INFORMATION FOR HEALTH PROFESSIONALS
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Each white, oblong-shaped tablet 19.5 mm by 9 mm, marked "Merrell" on one side and "869" on the other, contains 75 mg diethylpropion hydrochloride in a hydrophilic colloid gum designed to release the ingredient over a 10 hour period.
Diethylpropion hydrochloride has been shown to reduce food intake in animals and numerous double-blind controlled clinical studies have demonstrated weight reduction with diethylpropion hydrochloride administration. Actions include some central nervous system stimulation and blood pressure elevation. The blood pressure effects are less than those of amphetamines on a mg basis.
Diethylpropion hydrochloride is rapidly absorbed after oral administration. Less than 5% of the parent compound is excreted unchanged and between 75 to 100% of the oral dose is excreted as diethylpropion hydrochloride and its metabolites in the urine. The half-life of unchanged diethylpropion hydrochloride in the plasma is about 2 hours and the excretion half-life for diethylpropion hydrochloride and its metabolites is about 10 hours.
TENUATE DOSPAN is indicated as a short-term (up to 12 weeks) adjunct in a medically monitored comprehensive regimen of weight reduction based on exercise, calorie restriction, and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or higher who have not achieved an adequate clinical response to an appropriate weight reducing regimen (diet and/or exercise) alone. Patients with the following co-morbidities are particular candidates for medical assistance with weight reduction, and may be considered for treatment even if their BMI does not exceed 30 kg/m2:
Failure to achieve a weight reduction of 5% within a period of 12 weeks is an indication for discontinuation of treatment.
Secondary organic causes for obesity should be excluded by diagnosis before prescribing TENUATE DOSPAN.
Adults over 18 years - one tablet swallowed whole mid-morning. Not recommended for children under 18 years. Current medical opinion supports short-term, intermittent use of an appetite suppressant. Courses of TENUATE DOSPAN may be given over periods up to twelve weeks, with intervening periods of one month without treatment.
Advanced arteriosclerosis, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma, agitated states, and patients with a history of drug abuse. Also contraindicated in patients with pulmonary artery hypertension or severe hypertension.
Use in combination with other anorectic agents is contraindicated.
Diethylpropion hydrochloride should not be given during or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crisis may result.
In a case-control epidemiological study, the use of anorexigens was associated with an increased risk of developing primary pulmonary hypertension (PPH), a rare but often fatal disorder. The use of anorexigens for longer than 3 months was associated with a 23 fold increase in the risk of developing PPH. Increased risk of PPH with repeated courses of therapy cannot be excluded.
The onset or aggravation of exertional dyspnoea, or unexplained symptoms of angina pectoris, syncope or lower extremity oedema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, treatment should be immediately discontinued, and the patient should be evaluated for the possible presence of PPH.
Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing risk factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs.
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 pre-existing valvular heart disease or pulmonary hypertension prior to initiation of diethylpropion hydrochloride treatment. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur.
To limit unwanted exposure and risks, treatment with diethylpropion should be continued only if the patient has satisfactory weight loss within the first four weeks of treatment.
Diethylpropion is not recommended in patients who used any anorectic agents within the prior year.
Those who have failed to respond to medical treatment for weight loss in the past should only be treated after review by a medical practitioner specialising in the treatment of weight loss.
The recommended dose should not be exceeded in an attempt to increase the effect; rather the drug should be discontinued when the patient stops losing weight. In some patients, diethylpropion may interfere with operating machinery or driving a motor vehicle; the patient should, therefore, be cautioned accordingly.
Although diethylpropion hydrochloride is generally safer than the amphetamines, it should be used with caution in patients with hypertension or symptomatic cardiovascular disease, including arrhythmias.
Diethylpropion is not recommended in patients with known heart murmur or valvular heart diseases.
Reports suggest that diethylpropion hydrochloride may increase convulsions in some epileptics. Epileptic patients should be carefully monitored. Dose titration or drug discontinuation may be necessary.
Diethylpropion should not be used in men or women for loss of weight for cosmetic reasons.
Diethylpropion should not be used by children or adolescents or during pregnancy or lactation.
