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Resurgence of Penfluridol : Merits and Demerits Review Article

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Resurgence of Penfluridol : Merits and Demerits Review Article Resurgence of Penfluridol : Merits and Demerits REVIEW ARTICLE Resurgence of Penfluridol : Merits and Demerits Dr Ranjan Bhattacharyya, Dr Rajarshi Bhadra1, Dr Utpal Roy, 2 Dr Sumita Bhattacharyya, 3 Dr Jayanta Pal, 4Dr Siddhartha Shankar Saha.5 Deptt of Psychiatry, Murshidabad Medical College & Hospital, 1Deptt of Pharmacology, ICARE Institute of Medical Science & Research & Dr Bidhan Ch Roy Hospital, 2Deptt of Anesthesiology, Murshidabad Medical College & Hospital, 3Deptt of Dermatology, Institute of Post Graduate Medical Education & Research, 4Deptt of Radiology, Murshidabad Medical College & Hospital, 5Deptt of Psychiatry, Murshidabad Medical College & Hospital ABSTRACT Background : Penfluridol is oral long acting depot antipsychotic introduced in 1970s. The re-emergence of the molecule in the practicing field draws attention of clinicians. Objectives: The systematic search and review of literature done in order to find current perspectives of use of Penfluridol. Methods : Systematic search of prospective clinical research studies has been done. Cochrane Database review of twenty-seven studies done with a total of 1024 patients revealed that penfluridol was superior to placebo in improvement in clinical global impression and reduces the need of additional antipsychotic. Results : Indications of penfluridol include acute psychosis, chronic schizophrenia and Tourette’s syndrome. The notable adverse effects include orthostatic hypotension,osteoporosis leading to fracture in elderly, extrapyramidal side effects and QT prolongations with arrhythmia. Conclusions : Most of the studies were done in 1970s and 1980s when the proper conduct of clinical trials were not established. Key words : penfluridol oral depot, extrapyramidal symptoms, resurgence, adverse effects, Cochrane review. INTRODUCTION First discovered at the Janssen Pharmaceutica in dopamine receptor in the mesolimbic dopaminergic 1968,Penfluridol(marketted under the trade name of system and inhibits the release of hypothalamic and Semap, Acemap Micefal, Longoperidol) is a highly hypophyseal hormones Unlike other drugs in the potent, first generation diphenylbutylpiperidine group (e.g pimozide and fluspirilene), penfluridol antipsychotic. Penfluridol blocks the postsynaptic has an extremely long elimination half-life (approximate 66hours) and the effect of a single dose Corresponding Author : lasts for many days (3-7 days, by some estimates).1 Dr Ranjan Bhattacharyya. Assistant Professor Its potency, in terms of dose needed to produce & Head of the Department, Deptt of Psychiatry, comparable effects, is similar to both haloperidol and Murshidabad Medical College & Hospital, West pimozide.2 Though it is only slightly sedative often Bengal, India. Email : [email protected]/ [email protected] causes extrapyramidal side-effects, such as akathisia, Eastern Journal of Psychiatry | January – June 2015 Volume 18, Issue 1 23 Resurgence of Penfluridol : Merits and Demerits dyskinesiae and pseudo-Parkinsonism. It is only and enterohepatic recycling occur. Penfluridol slightly sedative, but often causes extrapyramidal is characterised pharmacologically by the side-effects, such as akathisia, dyskinesiae and traditional neuroleptic properties: cataleptogenic pseudo-Parkinsonism. Indication: Penfluridol is effect, antagonism against apomorphine and indicated for antipsychotic treatment of chronic amphetamine induced stereotypes and inhibition of schizophrenia and similar psychotic disorders, it controlled behaviour. It also has a relatively specific is, however, like most typical antipsychotics, being antidopaminergic effect via the blocking of the increasingly replaced by the atypical antipsychotics. dopaminergic receptor membrane.7,8 Due to its extremely long-lasting effects, it is often prescribed to be taken orally as tablets only once a MODE OF ACTION week (q 7 days). Due to its extremely long-lasting Penfluridol acts by blocking the postsynaptic effects, it is often prescribed to be taken orally as dopamine receptor in the mesolimbic dopaminergic tablets only once a week. The once-a-week dose is system and by inhibiting the release of hypothalamic usually 10–60 mg. The molecule is available in 20 and hypophyseal hormones.9 mg tab. The synthesis of penfluridol represented the result of PHARMACOKINETICS a well-planned scientific search for a highly lipophilic This unique, long-acting, oral neuroleptic was the compound structurally related to haloperidol and end result of a systematic scientific research for a pimozide. Because of its unusual lipophilicity, highly lipophilic molecule structurally related to penfluridol distributes extensively in fatty tissues haloperidol