1. Name Of The Medicinal Product
Betadine Dry Powder Spray.
2. Qualitative And Quantitative Composition
Povidone Iodine 2.5% w/w.
3. Pharmaceutical Form
Pressurised aerosol spray.
4. Clinical Particulars
4.1 Therapeutic Indications
Antiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.
4.2 Posology And Method Of Administration
For topical use only. Adults and children aged 2 years and over: Shake the can well before use. Spray the required area from a distance of 15-25cm (6-10 inches) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing.
4.3 Contraindications
Hypersensitivity to iodine. Betadine Dry Powder Spray should not be used in serous cavities. Do not use this product regularly if the patient suffers from thyroid disorders or is receiving concurrent lithium therapy. Do not use on children under two years of age.
4.4 Special Warnings And Precautions For Use
Avoid inhaling or spraying into the eyes. Avoid use on patients with renal impairment. Should evidence of local irritation or sensitivity occur, use of the product should cease. If no improvement occurs, a doctor should be consulted.
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.
4.6 Pregnancy And Lactation
Use in pregnancy or lactation should be limited. Although no adverse effects are anticipated from such limited usage, caution is recommended and therapeutic benefit must be balanced against the possible effects of the absorption of iodine on foetal thyroid function and development.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin. Following prolonged application of Betadine Dry Powder Spray to severe burns or large areas of denuded skin, systemic effects such as metabolic acidosis, parametrical renal impairment and thyroid dysfunction may occur.
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, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.
Treatment: In the case of deliberate or 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
Povidone iodine is a complex of iodine which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Isopropyl myristate; n-pentane; butane 40; soya lecithin.
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months unopened.
6.4 Special Precautions For Storage
Store at or below 25oC.
6.5 Nature And Contents Of Container
Aerosol cans containing 100ml of product.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 21248/0005.
9. Date Of First Authorisation/Renewal Of The Authorisation
19th April 2006.
10. Date Of Revision Of The Text
April 2006.
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