Piracetam

The daily dose must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula:

Clcr = [140 – age (years)] X weight (kg) / 72 X serum creatinine (mg/dl) (X 0.85 for women)

Confusion, irritability and sleep disorder have been reported during concomitant treatment with thyroid extract (T3 and T4).

In a published single-blind study on patients with severe recurrent venous thrombosis, piracetam 9.6 g/d did not modify the doses of acenocoumarol necessary to reach INR 2.5 to 3.5, but compared with the effects of acenocoumarol alone, the addition of piracetam 9.6 g/d significantly decreased platelet aggregation, β-thromboglobulin release, levels of fibrinogen and von Willebrand.s factors (VIII : C; VIII : vW : Ag; VIII : vW : RCo) and whole blood and plasma viscosity.

Due to the effect of piracetam on platelet aggregation, caution is recommended in patients with severe haemorrhage, patients at risk of bleeding such as gastrointestinal ulcer, patients with underlying disorders of haemostasis, patients with history of haemorrhagic CVA, patients undergoing major surgery including dental surgery, and patients using anticoagulants or platelet antiaggregant drugs including low dose aspirin.

There are no adequate data from the use of piracetam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development.

Piracetam crosses the placental barrier. Drug levels in the newborn are approximately 70% to 90% of maternal levels. Piracetam should not be used during pregnancy unless clearly necessary, when benefit exceeds the risks and the clinical condition of the pregnant mother requires treatment with piracetam.

Piracetam is excreted in human breast milk. Therefore, piracetam should not be used during breastfeeding or breastfeeding should be discontinued, while receiving treatment with piracetam. A decision must be made whether to discontinue breast-feeding or to discontinue piracetam therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Given the adverse events observed with the drug, an influence on driving and using machines is possible and should be taken into account.

Summary of safety profile

Double-blind placebo-controlled clinical or pharmacoclinical trials, of which quantified safety data are available (extracted from the UCB Documentation Data Bank on June 1997), included more than 3000 subjects receiving piracetam, regardless of indication, dosage form, daily dosage or population characteristics.

Tabulated list of adverse reactions

Undesirable effects reported in clinical studies and from post-marketing experience are listed in the following table per System Organ Class and per frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000).

Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.

Blood and lymphatic system disorders

Not known: haemorrhagic disorder

Immune system disorders

Not known: anaphylactoid reaction, hypersensitivity

Psychiatric disorders

Common: nervousness

Uncommon: depression

Not known: agitation, anxiety, confusion, hallucination

Nervous system disorders

Common: hyperkinesia

Uncommon: somnolence

Not known: ataxia, balance impaired, epilepsy aggravated, headache, insomnia,

Ear and labyrinth disorders

Not known: vertigo

Vascular disorders

Rare: Thrombophlebitis (only for injectable form), hypotension (only for injectable form)

Gastrointestinal disorders

Not known: abdominal pain, abdominal pain upper, diarrhoea, nausea, vomiting

Skin and subcutaneous tissue disorders

Not known: angioneurotic oedema, dermatitis, pruritus, urticaria

General disorders and administration site conditions

Uncommon: asthenia

Rare: injection site pain (only for injectable form), pyrexia (only for injectablet form)

Investigations

Common: weight increased