Description
Fluoxetine Hydrochloride Capsules
Healthy Inc is a specialized global supplier and exporter of advanced central nervous system (CNS) and psychiatric therapeutics. We provide high-purity Fluoxetine Capsules (20 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Selective Serotonin Reuptake Inhibitor (SSRI)” is a mandatory, high-volume export to psychiatric hospitals, community mental health centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a frontline intervention for Major Depressive Disorder, Obsessive-Compulsive Disorder (OCD), and Bulimia Nervosa.
Product Overview
This formulation contains Fluoxetine Hydrochloride, a highly potent, activating antidepressant belonging to the SSRI class.
The “Synaptic Serotonin” Specialist:
- Mechanism (SERT Blockade): Fluoxetine specifically binds to and inhibits the Serotonin Transporter (SERT) on the presynaptic neuronal membrane. By blocking the reuptake pump, it prevents the clearance of serotonin (5-HT) from the synaptic cleft. This leads to an accumulation of serotonin, enhancing serotonergic neurotransmission and down-regulating postsynaptic receptors over time, which clinically translates to elevated mood and reduced anxiety.
- The Activating Profile: Unlike some SSRIs that cause significant sedation (like Paroxetine), Fluoxetine is known for its “activating” or energizing profile. It is highly beneficial for patients experiencing lethargic, hypersomnic, or severe fatigue-dominant depression.
- Long Half-Life Advantage: Fluoxetine and its active metabolite (norfluoxetine) have an exceptionally long combined elimination half-life (up to 7-15 days). This provides a “built-in taper,” drastically minimizing the risk of severe SSRI withdrawal syndrome (brain zaps, agitation) if a patient accidentally misses a dose or abruptly stops therapy.
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed in moisture-resistant blister strips or bulk hospital jars.
| Active Ingredient | Strength (Base Equivalent) | Primary Clinical Use |
|---|---|---|
| Fluoxetine Hydrochloride USP/BP | 10 mg | Pediatric Dosing / Sensitive Patient Titration |
| Fluoxetine Hydrochloride USP/BP | 20 mg | Standard Adult Maintenance Dose |
| Excipients | Pregelatinized Starch / Magnesium Stearate | Diluent / Glidant (Ensures consistent API flow) |
*Pack Sizes: 10×10 Alu-PVC Blisters or Bulk Jars of 500/1000 Capsules for institutional dispensing.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Number | 56296-78-7 (Fluoxetine Hydrochloride) |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | Alu-PVC Blisters. |
| Storage | Store below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- API Uniformity: Because Fluoxetine requires precise dosing to prevent serotonin toxicity, our powder blending process utilizes high-shear granulation to ensure absolute content uniformity within every capsule, meeting strict pharmacopeial assay standards.
- Bioequivalence: Formulated to demonstrate strict bioequivalence to the innovator brand (Prozac), ensuring predictable, steady-state plasma concentrations for chronic psychiatric management.
Therapeutic Indications (Human Use)
Indicated for the management of chronic psychiatric and eating disorders:
- Major Depressive Disorder (MDD): Acute and maintenance treatment of severe depression.
- Obsessive-Compulsive Disorder (OCD): Reduction of obsessions and compulsions.
- Bulimia Nervosa: To decrease binge-eating and purging behaviors (often requires higher dosing, e.g., 60 mg/day).
- Panic Disorder: Treatment of severe panic attacks, with or without agoraphobia.
Dosage & Administration
Recommended Dosage (Strictly as per Psychiatrist/Physician):
- Administration: Taken orally once daily, usually in the morning (to prevent insomnia, given its activating nature), with or without food.
- Depression & OCD (Adults): Typically initiated at 20 mg/day. Dose may be increased cautiously after several weeks if clinical improvement is insufficient.
- Bulimia Nervosa: The target dose is typically 60 mg/day.
- Therapeutic Lag: Patients must be explicitly counseled that the full antidepressant effect may take 4 to 6 weeks of continuous daily dosing to become apparent.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Suicidality): Antidepressants, including SSRIs, increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (up to age 24) during the initial months of treatment. Close clinical monitoring for clinical worsening or unusual behavior is mandatory.
- Serotonin Syndrome: Co-administration with other serotonergic drugs (like MAOIs, Triptans, or Linezolid) can cause a potentially fatal accumulation of serotonin, resulting in hyperthermia, severe rigidity, myoclonus, and rapid autonomic fluctuation. A strict 14-day to 5-week washout period is required when switching between Fluoxetine and MAOIs.
- Bipolar Disorder (Mania Switch): Can precipitate a manic or hypomanic episode in patients with undiagnosed Bipolar Disorder. Must be used with a mood stabilizer if prescribed to bipolar patients.
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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for CNS and Psychiatric Medicines, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.









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