Intalith CR 450 Mg Tablets

Description

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Intalith CR 450 Mg Tablets

Intalith CR 450 Mg Tablets contain lithium carbonate 450 mg in a controlled-release (CR) formulation. Lithium is a mood stabiliser with established efficacy in the treatment and prevention of manic and depressive episodes in bipolar disorder. The controlled-release formulation reduces peak plasma lithium concentrations, which may lower the risk of side effects compared with immediate-release lithium and supports twice-daily dosing.

Composition

About the Manufacturer

Intalith CR is manufactured by Intas Pharmaceuticals Limited, a leading Indian pharmaceutical company headquartered in Ahmedabad. Intas has a broad psychiatry and specialty medicines portfolio and distributes products to regulated and emerging markets worldwide.

Mechanism of Action

The precise mechanism of lithium’s mood-stabilising effect is not fully understood. Lithium is thought to modulate intracellular signal transduction pathways, including inhibition of inositol monophosphatase (which affects phosphatidylinositol signalling) and inhibition of glycogen synthase kinase-3 (GSK-3). It also influences serotonin and noradrenaline neurotransmission, reduces neuronal excitability, and may exert neuroprotective effects. These combined actions are believed to underlie its ability to blunt both manic and depressive episodes.

Indications

• Treatment of acute manic episodes in bipolar disorder
• Prevention (prophylaxis) of recurrent manic, depressive, and mixed episodes in bipolar disorder
• Augmentation of antidepressants in treatment-resistant unipolar depression (specialist use)

Dosage & Administration

• Swallow tablets whole; do not crush, chew, or split
• Doses are individually adjusted based on serum lithium levels; do not adjust dose without medical guidance
• Acute mania: Typical doses range from 900–1800 mg daily in divided doses
• Maintenance: 450–900 mg twice daily, adjusted to maintain serum lithium within the target therapeutic range (usually 0.6–1.0 mEq/L for maintenance; 0.8–1.2 mEq/L for acute mania)
• Serum lithium should be checked 12 hours after the last dose, 5–7 days after any dose change, and at least every 3–6 months when stable
• Ensure adequate fluid and salt intake; reduced sodium or fluid intake increases lithium retention and toxicity risk

Special Populations

• Renal impairment: Lithium is entirely excreted by the kidneys; use with extreme caution; dose reduction and more frequent monitoring are essential
• Elderly: More susceptible to toxicity; start at lower doses and monitor more frequently
• Children <12 years: Not recommended
• Pregnancy: Associated with teratogenicity (Ebstein’s anomaly); use only if clearly essential; specialist monitoring required
• Breastfeeding: Lithium passes into breast milk; breastfeeding is generally not recommended during lithium therapy

Precautions

• Narrow therapeutic index: Lithium toxicity can occur at plasma levels only slightly above the therapeutic range; regular serum level monitoring is mandatory
• Signs of lithium toxicity include coarse tremor, nausea, vomiting, diarrhoea, confusion, drowsiness, ataxia, seizures; seek immediate medical attention if these occur
• Dehydration, sodium-restricted diets, fever, and concurrent NSAID or diuretic use all increase lithium levels; caution required
• Renal and thyroid function should be checked before starting and monitored regularly (every 6 months) during treatment
• Cardiac monitoring may be required in patients with pre-existing heart disease

Contraindications

• Hypersensitivity to lithium or any excipient
• Severe renal impairment
• Addison’s disease (insufficient adrenal function affects sodium balance)
• Brugada syndrome
• Dehydration or significant sodium depletion
• First trimester of pregnancy (relative — risk of Ebstein’s anomaly)

Side Effects

• Common: Fine hand tremor, polyuria, polydipsia, weight gain, nausea, diarrhoea, mild cognitive dulling
• Long-term: Hypothyroidism, nephrogenic diabetes insipidus, renal impairment, hyperparathyroidism
• Toxicity signs (require immediate attention): Coarse tremor, ataxia, confusion, slurred speech, seizures, cardiac arrhythmia

Drug Interactions

• NSAIDs (ibuprofen, naproxen): Reduce renal lithium clearance, increasing plasma levels and toxicity risk; avoid if possible
• Thiazide and loop diuretics: Increase lithium retention; use with caution with close level monitoring
• ACE inhibitors and ARBs: Reduce renal lithium excretion; monitor levels closely
• Antipsychotics (haloperidol, risperidone): Combined use may increase neurotoxicity risk; monitor carefully
• SSRIs: Risk of serotonin syndrome; monitor for agitation, confusion, hyperthermia
• Metronidazole, tetracyclines: May increase lithium levels

Storage

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.

Related Products

• Zeptol CR 400 Mg Tablets – carbamazepine for bipolar disorder and epilepsy
• Zeptol CR 200 Mg Tablets – lower-dose carbamazepine for mood stabilisation
• Admenta 10 Mg Tablets – memantine for cognitive and neurological conditions

Frequently Asked Questions

What is Intalith CR 450 Mg used for?

Intalith CR 450 Mg is a mood stabiliser used to treat and prevent recurrent episodes of mania and depression in bipolar disorder. It may also be used by specialists to enhance antidepressant treatment in resistant depression.

What does CR mean in Intalith CR?

CR stands for Controlled Release. The tablet releases lithium gradually rather than all at once, reducing peak plasma levels that can cause side effects such as nausea and tremor, while maintaining therapeutic levels over a longer period.

Why are blood tests needed during lithium treatment?

Lithium has a narrow therapeutic index, meaning the difference between an effective level and a toxic level is small. Regular blood tests are essential to ensure levels remain within the safe therapeutic range (0.6–1.0 mEq/L for maintenance). Tests should also monitor kidney and thyroid function, which lithium can affect over time.

What are the signs of lithium toxicity?

Early signs include coarse tremor, nausea, vomiting, and diarrhoea. More severe toxicity causes confusion, drowsiness, unsteady gait, slurred speech, and in extreme cases, seizures or cardiac arrhythmia. If you notice any of these, seek immediate medical attention and do not take the next dose.

Can I take pain relief medicines while on lithium?

NSAIDs such as ibuprofen and naproxen (available over the counter) can significantly increase lithium levels and cause toxicity. Paracetamol (acetaminophen) is a safer alternative for pain relief. Always inform your pharmacist that you are on lithium before taking any new medication.

References

1. NHS – Lithium
2. MedlinePlus – Lithium
3. FDA – Lithium Carbonate Prescribing Information
4. EMA – Lithium Carbonate Assessment

Disclaimer: This page is for informational purposes only and does not constitute medical advice. Lithium treatment must be initiated and monitored by a qualified psychiatrist or physician. Regular blood level monitoring is mandatory. If you experience signs of lithium toxicity, seek emergency medical care immediately.

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