The ability of the patient to maintain effective lifestyle interventions of exercise and diet, and adhere to a medical regimen should be assessed before treatment is commenced.
Against this background of extensive clinical use, reports of abuse have been uncommon. Most of the subjects had previously abused other drugs such as amphetamine and phenmetrazine and many were described as having unstable personalities.
Addicts have reported relatively little euphoria, and dissatisfaction in the few cases where diethylpropion was administrated intravenously. Other abusers after oral administration of diethylpropion have shown marked anxiety and agitation as the effects wore off. After diethylpropion had been taken for 24-72 hours, additional doses did not produce euphoria but agitation and anxiety instead. Hallucinations occurred rarely following relatively high doses of the drug.
Several cases of toxic psychosis have been reported following the excessive use of diethylpropion and a very small number have been reported in which the recommended dose appears not to have been exceeded. The psychosis was temporary and cleared up after the drug was discontinued.
Prolonged use of diethylpropion hydrochloride may induce dependence with withdrawal symptoms on cessation of therapy.
Category B2.
Diethylpropion hydrochloride should not be used during pregnancy, unless, in the opinion of the prescribing doctor, the potential benefits outweigh the potential risks.
Isolated spontaneous reports of congenital malformations have been recorded in humans, but no causal relationship to diethylpropion has been established.
Use during pregnancy may result in withdrawal symptoms in the neonate.
It is not known if diethylpropion hydrochloride or its metabolites pass into human milk. Use in nursing women is not recommended.
Cardiovascular: Palpitation, tachycardia, elevation of blood pressure, precordial pain, arrhythmia (including ventricular), electrocardiogram changes and rare reports of pulmonary hypertension. One published report described T-wave changes in the ECG of a healthy young male after ingestion of diethylpropion hydrochloride.
Valvular heart disease has been rarely reported with diethylpropion but the causal relationship remains uncertain.
Central Nervous System: Overstimulation, nervousness, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, depression, dysphoria, tremor, dyskinesia, mydriasis, drowsiness, malaise, cerebrovascular accident, headache, seizures, blurred vision, rarely psychotic episodes at recommended doses. In a few epileptics an increase in convulsive episodes has been reported (see WARNINGS AND PRECAUTIONS). Careful monitoring and, in susceptible patients, dose titration or discontinuation may be required.
Gastrointestinal: Dryness of the mouth, unpleasant taste, nausea, vomiting, abdominal discomfort, diarrhoea, constipation, other gastrointestinal disturbances.
Allergic: Urticaria, rash, ecchymosis, erythema.
Endocrine: Impotence, changes in libido, gynaecomastia, menstrual upset.
Haematopoietic System: Bone marrow, depression, agranulocytosis, leukopenia.
Drug Abuse and Dependence: There have been reports of subjects becoming psychologically dependent on diethylpropion.
Miscellaneous: A variety of miscellaneous adverse reactions have been reported by physicians. These include complaints such as dyspnoea, hair loss, muscle pain, dysuria, increased sweating, and polyuria.
Diethylpropion is contraindicated with monoamine oxidase (MAO) inhibitors.
The efficacy of diethylpropion administered together with other anorectic agents has not been studied, and the combined use may have the potential for serious cardiac problems; concomitant use of diethylpropion with other anorectic agents is contraindicated.
Arrhythmias have been associated with some sympathomimetic agents given concomitantly with general anaesthetics, therefore caution should be used in patients during general anaesthesia receiving diethylpropion hydrochloride therapy.
Antidiabetic drug requirements (eg, insulin) may be altered.
Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, tachycardia, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhoea, and abdominal cramps. Overdose of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions, coma and death. Management of acute TENUATE intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with haemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard.
Intravenous phentolamine has been suggested on pharmacological grounds for possible acute, severe hypertension, if this should complicate TENUATE overdosage.
Controlled Drug C5.
Tablets in blister packs of 100.
Aventis Pharma Limited
PO Box 12851
Penrose
AUCKLAND
Telephone: (09) 580 1810
Facsimile (09) 580 1811
April 2004