Piracetam

Visa No.: VD-20992-14

Product: Naatrapyl 1g

API: Piracetam

Product Category: Others 

Version approved leaflet: 201/QĐ-QLD_20/04/2022_174.1

INDICATIONS

Adult: 
Piracetam is indicated for:
- Treatment of symptoms of psycho-organic syndrome, with features shown to improve with treatment, such as memory loss, impaired attention, and lack of motivation.
- Monotherapy or adjunctive therapy for cortical myoclonus.
- Treatment of vertigo and associated balance disorders, excluding vertigo of vasomotor or psychogenic origin.
- Prevention and reduction of vaso-occlusive crises in 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 sickle cell disease
 

DOSAGE AND ADMINISTRATION

When parenteral administration is required (e.g. in cases of dysphagia or coma), piracetam may be administered intravenously at the same recommended daily dose.
When piracetam is administered by injection/infusion, the physician first prescribes the appropriate dose. This dose determines the volume of solution to be administered. In many cases, the required volume exceeds one ampoule and is rarely an exact multiple of the available ampoule volume. For example, for an infusion dose of 2.4 g piracetam, the required volume is 12 mL. In this case, healthcare personnel should withdraw two 5-mL ampoules and add 2 mL from a third ampoule. The solution is administered intravenously over several minutes
Route of administration: intravenous.
Intravenous infusion: Piracetam is infused at a rate of 20–40 drops/minute. Accordingly, 12 g/60 mL piracetam is infused over approximately 30 minutes to 1 hour.
Intravenous injection: Piracetam is injected slowly into a large vein.
Dosage
Adult: 
Treatment of symptoms of psycho-organic syndrome: The recommended daily dose range is 2.4 g to 4.8 g, pided into 2–3 doses.
Treatment of cortical myoclonus: The initial daily dose is 7.2 g, then increased by 4.8 g every 3–4 days up to a maximum of 20 g, pided into 2–3 doses. Concomitant antimyoclonic therapies should be maintained at the same dosage. Depending on the clinical benefit achieved, doses of these medicines may be reduced, if possible. The dose must be inpidually determined by trial treatment.
Once initiated, treatment with piracetam should be continued as long as the underlying disease persists. In patients with an acute episode, spontaneous improvement may occur after a period of time; therefore, every 6 months an attempt should be made to reduce the dose or discontinue treatment. The dose should be reduced by 1.2 g every 2 days (every 3–4 days in patients with Lance–Adams syndrome) to prevent withdrawal seizures or sudden relapse.
Treatment of vertigo: The recommended daily dose is 2.4 g to 4.8 g, pided into 2–3 doses.
Prevention and reduction of vaso-occlusive crises in sickle cell disease: 
Recommended daily dose for prevention: 160 mg/kg orally, pided into 4 doses.
Recommended daily dose for reduction of acute crises: 300 mg/kg intravenously, pided into 4 doses.
Use of doses below 160 mg/kg/day or irregular administration may lead to 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 preventive dose is 160 mg/kg/day, pided into 4 doses. In cases of reduction of acute 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).
Elderly
Dose adjustment is recommended in elderly patients with impaired renal function. 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 The daily dose should be inpidualized according to renal function. Refer to the table below and adjust the dose as indicated To apply this dosage, 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:
 

Patients with hepatic impairment
No dose adjustment is required in patients with hepatic impairment alone. Dose adjustment is recommended in patients with concomitant hepatic and renal impairment.

CONTRAINDICATIONS

Contraindicated in the following cases:
•    Hypersensitivity to piracetam, other pyrrolidone derivatives, or any excipient of the product.
•    End-stage renal disease (creatinine clearance < 20 mL/min).
•    Cerebral hemorrhage.
•    Patients with 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.