Tenuate Tablet (Diethylpropion) : Clinical Effect and actionDiethylpropion is the psychomotor stimulant similar to amphetamine with sympathomimetic. Anorectic and other effects. The studies suggest that the initial weight loss rate will be steady until it reaches the certain level, thereafter; regain of weight has been reported despite of the drug administration is continued. It also suggested that the return of weight gain might also be the case even after the discontinuation of the drug. It behaves and acts as an appetite suppression agent that enhances the efficacy of the diet and workout regimen.
Clinical uses Tenuate (Diethylpropion) Tablet and its Indications:
Psychomotor stimulant is often used as add-on to the short term weight loss regimen that could last for weeks to long term and continuous dietary treatment for medical obesity management. This is ideally used for the patients who failed to respond to the weight loss regimen such as workout and diet regimen. Basically, Diethylpropion is prescribed for the patients who have an initial body mass index ³ 30 kg/m.
The below mentioned chart indicates Body Mass Index (BMI), which is often calculated in heights and weights ratio. The BMI is calculated by dividing patient’s weight, in kg by the height meter and squared. The following are the metric conversion (m); inches´0.0254=meters (m), pounds (lbs)/2.2=kilograms (kg); feet (ft) ´0.3048=meters.
Before prescribing the anorectic agents, it should be clearly understood that the drug has limited scope of effects in obesity management. The fact is that the patients who use the drug lose only a fraction of pounds, which is just a little more than what patients with only diet would lose in ideal situations.
In addition, the weight loss rate will start to decline as the plateau is reached. It is recommended that the prolonged use of this drug should b avoided as t can lead to abuse and drug dependence (Refer to Weaning for more information). The fact of the matters that even when you are prescribing the short-term use of this ‘drugs, it should carefully be supervised and monitored.
Contraindication information: Tenuate (Diethylpropion) Tablet
This drug is contraindicated within 14 days following withdrawal of these agents or during rehabilitation with monoamine oxidizes inhibitor. It is likely that hypertensive crisis might result in patients with pulmonary artery hypertension, glaucoma, hyperthyroidism, advanced arteriosclerosis, severe hypertension and patients with heart valvular heart disease. In addition, it is contraindicated in patients with hypersensitivity along with people with emotional instability who are susceptible or incidents of having history of drug abuses.
Warnings and cautions in clinical conditions: Tenuate (Diethylpropion) Tablet
Primary Pulmonary Hypertension: Anorexigens and diethylpropionsubstantially increase the risk of developing primary pulmonary hypertension, which is a deadly disorder.
Epidemiological study suggested that use of diethylpropion and anorexigens for a prolonged period of 3 months increased the risk of developing Primary Pulmonary Hypertension (PPH) with a staggering 23 fold. There was no notable associated risks of this drug among the people who used the agent for only three months or less with BMI or body mass index ³ 30 kg/m
Unexplained symptoms of angina pectoris, syncope or lower extremity edema or the aggravation of exertional dyspnea could be the sign of possibility pulmonary hypertension. Under thesekind of occurrences and circumstances, the treatment must be stopped and the patient should go through a thorough evaluation process to find any hint of possible PPH.
Valvular Heart Disease: Reportedly use of anorectic agents such as fenfluramine and dexfenfluramine has led to Valvular heart disease. Therisk factor becomessubstantially alarming when the drug is overdosed or used for a prolongtimeframe. The risk factor also includes combination of the drug with other anorectic agents.
While prescribing, it is advisable that the potential side effects such as valvular heart disease and pulmonary hypertension must be censured and evaluated against the advantage of the weight loss.
It is alsorecommended that baseline cardiac testand evaluation must be cared out identify the possible and ore-existing pulmonary hypertension and valvular heart diseases before the commencement of the diethylpropion treatment. Echocardiogram is yet another option that can be used after and during the treatment to identify and detect valvular disorders.
