Savlon Dry

1. Name Of The Medicinal Product

Savlon Dry

2. Qualitative And Quantitative Composition

Povidone Iodine 1.14% w/w

For excipients, see 6.1.

3. Pharmaceutical Form

Cutaneous Spray, Powder

4. Clinical Particulars

4.1 Therapeutic Indications

Savlon Dry is a broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds. May be used in first aid for minor cuts, grazes, burns, abrasions and blisters.

4.2 Posology And Method Of Administration

Shake the can before use and spray the treatment area from a distance of 6-9 inches (15-22cm) until a light dusting of powder is deposited. Savlon Dry should be used directly from the aerosol container.

Adults:

The recommended usual maximum daily adult application for regular use on broken skin is 150mg available iodine.

Children and elderly patients:

There are no special dosage recommendations for either elderly patients or children. However, povidone-iodine is not recommended for regular use in neonates and is contra-indicated in very low birth weight infants (below 1500g).

4.3 Contraindications

Savlon Dry is contraindicated in patients with known or suspected iodine sensitivity or with thyroid disorders, in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis.

Savlon Dry must not be used in deep wounds or in clean surgical wounds.

4.4 Special Warnings And Precautions For Use

Avoid application of povidone-iodine into the eyes and nose. Care must be taken when Savlon Dry is used on known iodine sensitive subjects, although these do not normally react to povidone-iodine.

Povidone-iodine can be absorbed systemically during the topical treatment of burns and large areas of broken skin. The degree of absorption is proportional to the depth and extent of the burn or broken skin.

Prolonged treatment with povidone-iodine of patients with severe and extensive burns may cause metabolic acidosis, hypernatraemia and renal impairment. In patients at risk Savlon Dry should be used with caution.

Special caution is needed in patients with pre-existing renal insufficiency and in neonates.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Absorption of iodine from povidone-iodine may interfere with thyroid function tests by causing an increase in protein bound iodine levels. Contamination with povidone-iodine of several types of tests for the detection of occult blood in urine may produce false positive results.

4.6 Pregnancy And Lactation

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.

4.7 Effects On Ability To Drive And Use Machines

None have been reported or are known.

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

The amount of povidone-iodine contained in one aerosol can of Savlon Dry is unlikely to have any toxic effects if ingested.

Iodine ingested in large amounts can produce goitre and hypothyroidism as well as hyperthyroidism and may lead to a range of adverse effects, often called iodism, although some of the effects may be due to hypersensitivity.

High serum iodine levels resulting from excessive use can be reduced by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Povidone iodine is a broad spectrum anti-microbial agent with activity against a wide variety of bacteria, including acid fast bacilli and bacterial spores. It is also active against fungi, a wide range of viruses and protozoa.

5.2 Pharmacokinetic Properties

Povidone-iodine administered clinically via any route can result in systemic absorption of iodine. The amount of absorbed iodine will vary according to the concentration of the povidone-iodine preparation used, the number of applications and the route of administration. Whilst absorption of iodine may occur following topical administration of all povidone-iodine preparations, the effects are dose related. In view of the fact that a 10 second burst will deliver only 7mg of available iodine, the levels of iodine likely to be absorbed following administration of Savlon Dry will be exceedingly small and the effects on the internal organs minimal.

5.3 Preclinical Safety Data

There are no findings in the preclinical testing which are of relevance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Povidone

N-Pentane

Soya lecithin

Butane 40

6.2 Incompatibilities

Alkali will reduce the anti-microbial activity of povidone-iodine.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

PRESSURISED CONTAINER:	Protect from sunlight.
DO NOT	- expose to temperatures exceeding 50ºC
	- pierce or burn, even after use
	- spray on a naked flame or any incandescent material
	- apply while you are smoking.

Keep away from sources of ignition.

Do not store above 25ºC

6.5 Nature And Contents Of Container

Monobloc aluminium aerosol container, internally lacquered, containing micronised powder and propellants under pressure and fitted with a valve and actuator and white polypropylene overcap.

The aerosol containers may be provided as items in first aid kit containers.

6.6 Special Precautions For Disposal And Other Handling

Medicines should be kept out of the reach of children.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

Trading style: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0124

9. Date Of First Authorisation/Renewal Of The Authorisation

15 April 1998

10. Date Of Revision Of The Text

15 January 2004

Legal category: GSL