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Cyproterone / Ethinylestradiol (Diane-35)

Overview

Field Detail
Drug class Hormonal contraceptive
Route Oral
Stock vial Cyproterone 2 mg / Ethinylestradiol 35 µg tablet (Diane-35)
Reconstituted conc. Crush tablet, dissolve in NS for testing
Diluent Nil
Storage Room temp; Protect from light and moisture

Note

SPT only — no IDT protocol available for this drug. Tablets must be crushed and dissolved in normal saline to prepare the SPT test solution.

Preparation

Before you start

Check the expiry date and blister pack integrity before opening. Label every syringe immediately after drawing up — never leave unlabelled syringes on the tray.

Equipment needed

  • 1 × Diane-35 tablet (Cyproterone 2 mg / Ethinylestradiol 35 µg)
  • Mortar and pestle (for crushing tablet)
  • Normal saline (NS) 0.9% — for dissolving crushed tablet
  • 1 mL syringe × 1
  • 25 G needles

Step 1 — Prepare the SPT solution (neat — crushed tablet solution)

  1. Place one Diane-35 tablet into a clean mortar.
  2. Crush the tablet to a fine powder using the pestle.
  3. Add a small volume of NS (approximately 1–2 drops) to the powder and mix to form a paste/solution.
  4. Draw up the solution into a 1 mL syringe.
  5. Label: "Diane-35 SPT (crushed tablet solution)".

Skin prick test (SPT)

Reagent Concentration
Test solution Neat (crushed tablet solution)
Positive control Histamine 10 mg/mL
Negative control Normal saline

Interpretation: Wheal ≥3 mm vs negative control = positive.