Psychological Dependence: The self administrating study among animals suggest that the drug acts as the reinforce but with humans the use of the drug with anorectic drugs with amphetamine properties such as diethylpropion can generate tolerance, acute psychological dependency and can result in serious issuesif over used or for a prolong period.
Therefore, looking at the incidents of psychological dependency it can have on the patient, tor precautions must b followed. Especially, the use of the drugsmust beprescribed mindfully to thepeoplewho havehistory of drug abuses and psychological dependency.
Hence, it is advisable tat that gradual withdrawal of the medicine should b taken place because sudden cessation after prolonged consumption could lead to mental depression and changes in the sleep EEG and extreme fatigue.
Drug abuse can result in both mild and severe manifestation of chronic intoxication including irritability, hyperactivity, personality disorder, insomnia and psychosis.
Tolerance and remedy: Ideally, the tolerance of the drugs will manifest after a few weeks of treatment. In case of tolerance, the medicine should bestopped. The extra dose should never be used to tackle or nullify tolerance
Pregnancy: Diethylpropion should never be recommend or prescribed for the woman o are pregnant or wit child bearing potentiality. Thedrug can be use under the supervision of doctor after validatingfact that loss benefits overweigh t associated risks that the drug imposes to mother and fetus
- Children: Diethylpropion should not be recommended or prescribed to childrenless than 12 years of age.
- Geriatrics or old people: It is strictly not prescribed for the elderly.
- General use: Diethylpropion should never berecommended for patients who recentlyusedany anorectic agents
- Occupational Hazards: Diethylpropion might impair capability and ability of getting engaged in potentially hazards activities such as driving and operate machines.
Preventive Measures: Tenuate (Diethylpropion) Tablet
Diethylpropion must be always used carefully the great sense of caution especially for people with mild cardiovascular disease or hypertension. There must be regular checkup of the blood pressure and cardiovascular functions among such patients. People with severe cardiovascular disorderssuch as arrhythmias or hypertension should never use the drug.
It is also not recommended for patients with valvular diseases prolonged use of diethylpropion might lead to psychological dependency along with withdrawal symptoms upon cessation. There have been instanceswhere hallucination and toxic psychosis syndromes have been reported after overdoes of the drug. A smaller portion of patients also experienced the side effects of the recommended dosewas not exceeded. Psychosis subsided after stopping the drug.
Reports also conclude that use of the drug might increase the chances of convulsions in epileptic patients. Hence, there should be caution while administering the drug in people with Epileptics. Titration of dose or discontinuation of the drug might be necessary in some cases.
Occupational Hazards: Driving vehicles and performing hazardous activities
Drug Interactions: This drug is contraindicated with MAOIs (see Contraindications).
There are no studies to prove efficacy ofdiethylpropion with other anorectic agents and combined use can lead to serious cardiac issues, hence, the use of the drug is also contraindicated to other agents
There have been instances where Arrhythmias have been linked with some sympathomimetic agents while combined with general anesthetics. Therefore, it is advisable to becareful during general anesthesia in patients undergoing diethylpropion.
Diethylpropion might alter the effect of other drugs that act on the CNS. It is also likely that the Insulin requirements in diabetes mellitus might be altered with the use of diethylpropion with concomitant dietary regimen. It might also downgrade the hypertensive effect of guanethidine and can trigger pressor effects of exogenous catecholamines.
Pregnancy: This drug should never be used not during pregnancy. There have been reports referring to congenital malformations in humans. However, there has been no casual relationship to diethylpropion established yet.
Using the drug in the pregnancyperiod might lead to withdrawal symptoms in neonate.
Animal study suggests no evidence of teratogenicity. Reproduction studies on rats indicated no impairment to the fetus at doses up to 9 times that of the human dose. Animal reproduction studies showed that there were no sign of fertility mutilation at the doses up to 60 mg/kg/day. However, higher doses might cause disastrous effects resulting embryo toxicity
Lactation: It has not been established whether diethylpropion and / or its metabolites gets transferred into human milk but it is not advisable for nursing woman to use the drugs.
