Description
Amitriptyline Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of versatile Tricyclic Antidepressants (TCAs). We provide high-purity Amitriptyline Hydrochloride Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Multi-Modal” therapeutic agent is a top export to pain management clinics, psychiatric wards, and neurology departments in Africa, LATAM, and Southeast Asia, serving as a cost-effective solution for depression, neuropathic pain, and migraine prophylaxis.
[Image of Amitriptyline mechanism of action reuptake inhibition of serotonin and norepinephrine]
Product Overview
This formulation contains Amitriptyline Hydrochloride, a dibenzocycloheptene-derivative tricyclic antidepressant.
The “Mood & Pain” Specialist:
- Dual Reuptake Inhibition: It works by blocking the reuptake of both Serotonin and Norepinephrine at the nerve synapse, increasing their availability in the brain. This elevates mood and modifies the way the body perceives pain.
- Neuropathic Pain Control: While originally an antidepressant, it is now the “Gold Standard” first-line treatment for neuropathic pain (nerve pain), including diabetic neuropathy and post-herpetic neuralgia, often effective at much lower doses than required for depression.
- Migraine Prophylaxis: Highly effective in preventing the frequency and severity of migraine attacks when taken daily.
- Sedative Effect: Has strong antihistaminic properties, causing sedation. This makes it ideal for patients suffering from depression or pain accompanied by insomnia.
Product Composition & Strength
We supply this product as Film Coated Tablets (often Blue, Yellow, or Orange depending on strength) to mask the intensely bitter taste of the API.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Amitriptyline HCl IP/BP/USP | 10 mg | Neuropathic Pain / Migraine / Sleep |
| Amitriptyline HCl IP/BP/USP | 25 mg | Pain / Depression Initiation |
| Amitriptyline HCl IP/BP/USP | 50 mg | Major Depression (Maintenance) |
| Amitriptyline HCl IP/BP/USP | 75 mg | High Potency / Severe Depression |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 14s, or Bulk Jars of 500s/1000s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Film Coated Tablet (Oral) |
| Packaging | PVC-Alu Blister (Standard) or Alu-Alu |
| Storage | Store below 30°C. Protect from light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Content Uniformity: Low-dose Amitriptyline (10mg) requires precise blending validation to ensure every tablet has the exact dosage, which is critical for pain management where titration is sensitive.
- Coating Integrity: Amitriptyline has a local anesthetic effect on the tongue (numbing) and a bitter taste. Our film coating is robust to prevent premature dissolution in the mouth.
Therapeutic Indications (Human Use)
Indicated for the management of:
- Major Depressive Disorder: Especially when sedation is required.
- Neuropathic Pain: Peripheral neuropathy, post-herpetic neuralgia, and fibromyalgia.
- Prophylaxis of Migraine: Prevention of recurrent tension-type headaches and migraines.
- Nocturnal Enuresis: Treatment of bedwetting in children aged 6 years and older (used cautiously when organic pathology is excluded).
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Oral.
- Pain/Migraine (Adults): Start low with 10 mg to 25 mg at bedtime. Titrate slowly to 50–75 mg if needed.
- Depression (Adults): Initially 25 mg two to four times daily, or 50 mg to 100 mg at bedtime.
- Timing: Due to significant drowsiness, the entire daily dose is often administered at bedtime.
Safety Warnings:
- Anticholinergic Effects: Common side effects include dry mouth, blurred vision, constipation, and urinary retention.
- Cardiac Toxicity: High doses can cause arrhythmias and QT prolongation. **Contraindicated** in the acute recovery phase following a Heart Attack (MI).
- Suicide Risk: Antidepressants may increase the risk of suicidal thinking in young adults during the initial stages of treatment. Close monitoring is required.
- Withdrawal: Do not stop abruptly; taper over several weeks to avoid “cholinergic rebound” (nausea, headache, malaise).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
