Piracetam is a "nootrope" that is to say it is a psychotropic agent which acts directly on the brain to improve the efficacy of the telencephalon in both normal subjects and those suffering from some functional deficit. This area of the brain is involved in cognition and also has a role to play in learning and memory, in alertness and in consciousness. Piracetam does not produce either sedation or stimulation.
Piracetam can act on the Central Nervous System in a variety of ways. It will modify neurotransmission within the brain, and can help to improve the metabolic environment essential for good neuronal function. It is also a haemorrheological agent and can improve microcirculation without producing vasodilation.
When given as acute or long term treatment for patients suffering from a functional CNS deficit, it will heighten alertness and increase cognitive function. These changes are seen as a significant increase in the alpha and beta activity, with a reduction in delta activity, on an? EG trace.
Piracetam will protect and restore cognitive functional capacity after cerebral trauma such as hypoxia or intoxication, and after electroshock therapy.
Piracetam may be given alone, or together with other drugs when treating cortical myoclonia.
NOOTROPIL will reduce the duration of vestibular nystagmus.
Piracetam will improve regional oxygen and glucose uptake in the brain in patients suffering from dementia subsequent to multiple infarcts.
Piracetam will inhibit the increased aggregation of activated platelets and, in conditions where there is abnormal rigidity of the red blood cell, it can restore deformability and the ability to pass through the microvasculature.
When given by mouth, in either solute or tablet form, Piracetam is rapidly and almost totally absorbed in the gut.
Bioavailability is almost 100%. When given as a single 2 g dose, the peak blood level of 40 to 60µg/ml is attained after 30 minutes. In the cerebrospinal fluid the peak concentration is achieved at 2 to 8 hours post-dosage.
The apparent volume of distribution is in the region of 0.6 l/kg.
Plasma half-life is 4 to 5 hours, while the half-life in the cerebra-spinal fluid is 6 to 8 hours. The half-life is increased in cases of renal insufficiency.
Piracetam does not bind to plasma proteins and is eliminated unchanged principally via the kidney. Renal excretion is almost complete, i.e. over 95 %, after 30 hours.
Renal clearance of Piracetam in healthy volunteers is 86 ml/minute.
Piracetam will diffuse into all types of tissue and can cross both the blood-brain barrier and the placenta, as well as the membranes employed in renal dialysis. Piracetam is active in its unchanged form and is not metabolised by any of the animal species tested.
Piracetam is concentrated in the cerebral cortex, in the frontal, parietal and occipital lobes, in the cerebellum and in the basal ganglia.
l. Treatment of the elderly with some degree of cerebral functional impairment such as loss of memory, a lack of concentration or alertness, changes of mood, vertigo, personal negligence and deterioration in behaviour.
These symptoms can also provide an early warning of the onset of pathological ageing such as Alzheimer's Disease, an Alzheimer type of senile dementia, or the dementia produced by multiple cerebral infarcts.
2. Treatment of symptoms related to chronic alcoholism withdrawal and of chronic alcoholic patients suffering from a psycho-organic brain syndrome.
3. Treatment of coma of traumatic or toxic origin, as well as cognitive deficit and/or vertigo resulting from head injury.
4. NOOTROPIL is indicated for patients suffering from myoclonus of cortical origin, irrespective of aetiology and should be used in combination with other anti-myoclonic therapies.
DOSAGE AND ADMINISTRATION
– The total daily dose can range from 30 to 160 mg/kg/day depending on the indication. This is administered twice daily, but may also be given in three or four separate doses, either by mouth or parenterally. The oral route is preferred to parenteral it the patient's condition permits. Should parenteral treatment be discontinued, the contents of any remaining ampoules can be given by mouth.
– When treating severe symptoms, 12g daily may need to be administered as an intravenous infusion.
– In the treatment of chronic psycho-organic brain syndrome in the elderly 4.8 g daily is given initially, followed, after a few weeks, by maintenance therapy at 1.2 to 2.4 9 per day.
– When treating alcoholism the dose can be as high as 12 g daily during the initial withdrawal period.
Subsequent maintenance therapy is an oral daily dose of 2.4g.
– In the treatment of cortical myoclonias, dosage should commence at 7.2g/day, increasing by 4.8 g/day every three or four days up to a maximum of 24 g/day, the drug being given twice or three times daily.
Treatment with other anti-myoclonic medicinal products should be maintained at the same dosage. Depending on the clinical benefit obtained, the dosage of other such medicinal products should be reduced, if possible.
Once started, treatment with piracetam should be continued for as long as the original cerebral disease persists.
Nevertheless, an attempt should be made every 6 months to decrease or discontinue the medicinal treatment. This should be done by reducing the dose of piracetam by 1.2g every two days, in order to prevent the possibility of sudden relapse.