what is tenuate 75 mg dospan ?
tenuate 75 mg dospan a sympathomimetic amine, which is similar to an amphetamine, that stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite and is used as a short-term supplement to diet and exercise in the treatment of obesity.
TENUATE® 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.
INDICATIONS AND USAGE:
tenuate 75 mg dospan is indicated in the management of exogenous obesity as
a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction
in patients with an initial body mass index (BMI) of 30 kg/m2 or higher and who have not
responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart
of BMI based on various heights and weights. BMI is calculated by taking the patients weight, in
kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as
follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters.
Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or
idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension.
Patients with a history of drug abuse.
Use in combination with other anorectic agents is contraindicated.
During or within 14 days following the administration of monoamine oxidase inhibitors,
hypertensive crises may result.
Because tenuate 75 mg dospan is a monoamines, hypertension may result when
either agent is used with monoamine oxidase (MAO) inhibitors .
Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use
may have the potential for serious cardiac problems; therefore, the concomitant use with other
anorectic agents is contraindicated.
Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general
anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other
drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may
interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of
phenothiazines may antagonize the anorectic effect of diethylpropion.
DOSAGE AND ADMINISTRATION:
tenuate 75 mg dospan (diethylpropion hydrochloride) controlled-release:
One controlled-release 75 mg tablet daily, swallowed whole, in midmorning.
Clinical studies of tenuate 75 mg dospan did not include sufficient numbers of
subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly
and younger patients. In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic,
renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug in known to be substantially excreted by the kidney, and the risk of toxic reactions to
this drug may be greater in patients with impaired renal function. Because elderly patients are
more likely to have decreased renal function, care should be taken in dose selection, and it may
be useful to monitor renal function.
Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats
at doses up to 1.6 times the human dose (based on mg/m2
) and have revealed no evidence of
impaired fertility or harm to the fetus due to diethylpropion hydrochloride. There are, however,
no adequate and well-controlled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug should be used during pregnancy
only if clearly needed.
Spontaneous reports of congenital malformations have been recorded in humans, but no causal
relationship to diethylpropion has been established.
Non-Teratogenic Effects. Abuse with diethylpropion hydrochloride during pregnancy may
result in withdrawal symptoms in the human neonate.