MedPath
HSA Approval

RECTOGESIC OINTMENT 0.2% w/w

SIN12240P

RECTOGESIC OINTMENT 0.2% w/w

RECTOGESIC OINTMENT 0.2% w/w

March 27, 2003

STEWARD CROSS PTE LTD

STEWARD CROSS PTE LTD

Regulatory Information

STEWARD CROSS PTE LTD

STEWARD CROSS PTE LTD

Therapeutic

Prescription Only

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

GLYCERYL TRINITRATE

0.2% w/w

Nitroglycerin

Documents

Package Inserts

RECTOGESIC OINTMENT 0.2% PI.pdf

Approved: July 1, 2021

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