Doxycycline Tablets

Description

Doxycycline Tablets (100mg)

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 Manufacturer of Doxycycline Tablets in India. Doxycycline is a tetracycline-class antibiotic active against a range of susceptible bacteria and certain other organisms. Depending on local approval, organism susceptibility and clinical guidance, it may be used for conditions such as selected respiratory or sexually transmitted infections, acne, rickettsial infections, Lyme disease and malaria prevention. Antibiotics should be used only for appropriate indications to reduce treatment failure and antimicrobial resistance.

Film-coated Doxycycline Hydrochloride and dispersible Doxycycline Monohydrate formulations can have different product specifications and administration instructions. Product claims should therefore follow the exact registered dosage form rather than assuming that all Doxycycline formulations are interchangeable.

2. Product Specifications

3. Manufacturing Technology

• Film-Coated Tablets: Coating is applied according to the registered formulation to support tablet handling, taste masking and product stability. Coating does not eliminate the risk of pill esophagitis.
• Dispersible Tablets: Where registered, the formulation is designed to disperse according to its validated product specification and should be administered exactly as labeled.
• Process Control: Dispensing, blending, compression and in-process testing are controlled to support dosage-unit uniformity and reproducible performance.
• Light & Moisture Protection: Packaging systems are selected according to validated stability data rather than relying on a universal blister/coating configuration.

4. Quality Assurance

• Assay & Uniformity: Potency and dosage-unit uniformity are tested against applicable pharmacopoeial/registered limits.
• Dissolution: Drug release is evaluated using the product-specific registered method and acceptance criteria rather than a universal 85%/30-minute target.
• Related Substances: Relevant tetracycline-related impurities and degradation products are monitored with validated analytical methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Doxycycline binds to the bacterial 30S ribosomal subunit and inhibits protein synthesis. Its activity is generally bacteriostatic, although clinical effectiveness depends on the organism, site of infection and susceptibility.

• Acne: Oral Doxycycline may be used for selected moderate-to-severe inflammatory acne, usually as part of an antimicrobial-stewardship-conscious treatment plan.
• Sexually Transmitted Infections: It is used for selected infections such as chlamydial disease. Gonorrhea and syphilis treatment choices depend on current guidelines, susceptibility and patient factors; Doxycycline should not be presented as a universal first-line treatment for all STIs.
• Respiratory / Other Infections: May be used for selected susceptible infections according to diagnosis and local guidance.
• Malaria Prevention: Doxycycline is one option for prophylaxis in appropriate travelers, depending on destination, resistance patterns, contraindications and current travel-medicine guidance.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Market-Specific Packaging: Retail, institutional or travel-oriented pack sizes can be supplied only where consistent with product registration and procurement requirements.
• Logistics: Export support by air or sea according to applicable regulatory and commercial requirements.

7. Frequently Asked Questions

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

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

Q: Why is water important when taking an oral Doxycycline tablet?
A: Doxycycline can irritate the esophagus. Conventional oral tablets/capsules are commonly taken with adequate fluid and patients are generally advised not to lie down immediately afterward; follow the exact product label for administration instructions.

Q: Can Doxycycline increase sensitivity to sunlight?
A: Yes. Photosensitivity can occur. Patients should follow medical advice about limiting intense sun/UV exposure and using appropriate protective measures.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Regimen: Dose, frequency and treatment duration vary substantially by infection/indication, age, patient factors and local guideline. A universal “200mg day 1 then 100mg daily” regimen should not be applied to every use.
• Malaria Prophylaxis: Timing before, during and after travel should follow current destination-specific travel-medicine guidance and the registered label.
• Administration: Follow the dosage-form-specific instructions. Adequate fluid and avoiding lying down immediately after conventional oral Doxycycline can reduce esophageal injury risk.
• Food / Minerals: Food may improve gastrointestinal tolerance for some formulations, but calcium, iron, magnesium, aluminum and other polyvalent cations can reduce absorption. Separation requirements depend on the specific product and interacting medicine/supplement.

9. Side Effects and Precautions

• Gastrointestinal / Esophageal: Nausea, vomiting, diarrhea, esophagitis and esophageal ulceration can occur.
• Photosensitivity: Exaggerated sunburn reactions may occur; severity varies between patients.
• Pregnancy & Children: Tetracyclines can affect developing teeth and bone. However, age/pregnancy recommendations are indication-specific, and Doxycycline may still be recommended for certain serious infections when benefits outweigh risks. Follow current specialist guidance rather than treating age <8 years or pregnancy as an absolute rule for every circumstance.
• Intracranial Hypertension: Rarely, tetracyclines can cause intracranial hypertension; persistent headache or visual symptoms require prompt medical assessment.
• Antimicrobial Stewardship: Doxycycline should not be used for viral illnesses or without an appropriate indication. Complete treatment as prescribed and follow local resistance/susceptibility guidance.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive light, heat and moisture.
• Do not use expired or visibly deteriorated product; keep in original packaging and out of reach of children.