INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo STERIDINE ANTISEPTIC OINTMENT

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

STERIDINE ANTISEPTIC OINTMENT

COMPOSITION:
Each 1g contains 100 mg
povidone-iodine, equivalent to 10 mg available iodine.

PHARMACOLOGICAL CLASSIFICATION:
A 13.1 Antiseptics, Disinfectants, Cleansing agents.

PHARMACOLOGICAL ACTION:
Povidone-iodine is an iodophore which slowly releases iodine from the complex when in contact with the skin and mucus membranes. It has bactericidal and fungicidal properties and is also effective against viruses, protozoa, cysts and spores.

INDICATIONS:
STERIDINE Antiseptic Ointment is used as a general antiseptic in the treatment of minor skin wounds, skin infections, burns (if not sensitive) and post operative wounds.

CONTRA-INDICATIONS:
Patients with nodular goitres or with a history of thyroid disease should not use povidone-iodine.
Hypersensitivity to povidone-iodine.
Safety in pregnancy and lactation has not been established.

WARNINGS:
Avoid application to large areas of skin as excessive absorption of iodine may occur.
Not to be used by persons who are allergic to iodine.
Absorption of iodine from povidone-iodine may interfere with tests of thyroid function.

DOSAGE AND DIRECTIONS FOR USE:
FOR EXTERNAL USE ONLY.
Cleanse and dry the affected area. Apply STERIDINE Antiseptic Ointment to the affected areas twice daily or as directed. Cover with a bandage or dressing if necessary.
Use as often as required.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity reactions and irritation of the skin and mucus membranes. Hypersensitivity reactions may include urticaria, angioedema, cutaneous haemorrhage or purpuras, fever, arthralgia, lymphadenopathy, and eosinophilia. If irritation, swelling or redness occurs, discontinue treatment and consult a physician. A severe or persistent sore throat with or without a high fever, headache, nausea and vomiting indicate a serious condition and a physician should be consulted.
Metabolic acidosis, hypernatraemia and impairment of renal function could occur when applied to large areas denuded of skin. Avoid regular or prolonged use in patients with thyroid disorder or those receiving lithium therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects and special precautions.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A dark red brown to yellow coloured ointment.

PRESENTATION:
Plastic tubes of 25 g or plastic jars of 500 g.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
Keep well closed.

REGISTRATION NUMBER:
33/13.1/0382

NAME AND BUSINESS ADDRESS OF APPLICANT:
Xeragen Laboratories (Pty) Ltd
Units 8-11 Glen Park Industrial
1 Highdale Road
Glen Anil
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 2001

6624
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New addition to this site: March 2004
Source: Pharmaceutical Industry

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