P-cetam

P-cetam

piracetam

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Piracetam.
Indications/Uses
Capsule/Tablet: Patients suffering from myoclonus of cortical origin, irrespective of aetiology. P-Cetam should be used in combination with other anti-myoclonic therapies.
Ampoule: Cerebrocortical insufficiency disorders or states eg, trauma or surgery, alcoholism, vertigo, cerebrovascular accidents, learning disability, dyslexia and behavioral disorders in children. Piracetam is used as an adjunct in the treatment of myoclonus seizures and in senile dementia. Piracetam protects the cerebral cortex against hypoxia. Recurrent or chronic vertigo. Contract myoclonus.
Dosage/Direction for Use
Capsule/Tablet: Adults: Usual Dose: 800 mg 3 times daily. If the symptom is getting better, gradually reduce to 400 mg 3 times daily. Maximum Dose: 4.8 g/day.
Ampoule: 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, parenterally. When treating severe symptoms, 12 g daily may need to be administered as an IV infusion. 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.
Stroke: Adults: IV injection: For cerebrovascular accident, 12 g IV in 20 min followed by 12 g/day (IV) including the 1st day for 4 weeks, then 4.8 g/day for at least 12 weeks. Children: 30-50 mg/kg body weight/day.
Overdosage
P-Cetam appears to be devoid of toxicity even at very high doses and therefore, the need for specific measures to be taken in case of an overdosage is avoided.
Contraindications
Severe renal insufficiency.
Use in pregnancy & lactation: Ampoule: P-Cetam injection should not be administered during pregnancy or potential pregnancy as it is reported to cross the placental barrier which could affect the pregnancy or fetus.
P-Cetam injection should not be administered to breastfeeding mothers except under exceptional circumstances as it crosses the placental barrier.
Special Precautions
As the principal route of elimination of P-Cetam 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.
Use in pregnancy & lactation: P-Cetam capsule should not be prescribed during pregnancy or when breastfeeding, except under exceptional circumstances.
P-Cetam is able to cross the placenta.
Ampoule: Patients with psychiatric anxiety.
Use In Pregnancy & Lactation
Capsule: P-Cetam capsule should not be prescribed during pregnancy or when breastfeeding, except under exceptional circumstances.
P-Cetam is able to cross the placenta.
Ampoule: P-Cetam injection should not be administered during pregnancy or potential pregnancy as it is reported to cross the placental barrier which could affect the pregnancy or fetus. P-Cetam injection should not be administered to breastfeeding mothers except under exceptional circumstances as it crosses the placental barrier.
Side Effects
Capsule/Tablet: The side effects reported include nervousness, agitation, irritability, anxiety and sleep disturbances. The incidence of these during clinical trials was ≤5% and they were more often noted in older patients taking >2.4 g daily. In the majority of cases, a dose reduction sufficed to make these symptoms disappear.
Some patients may complain of fatigue or drowsiness. Gastrointestinal problems eg, nausea, vomiting, diarrhoea and stomachache have also been reported but their incidence during clinical trials was ≤2%.
Other symptoms eg, vertigo, headaches, trembling and sexual stimulation have occasionally been reported.
Ampoule: Psychiatric: Psychiatric hyperkinesia, sleep disturbance, insomnia, nervousness, aggression, depressive emotional inversion, anxiety, irritability, agitation, drowsiness, decrease of seizure threshold, hyperactivity in children, dizziness, headache, tremor, fatigue may occur.
Digestive: Nausea, vomiting, abdominal discomfort, diarrhoea, gastralgia may occur.
Circulatory: Elevation or decrease in blood pressure may occur.
Others: Libido, weight gain, allergic reaction, redness, rash, hypersensitivity may occur.
Drug Interactions
Capsule/Tablet: The classical treatment for alcoholism ie, vitamins and sedatives, may continue to be prescribed during cures for alcoholism, in cases where there is a known vitamin deficiency or severe excitability.
Only 1 case of interaction has been reported where P-Cetam and thyroid extract (T3 and T4) were given together and confusion, irritability and sleep disturbances were later observed. No other drug interactions have been described.
Ampoule: Concomitant use with CNS stimulants enhances CNS stimulation effects; with psychiatric drugs may cause atypical interaction; with thyroid hormone in patients with hypothyroidism enhances effect and causes confusion, hypersensitivity, sleep disturbance; with warfarin can prolong prothrombin time.
Storage
Capsule/Tablet: Store at room temperature, in air-tight container.
Ampoule: Store at controlled room temperature (1-30°C), in hermetic container.
Shelf-Life: Ampoule: 3 years.
ATC Classification
N06BX03 - piracetam ; Belongs to the class of other psychostimulants and nootropics.
Presentation/Packing
Cap 400 mg (orange-colored cap, white-colored body) x 10 x 10's. Tab 800 mg (orange, oblong) x 10 x 10's. Inj (amp) 1 g/5 mL x 10's. 3 g/15 mL (colorless, transparent solution) x 8's.
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