diethylpropion

Diethylpropion is a medication used for a short term to aid weight loss, in addition to calorie-restricted diet and exercise. Diethylpropion is used in people whose obesity is the result of excessive food intake and inadequate exercise (exogenous obesity), and who are unable to reduce weight with diet and exercise alone. Diethylpropion reduces appetite and fat storage, and increases energy expenditure.

Diethylpropion is a stimulant drug that has structural and chemical similarities to the amphetamine class of drugs and works similarly by stimulating the central nervous system. Diethylpropion is a sympathomimetic drug which mimics the action of natural chemicals in the body that stimulate the sympathetic nervous system. Diethylpropion increases the levels of chemicals known as catecholamines (neurotransmitters), including dopamine and norepinephrine in the brain, which stimulate the central nervous system.

High levels of dopamine and norepinephrine suppress appetite and hunger signals. Increase in catecholamine levels may also increase the levels of leptin, a peptide hormone signal satiety, and reduce the levels of another protein molecule known as neuropeptide Y that stimulates appetite, reduces energy expenditure and increases fat storage. Diethylpropion indirectly reduces appetite by increasing catecholamine levels in the brain.

• Do not use in patients with known hypersensitivity to diethylpropion, any of its components, or any other sympathomimetic amine.
• Do not prescribe diethylpropion to patients with the following conditions:
  • Severe hypertension
  • Pulmonary hypertension
  • Advanced arteriosclerosis
  • Glaucoma
  • Agitated states
• Do not prescribe diethylpropion to patients who have a history of substance abuse.
• Do not use diethylpropion with:
  • Other anorectic drugs concurrently
  • Monoamine oxidase inhibitor (MAOI) antidepressant drugs, concurrently or within 14 days of MAOI treatment, may lead to hypertensive crisis.
• Although rare, diethylpropion is associated with pulmonary hypertension, which is often fatal.
  • Pulmonary hypertension risk increases multifold if diethylpropion is used or longer than 3 months and the risk may also increase with repeated course of therapy.
  • Monitor patients and if a patient develops symptoms such as shortness of breath with exertion, unexplained symptoms of angina pectoris, peripheral edema and fainting, evaluate for pulmonary hypertension and discontinue diethylpropion, if confirmed.
• There have been rare reports of heart valve disease in patients treated with diethylpropion, however, the causal relationship is uncertain.
  • Perform cardiac evaluation of the patient before initiating diethylpropion and do not start treatment in patients with known heart murmur or valvular disorders.
  • Assess the potential risks for valvular heart disease or pulmonary hypertension and potential benefits from weight loss before starting treatment.
• Prescribe and dispense the least possible amount at one time to minimize the possibility of overdose.
• Do not continue diethylpropion treatment if a satisfactory weight loss of at least 4 pounds is not achieved within the first 4 weeks of therapy.
• Do not use diethylpropion within a year of using any other anorectic agent.
• Use diethylpropion with caution in patient with hypertension or symptomatic heart disease, including arrhythmia.
• Diethylpropion may increase convulsion in patients with epilepsy. Monitor epileptic patients and adjust dose or discontinue the drug, if required.
• Diethylpropion may impair the ability to engage in hazardous activities. Caution the patient appropriately.
• Discontinue diethylpropion if patient develops tolerance, do not exceed recommended doses in an effort to increase the effect.
• Prolonged use of diethylpropion may cause dependency and withdrawal syndrome upon discontinuation.
• Excessive use of diethylpropion can cause hallucination and toxic psychosis, and some cases of psychosis were reported even at recommended doses. Psychosis abated after discontinuation of diethylpropion.
• As with all central nervous system agents, there is a possibility of adverse interactions with alcohol, caution patients appropriately.

