Description

Metronidazole Vaginal Tablets (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 Metronidazole Vaginal Tablets in India. This gynecological formulation is a targeted antimicrobial therapy designed for the local treatment of Bacterial Vaginosis (BV) and Trichomoniasis. Unlike oral medication, vaginal tablets deliver the drug directly to the site of infection, ensuring high local concentration with significantly reduced systemic side effects (such as nausea or metallic taste).

We offer Contract Manufacturing (Third Party) services for this niche product, often referred to as “Pessaries” or “Vaginal Inserts.” Our WHO-GMP certified facility in Mumbai utilizes specialized tooling to create smooth, oval-shaped tablets for comfortable insertion. Healthy Inc manages the export logistics, often supplying these with individual applicators to meet the needs of women’s health programs and pharmacies across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Formulating for vaginal delivery requires understanding localized dissolution.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Disintegration Control: The vagina has very limited fluid compared to the stomach. We formulate these tablets with specialized Hydrophilic Disintegrants and mild surfactants to ensure they dissolve completely and spread even with minimal moisture.

  • Shape & Texture: We use dedicated “bullet” or “oval” shape tooling to ensure the tablet is smooth and easy to insert without causing irritation to the delicate mucosal tissue.

  • pH Balanced: The formulation is designed to be compatible with the natural vaginal pH, minimizing stinging or irritation upon release.

• The Exporter: Healthy Inc

  • Customized Packaging: We offer flexible packaging solutions, including “Combi-Kits” (Vaginal Tablet + Antifungal Cream) or standard blisters with disposable applicators, which are highly preferred in export markets for hygiene and ease of use.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards for Vaginal Products:

• Disintegration Time: We test strictly to ensure the tablet breaks down within the specified time (typically < 30 minutes) in simulated vaginal fluid.

• Microbial Limits: Given the application site, we enforce stringent bioburden testing to ensure the product is free from pathogens like Candida albicans or E. coli.

• Assay: We ensure 100% label claim of Metronidazole to guarantee infection clearance.

5. Why Use Metronidazole Vaginal Tablets?

Targeted action with fewer side effects.

• Mechanism: Metronidazole enters the bacterial or protozoal cells and disrupts their DNA structure, leading to cell death. It effectively targets anaerobic bacteria (like Gardnerella vaginalis) and protozoa (Trichomonas).

• Key Indications:

  • Bacterial Vaginosis (BV): The most common cause of vaginal discharge in women of childbearing age.

  • Trichomoniasis: A sexually transmitted infection caused by a parasite.

  • Pre-Surgical Prophylaxis: Sometimes used before gynecological surgeries.

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 Metronidazole Vaginal Tablets?

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

• Q: Can I drink alcohol while using this?

  A: No. Even though it is applied vaginally, some drug is absorbed into the bloodstream. Metronidazole can cause a severe reaction (vomiting, flushing) with alcohol. Avoid alcohol during treatment and for 24 hours after.

• Q: Should I use it during menstruation?

  A: It is generally recommended to avoid using vaginal tablets during menstruation as the blood flow can wash the medication away, reducing efficacy.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet inserted into the vagina, usually at bedtime.

• Duration: Typically 5 to 7 consecutive nights for BV.

• Administration: Insert high into the vagina using the applicator or finger. Remain lying down for 15-30 minutes to prevent leakage.

9. Side Effects and Precautions

• Local Effects: Mild vaginal burning, itching, or irritation.

• Discharge: A chalky white discharge may occur as the tablet dissolves; this is normal.

• Sexual Intercourse: Avoid intercourse during treatment to prevent cross-infection and because the infection itself requires rest to heal.

   

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly away from moisture (do not store in a humid bathroom cabinet).