Description
L-Ornithine L-Aspartate (LOLA) Film-Coated Tablets (150 mg / 250 mg / 500 mg)
Healthy Inc is a specialized global supplier and exporter of advanced hepatology, internal medicine, and critical metabolic-detoxification therapeutics. We provide ultra-high-purity, kinetically stabilized L-Ornithine L-Aspartate (LOLA) Film-Coated Tablets (150 mg / 250 mg / 500 mg), manufactured in WHO–GMP certified, high-capacity, moisture-controlled oral solid dosage facilities. This “Hepatic Ammonia Scavenger” is a massive-volume, highly critical export to hepatology centers, intensive care step-down units, addiction recovery networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for Hyperammonemia, Hepatic Encephalopathy, and severe Liver Cirrhosis.
Product Overview
This highly advanced formulation supplies the liver and skeletal muscles with massive doses of two critically depleted amino acids. It acts as a biochemical catalyst, instantly rebooting the body’s natural waste-disposal systems to flush lethal neurotoxins out of the bloodstream.
The “Urea Cycle Accelerator & Brain-Rescue” Specialist:
- Mechanism 1 (The Urea Cycle Overdrive – L-Ornithine): In a failing, cirrhotic liver, the urea cycle shuts down, allowing toxic ammonia (a byproduct of protein digestion) to accumulate. L-Ornithine acts as a direct, high-octane substrate for the urea cycle in the periportal hepatocytes. It forcefully restarts the enzymes required to convert highly toxic ammonia into harmless urea, which is then safely urinated out by the kidneys.
- Mechanism 2 (The Glutamine Synthesis Pathway – L-Aspartate): Because a diseased liver is often too damaged to clear all the ammonia, the body must rely on a backup system in the skeletal muscles. L-Aspartate is the essential fuel for glutamine synthetase. It massively upregulates the conversion of ammonia into non-toxic glutamine in both the perivenous hepatocytes and the patient’s muscle tissue, providing a crucial secondary detoxification pathway.
- Mechanism 3 (Hepatic Encephalopathy Reversal): High ammonia levels cross the blood-brain barrier, causing severe brain swelling, extreme confusion, flapping tremors (asterixis), and eventually, hepatic coma. By rapidly crashing systemic ammonia levels, oral LOLA therapy rescues the brain from toxic damage, restoring the patient’s cognitive function and preventing catastrophic ICU admissions.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical and physical stability of the highly hygroscopic amino acid salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| L-Ornithine L-Aspartate (LOLA) | 150 mg / 250 mg | Hepatology Maintenance Standard: Base therapeutic units for long-term chronic management of severe Non-Alcoholic Fatty Liver Disease (NAFLD), alcoholic hepatitis, and mild hyperammonemia. |
| L-Ornithine L-Aspartate (LOLA) | 500 mg | Acute Detoxification Standard: High-efficacy adult therapy utilized for immediate ammonia reduction and the step-down management of Hepatic Encephalopathy following hospital discharge. |
| Excipients | Microcrystalline Cellulose / Crospovidone / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Opadry Moisture-Barrier Film | Diluent / Superdisintegrant / Glidant / Film-Coating (Engineered specifically to lock out atmospheric moisture, preventing the heavy 500mg amino acid tablet from swelling, cracking, or prematurely degrading before it reaches the patient’s stomach) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, high-volume chronic hepatology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Hepatology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Hepatology/Detoxifiers) |
| CAS Number | 3230-94-2 (L-Ornithine L-Aspartate) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates, ensuring absolute tablet integrity. |
| Storage | Store strictly below 25°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.
- Hygroscopic Amino Acid Stabilization & High-Dose Compression (CRITICAL COMPLIANCE): L-Ornithine L-Aspartate is an intensely hydrophilic (water-loving) compound. In standard manufacturing environments, the powder absorbs ambient moisture, turning into an un-pressable paste or causing compressed tablets to violently expand and shatter the blister packs. Our specialized hepatology suites utilize strict climate control (Relative Humidity < 30%), advanced dry-granulation processing, and immediate heavy-gauge film-coating. This guarantees a structurally flawless, rock-solid tablet that delivers 100% of its ammonia-clearing payload upon ingestion.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of severe hepatic dysfunction and metabolic toxicity:
- Hepatic Encephalopathy (HE): The definitive oral step-down therapy for reversing confusion, altered mental status, and asterixis caused by liver failure.
- Hyperammonemia: Rapid clearance of elevated blood ammonia levels associated with acute or chronic liver disease.
- Liver Cirrhosis & Severe Hepatitis: Adjuvant therapy to support liver cell regeneration and reduce the toxic burden on surviving hepatocytes in alcoholic and non-alcoholic fatty liver disease (NAFLD/NASH).
Dosage & Administration
Recommended Dosage (Strictly as per Hepatologist Guidelines):
- Standard Adult Dosing: 1 to 2 tablets (of the 500mg strength) taken orally up to 3 times a day, depending on the severity of the hyperammonemia.
- Administration (The Mealtime Rule): MUST be taken after meals with a full glass of water. Taking massive doses of concentrated amino acids on an empty stomach can trigger severe, treatment-limiting nausea and vomiting.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Severe Renal Impairment (The Urea Paradox): FATAL WARNING: The entire mechanism of LOLA is to convert ammonia into urea. If a patient has severe renal failure (eGFR < 30 mL/min), their kidneys cannot excrete this sudden, massive surge of urea. This will lead to catastrophic uremic poisoning. LOLA is strictly contraindicated in severe renal impairment; BUN and Creatinine must be monitored.
- Gastrointestinal Upset: Nausea, vomiting, and transient diarrhea are the most common side effects, usually mitigated by taking the drug with a heavy meal.
- Not a Monotherapy for Acute Coma: While oral LOLA is excellent for maintenance and mild-to-moderate Hepatic Encephalopathy, patients presenting in an active hepatic coma require immediate IV LOLA infusions and intensive care.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Hepatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Hepatic Detoxifiers, Amino Acid Formulations, and High-Dose Compression Tablets. Whether you are looking for a reliable Government Tender Supplier for liver disease clinics in the CIS 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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