Standardised Betadine Antiseptic 100 mg/ml Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Iodinated povidone

Available from:

Ayrton Saunders Ltd

ATC code:

D08AG; D08AG02

INN (International Name):

Iodinated povidone

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Cutaneous solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Iodine products; povidone-iodine

Authorization status:

Not marketed

Authorization date:

1983-04-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Standardised Betadine Antiseptic 100 mg/ml Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of cutaneous solution contains 100 mg Iodinated Povidone (10%
w/v) yielding 10 mg/ml (1% w/v) of
available iodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A dark brown coloured cutaneous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic for the local management of minor skin trauma,
and in the preparation of skin for surgical
procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply locally to affected area.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
History of abnormal thyroid function or goitre (in
particular nodular colloid goitre, endemic goitre and Hashimoto's
thyroiditis). Use in children under two years of age.
Regular use should be avoided in patients on concurrent lithium
therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this preparation may interfere with tests of thyroid function.
Iodine is absorbed through burns and broken skin
and to a lesser extent through intact skin and may lead to toxic
levels of iodine in the blood, particularly in patients with
renal insufficiency.
If symptoms occur suggesting changes in thyroid function, these should
be investigated.
In
patients with impaired renal function, blood levels of iodine should
be monitored.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Standardised Betadine Antiseptic Solution can permanently discolour
white gold jewellery and it is recommended that
this type of jewellery should be removed before using Standardised
Betadine Antiseptic Solution.
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