Tetracycline (1% w/w) + Hydrocortisone (1% w/w)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

A fixed-dose combination topical preparation containing a broad-spectrum tetracycline antibiotic (Tetracycline) and a low-potency corticosteroid (Hydrocortisone). It is primarily used for the treatment of inflammatory dermatoses with secondary bacterial infections, particularly those caused by susceptible organisms. The combination provides anti-inflammatory, immunosuppressive, and antibacterial actions at the site of application.

OnsetDurationBioavailability
Anti-inflammatory effects of hydrocortisone may be noticeable within 1-2 hours; antibacterial effects of tetracycline begin upon contact with susceptible bacteria.Local effects last approximately 8-12 hours, necessitating application 2-3 times daily as prescribed.Topical bioavailability is low and variable (<5% for both agents), depending on skin integrity, vehicle, and site of application. Systemic absorption is minimal on intact skin but can increase on damaged skin or with occlusive dressings.

2. Mechanism of Action

The combination exerts a dual mechanism: Tetracycline inhibits bacterial protein synthesis, while Hydrocortisone provides potent anti-inflammatory and immunosuppressive activity, reducing redness, swelling, and itching.

3. Indications & Uses

  • Inflammatory acne vulgaris (papules, pustules)
  • Impetigo contagiosa (non-bullous)
  • Infected eczema/dermatitis
  • Folliculitis (bacterial)

4. Dosage & Administration

Adult Dosage: Apply a thin layer to the affected area 2 to 3 times daily, gently rubbing in. Duration should be limited to a maximum of 2 weeks for facial use and 4 weeks for body use, unless directed by a physician.

Administration: Wash and dry the affected area thoroughly before application. Use fingertips to apply a pea-sized amount for each area (approx. 0.5g). Avoid contact with eyes, nose, mouth, mucous membranes, and broken skin unless indicated. Do not use occlusive dressings unless specifically advised. Wash hands before and after application.

5. Side Effects

Common side effects may include:

  • Local burning or stinging sensation
  • Skin dryness or peeling
  • Itching (pruritus)
  • Erythema (redness) at application site

6. Drug Interactions

DrugEffectSeverity
Oral Anticoagulants (Warfarin)Tetracycline may potentiate anticoagulant effect, increasing INR risk.Moderate
Oral Retinoids (Isotretinoin)Concurrent use may increase risk of pseudotumor cerebri.High
Metallic cation-containing products (Oral/ Topical Iron, Calcium, Magnesium, Aluminum, Zinc)Can chelate tetracycline, reducing its antibacterial efficacy if applied to same area or ingested.Moderate
Systemic CorticosteroidsAdditive risk of adrenal suppression and Cushingoid effects.High
Live VaccinesHydrocortisone may diminish immunological response; avoid vaccination during therapy.Moderate

7. Patient Counselling

  • DO use exactly as prescribed by your doctor.
  • DO wash hands before and after application.
  • DO clean and dry the affected area before applying.
  • DO use a pea-sized amount for each affected area.
  • DON'T apply near eyes, nostrils, mouth, or on broken skin unless directed.
  • DON'T use occlusive dressings (bandages, wraps) unless advised.
  • DON'T use for longer than the prescribed duration.
  • DON'T share this medication with others.

8. Toxicology & Storage

Overdose: Topical overdose can lead to extensive systemic absorption: Symptoms may include Cushingoid features (moon face, central obesity), adrenal suppression, hyperglycemia, hypertension, electrolyte imbalance, and in severe cases, symptoms of tetracycline toxicity (nausea, vomiting, diarrhea, photosensitivity, hepatotoxicity).

Storage: Store at room temperature (15-25°C), in a cool, dry place, away from direct sunlight and heat. Keep the tube tightly closed. Do not freeze. Keep out of reach and sight of children. Do not use after the expiry date printed on the pack.