1. Name Of The Medicinal Product
Anusol Plus HC Suppositories
2. Qualitative And Quantitative Composition
Anusol Plus HC Suppositories contain:
Hydrocortisone acetate 10 mg
Benzyl benzoate 33 mg
Bismuth subgallate 59 mg
Bismuth oxide 24 mg
Balsam peru 49 mg
Zinc oxide 296 mg
For excipients, see 6.1
3. Pharmaceutical Form
Suppository
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic treatment of internal haemorrhoids and pruritus ani.
4.2 Posology And Method Of Administration
Anal insertion
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.
Elderly (over 65 years)
As for adults
Children (under 18 years)
Not recommended.
4.3 Contraindications
Tubercular, fungal and most viral lesions including herpes simplex, vaccinia and varicella. History of sensitivity to any of the constituents.
4.4 Special Warnings And Precautions For Use
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.
4.5 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.
4.6 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. There is evidence of harmful effects in animals. To be used in pregnancy only when there is no safer alternative and when the disease itself carries risks for the mother or child.
No special precautions required for use during lactation.
4.7 Effects On Ability To Drive And Use Machines
No effects have been reported on ability to drive or use machinery.
4.8 Undesirable Effects
Rarely, sensitivity reactions may occur. Patients may occasionally experience transient burning on application, especially if the anoderm is not intact.
4.9 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 methylene blue.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Anusol Plus HC provides antiseptic, astringent, emollient and decongestant properties. In addition, hydrocortisone exerts an anti-inflammatory action.
Bismuth oxide, zinc oxide and bismuth subgallate exert a protective action on mucous membranes and raw surfaces. They are mildly astringent and are reported to have antiseptic properties
Balsam Peru has protective properties and 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 general properties of hydrocortisone and the anti-inflammatory action is of primary interest in the product.
5.2 Pharmacokinetic Properties
Systemic absorption of hydrocortisone acetate from the rectum may occur but estimates of the extent of absorption have been variable and have always been less than 30%. Following absorption it is metabolised in the liver and most body tissues before being excreted in the urine. Biological half-life is approximately 100 minutes and it is 90% bound to plasma protein.
The other active ingredients in Anusol HC Plus Suppositories exert their therapeutic effect without being absorbed into the systemic circulation. These observations are supported by evidence from various studies and reviews.
5.3 Preclinical Safety Data
The active ingredients of Anusol are well known constituents of medicinal products and their safety profile is well documented.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Kaolin light
Hard Fat (Suppocire BS2)
6.2 Incompatibilities
No incompatibilities have been reported.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Do not store above 25oC.
6.5 Nature And Contents Of Container
Printed strip pack consisting of white opaque PVC/polyethylene laminated film. Each pack contains 12 suppositories.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
United Kingdom
8. Marketing Authorisation Number(S)
PL 15513/0040
9. Date Of First Authorisation/Renewal Of The Authorisation
10 March 2009
10. Date Of Revision Of The Text
10 March 2009
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