Schedule H

Oral, Intravenous

• Tablets: 400 mg, 800 mg, 1200 mg

• Syrup: 500 mg/5 mL

• Injection: 200 mg/mL (15 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Myoclonus of Cortical Origin (Progressive Myoclonic Epilepsy)

Parameter Recommendation

Starting dose 7.2 g/day orally in 2–3 divided doses

Titration Increase by 4.8 g/day every 3–4 days based on clinical response

Usual maintenance dose 16.8 g/day in 2–3 divided doses

Maximum dose 24 g/day

Key Clinical Notes:

• Typically combined with clonazepam or valproate for optimal seizure/myoclonus control

• Clinical response may take several weeks to manifest

• Do not abruptly discontinue — gradual tapering required to prevent withdrawal myoclonus

1. Cognitive Impairment / Dementia (Approved in India; Limited Evidence)

Parameter Recommendation

Starting dose 2.4 g/day orally in divided doses (e.g., 800 mg TID)

Titration May increase to 4.8 g/day based on tolerance

Usual maintenance dose 2.4–4.8 g/day

Maximum dose 4.8 g/day

Key Clinical Notes:

• Evidence of clinical benefit is limited and inconsistent

• Use should be restricted to short-term under specialist judgment

• Periodic reassessment required; avoid prolonged use beyond 6 months without documented benefit

Secondary Indications – Adults (Off-label, if any)

1. Acute Stroke Recovery (Adjunctive Therapy)

Parameter Recommendation

Indication Adjunctive cognitive/motor recovery post-ischemic stroke

Dose 4.8–12 g/day orally or IV in divided doses

Duration Up to 8 weeks post-stroke

Status OFF-LABEL

Supervision Specialist only (Neurology)

Evidence basis Limited small trials; used in Indian neurology practice empirically

1. Sickle Cell Disease (Vaso-occlusive Crisis Prophylaxis)

Parameter Recommendation

Indication Adjunct during vaso-occlusive crisis phase

Dose 160 mg/kg/day in 3 divided doses

Duration Short-term during crisis episodes

Status OFF-LABEL

Supervision Specialist only (Haematology)

Evidence basis Limited trial data; occasional use in Indian practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Cognitive Impairment Secondary to Perinatal Brain Injury

Parameter Recommendation

Minimum age ≥3 years only

Starting dose 30 mg/kg/day orally in 2–3 divided doses

Titration Increase gradually to 50 mg/kg/day based on response and tolerance

Usual maintenance dose 50 mg/kg/day in 2–3 divided doses

Maximum dose 3 g/day

Safety Monitoring:

• Monitor behavioural response, appetite, sleep pattern

• Assess for irritability or hyperactivity

• Periodic neurodevelopmental assessment

Secondary Indications – Paediatric Doses (Off-label, if any)

1. Learning Disabilities / ADHD (Adjunctive Therapy)

Parameter Recommendation

Indication Adjunct to structured academic and behavioural support

Dose 30–50 mg/kg/day in divided doses

Duration Short-term (up to 3 months); reassess benefit periodically

Status OFF-LABEL

Supervision Specialist only (Developmental Paediatrics / Paediatric Neurology)

Evidence basis Minimal RCT evidence; considered low-risk adjunct in selected cases

Important:

• Not recommended below 3 years of age except under paediatric neurology supervision

• Monitor for irritability, hyperactivity, sleep disturbance, appetite changes

Piracetam is primarily excreted unchanged by the kidneys. Dose reduction is mandatory in renal impairment:

80 No adjustment required

50–79 75% of standard dose

30–49 50% of standard dose

15–29 25% of standard dose

<15 or ESRD Avoid use; if essential, use 25% dose with specialist supervision

Dialysis Partially cleared; supplemental dose after haemodialysis may be considered

• Severe renal impairment (eGFR <15 mL/min/1.73m²)

• Hypersensitivity to piracetam or other pyrrolidone derivatives

• Acute cerebral haemorrhage (IV formulation contraindicated)

• Huntington's disease

• Chronic kidney disease — mandatory dose adjustment; monitor for accumulation

• History of epilepsy — may lower seizure threshold at very high doses; use with established antiepileptic therapy

• Bleeding disorders or concurrent anticoagulant therapy — theoretical interference with platelet aggregation

• Psychiatric illness — may exacerbate agitation, anxiety, or insomnia

• Major surgery scheduled — consider stopping 5–7 days prior due to potential bleeding risk

• Impaired hepatic function with concurrent renal impairment

Parameter Recommendation

Risk category Limited human data; not recommended unless benefit clearly outweighs risk

Preferred alternatives No proven alternatives for cognition; avoid unless indicated for myoclonus

When may be used Cortical myoclonus refractory to other agents — under neurology supervision only

Monitoring Fetal growth monitoring; CNS assessment at birth (limited data on teratogenicity)

Parameter Recommendation

Compatibility Not well studied; generally avoided during breastfeeding

Preferred alternatives None validated for nootropic indications

Expected milk levels Low levels reported in limited data

Infant monitoring Observe for irritability, feeding difficulties, excessive sedation

Parameter Recommendation

Starting dose 1.2 g/day in divided doses

Titration Slower titration recommended; increase at weekly intervals if tolerated

Extra risks Higher sensitivity to CNS effects (confusion, agitation, insomnia); falls risk increased

Renal consideration Age-related decline in eGFR — always assess renal function and adjust dose accordingly

Interacting Drug Effect Recommendation

Acenocoumarol / Warfarin Theoretical enhancement of bleeding risk due to platelet aggregation interference Monitor INR closely; use with caution

Thyroid hormones (high doses) May unmask or worsen anxiety, tremor, irritability Monitor clinical response; reduce piracetam if CNS excitation occurs

Interacting Drug Effect Recommendation

Antiepileptics (valproate, phenytoin, levetiracetam) No significant pharmacokinetic interaction; may alter seizure control balance Monitor seizure frequency; adjust antiepileptic doses if needed

CNS stimulants (methylphenidate, modafinil) Additive excitability, sleep disturbance Monitor sleep and behaviour; consider dose timing adjustment

Alcohol May potentiate CNS effects Advise moderation

• Nervousness, agitation

• Hyperkinesia

• Weight gain

• Somnolence or insomnia (dose and timing dependent)

• Headache

• Dizziness

• Nausea, diarrhoea, abdominal discomfort

• Asthenia

Adverse Effect Clinical Action

Extrapyramidal symptoms (rare, elderly) Discontinue; evaluate for alternative causes

Worsening of seizures (at high doses in epileptic patients) Reduce dose or discontinue; review antiepileptic regimen

Haemorrhagic events (rare, high-dose IV use) Stop drug; supportive management

Severe allergic reactions (angioedema, anaphylaxis — rare) Immediate discontinuation; emergency management

Baseline:

• Renal function (serum creatinine, eGFR)

• Neurological status and cognitive baseline (MMSE or equivalent)

• Bleeding history if anticoagulant use planned

After Initiation / Dose Change:

• Blood pressure monitoring

• Cognitive assessment (structured tool)

• Sleep pattern and behavioural changes

• Weight monitoring

Long-term:

• Renal function every 3–6 months if chronic use

• Periodic reassessment of clinical benefit (especially in dementia indication)

• Monitor for emergence of psychiatric symptoms

• Nootropil (UCB)

• Pirament (Sun Pharma)

• Memoril (Cipla)

• Neurocetam (Intas)

• Cerecetam (Torrent)

Note: FDCs with multivitamins/ginkgo exist but are not recommended for specialist neurological indications.

• Not included in NLEM — not under NPPA price control

• Wide price variation across brands

• Government supply availability limited

• Cortical myoclonus remains the only well-established indication with consistent benefit — start at high doses (7.2 g/day) and titrate aggressively

• Commonly overprescribed for dementia and stroke recovery without clear evidence — restrict use to defined, time-limited cases

• Monitor renal function in all elderly patients; risk of drug accumulation with subclinical CKD

• Evening doses may worsen insomnia — shift dosing to morning and early afternoon if sleep disturbance occurs

• IV formulation reserved for inpatient neurology use (e.g., acute myoclonus, post-stroke loading); not for routine outpatient care

• Gradual tapering required before discontinuation in myoclonus — abrupt withdrawal may precipitate rebound symptoms

piracetam; nootropic; myoclonus; dementia; cognitive enhancer; neurology; renal-adjustment; elderly; pregnancy-caution; Schedule H

RxIndia v1.0 — 22 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• AIIMS Neurology Treatment Protocols

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• NLEM 2022 (for price control status verification)

• Selected RCTs and Indian clinical experience (for OFF-LABEL sections)