidate
  • phenelzine
  • procarbazine
  • safinamide
  • selegiline transdermal
  • tranylcypromine
• Diethylpropion has serious interactions with at least 27 other drugs
• Diethylpropion has moderate interactions with at least 163 other drugs
• Diethylpropion has minor interactions with the following drugs:
  • desmopressin
  • eucalyptus
  • sage

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Advanced arteriosclerosis
• Hyperthyroidism
• Severe hypertension
• Pulmonary hypertension
• Hypersensitivity to sympathomimetic amines
• Glaucoma
• Agitated state
• History of drug abuse
• Pregnancy (especially first trimester)
• Within 14 days of MAOI
• Concurrent use with other anorectic agents

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Diethylpropion?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Diethylpropion?”

Cautions

• Therapy may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should be cautioned accordingly
• Prolonged use may induce dependence with withdrawal syndrome on cessation of therapy
• Hallucinations have occurred rarely following high doses of the drug
• Several cases of toxic psychosis reported following excessive use of drugs; some have been reported in which the recommended dose appears not to have been exceeded; new onset of mania may occur with stimulant use; observe for symptoms of aggression and/or hostility; psychosis has been abated after drug discontinued
• When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol
• Reports suggest the drug may increase convulsions in some patients with seizure disorders; therapy should be carefully monitored; titration of dose or discontinuance of therapy may be necessary
• Stimulants may unmask tics in Tourette’s syndrome; use with caution
• Use caution in patients with diabetes mellitus; requirements of antidiabetic agents may be altered with anorexiants and concomitant dietary restrictions
• Pulmonary hypertension
  • Use of anorectic agents, including dethylpropion, associated with increased risk of developing pulmonary hypertension, a rare, but often fatal disorder; use of anorectic agents for more than 3 months associated with 23-fold increase in risk of developing pulmonary hypertension; increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded
  • Onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension; if a patient develops these symptoms discontinue therapy, and evaluation patient for pulmonary hypertension
• Valvular heart disease
  • Valvular heart disease associated with the use of some anorectic agents reported; possible contributing factors include use for extended periods, higher than the recommended dose, and/or use in combination with other anorectic drugs
  • Valvulopathy has been very rarely reported with monotherapy; the potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss; consider baseline cardiac evaluation to detect preexisting valvular heart diseases or pulmonary hypertension before initiation of treatment
  • Therapy is not recommended in patients with a known heart murmur or valvular heart disease; an echocardiogram during and after treatment could be useful for detecting any valvular disorders that may occur
  • To limit unwarranted exposure and risks, treatment should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (eg, weight loss of at least 4 pounds, or as determined by physician and patient); therapy is not recommended for patients who used any anorectic agents within the prior year
  • If tolerance develops, do not exceed the recommended dose to increase the effect; discontinue the drug instead

Pregnancy and Lactation

• May be acceptable during pregnancy
• Lactation
  • Excreted in breast milk, use caution