COMPOSITIONS :
Piracetam Infusion 12 g/60 ml, each 60 ml contains : Piracetam 12 g.
DESCRIPTIONS :
Piracetam containing Piracetam as active ingredient is available as injection 1 g/5 ml, 3 g/15 ml and infusion 12 g/60 ml.
INDICATIONS :
Post traumatic syndrome : cerebral dysfunction to post traumatic sequelae (headache, vertigo, agitation, memory disorders, asthenia).
DOSAGE AND ADMINISTRATIONS :
Usually dosage 1 g, 3 times a day, IV.
CONTRAINDICATIONS :
- Severe renal insufficiency (creatinine clearance < 20 ml/minute).
- Cerebral hemorrhage and hypersensitivity to Piracetam.
- First trimester of pregnancy.
- Agitated depression.
- In end stage renal disease patients.
WARNINGS AND PRECAUTIONS :
- Patients with underlying disorders of hemostasis.
- Major surgery of severe hemorrhage.
- Abrupt discontinuation of treatment should be avoided in myoclonic patients as this may induce sudden relapse or withdrawal seizures.
- As Piracetam is almost exclusively eliminated by the kidney, precautions should be taken when treating patients suffering from renal insufficiency and in whom it is wise to check the renal function. The half-life time is increased in direct proportion to loss of renal function and the creatinine clearance; this is equally true in elderly patients, in whom the excretion of creatinine is dependent on age. For this reason, the dosage will be changed according to the table below :
| Group | Creatinine clearance
(ml/minute) |
Posology and frequency |
| Normal | > 80 | Usually daily dose, 2 – 4 divided doses . |
| Mild | 50 – 79 | 2/3 usual daily dose, 2 or 3 divided doses. |
| Moderate | 30 – 49 | 1/3 usual daily dose, 2 divided doses. |
| Severe | < 30 | 1/6 usual daily dose, 1 single dose. |
| End-stage Renal Disease | – | Contraindicated. |
DRUG INTERACTIONS :
The concomitant administration with thyroid hormone may cause confusion, irritability and sleep disturbances.
ADVERSE REACTIONS :
- Nervousness, irritability, insomnia, anxiety, tremor, agitation, sleep disturbances and restlessness. These were often noted in the older patients taking > 2.4 g daily.
- Fatigue, gastrointestinal disorders (nausea, vomiting, diarrhea and gastralgia), headaches and vertigo have been reported.
- Dry mouth, increased libido, accelerated body weight, most of dermato-hypersensitivity reactions have occasionally been reported.
PRESENTATIONS :
| Piracetam Infusion 12 g/60 ml
Reg. No. GKL0602338849A1 |
Box, 1 bottle @ 60 ml |
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
