Proctosedyl

Proctosedyl

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Hydrocortisone, cinchocaine hydrochloride, framycetin sulfate, aesculin.
Description
Each gram of ointment or suppository contains the following active ingredients: Cinchocaine Hydrochloride 5mg, Hydrocortisone 5mg, Framycetin Sulphate (Soframycin) 10mg, Aesculin 10mg.
Action
Pharmacology: 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.
Indications/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 postoperative treatment of haemorrhoidectomy patients; post‐partum haemorrhoidal conditions.
Dosage/Direction for Use
Ointment: Apply in small quantity with the finger on the painful or pruritic area, morning and evening and after each stool. For deep application, attach cannula to tube, insert to full extent and squeeze tube gently from lower end whilst withdrawing.
Suppository: A suppository is inserted morning and evening, and after each stool. The ointment may be used separately or concurrently with the suppositories.
Overdosage
Symptoms and treatment of overdose: In the rare event of overdosage, supportive and symptomatic therapy is indicated.
Contraindications
Use in the presence of untreated infections of viral, bacterial, tuberculous, parasitic or fungal origin. Known hypersensitivity to any of the ingredients. In pregnant animals, administration 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. Hydrocortisone may pass into human breast milk. This product should not be used in pregnancy or lactation unless considered essential by the physician. As with all preparations containing topical corticosteroids, the possibility of systemics absorption should be considered. In particular, long‐term continous therapy should be avoided in infants. Adrenal suppression and growth retardation can occur even without occlusion. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilation. Before prescribing the product any potential malignancies should be excluded. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Adverse Reactions
Itching, pain or rash may develop around the back passage.
Skin and subcutaneous disorders: Frequency not known: Urticaria, anal irritation, rash.
Endocrine disorders: Frequency not known: Pheochromocytoma crisis, adrenal suppression.
Eye disorders: Vision blurred.
Drug Interactions
None stated.
Storage
Ointment: Store below 25°C.
Suppository:
Store at 2-8°C.
ATC Classification
C05AA01 - hydrocortisone ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures.
Presentation/Packing
Oint (colourless, yellowish-white, translucent, greasy) 15 g. Supp (smooth, off-white) 12's.
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