Chemical formula: C₆H₉I₂NO Molecular mass: 364.877 g/mol
Povidone iodine interacts in the following cases:
There is a risk of (transient) hypothyroidism after regular or prolonged use in patients on concomitant lithium therapy.
Iodine freely crosses the placenta. Thyroid function disorders have been reported in the offspring of mothers exposed to pharmacological doses of iodine. Povidone iodine should not be used regularly during pregnancy unless there is no alternative treatment available.
Animal studies have not shown teratogenic effects. Given the absence of teratogenic effects in animals, malformation effects are not expected in humans.
Currently, relevant clinical data is not sufficiently available to assess the potential malformation impact of povidone iodine when it is administered within the first trimester of pregnancy. The foetal thyroid begins to accumulate iodine around the 14th week of amenorrhoea.
No effects during pregnancy are anticipated, since systemic exposure to iodine is negligible.
Povidone iodine eye drops, solution can be used during pregnancy. In pregnant or breastfeeding women an alternative form of antisepsis should be considered if multiple repeat injections requiring conjunctival and periorbital application are anticipated.
Excessive use of povidone iodine should be avoided in pregnant or lactating women because absorbed iodine can cross the placental barrier and is secreted in breast milk.
Under these circumstances, povidone iodine should only be administered if clearly necessary.
No effects on fertility are anticipated, since systemic exposure to iodine is negligible.
Povidone iodine has no or negligible influence on the ability to drive and use machines.
The most serious adverse reaction that occur with povidone iodine 5% w/v eye drops, solution is hypersensitivity reaction.
Adverse events are categorized by frequency as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Not known: hypersensitivity, anaphylactic reactions (urticaria, Quincke’s oedema, anaphylactic shock and anaphylactoid reaction).
Not known: Regular and prolonged application may lead to toxic levels of iodine likely to develop abnormal thyroid function, particularly in pre-term infants and neonates. Exceptional cases of hypothyroidism have been reported.
Not known: conjunctival hyperemia, superficial punctate keratitis, eye irritation, superficial punctate epitheliopathy, keratoconjunctivitis sicca, residual yellow coloration of the conjunctiva.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Not known: contact dermatitis (with such symptoms as erythema, blisters, itching), angioedema, cases of reversible, transient brown coloration of the skin have been reported.
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10) common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) or unknown (can not to be estimated from available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Rare: Hypersensitivity
Very rare: Anaphylactic reaction
Very rare: Hyperthyroidism
Unknown: Metabolic acidosis, hypernatraemia
Rare: Skin reaction localised
Unknown: Renal impairment
Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine.
The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
Local irritation, skin burns and sensitivity reactions have been reported rarely.
Anaphylactic reactions, anaphylactoid reactions and anaphylactic shock have been reported uncommonly with products containing povidone iodine or povidone.
Excess iodine can produce goitre and hypothyroidism or hyperthyroidism.
Such effects have occasionally been seen with extensive or prolonged use of povidone iodine. Other effects that have been reported are metabolic acidosis and acute renal failure.
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