diethylpropion HCl 25 MG Oral Tablet


Diethylpropion hydrochloride should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products.

In a case-control epidemiological study, the use of anorectic agents, including diethylpropion, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder.

The use of anorectic agents for longer than 3 months was associated with a 23-fold increase in the risk of developing pulmonary hypertension.

Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded.

The 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.

Under these circumstances, diethylpropion hydrochloride should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported.

Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs.

Valvulopathy has been very rarely reported with diethylpropion hydrochloride monotherapy, but the causal relationship remains uncertain.

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.

Baseline cardiac evaluation should be considered to detect preexisting valvular heart diseases or pulmonary hypertension prior to initiation of diethylpropion hydrochloride treatment.

Diethylpropion hydrochloride is not recommended in patients with known heart murmur or valvular heart disease.

Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur.

To limit unwarranted exposure and risks, treatment with diethylpropion hydrochloride should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds, or as determined by the physician and patient).

Diethylpropion hydrochloride is not recommended for patients who used any anorectic agents within the prior year.

If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Diethylpropion hydrochloride 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 therefore be cautioned accordingly.

Prolonged use of diethylpropion hydrochloride 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 have been reported following the excessive use of the drug and some have been reported in which the recommended dose appears not to have been exceeded.

Psychosis abated after the drug was discontinued.

When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.


Drug Interactions Because diethylpropion hydrochloride is a monoamine, hypertension may result when this agent is used with monoamine oxidase (MAO) inhibitors (see CONTRAINDICATIONS ).

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, α-methyldopa).

Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.


Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, and mydriasis.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include tachycardia, arrhythmias, hypertension or hypotension and circulatory collapse.

Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps.

Overdose of pharmacologically similar compounds has resulted in convulsions, coma and death.

The reported oral LD 50 for mice is 600 mg/kg, for rats is 250 mg/kg and for dogs is 225 mg/kg.

Management of acute diethylpropion hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate.

Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard.

Intravenous phentolamine (Regitine ® ) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates diethylpropion hydrochloride overdosage.


Diethylpropion hydrochloride 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: cornstarch, lactose, magnesium stearate, pregelatinized cornstarch, 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.

The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethylamino-1-propanone hydrochloride.

Its chemical structure is: The diethylpropion hydrochloride 75 mg formulation is dispersed in a hydrophilic matrix.

On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix.

The result is controlled release of the anorectic agent.


25 mg immediate-release tablets.

Each white, round tablet is debossed Watson over 783.

75 mg controlled-release tablets.

Each white, capsule-shaped tablet is debossed Watson 782.

They are supplied by Keltman Pharmaceuticals Inc.

as follows: NDC Strength Quantity/Form Color Source Prod.

Code 68387-695-07 25 mg 7 Tablets in a Plastic Bottle WHITE 0591-0783 68387-695-14 25 mg 14 Tablets in a Plastic Bottle WHITE 0591-0783 68387-695-21 25 mg 21 Tablets in a Plastic Bottle WHITE 0591-0783 68387-695-28 25 mg 28 Tablets in a Plastic Bottle WHITE 0591-0783 68387-696-07 75 mg 7 Tablets in a Plastic Bottle WHITE 0591-0782 68387-696-14 75 mg 14 Tablets in a Plastic Bottle WHITE 0591-0782 68387-696-21 75 mg 21 Tablets in a Plastic Bottle WHITE 0591-0782 68387-696-28 75 mg 28 Tablets in a Plastic Bottle WHITE 0591-0782 Keep tightly closed.

Store at room temperature, below 30°C (86°F).

Rx only Manufactured for: Watson Laboratories, Inc.

Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc.

Cincinnati, OH 45237 USA This Product was Repackaged For: Keltman Pharmaceuticals Inc.

1 Lakeland Square, Suite A Flowood, MS 39232 United States a9b96da2-figure-01


Geriatric Use Clinical studies of diethylpropion hydrochloride 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 is 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.


Diethylpropion hydrochloride 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/m 2 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 patient’s 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.

Body Mass Index (BMI), kg/m 2 Weight (pounds) Height (feet, inches) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The usefulness of agents of this class (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.

Diethylpropion hydrochloride is indicated for use as monotherapy only.


Pediatric Use Since safety and effectiveness in pediatric patients below the age of 16 have not been established, diethylpropion hydrochloride is not recommended for use in pediatric patients 16 years of age and under.


Pregnancy 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/m 2 ) 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.


Nursing Mothers Since diethylpropion hydrochloride and/or its metabolites have been shown to be excreted in human milk, caution should be exercised when diethylpropion hydrochloride is administered to a nursing woman.


Information for Patient The patient should be cautioned about concomitant use of alcohol or other CNS-active drugs and diethylpropion hydrochloride.

(See WARNINGS .) The patient should be advised to observe caution when driving or engaging in any potentially hazardous activity.


Diethylpropion hydrochloride immediate-release: One immediate-release 25 mg tablet three times daily, one hour before meals, and in midevening if desired to overcome night hunger.

Diethylpropion hydrochloride controlled-release: One controlled-release 75 mg tablet daily, swallowed whole, in midmorning.

Geriatric Use: This drug is 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.

(See PRECAUTIONS, Geriatric Use .)