Description

Clotrimazole Vaginal Tablets (100mg / 200mg / 500mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Clotrimazole Vaginal Tablets (Pessaries) in India. This product is the first-line gynecological treatment for Vulvovaginal Candidiasis (Vaginal Thrush/Yeast Infection). It offers a localized, high-concentration antifungal therapy that resolves infections rapidly without systemic side effects.

We offer Contract Manufacturing (Third Party) services for this specialized dosage form. Unlike oral tablets, vaginal tablets must disintegrate in a low-moisture environment. Our WHO-GMP certified facility in Mumbai utilizes specialized Porous Matrix Technology to ensure the tablet breaks down and disperses the drug effectively using only the limited natural vaginal secretions. We offer the full range of treatment options: the 6-Day Course (100mg), the 3-Day Course (200mg), and the convenient Single Dose (500mg). Healthy Inc manages the export logistics, supplying women’s health clinics and pharmacy chains across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Designed for the delicate vaginal environment.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Rapid Disintegration Matrix: The vagina contains very little fluid compared to the stomach. We formulate these tablets with highly soluble excipients (like Lactose Monohydrate and Adipic Acid) and super-disintegrants that foam slightly or wick moisture rapidly. This ensures the tablet dissolves completely within minutes of insertion, preventing “chalky residue” or incomplete dosing.

  • pH Optimization: We often include Lactic Acid in the formulation to help restore the natural acidic pH (3.8 – 4.5) of the vagina, which naturally inhibits fungal growth and supports the restoration of healthy flora (Lactobacillus).

  • Shape Engineering: The tablets are compressed into a smooth, Ovoid or Bullet shape to facilitate comfortable insertion without causing abrasion to the sensitive vaginal mucosa.

• The Exporter: Healthy Inc

  • Combi-Packs: We can manufacture “Combi-Kits” containing the Vaginal Tablet (for internal infection) + Clotrimazole Cream (for external vulvar itching) in a single retail box.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Disintegration: We test using simulated vaginal fluid to ensure the tablet breaks down in < 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Microbial Limits: We strictly monitor for pathogens (E. coli, S. aureus, Pseudomonas) to ensure the product is sterile-grade safe for internal use.

5. Why Use Clotrimazole Vaginal Tablets?

Direct action where it’s needed most.

• Mechanism: Clotrimazole is a broad-spectrum azole antifungal. It works by inhibiting the enzyme Lanosterol 14α-demethylase. This prevents the fungus from producing Ergosterol, a vital component of its cell membrane. Without ergosterol, the fungal cell wall becomes leaky and the cell dies.

• Key Indications:

  • Vaginal Candidiasis (Thrush): Treatment of itching, burning, and discharge caused by Candida albicans.

  • Trichomoniasis: Provides relief (though Metronidazole is primary).

  • Sanitization: Pre-operative sanitization of the birth canal before delivery.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Clotrimazole Vaginal Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Canesten?

  A: Canesten is the brand name (Bayer). We manufacture the Generic Equivalent (Clotrimazole), which uses the same active ingredient.

• Q: Can I use it during my period?

  A: Ideally, No. Menstrual flow can wash the medication out before it works. It is best to finish the treatment before menstruation starts.

• Q: Does it come with an applicator?

  A: Yes. We can supply packs with a hygienic plastic applicator to ensure the tablet is placed high enough in the vagina for maximum effectiveness.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• 100mg: One tablet inserted nightly for 6 consecutive nights.

• 200mg: One tablet inserted nightly for 3 consecutive nights.

• 500mg: Single tablet inserted once (usually effective for mild cases).

• Administration: Insert deep into the vagina using the applicator (or finger) before going to sleep. Lying down prevents the tablet from falling out.

9. Side Effects and Precautions

• Local Reactions: Mild burning, stinging, or irritation upon insertion (usually subsides quickly).

• Condom Damage: Warning: Clotrimazole can weaken latex condoms and diaphragms, causing them to break. Avoid relying on condoms for contraception during treatment and for 3 days after.

• Pregnancy: Generally considered safe in the 2nd and 3rd trimesters (Category B), but manual insertion (without applicator) is recommended to avoid cervical trauma. Consult a doctor first.

10. Storage Instructions

• Store below 25°C in a dry place.

• Avoid Heat. (Tablets generally stable, but high heat can degrade excipients).