VIDENE ALCOHOLIC TINCTURE (Ecolab)

1. Name Of The Medicinal Product

VIDENE ALCOHOLIC TINCTURE

2. Qualitative And Quantitative Composition

Povidone-iodine 10% w/w

3. Pharmaceutical Form

Topical Solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Videne Alcoholic Tincture is a broad-spectrum antiseptic for topical application. It is indicated for quick-drying pre-operative skin disinfection, particularly in orthopaedic surgery.

4.2 Posology And Method Of Administration

Videne Alcoholic Tincture is applied undiluted to the area to be incised and painted on thoroughly using a gauze swab. The solution may be allowed to dry to form a protective film or may be removed using a sterile gauze swab.

There are no special dosage recommendations for children or elderly patients.

4.3 Contraindications

Videne Alcoholic Tincture must never be administered orally.

4.4 Special Warnings And Precautions For Use

Care should be taken with known iodine-sensitive subjects, although such people do not normally react to povidone-iodine.

Videne Alcoholic Tincture must not be used on broken skin because of the intense stinging caused by the alcohol present.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

Videne Alcoholic Tincture is not recommended for use during pregnancy because of the possibility of absorption through broken skin and subsequent interference with tests of neonatal thyroid function.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In very rare instances Videne Alcoholic Tincture may produce skin reactions in iodine-sensitive subjects. These reactions subside on cessation of treatment.

4.9 Overdose

In cases where Videne Alcoholic Tincture has been taken orally, gastric lavage with dilute starch mucilage or a 1% solution of sodium thiosulphate must be administered. The electrolyte balance must be corrected and lost fluids replaced.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Povidone-iodine has antiseptic activity and is used mainly for the treatment of contaminated wounds and preparation of pre-operative skin and mucous membranes. It is considered to be less irritant than iodine.

5.2 Pharmacokinetic Properties

Povidone-iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3 Preclinical Safety Data

Povidone-iodine had a low acute toxicity in both dogs and rats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of povidone-iodine although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into cavities of the body. At subcutaneous dose levels of up to 75mg/kg/day, povidone-iodine was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for povidone-iodine. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for povidone-iodine. Although conflicting data have been published, there is no convincing evidence to suggest that povidone-iodine adversely affects wound healing. Concentration of 0.05 and 0.5% povidone-iodine did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that povidone-iodine-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Alkyl Phenol Ether Sulphate (ammonium salt)

Industrial Methylated Spirit 95%

Citric Acid

Di-sodium Phosphate, Anhydrous

Purified Water

6.2 Incompatibilities

None stated

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Store below 20°C in a dry place, protected from light.

6.5 Nature And Contents Of Container

Videne Alcoholic Tincture is packaged in a 500 ml HDPE bottle sealed with a plastic screw cap.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Ecolab Ltd, Lotherton Way, Garforth, Leeds, LS25 2JY.

8. Marketing Authorisation Number(S)

PL 04509/0040

9. Date Of First Authorisation/Renewal Of The Authorisation

1 March 2003

10. Date Of Revision Of The Text

August 2006