Septadine Antiseptic Ointment 250 mg/25 g Ointment
PDF Leaflet Revision Date: 24 August 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Antiseptic for skin infections, wounds, and post-operative care.
Dosage (summary)
Apply to affected areas twice daily or as directed.
Special Populations
- Neonates
Pregnancy & Breastfeeding
Not to be used during pregnancy or by lactating women.
Key Drug Interactions
- Lithium therapy may enhance hypothyroidic effects
- May interfere with thyroid function tests
Contraindications
- Hypersensitivity to Povidone-Iodine
- Application to large areas of broken skin
- Non-toxic nodular colloid goitre
Common side effects
- Local irritation
- Swelling
- Redness
- Hypothyroidism in neonates
Counselling Points
- Clean and dry the affected area before application
- Avoid contact with synthetic fabrics
Serious warnings
- Discontinue if irritation occurs
- May interfere with thyroid function tests
Important Disclaimer
The Septadine Antiseptic Ointment 250 mg/25 g Ointment professional information leaflet below is the property of Ranbaxy Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1. Therapeutic indications
SEPTADINE u00ae ANTISEPTIC OINTMENT is used as an antiseptic in the treatment of skin infections, decubitus ulcers, wounds, cuts, abrasions, burns and for post-operative wounds.
4.2 Posology and method of administration
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
- Hypersensitivity to Povidone-Iodine, or to any of the excipients in listed in section 6.1.
- Application to large areas of broken skin (eg. severe and extensive burns) should be avoided as excessive absorption of iodine may occur.
- Not to be used during pregnancy or by lactating women.
- Povidone-iodine should not be used on patients with non-toxic nodular colloid goitre.
4.4 Special warnings and precautions for use
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 medicines 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
Not to be used during pregnancy or by lactating women.
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 Local irritation, swelling, redness
Investigations Interference with thyroid function tests
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.
