Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
OINTMENT
**DOSAGE AND ADMINISTRATION** _Adults_ Insert a 1 to 1.5 cm strip of ointment (see measurement on box) into the anal canal, either with the finger or an applicator. Apply the ointment 3 times daily and do not exceed this dosage. Close the tube tightly, immediately after each use. _Use in children_ Safety and effectiveness in children have not been established.
TOPICAL
Medical Information
**INDICATIONS** For the treatment of anal fissure and relief of the symptoms associated with anal fissure.
**CONTRAINDICATIONS** Severe anaemia, glaucoma, pregnancy, lactation, hypotension, increased intracranial pressure and idiosyncrasy to glyceryl trinitrate. Glyceryl trinitrate should not be coadministered with Viagra™ (sildenafil citrate) and/or other Phosphodiesterase Type 5 (PDE5) Inhibitors as this may potentiate the hypotensive effects of organic nitrates.
C05AE01
glyceryl trinitrate
Manufacturer Information
STEWARD CROSS PTE LTD
Mayne Pharma International Pty Ltd
Active Ingredients
Documents
Package Inserts
RECTOGESIC OINTMENT 0.2% PI.pdf
Approved: July 1, 2021