Description

Secnidazole Tablets (500mg / 1g)

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 Secnidazole Tablets in India. Secnidazole is a second-generation Nitroimidazole Antibiotic and Antiprotozoal agent. It is clinically distinct because of its exceptionally long half-life, which allows for a Single-Dose Cure for many common parasitic and bacterial infections, such as Amoebiasis, Giardiasis, and Bacterial Vaginosis.

We offer Contract Manufacturing (Third Party) services for this high-compliance formulation. Unlike Metronidazole, which requires multi-day dosing, Secnidazole is typically taken just once. Our WHO-GMP certified facility in Mumbai utilizes advanced masking technologies to cover the naturally bitter taste of the API, ensuring patient acceptance. Healthy Inc manages the export logistics, supplying this convenient therapy to developing markets in Africa, Latin America, and Southeast Asia where water-borne parasitic infections are endemic.

2. Product Specifications

3. Manufacturing Technology

Compliance is driven by convenience and taste.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Taste Masking: Secnidazole is intensely bitter (metallic). We use a premium Opadry Film Coating that remains intact in the mouth but dissolves rapidly in the stomach. This prevents the bitter taste from causing gagging or nausea during swallowing.

  • High-Dose Compression: The standard adult dose is 2g (often two 1g tablets). Manufacturing a 1g tablet requires specialized tooling to ensure the tablet is compressed hard enough to be stable but shaped (caplet) to be swallowable.

  • Dissolution: We optimize the disintegration time to ensure the drug releases rapidly to attack the parasites effectively.

• The Exporter: Healthy Inc

  • Combi-Packs: We specialize in “Single Treatment Packs” (e.g., a blister of 2 tablets of 1g). This packaging ensures the patient takes the full curative dose at once, eliminating the issue of patients stopping medication early when symptoms improve.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency is strictly within 90-110% limits.

• Dissolution: We test release profiles to ensure rapid bioavailability.

• Related Substances: We monitor for impurities to ensure safety over the 3-year shelf life.

5. Why Use Secnidazole?

It is the most convenient option for parasitic infections.

• Mechanism: It enters the microorganism, where its nitro group is reduced. This reduced form damages the DNA of the parasite or anaerobic bacteria, causing cell death.

• Key Indications:

  • Intestinal Amoebiasis: Acute dysentery caused by Entamoeba histolytica.

  • Giardiasis: Infection of the small intestine.

  • Trichomoniasis: A common sexually transmitted infection.

  • Bacterial Vaginosis: Infection of the vagina.

• Advantage: Its half-life is ~25 hours (compared to 8 hours for Metronidazole). This makes a single dose as effective as a 5-7 day course of Metronidazole.

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 Secnidazole Tablets?

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

• Q: Can I drink alcohol with this?

  A: NO. Like all nitroimidazoles, Secnidazole can cause a severe “Disulfiram-like reaction” (vomiting, flushing, tachycardia) if mixed with alcohol. Avoid alcohol for 48 hours after the dose.

• Q: Is it safe for children?

  A: Yes, dosage is calculated by weight (usually 30mg/kg) for children with Amoebiasis or Giardiasis.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults (Urethritis/Vaginitis/Amoebiasis/Giardiasis): 2g taken as a Single Dose (e.g., two 1g tablets or four 500mg tablets).

• Hepatic Amoebiasis: 1.5g per day for 5 days.

• Administration: Swallow whole with water. Best taken with a meal to improve tolerance.

9. Side Effects and Precautions

• Common Side Effects: Metallic taste in the mouth, nausea, glossitis (sore tongue), and abdominal pain.

• Neurological: Rare cases of dizziness or coordination issues (ataxia).

• Pregnancy: Contraindicated in the first trimester. Can be used in 2nd/3rd trimesters if benefit outweighs risk. Breastfeeding should be suspended for 3-4 days after the dose.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.