SCHERIPROCT

What it is

Scheriproct contains synthetic corticosteroids, prednisolone hexanoate and cinchocaine hydrochloride. The ointment formulation contains 1.9 mg prednisolone hexanoate (equivalent to 1.5 mg of prednisolone) and 5 mg cinchocaine hydrochloride per 1 g. The suppository formulation contains 1.3 mg prednisolone hexanoate (equivalent to 1 mg of prednisolone) and 1 mg cinchocaine hydrochloride per suppository. Prednisolone exerts an anti-inflammatory, anti-allergic and anti-pruritic effect, whilst cinchocaine eases pain as a local anaesthetic.

Approved indications

— Symptomatic relief of pain and irritation associated with haemorrhoids. — Symptomatic relief of pain and irritation associated with superficial anal fissures. — Symptomatic relief of pain and irritation associated with proctitis.

Dosing overview

Scheriproct ointment should generally be applied twice daily; on the first day, for faster symptomatic relief, it may be applied up to four times. A small amount of ointment (about the size of a pea) should be smeared around the anus and in the anal ring with a finger. Scheriproct suppositories are generally inserted once daily high into the rectum; if symptoms are severe, one suppository may be inserted two to three times on the first day. Treatment should be continued for at least one week, though less frequently (ointment once a day or one suppository every other day), even when symptoms have completely disappeared; however, duration of treatment should not exceed 4 weeks.

Key safety warnings

Prolonged use leads to atrophy, and systemic absorption may be increased when there is local trauma or prolonged use. 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). The excipients in Scheriproct ointment and suppository may reduce the effectiveness of latex products such as condoms. Additional specific therapy is required in fungal, bacterial and viral infections.

Contraindications

Scheriproct is contraindicated in tuberculous or syphilitic processes in the area to be treated, viral diseases (such as vaccinia and chickenpox), hypersensitivity to individual components, traumatised skin, and local infections where concomitant therapy is not in place.

Regulatory history

Scheriproct was first approved on 8 May 2000. The ointment (ARTG 70062) and suppository (ARTG 70063) formulations were both first listed on 2000-05-08 under licence category RE.