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

Logo BETADINE* ANTISEPTIC OINTMENT

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form)

BETADINE* ANTISEPTIC OINTMENT

COMPOSITION:
Each 1 g contains
povidone-iodine 100 mg, equivalent to 10 mg available iodine in a water soluble base.

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

PHARMACOLOGICAL ACTION:
Povidone-iodine is a multivalent broad spectrum local antiseptic having bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Many viruses, protozoa, yeasts, cysts and spores are also susceptible.

INDICATIONS:
As an antiseptic in:
Skin infections
Decubitus ulcers
Wounds, cuts and abrasions
Burns
Postoperative wounds

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. Povidone-iodine should not be used on patients with non-toxic nodular colloid goitre. Application to large areas of broken skin should be avoided as excessive absorption of iodine may occur.

WARNINGS:
1. Not to be used by persons who are allergic to iodine.
2. Not to be used in pregnancy or by lactating women.

DOSAGE AND DIRECTIONS FOR USE:
The affected area should be cleaned and dried. Apply BETADINE ANTISEPTIC OINTMENT liberally and cover with a dressing or bandage. BETADINE ANTISEPTIC OINTMENT may be used as often as required.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity and local irritation may occur. However, if irritation, swelling or redness occur, discontinue treatment and consult your physician. Hypothyroidism may occur after topical application to neonates. Absorption of povidone-iodine may interfere with thyroid function tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic effects include metabolic acidosis, hypernatraemia and renal impairment. These effects could occur if applied to large areas or denude skin. Treatment is symptomatic and supportive.

IDENTIFICATION:
BETADINE * ANTISEPTIC OINTMENT is an amber coloured ointment, having a characteristic iodine odour.

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

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

REGISTRATION/REFERENCE NUMBER:
G1574 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
Bryanston
2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 January 1987

Under licence from : Mundipharma AG, Switzerland
* BETADINE is a Registered Trade Mark

New addition to this site: April 2004
Source: Pharmaceutical Industry

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