and pimozide. It is orally well absorbed following oral administration. This depot effect from the GI tract though antacids may reduce its produces a very slow release of drug from the tissues, absorption; peak plasma concentration is attained and results in a very long duration of activity. When after 2 hours. Owing to its extreme lipophilic administered clinically at oral doses of 20 to 100 mg/ nature, penfluridol distributes extensively in fatty week, penfluridol has been found to be an effective tissues following oral administration. The drug antipsychotic agent. This frequency of dosing is is very slowly released from the tissues resulting consistent with the pharmacokinetic behavior of the in very long half life. Penfluridol is extensively drug in man, and does not appear to result in any metabolized in the liver by glucorinide conjugation. inappropriate accumulation of the drug in patients. Administered clinically at oral doses of 20 to 100 mg/ Wide variations in steady-state levels and plasma week(increased up to 250 mg once a week in severe elimination half-life have been observed in patient or resistant conditions.), penfluridol has been found populations. 4 It has been said that Penfluridol to be an effective antipsychotic agent. Inspite of once is the first truly long-acting oral antipsychotic a week administration,wide variations in steady- agent for the treatment of acute psychosis, chronic state plasma concentrations and elimination half-life schizophrenia and Tourette’s syndrome. 2,5 First have been observed in some patient populations. synthesised in 1968, it is a white micro-crystalline However, once-weekly dosing is an important tertiary amine, only slightly soluble in water and advantage for poorly compliant patients. Itis well belongs to the diphenylbutylpiperidines; pimozide absorbed from the GI tract (oral); peak plasma also belongs tothis group. 6 Penfluridol is absorbed concentration reaches after 2 hours. The molecule from the gastrointestinal tract and deposited in fatty undergoes enterohepatic recycling. and excreted tissue from which it is slowly released, resulting via urine and faeces (as N-dealkylated metabolite). in a prolonged duration of action with a half-life Penfluridol has half-life of sixty-six (66) hours. of 70 hours. It is primarily excreted unchanged The elimination half-life of Penfluridol is 36 hours in the faeces; however, some hepatic metabolism (initial) and 120 hours (terminal). After dosing, it 24 Volume 18, Issue 1 Eastern Journal of Psychiatry | January – June 2015 Resurgence of Penfluridol : Merits and Demerits enters lipid reservoirs in the body, and is gradually hypotension are common. Other adverse effects released from these reservoirs across succeeding include weight gain, impaired glucose tolerance, days. The effective half-life of the drug is therefore allergic skin rashes, cholestatic jaundice, delirium, long; 3-7 days, by some estimates. This allows the agitation, anxiety, depression, euphoria; anorexia, once-weekly dosing of the drug. Once-weekly constipation, diarrhoea; alopecia; amenorrhoea, dosing is an important advantage for patients who hypoglycaemia, hyponatraemia; hypersalivation, are poorly adherent to antipsychotic medication. nausea, vomiting; bronchospasm etc. There are Penfluridol is extensively metabolized by oxidative reports that Penfluridol can increase the risk of N-dealkylation to afford, as isolated metabolites, the breast cancer. The potentially fatal adverse reactions beta-glucuronide conjugate of the diphenylbutyric are blood dyscrasias, neuroleptic malignant acid derivative A1 and the unconjugated basic syndrome; alteration of heart conduction leading to piperidine moiety B1. It is assumed, at this time, QT prolongation and life threatening arrhythmias. that the pharmacological activity is attributable to Special Precautions are required during pregnancy the parent compound.10,11 and lactation; elderly; epilepsy; pre-existing cardiac conduction problems; hypokalaemia, DRUG INTERACTION AND hypomagnesemia; hypothyroidism. 12,13,14 ADVERSE EFFECT PROFILE The notable drug Interactions include: orthostatic A plethora of drug interactions have been observed hypotension with MAOIs; may increase sedation with various drugs. These include orthostatic with alcohol, hypnotics, antihistamines, opiates; hypotension with MAOIs; increased sedation antacids containing aluminum salts may decrease with alcohol, hypnotics, antihistamines, opiates; absorption; additive antimuscarinic effects with exaggerated antimuscarinic adverse effects with TCAs; may reduce bromocriptine’s ability to reduce TCAs; possible additive effects on QT interval with serum prolactin; amphetamines may increase type 1a antiarrhythmics, TCAs, some quinolone psychosis; may inihibit antiparkinsonian effects antibiotics (e.g. moxifloxacin) as well as fatal of
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