Description

Paroxetine Controlled-Release (CR) Tablets (12.5 mg / 25 mg / 37.5 mg)

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, neurology, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically stabilized Paroxetine Hydrochloride Controlled-Release (CR) Tablets (12.5 mg / 25 mg / 37.5 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “GI-Sparing SSRI Neuromodulator” is a premium, high-value export to psychiatric hospitals, specialized mental health clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for Major Depressive Disorder, Panic Disorder, and severe Anxiety Syndromes.

Product Overview

This highly advanced formulation utilizes a sophisticated degradable polymer matrix to safely escort a potent Selective Serotonin Reuptake Inhibitor (SSRI) past the stomach, delivering powerful neurochemical balancing without the crippling nausea associated with older antidepressants.

The “GI-Sparing & Serotonergic” Specialist:

• Mechanism 1 (The Serotonin Reuptake Blockade): In patients suffering from severe depression and panic disorders, the brain rapidly reabsorbs (depletes) serotonin before it can successfully transmit calming signals between neurons. Paroxetine aggressively binds to the Serotonin Transporter (SERT), physically blocking this reuptake process. This forces massive amounts of serotonin to pool and remain active in the synaptic cleft, drastically improving mood, stabilizing emotions, and preventing panic attacks.
• Mechanism 2 (The “GI-Sparing” Polymeric Matrix – CRITICAL): Standard Paroxetine dissolves immediately in the acidic stomach, flooding local serotonin receptors in the gut and causing severe nausea and vomiting. Our Controlled-Release (CR) formulation utilizes an advanced double-layer matrix. An enteric outer layer protects the pill in the stomach, while an internal hydrophilic polymer core slowly releases the active drug only when it reaches the alkaline environment of the small intestine. This virtually eliminates early-onset nausea, guaranteeing patient compliance during the critical first weeks of psychiatric therapy.
• The Broad-Spectrum Anxiolytic: Among all SSRIs, Paroxetine possesses one of the strongest affinities for calming severe, generalized anxiety. It is the heavy-hitting, gold-standard therapy for patients whose depression is heavily complicated by debilitating panic attacks or social phobias.

Product Composition & Strength

We supply this product as a Precision-Engineered Polymeric Matrix Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or high-density PVC/PVDC blister strips to ensure the absolute chemical stability of the extended-release hydrogel network.

*Pack Sizes: 10×10 Blisters (Optimized specifically for strict 30-day chronic 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.

• Dual-Barrier Matrix Engineering (CRITICAL COMPLIANCE): Manufacturing a Paroxetine CR tablet is exceptionally complex. If the tablet breaks down in the stomach, it entirely defeats the purpose of the CR formulation. Our facilities utilize advanced Fluid Bed Coating technology. We first create an internal Hypromellose (HPMC) hydrogel core that slowly swells and diffuses the Paroxetine. We then coat this core in a strict pH-dependent Methacrylic Acid Copolymer (Enteric Coat). This guarantees zero drug release in the stomach and flawless, 24-hour sustained release in the small intestine, eliminating peak-to-trough blood spikes.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe depressive and anxiety spectrum disorders:

• Major Depressive Disorder (MDD): Acute and maintenance treatment of severe clinical depression.
• Panic Disorder: Treatment of panic disorder, with or without agoraphobia.
• Social Anxiety Disorder (SAD): Treatment of debilitating social phobias.
• Premenstrual Dysphoric Disorder (PMDD): Management of severe, disabling mood dysregulation occurring prior to menstruation (utilizing the 12.5 mg CR dose).

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist Guidelines):

• Administration (THE INTACT TABLET RULE): Tablets MUST be swallowed completely whole with water, typically as a single daily dose in the morning. They must never be chewed, crushed, or divided. Breaking the tablet physically destroys both the enteric coating and the CR polymer matrix, causing a massive, highly emetic (nausea-inducing) dose to dump into the stomach all at once.
• Food Independence: Can be taken with or without food.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Suicidality): All antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (up to age 24) during initial treatment. Patients must be heavily monitored for clinical worsening or unusual behavioral changes.
• Severe Discontinuation Syndrome (CRITICAL): Paroxetine has a very short half-life compared to other SSRIs. Abruptly stopping this medication causes severe withdrawal symptoms, including “brain zaps” (electric shock sensations in the head), severe dizziness, extreme nausea, and rebound panic. It must be tapered off incredibly slowly over weeks or months.
• Teratogenicity (Pregnancy Category D): Unlike most SSRIs, epidemiological studies have shown that Paroxetine significantly increases the risk of major congenital malformations, particularly cardiovascular defects (e.g., ventricular septal defects), if taken during the first trimester of pregnancy. It should be avoided in pregnant women or women planning to conceive.
• Serotonin Syndrome: Concomitant use with MAO Inhibitors, SNRIs, Tramadol, or Triptans can trigger fatal Serotonin Syndrome.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Psychiatric and Modified-Release 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.