Lucetam

• Approved indications:
• Cognitive disorders associated with aging and cerebrovascular insufficiency
• Myoclonus (adjunctive therapy)
• Cognitive impairment in dementia and Alzheimer's disease (adjunctive)
• Post-stroke cognitive rehabilitation and recovery
• Vertigo and dyslexia (off-label in some regions)
• Off-label and clinically accepted uses:
• Neuroprotection in traumatic brain injury
• Enhancement of cognitive function in mild cognitive impairment
• Treatment of speech and learning disorders in children
• Adjunct in epilepsy management (to reduce myoclonic jerks)

• Route: Oral administration (tablets, capsules, oral solution).
• Adults:
• Typical dose ranges from 1,200 mg to 4,800 mg daily, divided into two or three doses.
• For cognitive disorders: 1,200–4,800 mg/day in divided doses, often 800 mg three times daily.
• For myoclonus: up to 7,200 mg/day divided doses depending on clinical response.
• Elderly:
• Usually start at lower doses (1,200–2,400 mg/day) and titrate carefully.
• Pediatrics:
• Dosage varies by indication and weight; often 40–100 mg/kg/day divided doses for cognitive or neurological conditions.
• Renal impairment:
• Dose adjustment recommended due to renal excretion; reduce dose proportionally to renal function.
• Hepatic impairment:
• No significant dose adjustment usually needed.
• Duration:
• Varies from weeks to months depending on indication and clinical response.

Piracetam is a nootropic agent that modulates neuronal and vascular functions. It is believed to enhance neuroplasticity by modulating membrane fluidity and influencing ion channels, particularly increasing calcium influx in neurons. Piracetam facilitates neurotransmission by enhancing acetylcholine function and improves microcirculation and oxygen delivery in the brain. These actions contribute to enhanced cognitive functions such as memory, learning, and attention, and help reduce myoclonic seizures by stabilizing neuronal excitability.

• Absorption: Rapid and almost complete oral absorption; bioavailability approximately 100%.
• Distribution: Widely distributed in body tissues including the brain; crosses the blood-brain barrier.
• Metabolism: Not significantly metabolized; largely excreted unchanged.
• Elimination: Primarily renal elimination; >80% excreted unchanged in urine.
• Half-life: Approximately 4 to 5 hours in healthy adults; may be prolonged in renal impairment.
• Onset: Clinical effects typically observed after days to weeks of therapy.

• Pregnancy: FDA pregnancy category C; animal studies show no teratogenicity at therapeutic doses but human data are limited; use only if potential benefit justifies risk.
• Lactation: Excretion in breast milk is unknown; caution advised during breastfeeding.

• Nootropic (cognitive enhancer)

• Known hypersensitivity to piracetam or any excipients
• Severe renal impairment without dose adjustment
• History of hypersensitivity reactions to similar agents

• Use caution in patients with renal impairment; dose adjustment necessary.
• May increase risk of bleeding in patients on anticoagulants or with bleeding disorders; monitor accordingly.
• Safety in children under 1 year has not been established.
• Monitor for allergic reactions and discontinue if severe hypersensitivity occurs.
• Use caution in patients with history of mood disorders or psychiatric conditions.

• Common:
• Nervous system: agitation, nervousness, irritability, somnolence, headache
• Gastrointestinal: nausea, diarrhea, abdominal pain
• Musculoskeletal: tremor
• Serious (rare):
• Allergic reactions including rash, pruritus, angioedema
• Psychotic symptoms or mood changes
• Thrombocytopenia or bleeding complications (rare)
• Side effects are usually mild, transient, and dose-dependent.

• May potentiate anticoagulant effects (e.g., warfarin) increasing bleeding risk.
• Possible interaction with anticonvulsants; may enhance antiepileptic effects.
• No significant CYP450 enzyme involvement; minimal drug metabolism interactions expected.
• Caution with other CNS stimulants or depressants.

• Recent clinical guidelines support piracetam use as adjunctive therapy in myoclonus and certain cognitive impairments.
• Emerging data suggest neuroprotective roles in stroke recovery and traumatic brain injury, though further studies are ongoing.
• No major dosing or safety changes recommended by regulatory authorities recently.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep container tightly closed.
• No refrigeration required.