Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, UK
Rectogesic 4 mg/g Rectal Ointment is indicated in adults for relief of pain associated with chronic anal fissure.
In the clinical development of the drug, a modest effect has been shown on improvements in average daily pain intensity (see Section 5.1).
Rectal use.
A finger covering, such as cling film or a finger cot, may be placed on the finger to be used to apply the ointment. (Finger cots to be obtained separately from local pharmacy or surgical supplies retailer or cling film from local store.) The finger is placed along side a 2.5cm dosing line which is provided on the outside carton in which Rectogesic is supplied, and a strip of ointment the length of the line is expressed onto the end of the finger by gently squeezing the tube. The amount of ointment expressed is approximately 375 mg (1.5 mg GTN). The covered finger is then gently inserted into the anal canal to the distal interphalangeal joint of the finger and applied circumferentially to the anal canal.
The dose delivered from the 4 mg/g ointment is 1.5 mg glyceryl trinitrate. The dose is to be applied intra-anally every twelve hours. Treatment may be continued until the pain abates, up to a maximum of 8 weeks.
Rectogesic should be used following conservative treatment failure for acute symptoms of anal fissure.
No specific information concerning the usage of Rectogesic in the elderly is available
No specific information concerning the usage of Rectogesic in patients with hepatic or renal impairment is available
Rectogesic is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Accidental overdose of Rectogesic may result in hypotension and reflex tachycardia. No specific antagonist of the vasodilator effects of glyceryl trinitrate is known, and no intervention has been subjected to controlled study as a therapy for glyceryl trinitrate overdose. Because the hypotension associated with glyceryl trinitrate overdose is the result of venodilation and arterial hypovolaemia, prudent therapy in this situation should be directed toward increasing central fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary. In exceptional cases of severe hypotension or shock, resuscitation measures may be needed.
Excessive dosage may also give rise to methaemoglobinaemia. This should be treated with methylene blue infusion.
Shelf life: 36 months.
After first opening: 8 weeks.
Do not store above 25°C.
Do not freeze.
Keep the tube tightly closed.
30 g.
Aluminium tubes with white polyethylene non-piercing screw caps.
No special requirements.
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