TM
Piracetam
COMPOSITION
NeurolepTM Tablet: Each film coated tablet contains Piracetam BP 800 mg. Creatinine clearance Serum clearance Dosage
NeurolepTM Solution: Each 5 ml contains Piracetam BP 500 mg. (ml/min) (mg/100 ml)
60-40 1.25 - 1.7 1/ of normal dose
2
PHARMACOLOGY 40-20 1.70 - 3.0 1/ of normal dose
4
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 SIDE EFFECTS
and memory, in alertness and in consciousness. Piracetam does not The side effects reported include nervousness, agitation, irritability, anxiety
produce either sedation or stimulation. Piracetam can act on the central and sleep disturbances. The incidence of these during clinical trials was
nervous system in a variety of ways. It modifies neurotransmission within (5%) and these were more often noted in the older patients taking > 2.4 gm
the brain, and can help to improve the metabolic environment essential for daily. In the majority of cases, a dose reduction sufficed to make these
good neuronal function. It is also a haemorrheological agent and can symptoms disappear. Some patients may complain of fatigue or
improve microcirculation without producing vasodialation. When given as drowsiness, gastrointestinal problems, e.g. nausea, vomiting, diarrhoea and
acute or long term treatment for patients' suffering from a functional CNS stomachache have also been reported but their incidence during clinical
deficit, it heightens alertness and increase cognitive function. Piracetam trials was 2%. Other symptoms e.g. vertigo, headaches, trembling and
protects and restores cognitive functional capacity for cerebral trauma, e.g. sexual stimulation have occasionally been reported.
hypoxia or intoxication, and after electroshock therapy. Piracetam may be Overdose: Piracetam appears to be devoid of toxicity even at very high
given alone or together with other drugs when treating myoclonia due to doses and, therefore, the need for specific measures to be taken in case of
anoxia. It reduces the duration of vestibular nystagamus. an overdose is avoided.
INDICATION DRUG INTERACTIONS
Cerebral vascular accidents and cerebral insufficiencies: Ischaemic or even In a single case, confusion, irritability and sleep disorders were reported in
haemorrhagic acute accidents, chronic manifestations of the above concomitant use with thyroid extract. At present, no interaction has been
accidents or of cerebral atherosclerosis. observed with the following anti-epileptic drugs, clonazepam,
Mental retardation in children: Ease of resuming individual contact, carbamazepine, phenytoin, phenobarbitone and sodium valproate, based
sociability and learning, improved intellectual performances and school on a small number of studies.
results.
Behaviour and psychotic problems in old age: Memory deficits, particularly
with regard to fixation and evocation asthenia adaption disorders, USE IN PREGNANCY AND LACTATION
disturbed psychomotor reactions. Piracetam should not be prescribed during pregnancy or when breast
feeding, except under exceptional circumstances. Piracetam is able to cross
the placenta.
DOSAGE & ADMINISTRATION
Adults: In cerebro-cortical insufficiency disorders, usual dose is 800 mg 3 times a
day. In myoclonic seizures, a dose of 7.2 gm daily, increasing by 4.8 gm per STORAGE
day every 3 to 4 days up to maximum of 20 gm daily, given in 2 or 3 divided Store in a cool and dry place at a temperature below 30°C, Keep away from
doses. sunlight. Keep out of the reach of children.
Children: The daily dosage depends on the weight of the child, 50 mg/kg of
body weight in 3 divided doses. Once the desired results has been
obtained, reduce the initial dose by half. HOW SUPPLIED
NeurolepTM Tablet: Each box contains 50 tablets in blister packing.
NeurolepTM Solution: Each PET bottle contains 100 ml solution with a
CONTRAINDICATION & PRECAUTION measuring cup.
Piracetam is contra-indicated in patients with severe renal insufficiency
(creatinine clearance < 20 ml/min) and hepatic impairment. As the principal
route of elimination for Piracetam is via the kidney, special care must be
taken when treating patients known to suffer from renal insufficiency.
Monitoring of renal function is recommended in such cases. The increase in
half-life is directly related to the decrease in renal function and creatinine
clearance. This is also true for the older patient in whom creatinine
clearance is dependent on age. When the creatinine clearance is < 60
ml/min, or serum creatinine is >1.25 mg/100 ml, the dosage prescribed
should be calculated as following:
