Lithium Carbonate Schedule (India)

Schedule H

Lithium Carbonate Routes

Oral

Lithium Carbonate Formulations

Formulation Type Available Strengths

Immediate-release tablets 300 mg, 400 mg

Controlled-release (CR) tablets 300 mg, 400 mg (brand-specific availability)

Note: Injectable formulations are NOT AVAILABLE in India.

Lithium Carbonate Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Bipolar Disorder — Acute Mania (Adults)

Parameter Recommendation

Starting dose 600–900 mg/day in 2–3 divided doses

Titration Increase by 300 mg every 3–5 days guided by serum lithium levels and tolerability

Usual maintenance dose 900–1200 mg/day in divided doses

Maximum dose 1800 mg/day (only with therapeutic drug monitoring)

Target serum lithium: 0.8–1.0 mmol/L (acute phase)

Clinical notes:

Antimanic effect may take 7–10 days to manifest

Consider short-term adjunctive antipsychotic or benzodiazepine for immediate symptom control

Always obtain serum lithium level 12 hours post-dose (trough level), 5–7 days after any dose change

Bipolar Disorder — Maintenance/Prophylaxis (Adults)

Parameter Recommendation

Starting dose Continue from acute phase dosing or initiate at 600 mg/day

Titration Adjust based on serum lithium levels

Usual maintenance dose 600–1200 mg/day in divided doses

Maximum dose 1800 mg/day (rarely required)

Target serum lithium: 0.6–0.8 mmol/L (maintenance)

Clinical notes:

Long-term therapy requires regular monitoring of renal and thyroid function

Controlled-release formulations may improve tolerability and adherence

Avoid abrupt discontinuation — risk of relapse or rebound mania

Augmentation in Treatment-Resistant Major Depressive Disorder (Adults)

Parameter Recommendation

Starting dose 300 mg once daily

Titration Increase by 300 mg every 5–7 days based on response and serum levels

Usual maintenance dose 600–900 mg/day

Maximum dose 1200 mg/day

Target serum lithium: 0.4–0.6 mmol/L (lower than for bipolar disorder)

Clinical notes:

Specialist-initiated therapy only

Used as augmentation to antidepressants in treatment-resistant depression

Response typically assessed over 4–6 weeks

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence

Schizoaffective disorder As per bipolar dosing; target serum level 0.6–1.0 mmol/L Long-term OFF-LABEL; Specialist only; used with antipsychotics Indian psychiatric centre protocols; case series

Cluster headache prophylaxis 600–900 mg/day in divided doses Specialist-guided duration OFF-LABEL; Specialist only International RCTs; limited Indian data

Lithium Carbonate Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Bipolar Disorder — Acute Mania and Maintenance (Age ≥12 years)

Body Weight Starting Dose Titration Target Serum Level Maximum Dose

20–30 kg 300 mg/day in divided doses Increase by 300 mg every 5–7 days 0.6–1.0 mmol/L 900 mg/day

30–50 kg 300 mg twice daily Increase by 300 mg every 5–7 days 0.6–1.0 mmol/L 1200 mg/day

50 kg 600 mg/day in divided doses (adult-like dosing) Increase by 300 mg every 5–7 days 0.6–1.0 mmol/L 1500 mg/day

Safety Monitoring in Paediatrics:

Serum lithium level (12-hour trough) — 5–7 days after each dose change

Renal function (creatinine, eGFR) at baseline and every 3–6 months

Thyroid function (TSH) at baseline and every 6 months

Weight and growth parameters at each visit

Monitor for signs of toxicity at each visit

Secondary Indications — Paediatric (Off-label)

Not applicable. No documented off-label paediatric indications in Indian sources.

Important statements:

Not recommended below 12 years of age except in exceptional circumstances under tertiary psychiatric care

Paediatric use requires child and adolescent psychiatrist supervision

Family counselling regarding signs of toxicity is mandatory

Lithium Carbonate Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation

60 No dose adjustment; monitor levels regularly

30–60 Specialist only; reduce starting dose by 25–50%; increase monitoring frequency to weekly initially

<30 Avoid use; consider only if no alternatives under very close specialist supervision

Haemodialysis Lithium is dialyzable; if used, administer dose post-dialysis; consult nephrologist

Critical considerations:

Lithium is almost exclusively renally excreted

Avoid dehydration — may precipitate toxicity

Any condition causing sodium/fluid loss (diarrhoea, vomiting, fever) increases toxicity risk

Exercise extreme caution with concomitant diuretics, ACE inhibitors, or ARBs

Lithium Carbonate Hepatic adjustment

Hepatic Impairment	Recommendation
Mild impairment	No dose adjustment required
Moderate impairment	No dose adjustment required
Severe impairment	No dose adjustment required

Note: Lithium is not hepatically metabolised — safe in hepatic impairment from a pharmacokinetic standpoint.