Possible side effects: Tenuate (Diethylpropion) Tablet
The most commonly side effects are insomnia, anxiety, nervousness, dizziness, agitation and dry mouth. The epidemiological study suggest that using the drugs for more than 3 months resulted the increased risk of developing Primary Pulmonary Hypertension (PPH) (see Warnings)
CNS: There have been instances where symptoms like, restlessness, dizziness, jitteriness, insomnia, anxiety, euphoria, dysphoria dyskinesia, blurred vision, overstimulation, nervousness, and occasionally depression, tremor, mydriasis, drowsiness, headache, cerebrovascular accident, and psychotic episodes.malaise, Increase in convulsive disorders been reported.
Cardiovascular:Sympotms such as arrhythmias tachycardia, precordial pain, palpitation, electrocardiogram changes,increased blood pressure.
A published report revealed that T wave changes in the ECG of a healthy young man (male) after intake of diethylpropion. There also have been news and reports of primary pulmonary hypertension linked to the use of diethylpropion (Refer to Warnings).
In rare cases Valvular heart disease have been reported with diethylpropion but the causal relationship still remains unknown at large
Gastrointestinal effects:There have been reports of diarrhea, abdominal discomfort, unpleasant taste,constipation, nausea, vomiting, dryness of the mouth, and other gastrointestinal disturbances.
Allergic effects : Urticaria, ecchymosis rash, and erythema.
Endocrine: The effects could manifest in the form of impotence, menstrual upset, dysmenorrhea, changes in libido, and gynecomastia.
Drug Abuse and psychological Dependence: There have been instances where subjects became psychologically dependent on diethylpropion.
Other: Other effects include dyspnea, hair loss, leukopenia muscle pain, dysuria, polyuria, bone marrow depression,agranulocytosis and increased sweating.
Symptoms, causes and treatment method Of Overdose: Tenuate (Diethylpropion) Tablet
Here is a list of Clinical manifestations of diethylpropion intoxication that includes restlessness, tremor, confusion, hyperreflexia, nervousness and irritability, rapid respiration, insomnia,assaultiveness, hallucinations, and panic.
In addition, Mydriasis has been also been reported. Convulsions and tachycardia are common occurrences. There might be cases of exhaustion, drowsiness, fatigue, depression frequently follow central stimulation, and coma. Cardiovascular effects might manifest in the form of arrhythmias, circulatory collapse and changes in blood pressure. Gastrointestinal symptoms include nausea, abdominal cramps, vomiting, and diarrhea. And Overdoses have been resulted in death.
Management of acute intoxication of the drug is quite symptomatic. It can include gastric lavage, and sedation with a barbiturate might just be desirable. Peritoneal dialysis or hemodialysis is not adequate to permit a recommendation at this juncture.
Right dosage and drug administration: Tenuate (Diethylpropion) Tablet
Adults: One 25 mg tablet ideally should be administered thrice a day and an hour before meals. Alternatively, one 75 mg sustained release tablet can be prescribed once a day; in midmorning. Administration should and must not be extended beyond a period of one month/ 4 weeks. The least feasible amount should be dispensed at one time (should not to exceed a 2-week supply) to minimize the risk of possibility of abuse.
Diethylpropion should only be used for a duration/period of no more than a few weeks (see Warnings).
Availability, Content and Storage: Tenuate (Diethylpropion) Tablet
Tenuate : Each tablet contains diethylpropionHCl25 mg. Nonmedicinal ingredients include lactose, talc, magnesium stearate, and tartaric acid. Bottles of 100.
Tenuate Dospan : Each capsule-shaped, continuous-release, white tablet contains diethylpropion HCl 75 mg. Nonmedicinal ingredients nlludscarboxypolymethylene, tartaric acid,mannitol, povidone, and zinc stearate. Bottles of 100 and 250.
Cartons of 30 strip packed tablets.
Store in between 15 and 30°C.[/pl_text] [/pl_col] [/pl_row]