Description

Dothiepin (Dosulepin) Hydrochloride Film-Coated Tablets (25 mg / 75 mg)

Healthy Inc is a specialized global supplier and exporter of advanced psychiatry, neuro-pharmacology, and targeted mood-stabilizing therapeutics. We provide ultra-high-purity, kinetically precise Dothiepin Hydrochloride Film-Coated Tablets (25 mg / 75 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Sedating Tricyclic Antidepressant (TCA)” is a massive-volume, highly lucrative export to psychiatric hospitals, behavioral health clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for major depressive disorder accompanied by severe anxiety, agitation, and chronic insomnia.

Product Overview

This highly advanced formulation operates as a multi-receptor neurological stabilizer. Unlike modern SSRIs that strictly target serotonin and often cause initial agitation, Dothiepin forcefully blocks the reuptake of multiple mood-elevating neurotransmitters while simultaneously dampening the central nervous system’s wakefulness and fear centers.

The “Monoamine Reuptake Inhibitor & Anxiolytic TCA” Specialist:

• Mechanism 1 (The Dual-Reuptake Blockade): Dothiepin violently inhibits the reuptake pumps for both Serotonin (5-HT) and Norepinephrine (NE) in the synaptic cleft. By trapping these neurotransmitters in the synapse, it forces continuous stimulation of the post-synaptic receptors, gradually down-regulating them over 2 to 4 weeks and fundamentally reversing the biochemical deficit driving severe clinical depression.
• Mechanism 2 (The H1 & Alpha-1 Sedation Shield): What separates Dothiepin from other antidepressants is its profound affinity for central Histamine (H1) and Alpha-1 adrenergic receptors. By blocking these receptors, it instantly shuts down hyperarousal. This provides a massive, immediate clinical benefit on Day 1: it chemically forces the severely anxious, panicking patient to sleep, bridging them safely until the core antidepressant effect builds up.
• Mechanism 3 (The Analgesic Synergy): Like other TCAs, Dothiepin is frequently utilized off-label to intercept and scramble pain signals in the spinal cord, making it highly effective for patients suffering from depression complicated by chronic, unexplained neuropathic pain or fibromyalgia.

Product Composition & Strength

We supply this product as a Precision-Blended, Heavy-Coated Macrodose Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure absolute chemical stability and patient safety.

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict, heavily monitored 30-day psychiatric dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Cardiotoxic Precision Blending (CRITICAL COMPLIANCE): The engineering challenge of Dothiepin defines its safety profile. Because TCAs are highly cardiotoxic in overdose, standard generic manufacturers who fail to properly blend the API risk creating “hot spots” within a batch. If a patient ingests a tablet with accidentally high levels of Dothiepin, it can trigger sudden ventricular arrhythmias. Our psychiatric suites utilize elite geometric dry-blending and intensive HPLC batch-testing to guarantee 100% Content Uniformity, ensuring absolute clinical predictability for the prescribing psychiatrist.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe mood and somatic disorders:

• Agitated Depression: Treatment of major depressive illness where prominent anxiety, tension, agitation, and severe insomnia are the primary presenting symptoms.
• Neuropathic Pain (Off-Label / Regional): Management of chronic, refractory nerve pain and fibromyalgia when first-line agents fail.

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist Guidelines):

• Standard Adult Dosing: Typically initiated at 25 mg to 75 mg daily, gradually increased to a maximum of 150 mg to 225 mg daily.
• The Nighttime Protocol (CRITICAL): The bulk of the daily dose (or the entire dose) MUST be given at night right before bedtime. Taking high doses of Dothiepin in the morning will cause severe daytime somnolence, heavy sedation, and total functional impairment.
• Tapering Rule: Abrupt discontinuation causes severe cholinergic rebound (nausea, vomiting, severe sweating). The drug must be tapered off slowly over several weeks.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• FATAL TOXICITY IN OVERDOSE (Cardiovascular Alert): Dothiepin is exceptionally lethal in overdose compared to modern SSRIs. It violently blocks sodium channels in the heart, leading to QRS complex widening, fatal ventricular arrhythmias, and cardiac arrest. Dispensing quantities must be strictly limited for patients with a high risk of suicide.
• BLACK BOX EQUIVALENT (Suicidal Ideation): Like all antidepressants, Dothiepin increases the risk of suicidal thinking and behavior in young adults (under 24) during the initial phases of treatment.
• Severe Anticholinergic Crisis: The drug causes profound anticholinergic side effects. It is strictly contraindicated in patients with closed-angle glaucoma (can trigger blindness) and severe benign prostatic hyperplasia (BPH) (can trigger acute urinary retention).
• Seizure Threshold Reduction: TCAs significantly lower the seizure threshold. It must be used with extreme caution in patients with a history of epilepsy.
• MAOI Interaction (FATAL): Absolutely contraindicated for use within 14 days of taking Monoamine Oxidase Inhibitors (MAOIs) due to the risk of fatal Serotonin Syndrome and hypertensive crisis.

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 Antidepressants, Tricyclic Formulations, and Content-Uniformity Assured CNS Therapeutics. Whether you are looking for a reliable Government Tender Supplier for mental health clinics in the CIS or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.