Lithium Carbonate Contraindications

Known hypersensitivity to lithium

Severe renal impairment (eGFR <30 mL/min) or renal failure

Significant dehydration or severe sodium depletion

Untreated Addison's disease

Brugada syndrome or significant cardiac conduction abnormalities

First trimester of pregnancy (teratogenicity risk — Ebstein's anomaly)

Concomitant use with thiazide diuretics without close monitoring capability

Lithium Carbonate Cautions

Narrow therapeutic index — requires meticulous serum level monitoring

Pre-existing thyroid disorders — lithium may cause or worsen hypothyroidism

Cardiovascular disease — ECG changes, risk of arrhythmias

Conditions causing fluid/electrolyte shifts (vomiting, diarrhoea, excessive sweating)

Concurrent nephrotoxic drugs or sodium-altering medications (NSAIDs, ACE inhibitors, ARBs, diuretics)

Psoriasis — may exacerbate

Myasthenia gravis

Elderly patients — increased sensitivity, reduced renal reserve

Surgery/anaesthesia — may need temporary dose reduction or cessation

Patients with cognitive impairment who may not report early toxicity symptoms

Lithium Carbonate Pregnancy

Parameter Recommendation

Overall safety Teratogenic risk — particularly first trimester; associated with Ebstein's anomaly (cardiac malformation)

Preferred alternative Antipsychotics (olanzapine, haloperidol) for acute mania; lamotrigine for maintenance if appropriate

When may be used Only if essential, no effective alternatives, and benefit clearly outweighs risk; shared decision with psychiatrist and obstetrician

What to monitor Fetal echocardiography in first trimester; maternal serum lithium levels throughout (increased renal clearance in pregnancy); growth scans; avoid near delivery due to rapid volume/clearance changes postpartum

Lithium Carbonate Lactation

Parameter Recommendation

Compatibility Not recommended — lithium passes into breast milk at significant levels

Preferred alternative Valproate (with caution), lamotrigine, or antipsychotics depending on clinical situation

Drug levels in milk High (30–50% of maternal serum level)

Infant monitoring If used despite recommendations: monitor infant serum lithium, TSH, renal function, hydration status, feeding adequacy

Note: Specialist-only decision if breastfeeding while on lithium is considered.

Lithium Carbonate Elderly

Parameter Recommendation

Starting dose 150–300 mg/day

Titration Very slow — every 1–2 weeks based on serum levels

Target serum level Lower end of therapeutic range (0.4–0.6 mmol/L for maintenance)

Special risks Reduced renal clearance — increased accumulation risk; increased neurotoxicity sensitivity; dehydration; falls; confusion; drug interactions with common medications (diuretics, antihypertensives)

Additional considerations More frequent monitoring of serum levels, renal function, and electrolytes; ensure adequate hydration; baseline ECG recommended

Lithium Carbonate Major drug interactions

Interacting Drug Effect / Risk Recommendation

Thiazide diuretics (hydrochlorothiazide, chlorthalidone) Increased lithium levels via enhanced renal reabsorption — high toxicity risk Avoid combination; if unavoidable, reduce lithium dose by 50% and monitor levels closely

ACE inhibitors (enalapril, ramipril, lisinopril) Reduced lithium clearance — increased levels and toxicity risk Avoid or monitor very closely; check lithium level within 5–7 days of initiation

ARBs (losartan, telmisartan) Similar mechanism to ACE inhibitors — increased lithium concentration Avoid or monitor closely; check levels frequently

NSAIDs (ibuprofen, diclofenac, naproxen) Reduced lithium clearance — may precipitate toxicity Avoid chronic NSAID use; short-term use requires close monitoring

Metronidazole Reduced lithium clearance Monitor lithium levels if combination necessary

Lithium Carbonate Moderate drug interactions

Interacting Drug Effect / Risk Recommendation

SSRIs (fluoxetine, sertraline) Possible serotonin toxicity; additive CNS effects Use with caution; monitor for serotonin syndrome symptoms

Antipsychotics (haloperidol, risperidone) Additive neurotoxicity (tremor, confusion, EPS) Monitor closely; reduce doses if neurotoxicity appears

Carbamazepine Additive neurotoxicity; risk of hyponatraemia Monitor sodium and neurological status

Topiramate Increased CNS side effects; rare encephalopathy Use with caution; monitor for confusion, cognitive effects

Loop diuretics (furosemide) Variable effect on lithium levels Monitor lithium levels; less risky than thiazides

Theophylline/aminophylline Increased lithium clearance — reduced efficacy May require increased lithium dose; monitor levels

Caffeine (high intake) Increased lithium clearance Counsel patient to maintain consistent caffeine intake

Sodium-containing antacids May lower lithium levels Monitor levels if significant antacid use

