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Logo PROCTOSEDYL OINTMENT
PROCTOSEDYL SUPPOSITORIES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form)

PROCTOSEDYL OINTMENT
PROCTOSEDYL SUPPOSITORIES

COMPOSITION
Each suppository or gram of ointment contains the following active ingredients:
       
Cinchocaine hydrochloride        5 mg
       
Hydrocortisone        5 mg
       
Framycetin Sulphate BP        10 mg
       
Aesculin        10 mg

PHARMACOLOGICAL CLASSIFICATION
A. 11.8 Suppositories and anal ointments

PHARMACOLOGICAL ACTION
The local anaesthetic cinchocaine hydrochloride prevents or relieves the severe pain sometimes encountered in strangulated haemorrhoids, fissures and perianal haematomata, whilst the corticosteroid acts as a decongestant, anti-inflammatory and anti-pruritic agent and by so doing eliminates itching, inflammation and mucous discharge. The broad spectrum antibiotic, framycetin sulphate, will eradicate most infections which may already be present or arise in lesions of the anorectal area.

INDICATIONS
a)        For the treatment of internal and external haemorrhoids
b)        Haemorrhoids post-partum
c)        Anal pruritus, peri-anal eczema, anal fissures and proctitis
d)        Post-haemorrhoidectomy application to relieve pain and discomfort

CONTRA-INDICATIONS
Known hypersensitivity to any of the ingredients. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore Proctosedyl should not be used during pregnancy. Topical corticosteroid preparations are contra-indicated in the treatment of herpes simplex, vaccinia or varicella, or tuberculous infection of the anal region (chronic fissure).

DOSAGE AND DIRECTIONS FOR USE
A suppository is inserted morning and evening, and after each stool. Apply the ointment 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. The ointment may be used separately or concurrently with the suppositories.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Long-term continuous treatment with topical corticosteroids should be avoided as far as possible as this may cause atrophic changes in the skin leading to thinning, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. These changes are particularly likely to occur when occlusive dressings are used. Systemic absorption of topically applied corticosteroids may occur, particularly under the following conditions: when large quantities are used or when application is made to wide areas of the body, or to damaged skin; when potent topical corticosteroids are used, and when the occlusive dressing technique is applied. Depression of the hypothalamic-pituitary-adrenal axis with consequent suppression of the adrenal gland may occur. These effects are most likely to be severe in children. Growth may be retarded and a Cushingoid state may be produced. Benign intracranial hypertension has been rarely reported.

The application of local anaesthetics to the skin for prolonged periods or to extensive areas should be avoided as local anaesthetics are potent sensitisers and allergic reactions may occur.

Prolonged local use of aminoglycosides should be avoided as it may lead to skin sensitisation. Ototoxicity has occurred following the topical application of aminoglycosides to mucous membranes. Reversible nephrotoxicity may occur.

The symptoms of overdosage of aesculin are muscle twitching, lack of co-ordination, dilated pupils, vomiting, diarrhoea, paralysis and stupor.

The following special precaution is recommended: if a secondary microbial skin infection is present, suitable concomitant anti-microbial therapy should be instituted.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Not applicable.

CONDITIONS OF REGISTRATION
To be advertised to the professions only.

IDENTIFICATION
Ointment:        An odourless yellowish-white translucent greasy ointment.
Suppositories:         Smooth, off-white suppositories.

PRESENTATION
Tubes containing 30 g ointment. Packs of 12 suppositories.

STORAGE INSTRUCTIONS
Store in a cool, dry place, below 25
°C.
Keep out of reach of children.

REFERENCE NUMBER
Ointment:        E530 (ACT 101/1965)
Suppositories:        E529 (ACT 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Roussel Laboratories (Pty) Ltd.,
REG. NO. 66/01057/07
5th Street, Marlboro Extension 1,
SANDTON 2199

DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 December 1993

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