Diethylpropion Hcl Immediate-release Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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/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 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/m2|
|Weight (pounds)||Height (feet, inches)|
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.
There is currently no drug history available for this drug.
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.
Diethylpropion Hcl Immediate-release Manufacturers
A-s Medication Solutions Llc
Keltman Pharmaceuticals Inc.
Pd-rx Pharmaceuticals, Inc.
Physicians Total Care, Inc.
A-s Medication Solutions Llc
Actavis Pharma, Inc.
Bryant Ranch Prepack
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