Lithium Carbonate Common Adverse effects

Fine postural tremor

Polyuria and polydipsia (nephrogenic diabetes insipidus)

Weight gain

Nausea, diarrhoea, abdominal discomfort

Dry mouth, metallic taste

Hypothyroidism (long-term use)

Oedema

Acneiform rash

Hair thinning

Cognitive dulling ("mental fog")

Lithium Carbonate Serious Adverse effects

Adverse Effect Notes

Lithium toxicity Coarse tremor, ataxia, dysarthria, confusion, seizures, coma — requires immediate discontinuation and hospitalisation

Nephrogenic diabetes insipidus May persist after discontinuation; monitor for polyuria

Chronic renal impairment / CKD Long-term use may cause interstitial nephritis; monitor renal function

Hypothyroidism / Goitre Common with prolonged use; may require thyroid supplementation

Cardiac arrhythmias T-wave flattening, sinus node dysfunction — especially in elderly or cardiac patients

Serotonin syndrome When combined with serotonergic drugs — agitation, hyperthermia, tremor

Ebstein's anomaly Fetal cardiac malformation if used in first trimester

All serious adverse effects require dose interruption or hospitalisation.

Lithium Carbonate Monitoring requirements

Timing	Parameters
Baseline	Serum creatinine, eGFR, electrolytes (especially sodium), TSH, T4, body weight, ECG (in elderly or cardiac history), pregnancy test in women of childbearing age
After initiation / dose change	Serum lithium level (12-hour trough) after 5–7 days; repeat until stable in therapeutic range

Target serum lithium levels Acute mania: 0.8–1.0 mmol/L; Maintenance: 0.6–0.8 mmol/L; Depression augmentation: 0.4–0.6 mmol/L

Long-term Serum lithium every 3 months (stable patients); renal function and electrolytes every 3–6 months; TSH every 6–12 months; body weight periodically; ECG annually in elderly

Additional monitoring triggers:

Any intercurrent illness with fluid loss

Addition or change of interacting medications

Signs/symptoms suggestive of toxicity

Lithium Carbonate Brands in India

Licab (Torrent)

Lithosun (Sun Pharma)

Intalith CR (Intas) — controlled-release

Licab CR (Torrent) — controlled-release

Eskalith (GSK — limited availability)

Lilithium (Mankind)

Multiple generic brands available

Note: Confirm whether immediate-release or controlled-release formulation — not interchangeable without dose adjustment.

Lithium Carbonate Price range (INR)

Formulation	Approximate Price (per tablet)
Lithium carbonate 300 mg tablet (IR)	₹1.00–3.00
Lithium carbonate 400 mg tablet (IR)	₹1.50–4.00
Lithium carbonate 300 mg CR tablet	₹2.00–5.00
Lithium carbonate 400 mg CR tablet	₹3.00–6.00

Notes:

Listed under NLEM 2022 — essential medicine; may be available through government supply

Private market prices vary by brand

CR formulations generally priced slightly higher

Lithium Carbonate Clinical pearls

Timing of serum lithium is critical: Always measure 12-hour trough level (12 hours post-dose); incorrect timing leads to misinterpretation

Recheck levels with any interacting drug: Any new medication affecting sodium balance or renal function (diuretics, ACE inhibitors, NSAIDs) mandates repeat lithium level within 5–7 days

Patient education is essential: Counsel patients and caregivers on early signs of toxicity (tremor, nausea, diarrhoea, confusion, unsteady gait) and importance of maintaining hydration

Avoid abrupt discontinuation: Taper gradually to prevent rebound mania or depressive relapse

Long-term monitoring is non-negotiable: Annual thyroid and renal function assessment is mandatory for all patients on chronic lithium therapy

Elderly require lower targets: Use lower serum lithium targets (0.4–0.6 mmol/L) and more frequent monitoring due to reduced renal reserve and increased sensitivity

IR vs CR formulations matter: Controlled-release formulations may reduce GI side effects and peak-related adverse effects but are not interchangeable without dose adjustment

Lithium Carbonate Tags

lithium; mood-stabiliser; bipolar-disorder; mania; nephrotoxic-risk; narrow-therapeutic-index; pregnancy-contraindicated; thyroid-monitoring; NLEM-India; psychiatry

Lithium Carbonate Version

RxIndia v1.0 — 29 Apr 2025

Lithium Carbonate Reference

CDSCO-approved prescribing information

Indian Pharmacopoeia

National Formulary of India (NFI)

NLEM 2022

API Textbook of Medicine

NIMHANS/AIIMS Psychiatry protocols

ICMR Guidelines for Bipolar Disorder

Goodman & Gilman's The Pharmacological Basis of Therapeutics

Harrison's Principles of Internal Medicine

WHO Essential Medicines List (supportive reference for paediatric use)

RxIndia

The Drug Registry

Lithium Carbonate