Description
Olanzapine & Fluoxetine Capsules / Bilayer Tablets (3mg/25mg, 6mg/25mg, 6mg/50mg)
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 synchronized Olanzapine & Fluoxetine Hydrochloride Hard Gelatin Capsules / Bilayer Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Synergistic Neurochemical Modulator” is an ultra-high-value, premium export to psychiatric hospitals, mental health rehabilitation centers, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, rapid-response intervention for Treatment-Resistant Depression (TRD) and acute Bipolar I Depression.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes two entirely different classes of psychoactive medications. When combined, they unlock a profound, third pharmacological mechanism that neither drug can achieve alone, violently lifting the darkest, most refractory depressive episodes.
The “Prefrontal Cortex Catalyst” Specialist:
- Mechanism 1 (The Serotonin Surge – Fluoxetine): Fluoxetine is a potent Selective Serotonin Reuptake Inhibitor (SSRI). It physically blocks the reabsorption of serotonin in the brain, forcing massive amounts of this mood-stabilizing neurotransmitter to pool in the synaptic cleft, easing severe anxiety and depressed mood.
- Mechanism 2 (The Atypical Modulator – Olanzapine): Olanzapine is a heavy-hitting atypical antipsychotic. It blocks 5-HT2A serotonin receptors and D2 dopamine receptors. This smooths out erratic, racing thoughts and provides profound, rapid-acting sedation to counteract manic agitation.
- Mechanism 3 (The Synergistic Dopamine Release – CRITICAL): When Fluoxetine and Olanzapine are administered together, the exact combination of SERT inhibition (Fluoxetine) and 5-HT2C blockade (Olanzapine) triggers a massive, synergistic release of Dopamine and Norepinephrine specifically in the prefrontal cortex. This profound neurochemical flood instantly breaks through treatment-resistant anhedonia (the inability to feel pleasure) and extreme lethargy, achieving clinical remission where all other monotherapies have completely failed.
Product Composition & Strength
We supply this product as a Precision-Engineered, API-Segregated Capsule or Bilayer Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly oxidative Olanzapine molecule.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Olanzapine Ph.Eur./USP | 3 mg / 6 mg / 12 mg | Atypical Base: Modulates 5-HT2A/D2 receptors to stabilize severe mood swings and trigger prefrontal synergy. |
| Fluoxetine (as HCl) Ph.Eur./USP | 25 mg / 50 mg | SSRI Driver: Forces a massive serotonin pool in the synaptic cleft to elevate refractory depressive lows. |
| Excipients | Pregelatinized Starch / Croscarmellose Sodium / Microcrystalline Cellulose / Magnesium Stearate / Opadry Film | Moisture-Scavenging Diluent / Superdisintegrant / Binder / Premium Oxygen-Barrier Film-Coating (Engineered specifically to physically isolate the highly sensitive Olanzapine from cross-reacting with Fluoxetine) |
*Pack Sizes: 10×10 Alu-Alu 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.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Neurology/Psychiatry FDC) |
| CAS Numbers | 132539-06-1 (Olanzapine) / 107868-30-4 (Fluoxetine HCl) |
| Dosage Form | Hard Gelatin Capsule or Film-Coated Bilayer Tablet |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Olanzapine is violently unstable when exposed to light, moisture, and oxygen, rapidly degrading and turning a dark yellow/brown color. Heavy-gauge Alu-Alu barrier packaging guarantees absolute chemical stability and full synergistic potency across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture, Light, and Oxygen. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dual-Active Segregation & Oxidation-Barrier Engineering: Combining an unstable thienobenzodiazepine (Olanzapine) with an SSRI (Fluoxetine) is a severe pharmaceutical challenge. Our facilities utilize advanced Bilayer Rotary Presses or multi-particulate encapsulation under strict, ultra-low humidity and nitrogen-purged environments. By creating distinct micro-environments within the dosage form, we ensure both APIs remain 100% chemically isolated and protected from oxidative stress, guaranteeing flawless bioequivalence and multi-year shelf life.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of severe, complex psychiatric dysfunction:
- Depressive Episodes Associated with Bipolar I Disorder: Acute treatment of the depressive phase of Bipolar I Disorder in adults.
- Treatment-Resistant Depression (TRD): Acute treatment of severe Major Depressive Disorder in adults who do not respond to two separate trials of different antidepressants of adequate dose and duration.
Dosage & Administration
Recommended Dosage (Strictly as per Psychiatrist Guidelines):
- Standard Adult Dosing: Initially 6 mg/25 mg taken orally once daily. Doses may be titrated cautiously up to a maximum of 18 mg/75 mg per day based on clinical response.
- Administration (THE BEDTIME RULE – CRITICAL): Because Olanzapine is an extremely heavy, sedating antipsychotic, the total daily dose MUST be taken in the evening or right before bedtime. Taking it in the morning will cause severe, paralyzing daytime drowsiness and extreme cognitive impairment.
- Food Independence: Can be administered with or without food.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Suicidality): Fluoxetine increases the risk of suicidal thinking and behavior in children, adolescents, and young adults (up to age 24) during initial treatment. Patients must be aggressively monitored for clinical worsening.
- BLACK BOX WARNING (Elderly Dementia Psychosis): Elderly patients with dementia-related psychosis treated with antipsychotic drugs (like Olanzapine) are at a massive, statistically significant increased risk of sudden death, primarily from cardiovascular events or infectious pneumonia.
- Severe Metabolic Syndrome (Olanzapine Toxicity): Olanzapine notoriously causes massive, rapid weight gain, extreme spikes in blood glucose (hyperglycemia leading to ketoacidosis), and severe dyslipidemia (spikes in cholesterol and triglycerides). Patients must have their weight, lipids, and A1C strictly monitored.
- Tardive Dyskinesia & NMS: Prolonged use of antipsychotics can cause Tardive Dyskinesia (irreversible, involuntary muscle movements of the face and jaw) and Neuroleptic Malignant Syndrome (a rare but fatal condition characterized by extreme fever and muscle rigidity).
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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Psychiatric and FDC 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.
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