Lithium Carbonate Tablets

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Description

Lithium Carbonate Immediate & Extended-Release Tablets (300 mg / 400 mg / 450 mg)

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, neuroprotective, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically precise Lithium Carbonate Immediate-Release and Extended-Release (ER/SR) Film-Coated Tablets (300 mg / 400 mg / 450 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Primary Mood Stabilizer” is a massive-volume, highly critical export to psychiatric hospitals, mental health networks, outpatient behavioral clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for acute manic episodes and the long-term maintenance of Bipolar I Disorder.


Product Overview

This highly advanced formulation utilizes the lightest solid element on earth to fundamentally alter the electrochemical environment of the human brain. By stabilizing hyperactive neural pathways, it acts as a massive “grounding wire” for patients suffering from extreme, destructive manic highs and devastating depressive crashes.

The “Neurochemical Grounding & Inositol Depletion” Specialist:

  • Mechanism 1 (The Cation Substitution): Lithium is an elemental cation (Li+) that mimics sodium (Na+) and potassium (K+) in the body. It aggressively infiltrates nerve and muscle cells, altering the cellular transport of these vital electrolytes. By subtly changing the electrical charge across the neuron’s membrane, it prevents the rapid, chaotic firing of brain cells that characterizes a manic episode.
  • Mechanism 2 (The Inositol Depletion Hypothesis): Inside the brain, manic episodes are driven by an overactive secondary messenger system (the phosphatidylinositol cascade). Lithium violently inhibits the enzyme inositol monophosphatase (IMPase). This completely depletes the brain’s supply of free inositol, effectively cutting the internal communication wires that allow manic signaling to cascade out of control.
  • Mechanism 3 (The Neuroprotective Shield): Beyond just stabilizing mood, long-term Lithium therapy is profoundly neuroprotective. It inhibits the destructive enzyme GSK-3β and actively increases the production of BDNF (Brain-Derived Neurotrophic Factor). This physically protects brain volume and dramatically reduces the risk of suicide in severely bipolar patients—a clinical benefit unmatched by newer antipsychotics.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute physical stability of the controlled-release polymers.

Active IngredientStrengthPrimary Clinical Function
Lithium Carbonate USP/Ph.Eur.300 mg (IR)Acute Mania Standard: Immediate-release base unit used for the rapid, aggressive titration of serum lithium levels during an active, severe manic episode.
Lithium Carbonate USP/Ph.Eur.400 mg / 450 mg (ER/SR)Global Maintenance Standard: Extended-release therapy designed to flatten the pharmacokinetic curve, preventing toxic blood spikes and minimizing severe hand tremors and nausea during lifelong maintenance therapy.
ExcipientsHypromellose (HPMC) / Microcrystalline Cellulose / Sodium Starch Glycolate / Magnesium Stearate / Premium Opadry FilmHydrophilic ER Polymer / Diluent / Disintegrant / Lubricant (Engineered specifically using high-shear wet granulation to form a highly reliable, slow-eroding matrix that trickles the elemental lithium into the bloodstream over 12 hours)

*Pack Sizes: Bottles of 100 or 10×10 Blisters (Optimized specifically for strict, massive-volume lifelong psychiatric dispensing regimens).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Psychiatric Distributors, and Hospital Procurement Boards.

HS Code3004.90.99 (Medicaments containing other active substances – Psychiatry/Mood Stabilizers)
CAS Number554-13-2 (Lithium Carbonate)
Dosage FormImmediate-Release (IR) / Extended-Release Film-Coated Tablet (ER / SR)
PackagingHigh-Density Alu-PVC or Alu-Alu Blisters. Protects the delicate HPMC extended-release matrix from environmental humidity, preventing premature cross-linking or fatal dose-dumping across Zone IVb tropical climates.
StorageStore strictly below 30°C in a dry place. Protect heavily from Moisture.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • Narrow Therapeutic Index (NTI) Matrix Engineering (CRITICAL COMPLIANCE): Lithium is one of the most dangerous, highly monitored drugs on the market. If a generic tablet fails to release consistently, the patient’s blood serum levels will cross the 1.5 mEq/L threshold, resulting in toxic seizures and permanent kidney damage. Our facilities utilize elite fluid-bed granulation and strict multi-stage geometric dilution to ensure flawless Content Uniformity. Furthermore, our Extended-Release (ER) matrix guarantees a smooth, predictable pharmacokinetic profile, preventing the sharp “Cmax spikes” that cause severe nausea and non-compliance.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe psychiatric disorders:

  • Bipolar I Disorder (Acute Mania): Rapid reduction of hyperactivity, grandiosity, extreme agitation, and reduced need for sleep during active manic episodes.
  • Bipolar I Disorder (Maintenance): Lifelong therapy to prevent or drastically reduce the frequency and intensity of subsequent manic and depressive episodes.
  • Major Depressive Disorder (Off-Label): Used as a highly effective augmentation strategy for patients suffering from severe, treatment-resistant unipolar depression.

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist Guidelines):

  • Acute Mania: Typically 1800 mg/day in divided doses (IR) or twice daily (ER) to achieve rapid serum levels between 1.0 and 1.5 mEq/L.
  • Long-Term Maintenance: Typically 900 mg to 1200 mg/day to maintain strict serum levels between 0.6 and 1.2 mEq/L.
  • Administration (THE INTACT RULE for ER): Extended-Release tablets MUST be swallowed completely whole with water. They must never be crushed or chewed, as destroying the ER matrix will cause an immediate, fatal spike in blood plasma levels (dose-dumping).

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • BLACK BOX WARNING (Lithium Toxicity): Toxicity is closely related to serum lithium levels and can occur at doses close to therapeutic levels (above 1.5 mEq/L). Symptoms include severe diarrhea, vomiting, severe hand tremors, ataxia, blurred vision, seizures, and cardiovascular collapse. Strict, regular blood monitoring is absolutely mandatory.
  • The Sodium & Dehydration Paradox: Lithium and Sodium compete for excretion in the kidneys. If a patient becomes dehydrated or goes on a low-sodium diet, the kidneys will aggressively hoard Lithium, rapidly triggering fatal toxicity. Patients must maintain a normal diet with adequate salt and high water intake.
  • Renal & Thyroid Destruction: Chronic Lithium therapy can cause severe, irreversible kidney damage (nephrogenic diabetes insipidus) and completely shut down the thyroid gland (hypothyroidism). Renal and thyroid panels must be monitored every 6 to 12 months.
  • Diuretic & NSAID Interaction: Concomitant use with NSAIDs (like Ibuprofen) or Thiazide Diuretics violently decreases renal clearance of Lithium, causing an immediate toxic spike.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Psychiatry Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced CNS, NTI (Narrow Therapeutic Index), and Extended-Release Formulations. Whether you are looking for a reliable Government Tender Supplier for mental health hospitals in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.

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