Sertaconazole Vaginal Tablets

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Description

Sertaconazole Nitrate Vaginal Tablets (500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced gynecological, dermatological, and women’s health therapeutics. We provide ultra-high-purity, kinetically optimized Sertaconazole Nitrate Vaginal Tablets / Pessaries (500 mg), manufactured in WHO–GMP certified, high-precision targeted-release facilities. This “Dual-Action Fungicidal & Anti-Inflammatory Agent” is a highly lucrative, premium export to gynecology centers, specialized women’s health clinics, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, rapid-relief intervention for acute Vulvovaginal Candidiasis (VVC).


Product Overview

This highly advanced formulation contains Sertaconazole (as Sertaconazole Nitrate), a modern, broad-spectrum imidazole antifungal that vastly outperforms older generations by employing a brutal, two-pronged attack against aggressive yeast infections, combined with a built-in anti-itch mechanism.

The “Single-Dose Eradication” Specialist:

  • Mechanism 1 (The Ergosterol Starvation – Fungistatic): Like all azoles, Sertaconazole aggressively inhibits the fungal enzyme 14α-demethylase. This completely stops the yeast from synthesizing ergosterol, a vital component of its cell wall, halting the fungus from growing and multiplying.
  • Mechanism 2 (The Direct Cell Rupture – Fungicidal): This is the ultimate clinical differentiator. Sertaconazole possesses a unique benzothiophene ring that allows it to bind directly to non-sterol lipids already present in the fungal cell membrane. This physically rips microscopic holes in the yeast, causing its internal contents (like ATP) to leak out, resulting in rapid, violent cell death.
  • Mechanism 3 (The Anti-Pruritic / Anti-Inflammatory Shield): Yeast infections cause agonizing itching and burning. Sertaconazole directly inhibits the release of pro-inflammatory cytokines and prostaglandins from the patient’s immune cells. This means the tablet doesn’t just kill the infection; it rapidly shuts down the agonizing itch, providing immense, immediate relief to the patient.
  • The Single-Dose Compliance Advantage: Older therapies require women to insert messy creams or tablets for 3, 6, or even 7 consecutive nights. Our high-dose 500 mg tablet provides complete, clinical eradication of the yeast infection with a single, highly convenient bedtime dose.

Product Composition & Strength

We supply this product as a Precision-Compressed Vaginal Tablet (Pessary), packed exclusively in highly secure, moisture-resistant Alu-PVC blister strips. Each tablet is often packaged with a hygienic, medical-grade disposable applicator to ensure proper and comfortable insertion.

Active IngredientStrengthPrimary Clinical Function
Sertaconazole Nitrate BP/Ph.Eur.500 mgGlobal Clinical Standard: Single-dose acute therapy for the complete eradication of vaginal Candida infections.
ExcipientsLactose Monohydrate / Microcrystalline Cellulose / Adipic Acid / Sodium Bicarbonate / Magnesium StearateDiluent / Effervescent Base (Engineered to rapidly dissolve in the low-moisture vaginal environment and disperse evenly across the mucosal walls)

*Pack Sizes: 1 Tablet per Blister Box + 1 Disposable Applicator (Optimized specifically for premium, high-turnover OTC pharmacy shelves and acute gynecology dispensing).


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Gynecology Distributors, and Pharmacy Chains.

HS Code3004.90.99 (Medicaments containing other active substances – Gynecologicals/Antifungals)
CAS Number108777-13-6 (Sertaconazole Nitrate)
Dosage FormVaginal Tablet / Pessary (Mucosal Dispersion)
PackagingAlu-PVC Blisters with Applicator (STRICTLY MANDATORY). Vaginal formulations rely on specific disintegration properties that can be permanently ruined by environmental humidity. Strict barrier packaging guarantees multi-year shelf life across Zone IVb tropical climates.
StorageStore strictly below 30°C in a dry place. Protect from Light and Moisture. Do not freeze.
CertificatesWHO-GMP, COPP, Free Sale Certificate

Manufacturing Authority

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

  • Mucosal Disintegration Engineering: Standard oral tablets require stomach acid and heavy fluid to dissolve. Vaginal tablets must be uniquely engineered. Our facilities utilize advanced mildly effervescent or specialized hydrophilic matrices (such as Lactose and Adipic Acid combinations) to guarantee the 500 mg tablet completely and rapidly melts into a soothing coating using only the minimal natural moisture present in the vaginal tract, ensuring zero gritty residue and maximum mucosal contact time.

Therapeutic Indications (Human Use)

Indicated strictly for the targeted management of female genitourinary infections:

  • Vulvovaginal Candidiasis (VVC): Localized treatment of acute vaginal yeast infections caused by Candida albicans and other non-albicans Candida species.
  • CRITICAL LIMITATION: This product is strictly for intravaginal administration. It is NOT for oral ingestion or ophthalmic use.

Dosage & Administration

Recommended Dosage (Strictly as per Gynecologist/Pharmacist Guidelines):

  • Standard Adult Dosing: One 500 mg vaginal tablet administered as a single dose.
  • Administration (THE BEDTIME RULE): The tablet must be inserted deeply into the vagina using the supplied applicator (or thoroughly washed fingers) at night, immediately before going to sleep. Lying down ensures the melting tablet does not leak out, maximizing the therapeutic exposure overnight.
  • Menstruation Protocol: Treatment should generally be avoided during menstruation. The patient should wait until the menstrual period has finished before administering the tablet to prevent the medication from being flushed out.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • Latex Degradation (Contraceptive Failure): Like many intravaginal antifungals, the excipients or base in this formulation may cause severe damage to latex contraceptives (condoms and diaphragms), causing them to tear or fail. Patients must be warned to use alternative methods of contraception or abstain from intercourse for at least 5 days after using the tablet.
  • Partner Treatment: If the patient experiences recurring infections, or if her male partner exhibits symptoms of balanitis (redness, itching of the penis), the partner must also be treated simultaneously with a topical antifungal cream to prevent “ping-pong” reinfection.
  • Localized Reactions: A transient, mild burning sensation or localized irritation may occur immediately following insertion as the inflamed mucosa reacts to the tablet. This usually subsides quickly. If severe burning or hives develop, the patient must discontinue use and seek medical attention, as this indicates a rare hypersensitivity reaction.

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 Gynecological and Women’s Health Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Pharmacy Chain Supplier for OTC women’s health products 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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