Povidone Iodine 7.5% Solution is an antiseptic solution against all organism including bacteria, fungi, viruses, protozoa, mycobacteria and spores. It`s used as an antiseptic handwashing for surgeon and operating room`s staff before surgery.
Packaging:
250ml PE Bottle
1000ml PE Bottle
3800ml PE Gallon
Povidone Iodine 7.5% w/v.
3. PHARMACEUTICAL FORM
Surgical scrub.
4.1 Therapeutic indications
For use as an antiseptic cleanser for pre-operative scrubbing and washing by surgeons and theatre staff, and pre-operative preparation of patients' skin.
4.2 Posology and method of administration
For topical administration. Adults, the elderly and children: Apply full strength as a pre-operative antiseptic skin cleanser. Povidone iodine is not recommended for regular use in neonates and is contraindicated in very low birth weight infants (below 1500 grams).
4.3 Contraindications
Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).
4.4 Special warnings and precautions for use
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.
4.5 Interaction with other medicinal products and other forms of interaction
Absorption of iodine from povidone iodine through either intact or damaged 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 Pregnancy and lactation
Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption on foetal thyroid function and development.
4.8 Undesirable effects
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.
4.9 Overdose
Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and impairment of renal function. In the case of accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The active ingredient, povidone iodine, slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations: I2↔ I+ + I- ; I2 + H2O ↔ H2O I+ + I- ; I2 + I- ↔ I3-. The microbicidal species H2O I+ preferentially displaces oxygen as the end electron acceptor in the microorganism's respiratory cycle. H2O I+ similarly interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.
5.2 Pharmacokinetic properties
Betadine Surgical Scrub is intended for topical application and therefore a consideration of the absorption, distribution, metabolism and elimination of povidone iodine is largely without relevance.