Description
Amitriptyline & Chlordiazepoxide Tablets (12.5 mg / 5 mg or 25 mg / 10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced CNS, psychiatry, and targeted neurological therapeutics. We provide ultra-high-purity, kinetically balanced Amitriptyline & Chlordiazepoxide FDC Tablets, manufactured in WHO–GMP certified, high-precision specialized CNS facilities. This “Tricyclic Antidepressant (TCA) & Benzodiazepine FDC” is a massive-volume strategic export to mental health hospitals, neurology clinics, and government health ministries, serving as the globally mandated intervention for Moderate-to-Severe Depression accompanied by significant Anxiety.
Product Overview
This formulation operates as a “Dual-Phase Neural Stabilizer.” It is engineered to lift the patient’s emotional state (Amitriptyline) while simultaneously “quieting” the overactive nervous system (Chlordiazepoxide) that causes physical agitation.
Mechanism 1 (The Mood Elevator – Amitriptyline): As a Tricyclic Antidepressant, Amitriptyline inhibits the reuptake of Serotonin and Norepinephrine at the synaptic cleft. This increases the concentration of these neurotransmitters in the brain, physically lifting the patient’s mood and relieving depressive symptoms.
Mechanism 2 (The Anxiety Brake – Chlordiazepoxide): As a Benzodiazepine, Chlordiazepoxide enhances the effect of GABA (Gamma-Aminobutyric Acid), the brain’s primary inhibitory chemical. By making the brain’s “brakes” more effective, it reduces the physical and mental symptoms of anxiety, tension, and apprehension.
Mechanism 3 (The Sleep-Regulating Synergy): Both components possess sedative properties. This combination is exceptionally effective for depressed patients suffering from Early-Morning Awakening (Insomnia), ensuring a restful sleep cycle which is critical for mental recovery.
Product Composition & Strength
We supply this product as a Precision-Blended, Film-Coated Tablet, packed in high-barrier Alu-Alu blister strips to ensure the stability of the benzodiazepine component.
| Active Ingredient | Strength | Primary Clinical Function |
| Amitriptyline (as HCl) USP/BP | 12.5 mg / 25 mg | The Antidepressant Anchor: Elevates mood and energy levels by modulating neurotransmitter reuptake. |
| Chlordiazepoxide USP/BP | 5 mg / 10 mg | The Anxiolytic Shield: Provides rapid relief from nervousness, agitation, and muscle tension. |
| Excipients | Proprietary Matrix | Bio-Synchronized System: Engineered to ensure the rapid onset of the anxiolytic effect while the antidepressant effect builds over time. |
Technical & Logistics Specifications
HS Code: 3004.90.79 (Other medicaments acting on the CNS – Psychotropics)
CAS Numbers: 549-18-8 (Amitriptyline HCl) / 58-25-3 (Chlordiazepoxide)
Dosage Form: Film-Coated Tablet
Packaging: Alu-Alu or Alu-PVC Blisters. Protects the API from light and environmental humidity; our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
API Purity Excellence: Our manufacturing process focuses on absolute chemical stability, ensuring the Chlordiazepoxide remains potent and free from degradation, providing the predictable sedation required for anxious patients.
Neuro-Grade Containment: We utilize Segregated CNS Production Blocks with advanced air filtration to ensure zero cross-contamination, meeting the strictest international regulatory standards for psychotropic medications.
Primary Indications
Psychiatry: Treatment of patients with Moderate-to-Severe Depression associated with moderate-to-severe Anxiety.
Psychosomatic Medicine: Management of Depression and Anxiety manifesting as physical symptoms (Gastrointestinal distress, Insomnia, Tension Headaches).
Geriatrics: Management of agitated depression in elderly patients (under careful specialist supervision).
Dosage & Administration
Standard Adult Dosing: Initially 1 tablet three or four times daily. Once a therapeutic response is achieved, the dose is typically reduced to the smallest amount necessary to maintain relief.
The “Bedtime” Strategy: If sedation is pronounced, a larger portion of the daily dose may be taken at bedtime to aid sleep and minimize daytime drowsiness.
Safety Warning: Dependence Potential. Chlordiazepoxide is a habit-forming benzodiazepine; use should be monitored to prevent addiction. Black Box Warning: Risk of profound sedation and respiratory depression if taken with opioids or alcohol. Avoid in patients with Glaucoma or Urinary Retention.
Global Export & Contract Manufacturing
Healthy Inc is a premier CNS Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-precision Psychotropic FDCs. Whether you are a Mental Health Hospital Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.
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