Description
Escitalopram Oxalate & Clonazepam Film-Coated Tablets (10 mg / 0.5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced psychiatry, neuro-pharmacology, and rapid-onset anxiolytic therapeutics. We provide ultra-high-purity, kinetically synchronized Escitalopram Oxalate & Clonazepam Film-Coated Tablets (10 mg / 0.5 mg), manufactured in WHO–GMP certified, high-precision micro-dosing oral solid dosage facilities. This “SSRI & Benzodiazepine Bridging FDC” is a massive-volume, highly lucrative export to psychiatric hospitals, acute panic disorder clinics, and government health ministries in approved regions across LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for severe Generalized Anxiety Disorder (GAD), acute panic attacks, and severe co-morbid depression with insomnia.
Product Overview
This highly advanced formulation operates as a perfectly timed, dual-phase neurological rescue protocol. It instantly terminates acute panic symptoms using a powerful central nervous system depressant, while simultaneously rewiring the brain’s baseline serotonin levels to provide a permanent, long-term cure for the underlying neurosis.
The “GABA-A Allosteric Modulator & Pure Serotonin Anchor” Specialist:
- Mechanism 1 (The Instant Panic Halt – Clonazepam): Clonazepam is a highly potent, long-acting benzodiazepine. It aggressively binds to the allosteric site on the GABA-A receptor. This massively amplifies the efficiency of GABA, forcing chloride ions into the neurons and causing hyperpolarization. The hyperactive neurons driving the panic attack physically cannot fire, instantly shutting down the cascading electrical storm and providing profound, immediate anxiety relief on Day 1.
- Mechanism 2 (The Long-Term Neuro-Rewiring – Escitalopram): Escitalopram is the most highly selective Serotonin Reuptake Inhibitor (SSRI) in existence. It violently binds to the Serotonin Transporter (SERT) on the presynaptic neuron, locking Serotonin in the synaptic cleft. Over 3 to 6 weeks, this sustained serotonin bath forces the brain’s receptors to down-regulate and physically rewire the neural pathways driving the baseline depressive and anxious states.
- The “Bridging” Synergy: SSRIs frequently cause “Activation Syndrome” during the first week of therapy, where the patient’s anxiety and insomnia actually get worse before getting better. This causes massive treatment abandonment. The Clonazepam in this FDC acts as a chemical shield, completely blocking this activation syndrome, forcing the patient to sleep, and ensuring they remain compliant until the Escitalopram takes full effect.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Microdose FDC Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of both active pharmaceutical ingredients.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Escitalopram (as Oxalate) USP/Ph.Eur. | 5 mg / 10 mg | The Serotonin Anchor (Macro-Dose): The foundational, highly selective SSRI required to cure the underlying clinical depression and generalized anxiety. |
| Clonazepam USP/Ph.Eur. | 0.25 mg / 0.5 mg | The Anxiolytic Bridge (Micro-Dose): The highly potent, long-acting benzodiazepine required to suppress acute panic attacks and SSRI-induced activation syndrome. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Polymeric Film | Diluent / Superdisintegrant / High-Shear Binder / Glidant / Film-Coating (Engineered specifically utilizing advanced multi-stage geometric dilution to ensure the lethal 0.25mg/0.5mg micro-dose of Clonazepam is flawlessly distributed throughout the Escitalopram matrix, preventing toxic “hot spots”) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict 2-to-4 week short-term bridging regimens before stepping down to Escitalopram monotherapy).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Psychiatric Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Psychiatry/Anxiolytics & Antidepressants) |
| CAS Numbers | 219861-08-2 (Escitalopram Oxalate) / 1622-61-3 (Clonazepam) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-Alu Blisters (STRICTLY MANDATORY). Protects the formulation from environmental humidity across Zone IVb tropical climates, preventing premature degradation of the psychiatric payload. |
| Export Compliance | Highly Controlled Psychotropic Substance. Export is strictly subject to the issuance of an Import Certificate from the destination country’s Ministry of Health and a corresponding Narcotic/Psychotropic Export Authorization from the manufacturing state (due to the Clonazepam component). |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Ultra-Microdose Content Uniformity & EPS Prevention (CRITICAL COMPLIANCE): The engineering challenge of this FDC defines its safety. Standard generic manufacturers struggle to blend an ultra-potent 0.25 mg or 0.5 mg active ingredient evenly. If Content Uniformity fails, a patient could ingest an accidental overdose of Clonazepam, instantly triggering severe respiratory depression or profound somnolence. Our psychiatric suites utilize elite dry-blending, geometric dilution, and intensive HPLC batch-testing to guarantee 100% uniformity. This proves to major hospital boards that our dosing is clinically flawless and safe.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of severe anxiety and depressive disorders:
- Comorbid Depression & Anxiety: Treatment of major depressive disorder (MDD) when accompanied by severe, crippling generalized anxiety.
- Panic Disorder: Rapid stabilization of patients suffering from frequent, terrifying panic attacks with or without agoraphobia.
- SSRI Initiation (The Bridging Protocol): Short-term management to increase patient compliance during the difficult first weeks of SSRI therapy.
Dosage & Administration
Recommended Dosage (Strictly as per Psychiatrist Guidelines):
- Standard Adult Dosing: Typically initiated as one tablet taken daily, often at bedtime due to the highly sedative properties of the Clonazepam component.
- Duration of Therapy (The Tapering Mandate): The FDC is designed for short-term use (typically 2 to 4 weeks) to bridge the patient until the Escitalopram takes effect. The Clonazepam must then be slowly tapered off to prevent severe withdrawal, transitioning the patient to Escitalopram monotherapy.
- Administration: Can be taken with or without food. Tablets should be swallowed whole.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Fatal Respiratory Depression (Opioid Interaction): Co-administration with Opioids (like Tramadol or Codeine) causes profound, potentially fatal respiratory depression, coma, and death due to the Clonazepam component.
- BLACK BOX WARNING (Suicidal Ideation): Like all antidepressants, Escitalopram massively increases the risk of suicidal thinking and behavior in children, adolescents, and young adults (under 24) during the first few months of therapy.
- Tolerance, Dependence, & Withdrawal Seizures: Prolonged use of Clonazepam leads to severe physical dependence. Abrupt discontinuation can trigger terrifying withdrawal symptoms, including rebound anxiety, tachycardia, and continuous, life-threatening seizures (Status Epilepticus).
- Serotonin Syndrome: Co-administration with MAOIs, Triptans, or Tramadol can trigger a fatal cascade of hyperthermia, rigid muscles, and autonomic instability.
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, Anxiolytics, and Ultra-Microdose Content-Uniformity Assured Formulations. Whether you are looking for a reliable Government Tender Supplier for mental health clinics in Southeast Asia or a B2B Pharma Marketplace partner for the CIS, our highly regulated logistics network ensures timely, fully compliant delivery of WHO-GMP certified products.










Reviews
There are no reviews yet.