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Lithium

Lithiumchlorid Lidco · ATC code N05AN01

Also known as: Lityum (ilaç)

Key facts
Active substance
Lithium
Drug class
Lithium
ATC code
N05AN01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Boxed warning

Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration ( 2.3), Warnings and Precautions ( 5.1) ].

Key facts

Lithium is a mood-stabilizing agent indicated, per the US prescribing information (oral solution), as monotherapy for bipolar I disorder in patients 7 years and older.

What it is used for

  • Acute manic and mixed episodes of bipolar I disorder in patients 7 years and older
  • Maintenance treatment of bipolar I disorder in patients 7 years and older

Dosing

  • Before starting: evaluate renal function, vital signs, electrolytes and thyroid function
  • Adults and children over 30 kg: start 8 mEq (5 mL) three times daily, titrate by 8 mEq every 3 days
  • Acute goal serum level 0.8 mEq/L to 1.2 mEq/L; maintenance 0.8 mEq/L to 1 mEq/L
  • Serum level after 3 days, drawn 12 hours after the last dose, and regularly until stabilized
  • Children 20 kg to 30 kg: lower starting dose (table in full text)
  • Not recommended in severe renal impairment

Contraindications

  • Known hypersensitivity to any inactive ingredient in lithium citrate products

Important warnings

  • Boxed warning: lithium toxicity is closely related to serum concentrations and can occur near therapeutic levels; serum level testing must be available
  • Toxic concentrations (≥ 1.5 mEq/L) are close to the therapeutic range; symptoms range from tremor to seizure, coma and death
  • Polyuria, nephrogenic diabetes insipidus, hyponatremia, chronic kidney disease
  • Thyroid disorders, hypercalcemia, unmasking of Brugada syndrome, serotonin syndrome

Side effects

  • Early in treatment: fine hand tremor, polyuria, thirst, nausea, general discomfort
  • Others: hypo- or hyperthyroidism, hyperparathyroidism, pseudotumor cerebri, encephalopathic syndrome

Interactions

  • Diuretics, NSAIDs, renin-angiotensin system antagonists and nitroimidazole antibiotics raise lithium levels; monitor more often
  • Acetazolamide, urea, xanthine preparations and alkalinizing agents lower levels
  • Serotonergic drugs: risk of serotonin syndrome

Pregnancy and breastfeeding

  • May cause fetal harm; reports of cardiac malformations (e.g. Ebstein's anomaly) with first-trimester use
  • Present in human milk; signs of lithium toxicity possible in breastfed infants

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

Patient information (US) →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • Lithiumchlorid LidcoLidco Netherlands B.V. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • Kilonum RetardRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • LithurilKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
  • LitomaksFARMAKO ECZACILIK A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 10 more European countries
Croatia
Litijev Klorid Lidco
Czechia
Lithium Chlorid Lco
Denmark
Litarex, Litiumklorid Lidco
France
Lithioderm, Lithium Granions, Oligosol
Ireland
Lithium Chloride Lidco Netherlands
Italy
Resilient
Luxembourg
Oligosol
Norway
Lithium Chloride Lidco
Spain
Cloruro De Litio Lidco Netherlands
Sweden
Lithionit, Litiumklorid Lidco

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Lithium (Saptalis Pharmaceuticals, LLC) – Prescribing Information, 2025-08-20. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e95036c7-542a-437a-969b-f95f6f949f84
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC N05AN.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.