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Carbidopa with Levodopa Tablets

Carbidopa and Levodopa Tablets

Carbidopa and Levodopa Tablets IP
Each uncoated tablet contains :
Levodopa IP 100 mg
Carbidopa IP
As Anhydrous Carbidopa 10 mg

Combimet Tablets
Carbidopa and Levodopa Tablets IP
Each Uncoated tablet contains :
Carbidopa IP
Eq. To anhydrous Carbidopa 25 mg
Levodopa IP 250 mg

LEVODOPA AND CARBIDOPA TABLETS 100 +10 MG
Each filmcoated tablet contains: Levodopa BP 100 mg
– Carbidopa BP –
– As Anhydrous Carbidopa BP 10 mg
– Titanium dioxide –
– Excipients – QS

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Description

Carbidopa with Levodopa Tablets (10/100, 25/100, 25/250)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Carbidopa and Levodopa Tablets in India. This combination is the global “Gold Standard” treatment for Parkinson’s Disease. We produce both Immediate Release (IR) and Controlled Release (CR) formulations to help manage the complex “On-Off” motor fluctuations patients experience. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and neurology tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Carbidopa & Levodopa Tablets | | Generic Name | Co-Careldopa / Levodopa + Carbidopa | | Strength (Ratio) | 10mg/100mg | 25mg/100mg | 25mg/250mg | 50mg/200mg (CR) | | Dosage Form | Uncoated Tablet / Controlled Release (CR) Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Anti-Parkinson (Dopamine Precursor + Decarboxylase Inhibitor) | | Shelf Life | 36 Months | | Packaging | 10×10 Alu-Alu Blister / 100s HDPE Bottle |

3. Manufacturing Carbidopa & Levodopa Tablets We divide our operations to ensure specialized focus.

  • The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Levodopa is extremely sensitive to oxygen and moisture; degradation causes the tablets to develop black spots or darken. To prevent this, we manufacture in Low-Oxygen Environments and use high-grade antioxidants in the formulation. We also offer Functionally Scored Tablets (break-lines) that allow patients to fine-tune their dose (e.g., taking a half-tablet) to control dyskinesia or rigidity.

  • The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Carbidopa and Levodopa Tablets. We supply neurology clinics and geriatric care facilities globally. We understand the critical need for bioequivalence in Parkinson’s medications, where even slight variations in drug release can cause a patient to “freeze” (Off-period).

4. Quality Assurance We test every batch rigorously.

  • Dissolution Profiling: We strictly test the release rate. For Immediate Release, rapid dissolution is vital for morning “kick-in.” For Controlled Release, sustained dissolution is vital to prolong the “On” time.

  • Appearance Check: We inspect for any darkening or spotting, ensuring the Levodopa has not oxidized.

  • Assay: We confirm the precise ratio (e.g., 1:4 or 1:10) of Carbidopa to Levodopa to ensure peripheral protection is adequate.

5. Why Use Carbidopa & Levodopa Tablets? This drug replenishes the brain’s dopamine supply.

    • Levodopa: It crosses the Blood-Brain Barrier (BBB) and is converted into Dopamine, replacing what the Parkinson’s patient has lost.

    • Carbidopa: It cannot cross the BBB. It stays in the body and prevents Levodopa from being converted into dopamine before it reaches the brain. This reduces nausea and ensures more Levodopa gets to where it is needed.

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Key Indications:

  • Parkinson’s Disease: Idiopathic Parkinson’s (tremor, rigidity, bradykinesia).

  • Parkinsonism: Post-encephalitic parkinsonism and symptomatic parkinsonism (following carbon monoxide or manganese intoxication).

6. Export and Regulatory Support We provide complete documentation for registration.

  • Dossier: We offer CTD and ACTD formats.

  • Certificates: We supply the Free Sale Certificate (FSC) and COPP.

  • Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

  • Q: Who manufactures Carbidopa Levodopa Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

  • Q: Do you make the CR (Controlled Release) version? A: Yes, we manufacture CR tablets (often 50mg/200mg) to help reduce “wearing-off” effects at the end of a dose.

  • Q: Why are the tablets packed in Alu-Alu? A: Alu-Alu offers the highest protection against moisture and light, preventing the Levodopa from oxidizing and turning black.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Initiation: Usually started with 25/100mg three times daily.

  • Titration: Dosage is increased carefully by the physician until optimal motor control is achieved.

  • Administration: Best taken on an empty stomach (30 mins before or 1 hour after meals). High-protein meals can interfere with absorption.

9. Side Effects and Precautions

  • Dyskinesia: Involuntary movements (jerking/twisting) often occur at peak dose levels.

  • Nausea: Common initially, but reduced by the Carbidopa component.

  • Hallucinations: Can occur in elderly patients.

  • Dark Urine: Metabolites may cause urine, sweat, or saliva to turn dark red, brown, or black (harmless but alarming to patients).

10. Storage Instructions

  • Store below 25°C in a dry place.

  • Critical: Keep tightly closed. Levodopa degrades rapidly if exposed to air.

  • Keep out of reach of children.

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