Description

Mirtazapine Film-Coated / Orally Disintegrating Tablets (15 mg / 30 mg / 45 mg)

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, geriatric-support, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically optimized Mirtazapine Film-Coated and Orally Disintegrating Tablets (15 mg / 30 mg / 45 mg), manufactured in WHO–GMP certified, high-precision rapid-release oral solid dosage facilities. This “Noradrenergic and Specific Serotonergic Antidepressant (NaSSA)” is a massive-volume, highly lucrative export to psychiatric hospitals, geriatric care centers, oncology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for Major Depressive Disorder (MDD) accompanied by severe insomnia, weight loss, and severe anxiety.

Product Overview

This highly advanced formulation utilizes a unique, multi-receptor blockade to completely rewire the brain’s emotional and physical baseline. Instead of just trapping serotonin like an SSRI, it cuts the brakes on the brain’s natural neurotransmitter production while actively shielding the patient from traditional antidepressant side effects.

The “NaSSA & Sleep/Appetite Restoring” Specialist:

• Mechanism 1 (The Alpha-2 Auto-Receptor Blockade): Mirtazapine works by aggressively blocking central alpha-2 adrenergic auto-receptors and hetero-receptors. Normally, these receptors act as “brakes” to stop the brain from releasing too much norepinephrine and serotonin. By destroying these brakes, Mirtazapine forcefully floods the central nervous system with mood-lifting neurotransmitters, rapidly breaking the cycle of severe clinical depression.
• Mechanism 2 (The 5-HT2 & 5-HT3 Shield – ZERO Sexual Dysfunction): When SSRIs flood the brain with serotonin, the serotonin hits *all* receptors, causing severe insomnia, nausea, and libido loss. Mirtazapine surgically blocks the 5-HT2 and 5-HT3 receptors. This means the therapeutic serotonin is funneled exclusively into the 5-HT1A receptor (which cures depression), while the receptors that cause sexual dysfunction and nausea are physically shielded. It actually acts as a powerful anti-emetic (anti-nausea) agent.
• Mechanism 3 (The H1 Histamine Antagonism – Sleep & Weight): Mirtazapine is a highly potent antagonist of the H1 histamine receptor. This triggers profound, heavy sedation and massively stimulates the appetite. For deeply depressed patients who have stopped eating and cannot sleep, or oncology patients suffering from severe cachexia (wasting syndrome), this side-effect profile is incredibly therapeutic and literally life-saving.

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.

• Rapid-Disintegration & Taste-Masking Engineering (CRITICAL COMPLIANCE): Elderly patients or those suffering from severe depression frequently suffer from dysphagia (difficulty swallowing) or pill-refusal. If Mirtazapine touches the tongue without advanced masking, its severe bitterness will induce vomiting. Our facilities utilize advanced high-shear dry blending to integrate the API with sweetening agents (like Mannitol and Aspartame) and elite superdisintegrants (Crospovidone). This guarantees that the tablet shatters instantly upon contact with saliva or gastric fluid, ensuring 100% dose delivery and absolute patient compliance.

Therapeutic Indications (Human Use)

Indicated for the comprehensive, highly targeted management of severe psychiatric and metabolic dysfunction:

• Major Depressive Disorder (MDD): First-line or second-line treatment of severe clinical depression, particularly in patients exhibiting severe weight loss, anorexia, or severe insomnia.
• Off-Label Geriatric & Oncology Use: Heavily prescribed to stimulate appetite, induce weight gain, and restore sleep architecture in elderly patients and those undergoing heavy chemotherapy.
• SSRIs Augmentation (California Rocket Fuel): Frequently co-prescribed with Venlafaxine or SSRIs to aggressively treat highly refractory, treatment-resistant depression.

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist Guidelines):

• Standard Adult Dosing: Initially 15 mg taken orally once daily. Titrated up to 30 mg or 45 mg based on clinical response.
• Administration (THE BEDTIME RULE): Due to its profound sedative properties, the tablet MUST be taken exactly at bedtime. Taking it during the day will cause severe impairment and daytime somnolence.
• Abrupt Cessation Risk: Therapy should not be stopped abruptly to avoid discontinuation syndrome (rebound anxiety, dizziness, nausea). The dose must be tapered.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Suicidality): Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (up to age 24) with Major Depressive Disorder and other psychiatric disorders. Patients must be heavily monitored for clinical worsening during the first few months of therapy.
• Agranulocytosis & Severe Neutropenia (CLINICAL ALERT): Mirtazapine carries a rare but highly dangerous risk of severely dropping the patient’s white blood cell count, destroying their immune system. If a patient develops a sudden sore throat, fever, or signs of infection, the drug must be stopped immediately and a full blood count performed.
• Metabolic Shift (Extreme Weight Gain): Can cause massive, rapid weight gain and elevated cholesterol/triglycerides. While useful in cachexia, it can be detrimental to overweight diabetic patients.
• CNS Depression & Operating Machinery: Patients must be explicitly warned against driving or operating heavy machinery, particularly during the first few weeks of therapy, as the sedation can be overwhelming.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Psychiatric Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced CNS, Antidepressant, and Rapid-Disintegrating Formulations. Whether you are looking for a reliable Government Tender Supplier for mental health clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.