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 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 extended release tablets, 75 mg 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. Valvulopathy has been very rarely reported with diethylpropion hydrochloride extended release tablets, 75 mg 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 extended release tablets, 75 mg treatment. Diethylpropion hydrochloride extended release tablets, 75 mg are 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 extended release tablets, 75 mg should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment e.
Diethylpropion hydrochloride extended release tablets, 75 mg are 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 extended release tablets, 75 mg 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.
Precautions General Caution is to be exercised in prescribing diethylpropion hydrochloride extended release tablets, 75 mg for patients with hypertension or with symptomatic cardiovascular disease, including arrhythmias. The possibility of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses.
In such cases, withdrawal symptoms such as depression , severe tiredness may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction.
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.
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.
Precordial pain, arrhythmia including ventricular , ECG changes, tachycardia, elevation of blood pressure, palpitation and rare reports of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination, have been reported. In a few epileptics an increase in convulsive episodes has been reported; rarely psychotic episodes at recommended doses; dyskinesia, blurred vision, overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, mydriasis, drowsiness, malaise, headache, and cerebrovascular accident Gastrointestinal: Vomiting, diarrhea, abdominal discomfort, dryness of the mouth, unpleasant taste, nausea, constipation, other gastrointestinal disturbances Allergic: Urticaria, rash, ecchymosis, erythema Endocrine: Impotence, changes in libido, gynecomastia, menstrual upset Hematopoietic System: Bone marrow depression, agranulocytosis, leukopenia Miscellaneous: A variety of miscellaneous adverse reactions has been reported by physicians.
These include complaints such as dysuria, dyspnea, hair loss, muscle pain, increased sweating, and polyuria.
Diethylpropion hydrochloride has some chemical and pharmacologic similarities to the amphetamines and other related stimulant drugs that have been extensively abused.
There have been reports of subjects becoming psychologically dependent on Diethylpropion. The possibility of abuse should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with varying degrees of psychologic dependence and social dysfunction which, in the case of certain drugs, may be severe.
Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. 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.
Reports suggest that diethylpropion hydrochloride may increase convulsions in some epileptics. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Laboratory Tests None Carcinogenesis, Mutagenesis, and Impairment of Fertility No long-term animal studies have been done to evaluate diethylpropion hydrochloride for carcinogenicity.
Mutagenicity studies have not been conducted. Animal reproduction studies have revealed no evidence of impairment of fertility see Pregnancy.
Reproduction studies have been performed in rats at doses up to 1. Copyright Cerner Multum, Inc. You can browse Drugs A-Z for a specific prescription or over-the-counter drug or look up drugs based on your specific condition. This information is for educational purposes only, and not meant to provide medical advice, treatment, or diagnosis. Remember to always consult your physician or health care provider before starting, stopping, or altering a treatment or health care regimen.
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The 75mg of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs. Use this medication regularly and exactly as prescribed in order to get the most benefit from it. How to use Diethylpropion HCL ER Take the immediate-release form of this medication by mouthusually 3 times a day 1 hour before meals or as directed by your doctor. Under these circumstances, Diethylpropion hydrochloride should be immediately discontinued, diethylpropion 75mg tab er, and the patient should be evaluated for the possible presence of pulmonary hypertension. Overdose of pharmacologically similar compounds has diethylpropion in convulsions, coma and death. During or within 75mg days following the administration of monoamine oxidase inhibitors, hypertensive crises tab result. 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. Valvulopathy has been very rarely reported with Diethylpropion hydrochloride monotherapy, but diethylpropion causal relationship remains uncertain. Titration of dose or discontinuance of Diethylpropion hydrochloride may be necessary. Skip the missed dose if it is almost time for your next scheduled dose. Geriatric Use Clinical studies of diethylpropion hydrochloride extended release tablets, 75 mg did not include sufficient numbers of subjects aged 65 and over tab determine whether they respond differently from younger subjects.
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