Cinchocaine Hydrochloride BP
Framycetin Sulphate (Soframycin)
Proctosedyl is available as smooth off-white suppositories. Each suppository
contains the following active ingredients:
Cinchocaine Hydrochloride BP 5mg
Hydrocortisone BP 5mg
Framycetin Sulphate (Soframycin) 10mg
Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
Framycetin Sulphate is administered topically in the treatment of infection
of the skin due to susceptible organism such as Staphylococci. Application
to the skin have been reported to produce no detectable levels in the blood
and urine or sufficient absorption to cause systemic toxicity. However,
application to areas of denuded skin (e.g. in serious burns) has resulted in
significant absorption and it has been reported to occur from wounds and
Once absorbed, it is rapidly excreted by the kidneys in the active form:
30-50% of a parenteral dose has been detected in the urine.
Due to its known toxicological profile contraindicating its parenteral use
and its excellent activity, Framycetin is well suited for topical use.
Hydrocortisone is absorbed through the skin, particularly in denuded areas
when applied topically. it acts locally as an anti-inflammatory agent. When
absorbed systematically, it has a biological half-life of about 100 minutes
and is more than 90% bound to plasma proteins. It is metabolized in the
liver and most body tissues to hydrogenated and degraded forms which are
then excreted in the urine as glucoronides with a small proportion of
Cinchocaine Hydrochloride is a local anaesthetic suitable for surface
anaesthesia. It has a more prolonged action than Lignocaine. Like other
local anaesthetics of the amide type it is metabolized in the liver.
Aesculin is used for external application only.
The local anaesthetic cinchocaine relieves pain and relaxes sphincteric
spasm. Pruritus and inflammation are relieved by hydrocortisone, which also
decreases serous discharge, while Framycetin controls local infection (a
cause of inflammation and irritation).
Proctosedyl is thus used for the following internal and external
haemorrhoids; prophylaxis between attacks to prevent recurrences;
haemorrhoidal complications - anal pruritus, perianal eczema, proctitis,
fissure; pre-operative and post operative treatment of haemorrhoidectomy
patients; post-partum haemorrhoidal conditions.
Dosage and administration
A suppository is inserted morning and evening, and after each stool. The
ointment may be used separately or concurrently with the suppositories.
Known hypersensitivity to any of the ingredients. In pregnant animals, a
ministration of corticosteroids can cause abnormalities of foetal
development. The relevance of this finding to human beings has not been
established. However topical steroids should not be used extensively in
pregnancy, i.e. in large amounts or for long periods.
As with all preparations containing topical corticosteroids, the possibility
of systemics absorption should be considered. In particular, long-term
continuous therapy should be avoided in infants. Adrenal suppression can
occur even without occlusion.
Interaction with other medicaments
Symptoms and treatment of overdose
In the rare event of overdosage, supportive and symptomatic therapy is
Store at 2-8°C
Pack of 12 suppositories.
Do not use later than expiry date indicated on the packaging.