Description
Desloratadine Film-Coated Tablets (5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced immunology, dermatology, and targeted non-sedating antihistamine therapeutics. We provide ultra-high-purity, kinetically optimized Desloratadine Film-Coated Tablets (5 mg), manufactured in WHO–GMP certified, high-precision rapid-release oral solid dosage facilities. This “Third-Generation Active Metabolite & H1-Receptor Antagonist” is a massive-volume, highly lucrative export to allergy centers, specialized dermatology networks, retail pharmacy chains, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally preferred, zero-drowsiness intervention for severe Allergic Rhinitis and Chronic Idiopathic Urticaria.
Product Overview
This highly advanced formulation operates as a direct, pre-activated allergy shield. It eliminates the biological middleman, flooding the peripheral nervous system with the ultimate active antihistamine molecule while actively preventing the release of deeper inflammatory chemicals that cause chronic tissue swelling.
The “Active Metabolite & Mast Cell Stabilizer” Specialist:
- Mechanism 1 (The Hepatic Conversion Bypass): Standard Loratadine is clinically inactive until the liver’s CYP450 enzymes metabolize it. If a patient has compromised liver function or takes conflicting medications, the allergy pill fails. Desloratadine is the major active metabolite of Loratadine. It completely bypasses this hepatic bottleneck, guaranteeing immediate, highly predictable, and massive systemic absorption within 30 minutes of ingestion.
- Mechanism 2 (Selective Peripheral H1 Blockade): Desloratadine exhibits an incredibly high affinity for peripheral H1-histamine receptors located in the skin, nasal passages, and respiratory tract. By locking onto these receptors, it physically prevents the histamine released by mast cells from binding, instantly shutting down the cascade of itching, swelling, sneezing, and vasodilation.
- Mechanism 3 (The Anti-Inflammatory Cascade): Unlike older antihistamines, Desloratadine provides true “mast cell stabilization.” It actively inhibits the release of a broad spectrum of inflammatory cytokines (including IL-4, IL-6, IL-8, and PGD2). This means it doesn’t just block histamine; it physically stops the allergic inflammation at its cellular source, making it vastly superior for chronic hives.
- Mechanism 4 (Absolute Blood-Brain Barrier Exclusion): The molecule is highly lipophobic and physically cannot cross the blood-brain barrier. This guarantees that patients experience profound 24-hour allergy relief with absolutely zero “hangover” lethargy, daytime somnolence, or cognitive impairment.
Product Composition & Strength
We supply this product as a Precision-Blended, Rapid-Dissolution Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the highly potent API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Desloratadine USP/Ph.Eur. | 5 mg | The Global Allergy & Dermatology Anchor: The definitive once-daily therapeutic unit utilized for the continuous, 24-hour baseline control of Allergic Rhinitis (Hay Fever) and severe Chronic Urticaria. |
| Excipients | Microcrystalline Cellulose / Dibasic Calcium Phosphate / Maize Starch / Talc / Premium Polymeric Film | Diluent / Densifier / Disintegrant / Glidant / Heavy Film-Coating (Engineered specifically utilizing elite rapid-burst disintegrants to ensure the tablet shatters instantly in gastric fluid. The dense polymer coating masks the inherent bitterness of the API, ensuring a flawless patient experience) |
*Pack Sizes: 10×10 Blisters or Bottles of 30 (Optimized specifically for strict, 30-day chronic allergy and dermatology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Allergy Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antihistamines/Immunology) |
| CAS Number | 100643-71-8 (Desloratadine) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the rapidly disintegrating formulation from environmental humidity across Zone IVb tropical climates, preventing premature swelling in the blister card. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Rapid-Release Disintegration & Bioavailability (CRITICAL COMPLIANCE): The clinical superiority of Desloratadine relies entirely on its speed. If a patient is suffering from a massive urticaria (hives) flare-up, they cannot wait an hour for a poorly compressed generic tablet to dissolve. Our immunology suites utilize advanced high-shear granulation and highly calibrated rotary presses to guarantee a 15-minute dissolution profile perfectly matching the originator brand, ensuring doctors deliver a flawless, hyper-fast allergy rescue.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized symptomatic management of histamine-mediated disorders:
- Allergic Rhinitis: Rapid, sustained symptomatic relief of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, effectively targeting sneezing, rhinorrhea (runny nose), nasal pruritus (itching), and ocular itching/redness.
- Chronic Idiopathic Urticaria: First-line symptomatic relief of severe, unexplained chronic hives, significantly reducing the size, number, and intense pruritus of wheals.
Dosage & Administration
Recommended Dosage (Strictly as per Allergist/Dermatologist Guidelines):
- Standard Adult Dosing: 5 mg taken orally once daily.
- Administration: Can be taken with or without food. Because it does not cross the blood-brain barrier, it can be taken safely in the morning without causing daytime sleepiness.
- Renal & Hepatic Impairment Rule: In patients with severe renal or hepatic impairment, the half-life of the drug is significantly extended. Dosing must be strictly adjusted to 5 mg every other day to prevent accumulation.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- The “Absolute Non-Sedating” Profile: Desloratadine is one of the very few antihistamines approved for use by commercial airline pilots and heavy machinery operators because clinical trials prove it causes no more somnolence than a placebo.
- Hypersensitivity Warning: Strictly contraindicated in patients with a known hypersensitivity to Desloratadine or its parent drug, Loratadine.
- Pediatric Use: The 5 mg tablet is generally not recommended for children under 12 years of age (pediatric syrups are preferred to ensure exact weight-based micro-dosing).
- Pregnancy & Lactation: While animal studies show no teratogenicity, it should only be used during pregnancy if clearly needed. Desloratadine passes into breast milk; therefore, a decision must be made whether to discontinue nursing or the drug.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Allergy/Dermatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antihistamines, Active Metabolite Therapeutics, and Rapid-Dissolution Tableting. Whether you are looking for a reliable Government Tender Supplier for seasonal allergy programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products








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