Section :
Novacetam Syrup
📌 COMPOSITION
- Each 5 ml syrup contains: Piracetam Eur.P. 1 g.
- Each capsule contains: Piracetam Eur.P. 400 mg.
- Each tablet contains: Piracetam Eur.P. 800 mg.
📌 DESCRIPTION
Novacetam (Piracetam) is a nootropic agent which acts on the brain to improve the telencephalon, which is involved in cognition and plays a role in learning, memory and alertness. Piracetam acts by modifying neurotransmission within the brain by improving the metabolic environment essential for good neuronal function and by improving the microcirculation. Piracetam is rapidly absorbed from the GIT with almost 100% bioavailability. Peak blood levels of 40-60 mcg/ml are attained after 30 minutes following a single oral dose of 2 g. In the cerebrospinal fluid (CSF), the peak concentration is achieved 2-8 hours post‑dosage. Piracetam is concentrated in the cerebral cortex, in the frontal, parietal and occipital lobes. Piracetam is not metabolised and is excreted unchanged. The plasma half‑life is 4-5 hours, while the half‑life in CSF is 6-8 hours.
📌 INDICATIONS
Novacetam is indicated in:
- Improvement of loss of memory, vertigo, lack of concentration or alertness, changes of mood, deterioration in behaviour and personal negligence in elderly people.
- Treatment of sickle cell anaemia.
- Treatment of chronic alcoholism.
- Treatment of cognitive deficit as a result of head injury.
- Improvement of learning difficulties associated with written word in children.
📌 DOSAGE & ADMINISTRATION
Adults:
- Psycho‑organic syndrome: 1.2-2.4 g daily, administered twice daily, with a loading dose as high as 4.8 g/day for the first few weeks.
- Sickle cell anaemia: 160 mg/kg/day divided into four equal doses.
- Alcoholism: During the initial withdrawal period up to 12 g daily; maintenance: 2.4 g daily, administered twice daily.
- Cognitive deficits: Initially 9-12 g daily; maintenance: 2.4 g daily for not less than three weeks.
Children (8-13 years):
- Learning difficulties: 3.3 g daily (8 ml of Novacetam syrup twice a day before breakfast and before the evening meal).
📌 RESTRICTIONS ON USE
Contraindications
- Severe renal impairment.
Precautions
- Piracetam should not be prescribed to pregnant women and nursing mothers except under exceptional conditions.
- Administer with care in renal impairment.
📌 DRUG INTERACTIONS
Concomitant administration of Piracetam with thyroid extract may result in confusion, irritability and sleep disturbances.
📌 ADVERSE EFFECTS
- Nervousness, agitation, irritability, anxiety and sleep disturbances may occur at a rate of 5% or less, especially in elderly patients at doses of more than 2.4 g daily. In the majority of cases, these symptoms disappear with dose reduction.
- Nausea, vomiting, diarrhoea and stomach ache may occur at a rate of 2% or less.
- Other symptoms may include vertigo, headache and sexual stimulation.
📌 STORAGE INSTRUCTIONS
Store between 15-25°C. Protect from light.
📌 PHARMACEUTICAL FORMS
- Novacetam Syrup: Bottle of 100 ml.
- Novacetam Capsules: Blister pack of 60 capsules and hospital packs of different sizes.
- Novacetam Tablets: Blister pack of 30 tablets and hospital packs of different sizes.
** Other presentations may also be available in some countries.
