Država: Južnoafriška republika
Jezik: angleščina
Source: South African Health Products Regulatory Authority (SAHPRA)
Roussel
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 DIRECTIO Preberite celoten dokument