Pracetam 400 CAP

Rx

Indications:

Elderly suffering from loss of memory, vertigo, a lack of concentration or of alertness, changes of mood, a deterioration in behaviour and personal negligence, the dementia produced by multiple cerebral infarcts.

Treatment of vertigo.

Sickle-cell anemia.

Treatment for chronic alcoholism.

Adjunctive treatment of myoclonus of cortical origin.

Dosage:

As a long-term therapy for psycho-organic syndrome in the elderly: Doses ranging from 1.2 – 2.4 g daily. The loading dose can be as high as 4.8 g daily during the initial weeks of treatment.

Cognitive deficits resulting from head injury, whether or not these are associated with vertigo: The initial dose can vary from 9 – 12 g daily. Maintenance therapy thereafter: 2.4 g daily for 3 weeks at least.

Sickle-cell anemia: 160 mg/kg/day divided in 4 equal doses.

Alcoholism: 12 g daily during the initial withdrawal period. Subsequent maintenance therapy: 2.4 g daily

Cortical myoclonus: 7.2 g daily increasing by 4.8 g daily every 3 or 4 days up to a maximum of 20 g daily given in 2 or 3 divided doses.

Administration in renal impairment:

• 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: Contraindicated.

Usage:

Pracetam 400 CAP is orally administered. This is administered twice daily, but may also be given in 3 or 4 separated doses.

Hypersensitivity to piracetam, other pyrrolidone derivatives or any of the excipients.

Severe renal insuffciency, as demonstrated by a creatinine clearance of < 20 ml/min.

Patients with cerebral haemorrhage, suffering from Huntington’s Chorea.

Children under 16 years are not recommended.

Pracetam 400 CAP should not be used during pregnancy and during breastfeeding.

Common: Fatigue; nausea, vomiting, diarrhea and abdominal pain; nervousness, irritability, headache, insomnia, somnolence.

Uncommon: Vertigo; tremor, sexual stimulation.

Special care must be taken when treating patients known to suffer from renal insufciency, the older patient. Monitoring of renal function is recommended in such cases.

Extreme caution is recommended when use Pracetam 400 CAP 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.

Abrupt discontinuation of treatment with Pracetam 400 CAP should be avoided in myoclonic patients as this may induce sudden relapse or withdrawal seizures.

Pracetam 400 CAP should not be used during pregnancy and during breastfeeding or breastfeeding should be discontinued, while receiving treatment with piracetam.

Caution should therefore be exercised by patients intending to drive or use machinery whilst taking Pracetam 400 CAP.