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Proctosedyl

Suppository

     

Cinchocaine Hydrochloride BP
Hydrocortisone BP
Framycetin Sulphate (Soframycin)
Aesculin


Presentation
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
Aesculin 10mg

Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics)
Framycetin Sulphate
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 inflamed skin.


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
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 unchanged Hydrocortisone.


Cinchocaine Hydrochloride
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
Aesculin is used for external application only.

Uses
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.

 

Contra-indication, warning, etc.
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
None stated


Undesirable effects
None stated


Symptoms and treatment of overdose
In the rare event of overdosage, supportive and symptomatic therapy is indicated.


Pharmaceutical precautions
Store at 2-8C


Package quantities
Pack of 12 suppositories.


Shelf-life
Do not use later than expiry date indicated on the packaging.

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