Piracetam

Visa No.: VD-20326-13

Product: Naatrapyl 3g

API: Piracetam

Product Category: Others

Version approved leaflet: 277/QĐ-QLD_23/05/2022_175.1

INDICATIONS

Adults
Piracetam is indicated for:

• Symptomatic treatment of psycho-organic syndrome, with features that may improve with treatment such as memory impairment, attention disorders, and lack of motivation.
• Monotherapy or adjunctive therapy for cortical myoclonus.
• Treatment of vertigo and associated balance disorders, excluding dizziness of vasomotor or psychogenic origin.
• Prevention and reduction of vaso-occlusive crises in patients with sickle cell disease.

Children
Piracetam is indicated for: 

• Treatment of dyslexia, in combination with appropriate measures such as speech therapy.
• Prevention and reduction of vaso-occlusive crises in patients with sickle cell disease
   

DOSAGE AND ADMINISTRATION

When parenteral administration is required (e.g. in cases of swallowing difficulties or coma), piracetam may be administered intravenously at the same recommended daily dose.
When piracetam is administered by injection or infusion, the physician must first prescribe the appropriate dose. This dose determines the volume of solution to be administered. In many cases, the required volume exceeds that of a single ampoule and is rarely an exact multiple of the available ampoule volume. For example, when an infusion dose of 4.8 g of piracetam is required the corresponding volume of piracetam injection solution is 24 ml. In this case, the healthcare professional should withdraw 15 ml from one ampoule and add 9 ml from a second ampoule. The prepared solution should then be administered intravenously over several minutes.

Route of administration: Intravenous use.

Adults: 
Symptomatic treatment of psycho-organic syndrome: The recommended daily dose ranges from 2.4 g to 4.8 g, pided into 2–3 doses.
Treatment of cortical myoclonus: 
The initial daily dose is 7.2 g, which may be increased by 4.8 g every 3–4 days up to a maximum of 20 g/day, pided into 2–3 doses. Treatment with other anti-myoclonic medicines should be continued at the same dosage. Depending on the clinical benefit achieved, the dose of these medicines should be reduced if possible. Dosage must be inpidualized by trial therapy.
Once initiated, treatment with piracetam should be continued for as long as the underlying cerebral disorder persists. In patients with an acute episode, spontaneous improvement may occur over time; therefore, every 6 months an attempt should be made to reduce the dose or discontinue treatment. Dose reduction should be gradual, by 1.2 g every 2 days (every 3–4 days in patients with Lance–Adams syndrome), in order to prevent withdrawal seizures or sudden relapse.
Treatment of vertigo: The recommended daily dose ranges from 2.4 g to 4.8 g, pided into 2–3 doses.
Prevention and reduction of vaso-occlusive crises in sickle cell disease: The recommended daily dose for prevention of crises is 160 mg/kg, administered orally, pided into 4 doses. The recommended daily dose for reduction of crises is 300 mg/kg, administered intravenously, pided into 4 doses. Use of doses below 160 mg/kg/day or irregular administration may result in recurrence of acute crises.

Children:
Treatment of dyslexia (in combination with appropriate measures such as speech therapy): The recommended dose for school-aged children (from 8 years of age) and adolescents is 3.2 g/day, pided into 2 doses. 
Prevention and reduction of vaso-occlusive crises in sickle cell disease: In children from 3 years of age, the recommended preventive dose is 160 mg/kg/day, pided into 4 doses.
For reduction of crises, the dose is 300 mg/kg/day administered intravenously, pided into 4 doses.
Use of doses below 160 mg/kg/day or irregular administration may lead to disease relapse. Piracetam may be used in children with sickle cell anemia at the recommended daily dose (mg/kg – see above). Piracetam has been used in a limited number of children aged 1–3 years.
Elderly 
Dose adjustment is recommended in elderly patients with impaired renal function (see Warnings and Precautions, Renal impairment below).
During long-term treatment in elderly patients, creatinine clearance should be regularly assessed in order to adjust the dose when necessary.
Renal impairment
Piracetam is contraindicated in patients with severe renal impairment (creatinine clearance below 20 ml/min) (see Contraindications and Warnings and Precautions).
The daily dose should be inpidualized according to renal function. Please refer to the table below and adjust the dose as indicated. To apply this dosage table, the patient’s creatinine clearance (Clcr), expressed in ml/min, should be estimated. Creatinine clearance (ml/min) may be estimated from serum creatinine (mg/dl) using the following formula:

Hepatic impairment
No dose adjustment is required in patients with hepatic impairment alone. Dose adjustment is recommended in patients with both hepatic and renal impairment (see dose adjustment for renal impairment above).
 

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to other pyrrolidone derivatives.
• Severe renal impairment (creatinine clearance below 20 ml/min).
• Cerebral hemorrhage
• Huntington’s chorea.
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. 
Keep out of reach of children.