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Fluoxetine Capsules

Category: Therapy > Antipsychotic Capsule Therapy > CNS (Antidepressants\ Antipsychotics) Therapy > CNS Drugs
Product Name Fluoxetine Capsules

Short Description

Fluoxetine capsules, commonly known by the brand name <span data-sfc-cp="" data-wiz-uids="vAtHg_d" data-complete="true" data-processed="true"><a class="H23r4e" href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21235LBL.PDF" target="_blank" rel="noopener" data-hveid="CAEIAhAB" data-processed="true">Prozac (accessdata.fda.gov)</a></span>, contain <mark class="HxTRcb" data-complete="true" data-sae="">the active antidepressant <strong class="Yjhzub" data-complete="true">fluoxetine hydrochloride</strong> along with several inactive ingredients that vary by manufacturer and dosage strength</mark>.

Full Description

Fluoxetine Capsules

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, neurological, and central nervous system (CNS) therapeutics. We provide high-purity, therapeutically dosed Fluoxetine Hydrochloride Capsules (10 mg / 20 mg / 40 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This "First-in-Class SSRI Antidepressant" is a massive-volume, essential export to psychiatric hospitals, mental health NGOs, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, first-line intervention for Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), and Bulimia Nervosa.

Product Overview

This formulation contains Fluoxetine Hydrochloride, a highly potent and selective inhibitor of neuronal serotonin reuptake, engineered to restore critical neurotransmitter balance in the brain. The "Foundational Serotonin & Mood Elevator" Specialist:
  • Mechanism (Selective SERT Inhibition): Depression and anxiety disorders are heavily linked to depleted levels of serotonin in the brain's synaptic clefts. Fluoxetine physically binds to and blocks the Serotonin Transporter (SERT) on the presynaptic neuron. By preventing the neuron from reabsorbing (reuptaking) the serotonin, the drug forces the neurotransmitter to remain in the synaptic gap much longer, radically enhancing signal transmission to the postsynaptic receptors and elevating mood.
  • The "Long Half-Life" Adherence Advantage: Unlike other SSRIs (like Paroxetine or Venlafaxine) that trigger severe "brain zaps" and withdrawal symptoms if a single dose is missed, Fluoxetine and its active metabolite (norfluoxetine) have a remarkably long half-life (up to 16 days). This "auto-tapering" effect makes it the most forgiving antidepressant for non-compliant patients, highly favoring its use in challenging public health and NGO psychiatric settings.
  • Broad-Spectrum Psychiatric Utility: Beyond depression, Fluoxetine's activating profile makes it the absolute gold standard for treating severe lethargy in depression, paralyzing Obsessive-Compulsive loops, and the binge-eating cycles associated with Bulimia Nervosa.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in highly secure, moisture-resistant Alu-PVC or opaque Alu-Alu blister strips, as well as HDPE bottles for chronic psychiatric dispensing.
Active Ingredient Strength Primary Clinical Use
Fluoxetine Hydrochloride USP/BP/Ph.Eur. 10 mg Standard pediatric dosing, geriatric initiation, and severe panic disorder titration.
Fluoxetine Hydrochloride USP/BP/Ph.Eur. 20 mg Standard Adult Dose for Major Depressive Disorder and maintenance therapy.
Fluoxetine Hydrochloride USP/BP/Ph.Eur. 40 mg High-dose therapy for severe Obsessive-Compulsive Disorder and Bulimia Nervosa.
Excipients Maize Starch / Dimethicone / Gelatin Diluent / Glidant (Ensures uniform powder flow and absolute dose precision)
*Pack Sizes: 10x10 or 10x15 Blisters / HDPE Bottles of 30/100 Capsules (Optimized for 30-day chronic psychiatric adherence regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Psychiatric Distributors.
HS Code 3004.90.99 (Medicaments containing other active substances - Antidepressants)
CAS Number 59333-67-4
Dosage Form Hard Gelatin Capsule
Packaging Alu-PVC Blisters or HDPE Bottles. (API is highly stable, making Alu-PVC the ideal, cost-effective packaging choice for high-volume government mental health tenders).
Storage Store strictly 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.
  • Low-Dose Uniformity Engineering: Because Fluoxetine is heavily prescribed in low 10mg and 20mg doses, preventing sub-therapeutic or toxic "hot spots" within the capsule is critical. Our manufacturing utilizes advanced high-shear V-blenders and rigorous HPLC assay testing to guarantee absolute content uniformity across every batch.
  • Dissolution Profiling: Rigorous in vitro dissolution testing ensures the capsule releases the API rapidly and completely in the gastric fluid, providing reliable and predictable steady-state blood levels required for complex psychiatric management.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe psychiatric and mood disorders:
  • Major Depressive Disorder (MDD): Acute and maintenance treatment of severe clinical depression in adults and pediatric patients (8 years and older).
  • Obsessive-Compulsive Disorder (OCD): Reduction of obsessions and compulsions in adults and pediatric patients (7 years and older).
  • Bulimia Nervosa: Treatment of binge-eating and vomiting behaviors in adult patients with moderate to severe bulimia.
  • Panic Disorder: Treatment of panic disorder, with or without agoraphobia.

Dosage & Administration

Recommended Dosage (Strictly as per Psychiatrist/Physician Guidelines):
  • Administration (TIMING IS CRITICAL): Because Fluoxetine is an "activating" SSRI, it frequently causes insomnia if taken late in the day. It MUST be taken in the morning, with or without food.
  • Onset of Action (Counseling Point): Patients must be rigorously counseled that antidepressants do not work immediately. While side effects (like mild nausea or jitteriness) may appear on day one, significant therapeutic mood elevation typically takes 4 to 6 weeks of continuous daily use.
Safety Warnings (CRITICAL):
  • 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 the initial months of therapy or during dose changes. Patients must be monitored closely for clinical worsening or unusual changes in behavior.
  • Serotonin Syndrome: Co-administration with other serotonergic drugs (like MAOIs, SNRIs, Triptans, or Tramadol) can trigger a potentially fatal accumulation of serotonin. Symptoms include extreme agitation, hallucinations, tachycardia, hyperthermia, and severe muscle rigidity. Note: Because of Fluoxetine's long half-life, patients must wait at least 5 weeks after stopping Fluoxetine before starting an MAOI.
  • Activation of Mania/Hypomania: In patients with undiagnosed Bipolar Disorder, administering an SSRI without a mood stabilizer can violently trigger a severe manic episode.

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 Advanced Psychiatric Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government mental health programs 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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Frequently Asked Questions

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