Sulphacetamide (15% w/v) + Boric Acid (2% w/v) + Phenylephrine (0.002% w/v) + Zinc Sulphate Monohydrate (0.1% w/v)

Clinical Pharmacologist's Monograph

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

1. Clinical Overview

A fixed-dose ophthalmic solution combining a sulfonamide antibiotic (Sulphacetamide), an antiseptic/astringent (Boric Acid), a vasoconstrictor (Phenylephrine), and an astringent/anti-inflammatory agent (Zinc Sulphate). It is primarily indicated for the treatment of acute and chronic conjunctivitis, blepharitis, and other superficial ocular infections, providing antibacterial, anti-inflammatory, decongestant, and astringent actions. It is a mainstay in Indian ophthalmology for managing red eye and minor infections.

OnsetDurationBioavailability
Phenylephrine: 5-10 minutes for vasoconstriction; Sulphacetamide: Antibacterial action begins within hours of application.Phenylephrine: 2-4 hours; Sulphacetamide: Requires multiple daily applications to maintain therapeutic levels.Primarily topical ocular; minimal systemic absorption expected (<1%).

2. Mechanism of Action

The combination exerts a multi-pronged effect: Sulphacetamide competitively antagonizes para-aminobenzoic acid (PABA), inhibiting bacterial dihydropteroate synthase and thus folate synthesis, leading to bacteriostatic action against susceptible organisms. Boric Acid acts as a mild antiseptic and buffer, maintaining an acidic pH unfavorable for bacterial growth and providing soothing action. Phenylephrine is a potent alpha-1 adrenergic agonist causing vasoconstriction of conjunctival blood vessels, reducing redness and edema. Zinc Sulphate provides astringent properties, precipitating proteins to reduce exudation and inflammation, and may have mild antiseptic effects.

3. Indications & Uses

  • Acute and Chronic Conjunctivitis (bacterial)
  • Blepharitis
  • Superficial Ocular Infections
  • Bacterial Keratitis (superficial)

4. Dosage & Administration

Adult Dosage: 1-2 drops into the affected eye(s), 3-4 times daily, or as directed by the physician. Duration typically 5-7 days.

Administration: Wash hands before use. Tilt head back, pull lower eyelid down to form a pouch. Instill prescribed drops without touching the dropper tip to eye or any surface. Close eyes gently for 1-2 minutes, applying pressure at the inner corner of the eye (nasolacrimal occlusion) to reduce systemic absorption. Wait at least 5-10 minutes before instilling any other eye medication.

5. Side Effects

Common side effects may include:

  • Transient stinging/burning on instillation
  • Blurred vision temporarily
  • Mild irritation or itching
  • Reflex tearing

6. Drug Interactions

DrugEffectSeverity
Silver preparations (e.g., Silver Nitrate)Incompatible; forms precipitate with Sulphacetamide.Major
Local Anesthetics (e.g., Procaine, Tetracaine)Antagonize antibacterial effect of Sulphacetamide (PABA derivatives).Moderate
Monoamine Oxidase Inhibitors (MAOIs) e.g., PhenelzinePotentiate pressor effects of Phenylephrine, risk of hypertensive crisis.Major
Tricyclic Antidepressants (TCAs) e.g., AmitriptylineMay potentiate pressor effects of Phenylephrine.Moderate
Beta-blockers (e.g., Timolol eye drops)Potential for unopposed alpha-adrenergic stimulation (Phenylephrine) leading to severe hypertension/bradycardia if systemically absorbed.Moderate

7. Patient Counselling

  • DO wash hands before and after use.
  • DO apply nasolacrimal occlusion (press inner corner of eye) for 1-2 minutes after instillation.
  • DO wait at least 5-10 minutes before using other eye drops.
  • DO complete the full course as prescribed, even if symptoms improve.
  • DON'T touch the dropper tip to your eye, fingers, or any surface.
  • DON'T wear contact lenses during treatment unless advised by doctor.
  • DON'T share your eye drops with others.
  • DON'T use the solution if it changes color or becomes cloudy.

8. Toxicology & Storage

Overdose: Topical: Severe irritation, chemosis, corneal damage. Systemic (from accidental ingestion or massive topical absorption): Nausea, vomiting, diarrhea, dizziness, headache, hypertension, tachycardia (from Phenylephrine), metabolic acidosis (from Boric Acid), sulfonamide-related toxicity (crystalluria, blood dyscrasias).

Storage: Store below 25°C. Protect from light. Keep the bottle tightly closed. Keep out of reach of children. Discard the bottle 4 weeks after opening to prevent contamination. Do not freeze.