Cinchocaine/ Prednisolone

Registered South African indications:

• Symptomatic relief of perianal discomfort, inflammation, and itching
  - Due to thrombosed haemorrhoids
  - Due to anal fissure
  - Due to pruritus ani

Registered South African contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Known sensitivity to local anaesthetics
• Viral infections, primary bacterial or fungal infections in the treatment area
• Virus diseases (e.g. vaccinia, chickenpox)
• Secondary infections of the skin in the absence of appropriate anti-infective therapy
• Tuberculous or syphilitic processes in the area to be treated
• Cinchocaine/ prednisolone should not be used during pregnancy

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Known sensitivity to local anaesthetics
• Viral infections
• Primary bacterial or fungal infections
• Secondary infections of the skin in the absence of appropriate anti-infective therapy

• Pregnancy (Recommendations in other jurisdictions)
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly 
• Application of large quantities
• Concomitant use of latex products
• Infants

Forms avail. in SA and covered in this monograph: sup, oin

South African registered indications and dosages

Symptomatic relief of perianal discomfort, inflammation, and itching
- Due to thrombosed haemorrhoids
- Due to anal fissure
- Due to pruritus ani

Cinchocaine/Prednisolone
1/1.3 (mg)

• Rectal (sup): Initial (if symptoms are severe): Insert 1 sup, 2-3 times on the first day high into the rectum; Maintenance: Insert 1 sup, daily high into the rectum. The anal region should be cleaned thoroughly before use, and the suppository is best inserted after defaecation; Treatment duration: Short term (5-7 days)

There is usually a rapid improvement, but this should not mislead one into stopping treatment too soon

Cinchocaine/Prednisolone
5/1.9 (mg)

• Rectal (oin): Initial: Apply in a thin layer, 3-4 times on the first day for faster symptomatic relief; Maintenance: Apply in a thin layer, twice daily. The anal region should be cleaned thoroughly before use, and the ointment is best applied after defaecation; Treatment duration: Short term (5-7 days)

Ointment administration: Smear a little ointment (about the size of a pea) around the anus and in the anal ring with a finger, using the fingertip to overcome the resistance of the sphincter. For very inflamed and painful lesions, it is advisable initially to apply the ointment internally with the finger. Protruding lumps should be thickly smeared and carefully pressed back with the finger. If applying within the rectum, use the enclosed applicator (refer to relevant product information)

No information available

Pregnancy 

South African recommendations

• Contraindicated
• 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 cinchocaine/ prednisolone is contraindicated for use during pregnancy
• There is insufficient data on the use of cinchocaine/ prednisolone in pregnant women. Studies in animals (mice and rats) have shown reproductive toxicity for prednisolone hexanoate
• In general, the use of topical preparations containing glucocorticoids should be avoided during the first trimester of pregnancy
• Epidemiological studies suggest that there could possibly be an increased risk of oral clefts among newborns of women who were treated with glucocorticoids during the first trimester of pregnancy

Recommendations in other jurisdictions

• Caution
• There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects on the human foetus

Breastfeeding

South African recommendations

• Caution
• There is insufficient information on the excretion of prednisolone hexanoate and cinchocaine hydrochloride in human milk

Recommendations in other jurisdictions

• Caution; no information available

Fertility

Recommendations below are applicable to South Africa and other jurisdictions

• Caution; no information available

• Caution; no information available

• Caution; no information available

• Caution; no information available

Endocrine and Metabolic Disorders

• Adrenal suppression

Skin and Subcutaneous Tissue Disorders

• Skin atrophy

Immune, Blood and Lymphatic System Disorders

• Allergic skin reactions

• CYP3A4 inhibitors
• Cobicistat-containing products

None routine

Cinchocaine
Cinchocaine hydrochloride has a local anaesthetic effect on mucous membranes and, in combination with prednisolone hexanoate, provides quick relief of painful and pruritic symptoms.

Prednisolone
On local application, exerts a powerful anti-inflammatory action which is superior to that of both cortisone and hydrocortisone. Its effects include a reduction of capillary dilatation, intercellular oedema and inflammatory infiltration within tissues, and the inhibition of vascularisation.

COMBINATION PREPARATIONS

Cinchocaine/Prednisolone

Ointment 5/1.9mg

• Scheriproct (Adcock Ingram) originator

Suppository 1/1.3mg

• Scheriproct (Adcock Ingram) originator