Common side effects of diethylpropion include:

• Sharp pains in the chest (precordial pain)
• Irregular heart rhythms (arrhythmias)
• Ventricular arrhythmia
• ECG changes
• Rapid heart rate (tachycardia)
• Palpitations
• Increase in blood pressure (hypertension)
• Pulmonary hypertension (rare)
• Heart valve disease (rare)
• Cerebrovascular accident
• Overstimulation
• Uncontrolled, involuntary movements (dyskinesia)
• Nervousness
• Dizziness
• Restlessness
• Jitteriness
• Anxiety
• Drowsiness
• Insomnia
• Depression
• Euphoria
• Feeling of unease (dysphoria)
• Feeling unwell (malaise)
• Headache
• Tremor
• Blurred vision
• Dilation of pupils (mydriasis)
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Abdominal discomfort
• Dry mouth
• Unpleasant taste
• Shortness of breath (dyspnea)
• Bone marrow depression
• Low count of leukocyte immune cells (leukopenia)
• Low count of granulocyte immune cells (agranulocytosis)
• Hypersensitivity reactions including:
  • Rash
  • Hives (urticaria)
  • Redness of skin (erythema)
  • Bruising and skin discoloration (ecchymosis)
• Hair loss
• Muscle pain
• Menstrual upset
• Impotence
• Changes in libido
• Abnormal breast tissue growth in males (gynecomastia)
• Increased sweating
• Excessive urination (polyuria)
• Painful urination (dysuria)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

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

Tablet: Schedule IV

• 25 mg

Tablet, controlled-release: Schedule IV

• 75 mg

Obesity

Adult:

Immediate-release

• 25 mg orally once every 6-8 hours 1 hour before eating
• May add 1 additional 25 mg dose orally midevening to overcome night hunger

Controlled-release

• 75 mg orally once daily, swallowed whole, in midmorning

Pediatric:

Children below 16 years

• Safety and efficacy not established

Children above 16 years

• Immediate release: 25 mg orally once every 8 hours, 1 hour before eating
• Controlled release: 75 mg orally once daily, swallowed whole, in midmorning

Addiction/overdose

• Diethylpropion has some similarities to amphetamines and other related stimulant drugs which are extensively abused. Diethylpropion has a potential for psychologic dependence and abuse. Abrupt discontinuation can cause depression and fatigue.
• Acute overdose of diethylpropion can cause restlessness, tremor, excessive reflex response (hyperreflexia), rapid respiration, confusion, aggressiveness, hallucinations, panic states, and pupil dilation (mydriasis), followed by fatigue and depression. Other effects include nausea, vomiting, diarrhea, abdominal cramps, irregular heart rhythm, rapid heart rate, rise or drop in blood pressure and circulatory collapse.
• Chronic overdose can result in skin diseases, insomnia, hyperactivity, irritability, personality changes and psychosis that may be similar to schizophrenia.
• Overdose may be treated with gastric lavage to eliminate any undigested drug, administration of a barbiturate for sedation in acute overdose cases, and other symptomatic and supportive care as required.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of diethylpropion include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • methylphenidate
  • phenelzine
  • procarbazine
  • safinamide
  • selegiline transdermal
  • tranylcypromine
• Diethylpropion has serious interactions with at least 27 different drugs.
• Diethylpropion has moderate interactions with at least 163 different drugs.
• Mild interactions of diethylpropion include:
  • desmopressin
  • eucalyptus
  • sage

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Animal reproductive studies do not show evidence of fetal harm with the administration of diethylpropion during pregnancy, however, there are no adequate and well-controlled studies in pregnant women. Diethylpropion should be used in pregnant women only if clearly needed.
• Abuse of diethylpropion during pregnancy can cause withdrawal symptoms in the newborn.
• Obesity increases the risk for infertility. However, weight loss medications must be discontinued before conception.
• Diethylpropion and its metabolites are present in breastmilk. Use with caution in nursing mothers.

• Take diethylpropion exactly as prescribed. Do not take higher or more frequent doses.
• Diethylpropion has a potential for psychological dependence and abuse. Be alert of the risk and use with extreme caution.
• Avoid drinking alcohol and taking other central nervous system active drugs while on treatment with diethylpropion.
• Diethylpropion may impair the mental and physical abilities required for potentially hazardous tasks such as driving and operating heavy machinery. Avoid such activities while on treatment.
• Store diethylpropion safely out of reach of children and others.
• In case of overdose, seek immediate medical help or contact Poison Control.