Doxepin Hydrochloride Capsules

Healthy Inc is a specialized global supplier and exporter of advanced central nervous system (CNS) and neuro-dermatological therapeutics. We provide high-purity Doxepin Hydrochloride Capsules (10 mg / 25 mg / 50 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Tricyclic Antidepressant (TCA)” is a strategic, multi-specialty export to psychiatric hospitals, dermatology clinics, sleep medicine centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a powerful intervention for Major Depressive Disorder with severe anxiety, chronic insomnia, and refractory pruritus.

Product Overview

This formulation contains Doxepin (as Doxepin Hydrochloride), a classic tertiary amine tricyclic antidepressant.

The “Sedating Neuro-Modulator” Specialist:

• Mechanism 1 (Reuptake Inhibition – Mood): Like other TCAs, Doxepin blocks the reuptake of both serotonin and norepinephrine into the presynaptic nerve terminals. This increases the concentration of these neurotransmitters in the synaptic cleft, effectively alleviating the symptoms of depression and severe generalized anxiety.
• Mechanism 2 (H1 Receptor Antagonism – Sleep & Itch): Doxepin possesses one of the most potent affinities for the H1 (histamine) receptor of any known compound (significantly more potent than standard antihistamines like diphenhydramine). At very low doses, it profoundly blocks central histamine, making it an FDA-approved mechanism for sleep-maintenance insomnia, and highly effective for suppressing severe, systemic neuropathic or allergic itching (chronic urticaria).
• The Anxiolytic Advantage: Because of its pronounced sedating properties, Doxepin is particularly favored by psychiatrists for patients whose depression is accompanied by prominent psychomotor agitation, severe anxiety, and sleep disturbances.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in moisture-resistant blister strips or bulk hospital jars.

*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.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Low-Dose Uniformity (10 mg): Because the 10 mg capsule is frequently utilized as a precise sleep aid, our manufacturing process utilizes advanced geometric dilution and high-shear granulation to ensure absolute content uniformity, preventing daytime “hangover” sedation from over-filled capsules.
• Hygroscopic Stability: Doxepin Hydrochloride is slightly hygroscopic. Our encapsulation lines strictly control relative humidity to preserve the physical integrity of the gelatin shell and the stability of the API over a 36-month shelf life.

Therapeutic Indications (Human Use)

Indicated for the management of psychiatric, dermatological, and sleep disorders:

• Depression & Anxiety: Psychoneurotic patients with depression and/or anxiety, depression associated with alcoholism, and manic-depressive disorders (depressed phase).
• Insomnia (Low Dose): Treatment of insomnia characterized by difficulty with sleep maintenance.
• Chronic Pruritus (Off-Label / Dermatological Use): Highly effective systemic treatment for chronic idiopathic urticaria and severe atopic dermatitis itching that does not respond to standard antihistamines.

Dosage & Administration

Recommended Dosage (Strictly as per Physician):

• Administration: Taken orally. Because of its highly sedating nature, the major portion (or the entire daily dose) is typically administered at bedtime.
• Depression & Anxiety (Adults): Usually starts at 75 mg/day. Can be titrated up to 150 mg/day (or up to 300 mg/day in severely ill, hospitalized patients).
• Insomnia: Extremely low doses (typically 3 mg to 6 mg, though a single 10 mg capsule is often utilized off-label in clinical practice) administered 30 minutes before bedtime.
• Pruritus: Typically 10 mg to 25 mg at bedtime, titrated carefully to balance itch relief with morning grogginess.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Suicidality): Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults. Close monitoring is mandatory.
• Anticholinergic Toxicity: Causes significant dry mouth, blurred vision, severe constipation, and urinary retention. Use with extreme caution in the elderly (Beers Criteria) and in patients with narrow-angle glaucoma or benign prostatic hyperplasia (BPH).
• Cardiotoxicity: Overdose of TCAs like Doxepin is frequently fatal due to profound cardiac arrhythmias (QT prolongation, widened QRS complex). It should be prescribed in the smallest feasible quantities for severely depressed outpatients.
• MAOI Contraindication: Strict 14-day washout period required when switching between Doxepin and Monoamine Oxidase Inhibitors (MAOIs) to prevent fatal hypertensive crises or serotonin syndrome.

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.