Diethylcarbamazine Tablets

Description

Diethylcarbamazine Citrate Tablets (50mg / 100mg / other registered strengths)

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. manufactures Diethylcarbamazine Citrate (DEC) Tablets in India. DEC is an antifilarial medicine used in selected filarial infections and in public-health programs where recommended by national or international guidance. Appropriate use depends on the parasite, geographic setting, co-endemic infections and program-specific protocols. Particular caution is required where Onchocerca volvulus or high-burden Loa loa infection may be present because treatment can provoke serious inflammatory or neurologic reactions.

2. Product Specifications

3. Manufacturing Technology

• Moisture Control: Environmental controls, excipient selection and packaging are established according to validated process and stability requirements rather than a universal fixed relative-humidity claim.
• Blend Uniformity: Validated dispensing and blending processes support consistent active distribution across dosage units.
• High-Volume Supply: Batch scale and packaging can be configured for authorized institutional, tender and public-health requirements subject to capacity and regulatory approval.
• Packaging: Moisture-protective blister/bottle systems may be selected based on stability data and destination-market requirements.

4. Quality Assurance

• Assay & Uniformity: Potency and dosage-unit uniformity are verified against approved pharmacopoeial/registered limits.
• Dissolution: Drug release is tested according to the applicable finished-product method and acceptance criteria rather than a universal percentage/time target.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical methods.
• Microbial Quality & Stability: Testing follows applicable non-sterile product requirements, and shelf life is supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Diethylcarbamazine has activity against susceptible filarial parasites, particularly microfilariae, through mechanisms involving altered parasite surface properties and host-mediated clearance; its effects are not adequately described simply as “paralysis.”

• Lymphatic Filariasis: DEC may be used for treatment and in certain mass drug administration programs, depending on local epidemiology and public-health guidance.
• Tropical Pulmonary Eosinophilia: DEC may be used when this filarial-associated syndrome is appropriately diagnosed.
• Loiasis: Treatment requires specialist assessment. Patients with high Loa loa microfilarial loads can develop severe, potentially fatal neurologic reactions after microfilaricidal treatment.
• Onchocerciasis: DEC is generally avoided where onchocerciasis is present because severe Mazzotti reactions and ocular injury can occur; management should follow specialist/public-health guidance.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Institutional Supply: Tender or public-health packaging can be supported subject to approved specifications and procurement requirements.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Diethylcarbamazine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Diethylcarbamazine Citrate tablet formulations in India.

Q: Is Diethylcarbamazine available under brand names?
A: Yes. DEC is marketed under different brands. A product should only be described as bioequivalent or therapeutically interchangeable with a specific reference product when supported by the required regulatory evidence.

Q: Can treatment cause fever or headache?
A: Yes. Reactions can result from the medicine itself or inflammatory responses to dying parasites. Fever, headache, dizziness, nausea, rash or lymphatic symptoms should not simply be interpreted as proof that treatment is “working”; severity should be clinically assessed.

Q: Can DEC be used during pregnancy?
A: Pregnancy recommendations depend on the indication and public-health program. Mass-treatment programs commonly have specific exclusion criteria. Individual treatment should follow current local/WHO guidance and clinician assessment.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individual Treatment: Dose and duration vary by parasite, body weight, disease severity, geographic setting and local guideline. Use the registered prescribing information or specialist/public-health protocol.
• Mass Drug Administration: Regimens differ by country and co-endemic infections and may involve other medicines. MDA should be conducted only under authorized public-health programs; no universal annual combination should be inferred for every region.
• Renal Function: Clinically significant renal impairment may alter exposure and can require individualized adjustment/monitoring.
• Administration: Follow the specific registered label or program instructions regarding food and timing.

9. Side Effects and Precautions

• Common Reactions: Headache, dizziness, nausea, fever and other systemic symptoms may occur.
• Parasite-Related Inflammatory Reactions: Killing microfilariae can trigger inflammatory reactions. Management depends on severity and should be clinician-directed rather than automatically self-treating with antihistamines or antipyretics.
• Onchocerciasis: Avoid unsupervised DEC use where O. volvulus infection is known or suspected because severe reactions and ocular complications can occur.
• Loiasis: In endemic settings, assessment for high Loa loa microfilaremia may be essential before microfilaricidal treatment because of encephalopathy risk.
• Pregnancy / Children / Comorbidities: Eligibility and regimen should follow the registered label and current specialist/public-health guidance.

10. Storage Instructions

• Store below 30°C unless otherwise specified on the registered label.
• Keep in a dry place and protect from excessive moisture and heat.
• Keep the container/package securely closed and out of reach of children.