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Pronunciation:

(dye eth il PROE pee on)

U.S. Brand Names:

Tenuate®; Tenuate® Dospan®

Synonyms:

Amfepramone; Diethylpropion Hydrochloride

Generic Available:

Yes

Canadian Brand Names:

Tenuate®; Tenuate® Dospan®

Use:

Short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric reduction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m² or 27 kg/m² in the presence of other risk factors (diabetes, hypertension)

Use - Unlabeled/Investigational:

Migraine

Restrictions:

C-IV

Pregnancy Risk Factor:

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity or idiosyncrasy to sympathomimetic amines. Patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension (stage II or III), hyperthyroidism, glaucoma, agitated states, patients with a history of drug abuse, and during or within 14 days following MAO inhibitor therapy. Concurrent use with other anorectic agents; stimulant medications are contraindicated for use in children with attention-deficit/hyperactivity disorders and concomitant Tourette's syndrome or tics.

Warnings/Precautions:

Use with caution in patients with bipolar disorder, diabetes mellitus, cardiovascular disease, seizure disorders, insomnia, porphyria, or mild hypertension (stage I). May exacerbate symptoms of behavior and thought disorder in psychotic patients. Stimulants may unmask tics in individuals with coexisting Tourette's syndrome. Potential for drug dependency exists - avoid abrupt discontinuation in patients who have received for prolonged periods. Stimulant use in children has been associated with growth suppression. Not recommended for use in patients <12 years of age.

Serious, potentially life-threatening toxicities may occur when thyroid hormones (at dosages above usual daily hormonal requirements) are used in combination with sympathomimetic amines to induce weight loss. Treatment of obesity is not an approved use for thyroid hormone.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Hypertension, palpitation, tachycardia, chest pain, T-wave changes, arrhythmia, pulmonary hypertension, valvulopathy

Central nervous system: Euphoria, nervousness, insomnia, restlessness, dizziness, anxiety, headache, agitation, confusion, mental depression, psychosis, CVA, seizure

Dermatologic: Alopecia, urticaria, skin rash, ecchymosis, erythema

Endocrine & metabolic: Changes in libido, gynecomastia, menstrual irregularities, porphyria

Gastrointestinal: Nausea, vomiting, abdominal cramps, constipation, xerostomia, metallic taste

Genitourinary: Impotence

Hematologic: Bone marrow depression, agranulocytosis, leukopenia

Neuromuscular & skeletal: Tremor

Ocular: Blurred vision, mydriasis

Overdosage/Toxicology:

There is no specific antidote for amphetamine intoxication and treatment is primarily supportive. Hyperactivity and agitation usually respond to reduced sensory input; however, with extreme agitation, haloperidol (2-5 mg I.M. for adults) may be required.

Drug Interactions:

Anorectic agents: Concurrent use with other anorectic agents may cause serious cardiac problems and is contraindicated

Furazolidone: May induce a hypertensive episode in patients receiving furazolidone

Guanethidine: Diethylpropion may inhibit the antihypertensive response to guanethidine; probably also may occur with guanadrel

MAO inhibitors: Severe hypertensive episodes have occurred with amphetamine when used in patients receiving MAO inhibitors; concurrent use or use within 14 days is contraindicated

Norepinephrine: Diethylpropion may enhance the pressor response to norepinephrine

Sibutramine: Concurrent use of sibutramine and diethylpropion may cause severe hypertension and tachycardia; use is contraindicated

Tricyclic antidepressants: Concurrent use with tricyclic antidepressants may result in hypertension and CNS stimulation; avoid this combination

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Mechanism of Action:

Diethylpropion is used as an anorexiant agent possessing pharmacological and chemical properties similar to those of amphetamines. The mechanism of action of diethylpropion in reducing appetite appears to be secondary to CNS effects, specifically stimulation of the hypothalamus to release catecholamines into the central nervous system; anorexiant effects are mediated via norepinephrine and dopamine metabolism. An increase in physical activity and metabolic effects (inhibition of lipogenesis and enhancement of lipolysis) may also contribute to weight loss.

Pharmacodynamics/Kinetics:

Onset of action: 1 hour

Duration: 12-24 hours

Dosage:

Adults: Oral:

Tablet: 25 mg 3 times/day before meals or food

Tablet, controlled release: 75 mg at midmorning

Monitoring Parameters:

Monitor CNS

Patient Education:

Take exactly as directed; do not increase dose or frequency without consulting prescriber. Drug may cause physical and/or psychological dependence. Do not crush or chew extended release tablets. Take early in day to avoid sleep disturbance, 1 hour before meals. Avoid alcohol, caffeine, or OTC medications that act as stimulants. You may experience restlessness, false sense of euphoria, or impaired judgment (use caution when driving or engaging in tasks requiring alertness until response to drug is known); dry mouth (frequent mouth care, sucking lozenges, or chewing gum may help); nausea or vomiting (small, frequent meals, frequent mouth care may help); constipation (increased exercise, fluids, fruit, or fiber may help); or diarrhea (buttermilk, boiled milk, or yogurt may help); or altered libido (reversible). Patients with diabetes need to monitor serum glucose closely (may alter antidiabetic medication requirements). Report chest pain, palpitations, or irregular heartbeat; muscle weakness or tremors; extreme fatigue or depression; CNS changes (aggressiveness, restlessness, euphoria, sleep disturbances); severe unremitting abdominal distress or cramping; changes in sexual activity; changes in urinary pattern; or blurred vision. Breast-feeding precaution: Breast-feeding is not recommended.

Nursing Implications:

Do not crush 75 mg controlled release tablets; dose should not be given in evening or at bedtime

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation), and metallic taste (the use of local anesthetic without vasoconstrictor is recommended in these patients).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Use vasoconstrictor with caution in patients taking diethylpropion. Amphetamine-like drugs such as diethylpropion enhance the sympathomimetic response of epinephrine and norepinephrine leading to potential hypertension and cardiotoxicity.

Mental Health: Effects on Mental Status:

Insomnia, nervousness, and euphoria are common; may cause confusion, depression, or psychosis

Mental Health: Effects on Psychiatric Treatment:

Concurrent use with MAO inhibitors may cause hypertensive crisis; avoid combination; antipsychotics may blunt effect of diethylpropion. May cause bone marrow depression; use caution with clozapine.

Dosage Forms:

Tablet, as hydrochloride (Tenuate®): 25 mg

Tablet, controlled release, as hydrochloride (Tenuate® Dospan®): 75 mg

International Brand Names:

Atractil® (LU, TH); Dietil-retard® (BE, LU); Dietil Retard® (TH); Dualid® (BR); Hipofagin® (BR); Ifa Norex® (MX); Inibex-S® (BR); Neobes® (MX); Nulobes® (AR); Prefamone® (CH, LU); Regenon® (BE, CH, DE, DK, LU, RO, TH); Sacin® (CL); Tenuate® (AU, BE, CA, CH, DE); Tenuate® Dospan® (CA); Tenuate Dospan® (NZ, ZA)

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