Diethylpropion Hcl Immediate-release

Diethylpropion Hcl Immediate-release

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

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)
  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.

History

There is currently no drug history available for this drug.

Other Information

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:

Diethylpropion Hydrochloride chemical structure

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
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet Diethylpropion Hcl Controlled-release (Diethylpropion Hydrochloride) Tablet [A-s Medication Solutions Llc]
  • Keltman Pharmaceuticals Inc.
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet Diethylpropion Hcl Controlled-release (Diethylpropion Hydrochloride) Tablet [Keltman Pharmaceuticals Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet Diethylpropion Hcl Controlled-release (Diethylpropion Hydrochloride) Tablet [Physicians Total Care, Inc.]
  • A-s Medication Solutions Llc
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet Diethylpropion Hcl Controlled-release (Diethylpropion Hydrochloride) Tablet [A-s Medication Solutions Llc]
  • Actavis Pharma, Inc.
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet Diethylpropion Hcl Controlled-release (Diethylpropion Hydrochloride) Tablet [Actavis Pharma, Inc.]
  • Bryant Ranch Prepack
    Diethylpropion Hcl Immediate-release (Diethylpropion Hydrochloride) Tablet [Bryant Ranch Prepack]

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