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:
Wounds, cuts and abrasions
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.
Not to be used by persons who are allergic to iodine.
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.