| Composition |
Anasol- Proct Ointment:
Each 100g of ointment contains:
|
Hydrocortisone acetate
|
Benzyl benzoate
|
Bismuth subgallate
|
Bismuth oxide
|
Balsam peru
|
Zinc oxide
|
|
0.25 g
|
1.25g
|
2.25g
|
0.875g
|
1.875g
|
10.75g
|
Anasol- Proct Suppository:
Each Suppository contains:
|
Hydrocortisone acetate
|
Benzyl benzoate
|
Bismuth subgallate
|
Bismuth oxide
|
Balsam peru
|
Zinc oxide
|
|
10 mg
|
33 mg
|
59 mg
|
24 mg
|
49 mg
|
296 mg
|
|
| Pharmacodynamics properties |
This product provides antiseptic, astringent, emollient and anti-inflammatory actions. Bismuth oxide, zinc oxide, and bismuth subgallate exert a protective action on mucous membranes. They are mildly astringent and are reported to have antiseptic properties.
Balsam Peru has protective properties and a very mild antiseptic action by virtue of its content of cinnamic and benzoic acids. It is believed to promote the growth of epithelial cells.
Benzyl benzoate is used as a solubilizing agent and has mild antiseptic and preservative properties.
Hydrocortisone acetate has the anti-inflammatory action |
| Therapeutic indications |
| Anasol-proct is indicated for the comprehensive symptomatic treatment of internal and external haemorrhoids and pruritus ani. |
| Side effect |
| Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than seven days is not recommended. Rarely, there are sensitivity reactions and Patients may occasionally experience transient burning on application, especially if the anoderm is not intact. |
| Contraindication |
| Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents. |
| Warnings and precautions |
| As with all products containing topical steroids, the possibility of systemic absorption should be borne in mind. Prolonged or excessive use may produce systemic corticosteroid effects, and use for periods longer than seven days is not recommended. The product should be discontinued and the patient advised to consult a medical practitioner if symptoms do not improve or worsen or if rectal bleeding occurs. |
| Pregnancy and lactation |
| Pregnancy and lactation: There is inadequate evidence of safety in human pregnancy and there may be a very small risk of cleft palate and intrauterine growth retardation as well as suppression of the neonatal hypothalamic-pituitary-adrenal axis. No special precautions required for use during lactation, So Use in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child. |
| Drug interactions |
| Interaction with other medicinal products and other forms of interaction Concurrent use with other corticosteroid preparations, either topically or orally, may increase the likelihood of systemic effects. |
| DOSAGE & ADMINISTRATION |
Suppository:
ADULTS (over 18 years): Remove wrapper and insert one suppository into the anus at night, in the morning and after each evacuation up to a maximum of three per day for a maximum period of one week.
Ointment : topical application.
ADULTS :Apply ointment to the affected area at night, in the morning and after each evacuation. Thoroughly cleanse the affected area, dry and apply ointment on a gauze dressing. For internal conditions use rectal nozzle provided. Remove the nozzle cap. Clean the nozzle after each use.
Not to be taken orally.
ELDERLY (OVER 65 YEARS)
As for adults.
CHILDREN
Not recommended |
| Overdose |
Overdose: If swallowed, fever, nausea, vomiting, stomach cramps and diarrhoea may develop 3-12 hours after ingestion. Hydrocortisone normally does not produce toxic effects in an acute single overdose. Treatment of a large acute overdose should include gastric lavage, purgation with magnesium sulphate and complete bed rest. If necessary give oxygen and general supportive measures. Methaemoglobinaemia should be treated by intravenous methylthioninium chloride.
Effects on ability to drive and use machines: No effects have been reported on ability to drive or use machinery. |
| Package |
Suppository: Carton box of 10 suppository in tow strips with leaflet.
Ointment: Tube of 30 g ointment in carton box with leaflet and rectal nozzle . |
| Storage |
| Store below 25 °C, keep away from children. |
