Dosing and uses of Tenuate Dospan, Tenuate (diethylpropion)
Adult dosage forms and strengths
tablet: Schedule IV
- 25mg
tablet, controlled-release: Schedule IV
- 75mg
Obesity
Immediate-release
- 25 mg PO q8hr 1 hour AC
- May add 1 additional 25 mg dose PO midevening to overcome night hunger
Controlled-release
- 75 mg PO qDay, swallowed whole, in midmorning
Pediatric dosage forms and strengths
Obesity
<16 years
- Safety & efficacy not established
> 16 years
- Immediate release: 25 mg PO q8hr AC
- Controlled release: 75 mg PO qDay, swallowed whole, in midmorning
Tenuate Dospan, Tenuate (diethylpropion) adverse (side) effects
1-10%
Increased blood pressure
Palpitations
Rash
Urticaria
Constipation
Nausea
Stomach cramps
Vomiting
Xerostomia
Central nervous system stimulation
Dizziness
Headache
Insomnia
Pain
Blurred vision
Mydriasis
Restlessness
Menstrual irregularity
Impotence, changes in libido
<1%
Cardiac dysrhythmia
Cardiomyopathy
Agranulocytosis
Leukopenia
Cerebral ischemia
Cerebrovascular accident
Psychotic disorder (rare)
Primary pulmonary hypertension
Drug dependence (rare)
Warnings
Contraindications
Advanced arteriosclerosis
Hyperthyroidism
Severe HTn
Hypersensitivity to sympathomimetic amines
Glaucoma
Agitated state
History of drug abuse
Pregnancy (especially first trimester)
Within 14 days of MAOI
Prolonged use not indicated
Concurrent use with other anorectic agents
Cautions
Discontinue when tolerance develops - DO NOT EXCEED recommended dose
Pregnancy, lactation
Epilepsy
Use caution in patients with diabetes mellitus or Tourette's syndrome
Incidence of primary pulmonary hypertension has been associated with therapy use
Mild hypertension, symptomatic cardiovascular disease
Development of valvular heart disease reported
May impair ability to drive &/or operate heavy machinery
Pregnancy and lactation
Pregnancy category: B
Lactation: Excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Tenuate Dospan, Tenuate (diethylpropion)
Mechanism of action
Amphetamine-related anorexigenic agent; action in reducing apetite may be secondary to CNS effects that may involve stimulation of hypothalamus to release norepinephrine
Pharmacokinetics
Metabolism: Undergoes reduction and N-dealkylation to form active metabolites
Duration: 4 hr
Half-life elimination: 4-6 hr (aminoketone metabolites)
Excretion: primarily urine (>75%)
