(British Approved Name, US Adopted Name, rINN)
International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):
Pharmacopoeias. In China and Europe.
European Pharmacopoeia, 6th ed., 2008 and Supplements 6.1 and 6.2 (Piracetam). A white or almost white powder. It exhibits polymorphism. Freely soluble in water; soluble in alcohol. Protect from light.
Adverse Effects and Precautions
Piracetam is reported to produce insomnia or somnolence, weight gain, hyperkinesia, nervousness, and depression. Other reported adverse effects include gastrointestinal disorders such as abdominal pain, diarrhoea, nausea and vomiting, hypersensitivity reactions, ataxia, vertigo, confusion, hallucinations, angioedema, and rashes. Piracetam should not be given to patients with hepatic impairment or severe renal impairment; dosage reduction is recommended for those with mild to moderate renal impairment.
Therapy with piracetam should not be withdrawn abruptly in myoclonic patients due to the risk of inducing seizures. When used to treat cortical myoclonus, piracetam is contra-indicated in patients with cerebral haemorrhage, and should be used with caution after major surgery and in those with haemostatic disorders or severe haemorrhage.
For reference to the effect of piracetam on warfarin therapy.
Piracetam is rapidly and extensively absorbed from the gastrointestinal tract; peak plasma concentrations are reached within 1.5 hours after oral doses. The plasma half-life is reported to be 5 hours and it crosses the blood-brain barrier. Piracetam is excreted almost completely in the urine. It crosses the placenta and is distributed into breast milk.
Uses and Administration
Piracetam acts on the CNS and has been described as a nootropic; it is said to protect the cerebral cortex against hypoxia. It is also reported to inhibit platelet aggregation and reduce blood viscosity at high doses. Piracetam is used as an adjunct in the treatment of myoclonus of cortical origin, and has also been used in dementia (see also below). Other disorders or states in which it has been tried (on the basis of a supposed ‘cer-ebrocortical insufficiency’ responsive to piracetam) include alcoholism, vertigo, cerebrovascular accidents, dyslexia, behavioural disorders in children, and after trauma or surgery.
In cortical myoclonus, piracetam is given in oral doses of 7.2 g daily increasing by 4.8 g daily every 3 or 4 days up to a maximum of 20 g daily. It is given in 2 or 3 divided doses. Once the optimal dose of piracetam has been established, attempts should be made to reduce the dose of other drugs. For dosage in renal impairment see below.
Piracetam has been given for various other disorders in a usual oral dose of up to 2.4 g daily in 2 or 3 divided doses; higher doses of up to 4.8 g daily have been used in severe cases. In severe disorders it has also been given by intramuscular or intravenous injection.
Administration in renal impairment.
Dosage should be reduced in patients with mild to moderate renal impairment according to creatinine clearance (CC):
- CC between 50 and 79 mL/minute: two-thirds of the usual dose, given in 2 or 3 divided doses
- CC between 30 and 49 mL/minute: one-third of the usual dose, given in 2 divided doses
- CC between 20 and 29 mL/minute: one-sixth of the usual dose, given as a single dose
- CC less than 20 mL/minute: contra-indicated
Although piracetam is used in some countries in the management of cognitive impairment and dementia, a systematic review concluded that the evidence from the published literature did not support this use.
A review of 62 case reports, 3 open studies, and 2 double-blind studies concluded that piracetam is beneficial in the treatment of disabling myoclonus, either as adjunctive treatment or as monotherapy. Similar conclusions were made in another review in which experience of 12 patients with progressive myoclonus epilepsy, 8 of whom benefited from piracetam in doses of up to 45 g daily without significant adverse effects, was described.
Piracetam did not influence the outcome if given within 12 hours of the onset of acute ischaemic stroke in a multicentre, randomised, double-blind study, although post hoc analyses suggested that it might confer benefit when given within 7 hours of onset, particularly in patients with stroke of moderate to severe degree. Further analyses of the same data concluded that piracetam did not produce significant adverse effects when given in high doses to patients with acute stroke, and significantly more patients had recovered from aphasia on piracetam than placebo.
The results of two further randomised, double-blind, placebo-controlled studies supporting the role of piracetam as an adjunct to intensive speech therapy in improving aphasia following stroke were also reported. In contrast, a systematic review including the first study considered that the trend towards an increased risk of early death in patients allocated to piracetam was of concern, and concluded that the data did not support routine use of piracetam in acute ischaemic stroke.
Piracetam has been reported to be of benefit in patients with vertigo of both central or peripheral origin.
Austria; Cerebryl; Nootropil; Novocephal; Pirabene;
Belgium: Braintop; Docpirace; Geratam; Noodis; Nootropil; Piracemed; Piracetop;
Brazil: Cintilan; Nootrofic ; Nootron; Nootropil;
Czech Republic: Geratam; Kalicor; Nootropil; Oikamid; Pirabene;
France: Axonyl ; Gabacet; Nootropyl;
Germany; Avigilen; Cerebroforte ; Cerepar N; Cuxabrain ; Nemo-Puren ; Nootrop; Normabrain; Piracebral; Piracetrop; Sinapsan;
Greece: Aminotrophylle-88; Arterosol ; Cebragil; Latys; Lobelo; Neclivin ; Noforit; Nootrop; Oxynium; Piracem; Stamin;
Hong Kong; Nootropil; Piratin;
Hungary: Cerebryl; Lucetam; Nemoril; Nootropil; Pirabene; Fyramen ;
India: Nootropil; Normenta; Pirament; Piratarn-P;
Indonesia: Antikun; Benocetam; Cetoros; Chepamed; Ciclobrain; Encebion; Ethopil; Fepiram; Gotropil; Gracetam; Latropil; Lutrotam; Nersitropil; Neurocet; Neurotam; Noocephal; Nootropil; Nufacetam; Piratro ; Pratropil; Primatam; Procetam; Resibron; Revolan; Scantropil; Sotropil; Tropilex;
Italy: Cerebropanl; Nootropil; Psycoton;
Japan: Nyocalm; Nootropil;
Malaysia: Cebrotoning; Knowful; Nootropil;
Mexico: Dinagen; Nootropil;
The Netherlands: Nootropil;
Philippines: Irahex; Nootropil;
Poland: Lucetam; Nemotropil; Nootropil;
Portugal: Acetar; Noostan; Nootropil; Oxibran; Stimubral ;
Russia: Lucetam; Nemotropil; Nootropil; Phezam; Piratropil;
South Africa; Nootropil;
Singapore: Cebrotonin; Cetam ; Nootropil; Piratam; Racetam;
Spain: Ciclofalina; Nootropil;
Switzerland: Nootropil; Pirax;
Thailand: Embol; Nempil; Noocetam; Nootropil; Scarda;
Turkey: Nootropil; Norotrop;
United Kingdom (UK): Nootropil;
Venezuela: Breinox; Nootropil
Brazil: Energiclin; Energivit; Exit; Isketam; Vincetron ;
Portugal: Anacervix; Centracetam ; Stimilfar-P;
Russia: Omaron; Piracezine; Vinpotropile;
Spain: Anacervix; Devincal; Diemil; Piracetam Complex;