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Sedatives

Pracetam 800


Pack size:                

Box of 6 blisters x 15 film-coated tablets.


Composition:

Each film-coated tablet contains piracetam 800 mg.


Shelf-life:  

36 months from the date of manufacturing.

Store in  a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of vertigo. 
  • Elderly suffering from memory impairment, 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 for chronic alcoholism.
  • Sickle-cell anemia.
  • Adjunctive treatment of myoclonus of cortical origin.
     
  • Pracetam is administered orally.
     
  • The total daily dose can range from 30-160 mg/kg/day depending on the indication. This is administered twice daily, but may also be given in 3 or 4 separate doses.
  • As a long-term therapy for psycho-organic syndrome in the elderly, doses ranging from 1.2-2.4 g daily, according to the severity of the symptoms may be given. The loading dose can be as high as 4.8 g/day during the initial weeks of treatment.
  • Sickle-cell anemia: 160 mg/kg/day divided in 4 equal doses.
  • Alcoholism: 12 g daily during the initial withdrawal period. Subsequent maintenance therapy: Oral daily dose of 2.4 g.
  • 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 is a daily oral dose of 2.4 g, given for a period of not less than 3 weeks.
  • In cortical myoclonus: piracetam is given in oral doses of 7.2 g daily increasing by 4.8 g daily every 3 or 4 days up to a maximum of 20 g daily. It is given in 2 or 3 divided doses. Once the optimal dose of piracetam has been established, attempts should be made to reduce the dose of other drugs. Children under 16 years are not recommended.
  • Administration in renal impairment: Dosage should be reduced in patients with mild to moderate renal impairment according to creatinine clearance (CC):
    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.


Or as prescribed by physicians.

 

  • Hypersensitivity to piracetam, other pyrrolidone derivatives or to any ingredient of the drug.
  • Severe renal insufficiency, as demonstrated by a creatinine clearance of < 20 ml/min.
  • Patients with cerebral haemorrhage, suffering from Huntington's Chorea.
     

Common

  • Fatigue.
  • Nausea, vomiting, diarrhea and stomachache.
  • Nervousness, irritability, headache, insomnia, somnolence.

Uncommon

  • Vertigo.
  • Tremor, sexual stimulation.

     

  • As the principal route of elimination for piracetam is via the kidney, special care must be taken when treating patients known to suffer from renal insufficiency. Monitoring of renal function is recommended in such cases. The increase in half-life is directly related to the decrease in renal function and creatinine clearance. This is also true for the older patient in whom creatinine clearance is dependent on age.
  • Due to the effect of piracetam on platelet aggregation, caution is recommended 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 should be avoided in myoclonic patients as this may induce sudden relapse or withdrawal seizures.
  • Pregnancy: Piracetam is able to cross the placenta. Piracetam should not be used during pregnancy.
  • Lactation: Piracetam is excreted in human breast milk. Therefore, piracetam should not be used during breastfeeding or breastfeeding should be discontinued, while receiving treatment with piracetam.
  • Effects on ability to drive and use machines: In clinical studies, at dosages between 1.6 - 15 grams per day, hyperkinesia, somnolence, nervousness and depression were reported more frequently in patients on piracetam than on placebo. There is no experience on driving ability in dosages between 15 and 20 grams daily. Caution should therefore be exercised by patients intending to drive or use machinery whilst taking piracetam.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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