RECTOGESIC OINTMENT 0.2% w/w

Mayne Pharma International Pty Ltd (AUSTRALIA)🇸🇬 Health Sciences Authority

Approval Date: Mar 27, 2003
Approval ID: 190f67f7a3ffc8e3
Company: Mayne Pharma International Pty Ltd (AUSTRALIA)
Type: Therapeutic

Approval Details

Approval Id: 190f67f7a3ffc8e3
Drug Name: RECTOGESIC OINTMENT 0.2% w/w
Product Name: RECTOGESIC OINTMENT 0.2% w/w
Approval Number: SIN12240P
Approval Date: 2003-03-27
Registrant: STEWARD CROSS PTE LTD
Licence Holder: STEWARD CROSS PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: OINTMENT
Dosage: 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. The ointment is to be applied 3 times daily or more frequently on the advice of a medical practitioner. Close the tube tightly, immediately after each use. For anal fissure, treatment with Rectogesic® should be continued for 2 – 4 weeks, with assessment by a medical practitioner after 2 weeks. For haemorrhoidectomy, treatment with Rectogesic® should be continued for a minimum of 2 weeks, with assessment by a medical practitioner after the initial 2 weeks. Adverse effects If headache, fainting or dizziness are observed, treatment should cease for a minimum of 8 hours and then the dosage halved. Simple analgesics such as paracetamol may be helpful for headaches. If headaches are severe and persist, cease administration. Nitrate-free period A daily ‘nitrate-free period’ of 12 hours is required during treatment with Rectogesic® to avoid the development of tolerance. This would normally be overnight. Where Rectogesic® is used concurrently with another nitric oxide donor, the nitrate-free period should correspond with the nitrate-free period already applying to the nitric oxide donor (e.g. this may be during the day for those angina patients who require overnight treatment with glyceryl trinitrate patches). The frequency of use of Rectogesic® may need to be reduced to twice daily when it is used in conjunction with another nitric oxide donor, to reduce the likelihood of adverse systemic effects and to allow an adequate nitrate-free period for the other nitric oxide donor product. Use in children Safety and effectiveness in children and adolescents under 18 years of age have not been established.
Route Of Administration: TOPICAL
Indication Info: INDICATIONS For the treatment of anal fissure and relief of the symptoms associated with anal fissure. For relief of pain and to aid wound healing as part of post-operative management following haemorrhoidectomy.
Contraindications: CONTRAINDICATIONS Hypersensitivity to glyceryl trinitrate or any of the excipients in the formulation Severe anaemia, glaucoma, pregnancy, lactation, hypotension, increased intracranial pressure, idiosyncrasy to glyceryl trinitrate, migraine or recurrent headache, aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or pericardial tamponade, postural hypotension, and uncorrected hypovolaemia. Glyceryl trinitrate should not be coadminstered with Viagra™ (sildenafil citrate), Cialis™ (tadalafil) or Levitra™ (vardenafil) as these drugs may potentiate the hypotensive effects of organic nitrates.
Atc Code: C05AE01
Atc Item Name: glyceryl trinitrate
Pharma Manufacturer Name: STEWARD CROSS PTE LTD

Active Ingredients

GLYCERYL TRINITRATE

0.2% w/w

GLYCERYL TRINITRATE

0.2% W/W

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 27, 2003

Approval ID

190f67f7a3ffc8e3

Type

Therapeutic

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