Clotrimazole Vaginal Tablets

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. Clotrimazole is an azole antifungal used locally for the treatment of vulvovaginal candidiasis (vaginal thrush/yeast infection). We support contract manufacturing and export-oriented presentations in multiple strengths according to destination-market registration requirements.

2. Product Specifications

3. Manufacturing Technology

• Vaginal Disintegration: The formulation is designed to disintegrate and disperse appropriately after vaginal administration using excipients selected for the registered product.
• Formulation Control: Tablet hardness, disintegration, dissolution/release characteristics and moisture are controlled according to validated specifications.
• Shape & Administration: Product geometry is designed for vaginal administration and patient acceptability.
• Pack Options: Applicators or combination packs may be supplied only where included in the registered market presentation.

4. Quality Assurance

• Disintegration / Release: Testing follows the applicable pharmacopoeial or registered finished-product specification.
• Assay & Uniformity: Clotrimazole content is verified against approved limits.
• Microbial Quality: Microbial limits testing is performed according to applicable requirements. Vaginal tablets are not automatically considered sterile products unless specifically manufactured and registered as sterile.

5. Why Use Clotrimazole Vaginal Tablets?

Clotrimazole inhibits fungal ergosterol synthesis, disrupting fungal cell-membrane function. Vaginal formulations deliver the antifungal locally at the site of infection.

• Vulvovaginal Candidiasis: Used for vaginal yeast infections caused by susceptible Candida species.
• Symptoms: Can help relieve candidiasis-associated itching, burning and abnormal discharge as the infection responds to treatment.
• Other Infections: Clotrimazole vaginal monotherapy is not a substitute for recommended systemic treatment of trichomoniasis or other sexually transmitted infections.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to destination-market requirements.

7. Frequently Asked Questions

Q: Who manufactures Clotrimazole Vaginal Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Clotrimazole vaginal formulations in India.

Q: Is Clotrimazole available under different brands?
A: Yes. Clotrimazole is marketed under multiple brands worldwide. Generic equivalence and interchangeability depend on the specific registered product and local regulatory requirements.

Q: Can it be used during menstruation?
A: Instructions vary by product and treatment regimen. Follow the specific package leaflet or advice from a healthcare professional rather than interrupting or changing treatment independently.

Q: Does it come with an applicator?
A: Applicator availability depends on the registered pack configuration and destination market.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Regimen: Treatment schedules vary by strength, product label, country and patient circumstances. Follow the approved package instructions or clinician's directions.
• Route: For vaginal use only; do not swallow vaginal tablets.
• Administration: Insert as directed by the product instructions, generally at bedtime. Applicator use should follow the specific product leaflet.

9. Side Effects and Precautions

• Local Reactions: Burning, stinging, irritation, discomfort or pelvic symptoms can occur.
• Diagnosis: First-time symptoms, recurrent infections, fever, abdominal/pelvic pain, foul-smelling discharge, bleeding or symptoms that persist despite treatment require medical assessment.
• Latex Products: Some intravaginal clotrimazole products or their formulation components may reduce the effectiveness of latex contraceptives. Follow the specific product leaflet for how long alternative precautions are required.
• Pregnancy: Use during pregnancy should follow clinician advice and the registered product instructions. Applicator recommendations can differ, particularly during pregnancy.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Keep in a dry place and protect from excessive heat and moisture.
• Keep in the original packaging until use.
• Keep out of reach of children.