Dermadine Antiseptic Ointment 25 g OINTMENT
PDF Leaflet Revision Date: 10 February 2023
Clinical Summary
Quick overview from the medicine insert
Indication
General antiseptic for skin infections, wounds, and burns.
Dosage (summary)
Apply to affected areas twice daily or as directed.
Special Populations
- Neonates
- Patients with hypersensitivity to iodine
Pregnancy & Breastfeeding
Not to be used during pregnancy or breastfeeding.
Key Drug Interactions
- Lithium therapy may enhance hypothyroidic effects
- May interfere with thyroid function tests
Contraindications
- Hypersensitivity to povidone-iodine
- Large areas of broken skin
- Non-toxic nodular colloid goitre
Common side effects
- Hypothyroidism
- Hypersensitivity
- Local irritation
- Swelling
- Redness
Counselling Points
- Clean and dry affected area before application
- Avoid contact with eyes
- Report any adverse reactions
Serious warnings
- May cause hypothyroidism in neonates
- Discontinue if irritation occurs
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
DERMADINE ANTISEPTIC OINTMENT is used as a general antiseptic in the treatment of skin infections, wounds, cuts abrasions, burns if not extensive, bedsores and for post-operative wounds.
4.2 Posology and method of administration
Posology
The affected area should be cleaned and dried. Apply to affected areas twice daily or as directed. An occlusive dressing may be used if necessary.
4.3 Contraindications
DERMADINE ANTISEPTIC OINTMENT is contraindicated in:
u2022 Patients with known hypersensitivity to povidone-iodine or to any of the excipients used in the formulation of DERMADINE ANTISEPTIC OINTMENT (see section 6.1).
u2022 Application to large areas of broken skin (e.g. severe and extensive burns) should be avoided as excessive absorption of iodine may occur.
u2022 Not to be used during pregnancy or by lactating women.
u2022 Povidone-iodine should not be used on patients with non-toxic nodular colloid goitre.
4.4 Special warnings and precautions for use
Not to be used by persons allergic to iodine. Hypersensitivity reactions 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.
NOTE: Stains on synthetic fabrics may be removed by washing and rinsing in dilute ammonia.
4.5 Interaction with other medicinal products and other forms of interaction
Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects. Absorption of iodine from povidone-iodine through either intact skin or broken skin may interfere with thyroid function tests. Contamination with povidone-iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.
4.6 Fertility, pregnancy and lactation
Pregnancy: Not to be used during pregnancy.
Breastfeeding: Not to be used during breastfeeding.
4.7 Effects on ability to drive and use machines
The effects on ability to drive and use machines has not been established.
4.8 Undesirable effects
System Organ Class Frequency Unknown
Endocrine disorders Hypothyroidism may occur after topical application to neonates.
General disorders and administration site conditions Hypersensitivity and local irritation, swelling, redness
Investigations Absorption of povidone-iodine may interfere with thyroid function tests.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 and to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).
4.9 Overdose
Systemic effects including metabolic acidosis, hypernatraemia and renal impairment may follow the application of povidone-iodine to severe burns or large areas otherwise denuded of skin. Treatment is symptomatic and supportive.
