1 ml solution for injection contains 200 mg piracetam
POSOLOGY AND METHOD OF ADMINISTRATION
For symptomatic treatment of intellectual and memory disorders, the recommended dose is 2.4-4.8 g/day, divided in 2-3 doses.
Treatment of cortical myoclonia, terapy should begin at 7.2 g increasing by 4.8 g every three to four days, divided in two or three doses, up to a maximum of 24 g. 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. In patients with an acute episode, spontaneous evolution may occur over time and 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 1.2 g every two days (every three or four days in the case of a Lance-Adams syndrome, in order to prevent the possibility of sudden relapse or withdrawal seizures).
Adjustment of the dose is recommended in elderly patients with compromised renal function (see ’Dosage adjustment in patients with renal impairment’ below). For long term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed.
Patients with renal impairment
Piracetam is almost completely excreted by the kidneys. Caution should be exercised in the treatment of patients with renal insufficiency, and in those patients renal function should be controlled.
The elimination half-life increases in direct correlation of the decreasment of renal function and creatinine clearance. This, also applies to elderly patients in whom creatinine excretion is age-dependent.
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:
[140- age (years) х weight (kg)]
CLCR = ——————————————————————— (х 0,85 for women)
72 х serum creatinine (mg/dl)
Creatinine clearance (ml/min)
Posology and frequency
|Normal renal function||>80||Usual daily dose, divided into 2 to 4 doses
|Mild renal insufficiency||50-79||2/3 usual daily dose, divided into 2 or 3 doses
|Moderate renal insufficiency||30-49||1/3 usual daily dose, divided into 2 doses
|Severe renal insufficiency||<30||1/6 usual daily dose in 1 single intake|
|Terminal renal insufficiency||–||Contraindicated|
Patients with hepatic impairment
No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of dose is recommended (see ‘Dosage adjustment in patients with renal impairment’ above).
Method of administration
Injectable forms are used when there is no possibility of oral use. The dosage is the same as the recommended daily dose for oral administration of piracetam.
The solution for injection is administered intravenously for several minutes.
Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.
You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.
|1 ml раствор за инјектирање содржи 200 mg пирацетам.|
|Симптоматска терапија на интелектуални нарушувања и нарушувања на меморијата, при отсуство на утврдена дијагноза на деменција.
Терапија на кортикална миоклонија (како монотерапија и дел од комбинирана терапија).
|Хиперсензитивност на пирацетам, деривати на пиролидон или на некоја од помошните супстанции.
Пирацетам е контраиндициран кај пациенти со церебрална хеморагија и пациенти со терминална ренална инсуфициенција, како и кај пациенти со Хантингтонова хореа.
|Раствор за инјектирање за интравенска и интрамускулна примена 200 mg/ml; 5 ml во ампула.
Кутија со 10 стаклени ампули од 5 ml.