Piracetam Overview

Trade Name: Piracetam
International Nonproprietary Name: Piracetam
Dosage Form: 400 mg Tablet

Composition

Active Ingredient:

• Piracetam: 400 mg per tablet

Excipients:

• Povidone K-25
• Magnesium carbonate basic, light
• Calcium stearate
• Potato starch
• Opadry II white (85G)

Opadry II White (85G) Composition:

• Partially hydrolyzed polyvinyl alcohol
• Titanium dioxide
• Talc
• Polyethylene glycol 3350
• Lecithin (soya)

Pharmacological Classification

Pharmacotherapeutic Group: Psychoanaleptics; Psychostimulants and Nootropics
ATC Code: N06BX03

Pharmacological Effects

Piracetam positively impacts brain metabolic processes by improving integrative brain activity, enhancing memory consolidation, and facilitating the learning process. It alters the spread of excitation within the brain, improves microcirculation without vasodilation, and inhibits platelet aggregation. It also provides protection against brain injuries due to hypoxia, intoxication, and electric shock, enhances mental performance, and gradually improves cerebral blood flow.

Therapeutic Indications

• Memory Disorders/Intellectual Disturbances: Piracetam is used for symptomatic treatment in the absence of a dementia diagnosis.
• Cortical Myoclonus: Piracetam can help reduce the symptoms, with a test treatment course required to determine effectiveness.

Dosage and Administration

For Chronic Conditions:

• Starting Dose: 1,200 mg/day (400 mg three times daily), gradually increasing to 2,400 mg/day or more if needed.
• Maintenance Dose: After 2-3 weeks, reduce to 1,200-1,600 mg/day (400 mg 3-4 times daily).
• Treatment Duration: 2-3 weeks to 2-6 months. Repeat after 6-8 weeks if necessary.

For Chronic Psycho-Organic Syndrome:

• Dose: 1,200-2,400 mg/day, increasing to 4,800 mg/day in the first week if needed.

For Cortical Myoclonus:

• Starting Dose: 7,200 mg/day, increasing by 4,800 mg every 3-4 days to a maximum of 24,000 mg/day.
• Maintenance: Continue treatment as long as the disease persists, with attempts to reduce dosage every 6 months.

Renal Impairment Adjustments:

Note: Dose adjustments are necessary for elderly patients with renal insufficiency. No adjustment is needed for hepatic impairment alone, but patients with both renal and hepatic impairments should follow renal guidelines.

Contraindications

• Hypersensitivity to piracetam
• Severe renal impairment (creatinine clearance < 20 ml/min)
• Hemorrhagic stroke
• Psychomotor agitation
• Agitated depression
• Huntington’s disease
• Pregnancy and lactation

Precautions

• Monitor renal function during prolonged therapy, especially in patients with renal insufficiency.
• Avoid abrupt discontinuation in cortical myoclonus to prevent the recurrence of symptoms.
• Exercise caution when prescribing to patients with bleeding risks or those on anticoagulation therapy.
• The drug may cause excessive CNS stimulation when combined with other CNS stimulants.

Side Effects

• Nervous System: Irritability, insomnia, somnolence, depression, dizziness, headache, convulsions.
• Cardiovascular: Hypo/hypertension, worsening of coronary insufficiency in the elderly.
• Blood Disorders: Coagulation issues.
• Gastrointestinal: Stomach pain, nausea, vomiting, diarrhea.
• Allergic Reactions: Dermatitis, rash, itching, edema.
• Others: Increased sexual activity, weight gain, fatigue.

Side effects are more common in elderly patients at doses above 2,400 mg/day.

Overdose

• Symptoms: Exacerbation of side effects.
• Treatment: Gastric lavage, activated charcoal, symptomatic therapy, and possibly hemodialysis.

Storage

• Store in a dark place at or below 25°C.
• Keep out of reach of children.
• Shelf life: 2 years.

Prescription Status

Over-the-counter

Packaging

• 10 tablets per blister.
• Available in packs containing 2 or 3 blisters with a patient information leaflet.

Note: 

The brand name displayed above is specific to this product. Brand names can vary depending on the manufacturer.