Each ml of Betaiodine, 10% solution, contains:

active ingredient: povidone iodine – 100 mg;

excipients: sodium phosphate dibasic, citric acid, glycerin, nonoxynol 9, water purified.

2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine; 25655-41-8.

Antiseptic; D08AG02; G01AX11.

Betaiodine – povidone-iodine – is an iodophore that is used as a disinfectant and antiseptic mainly for the treatment of contaminated wounds and pre-operative preparation of the skin and mucous membranes as well as for the disinfection of equipment.

Iodophores are loose complexes of iodine and carrier polymers. Solutions of povidone-iodine gradually release iodine to exert an effect against bacteria, fungi, viruses, protozoa, cysts, and spores; povidone-iodine is thus less potent than preparations containing free iodine but it is less toxic.

Iodine is slightly absorbed when applied to the skin. When taken by mouth, iodine preparations (which are converted to iodide) are transported to, and concentrated in, the thyroid gland. Iodides not taken up by the thyroid are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva, and sweat. They cross the placenta and are distributed into breast milk.

For once-only use:

• Disinfection of intact external skin or as a mucosal antiseptic, for example prior to surgery biopsies, injections, punctures, blood-taking and bladder catheterisations.

For repeated, time-limited use:

Antiseptic wound treatment (e.g. decubitus and varicose ulcers), burns, infected and superinfected dermatoses.

Antiseptic and disinfectant

• Pre-and post-operative treatment of the skin and mucous membranes,
• Treatment and prevention of wound infections of the skin,
• Treatment and prevention of wound infections in surgery, travmatalogii, burn, dentistry,
• Treatment of bacterial, fungal skin, the prevention of superinfection in dermatological practice,
• Disinfection of the skin around drains, catheters, probes,
• Disinfection of the mouth with dental surgery,
• Disinfection of the birth canal in a ‘small’ gynecological surgery (abortion, intrauterine devices (IUDs), coagulation erosion and polyp, etc.)

Used as a disinfectant or antiseptic for the skin or mucosa, e.g., prior to surgery, biopsies, injections, punctures, blood-taking and bladder catheterisations Betaiodine should be applied undiluted.

For the disinfection of skin areas with a sparse distribution of sebaceous glands the exposure time is at least one minute, in skin areas with a dense distribution of sebaceous glands at least 10 minutes. The skin should be kept moist for the entire duration of the exposure time with the undiluted preparation.

For the antiseptic treatment of superficial wounds Betaiodine is applied undiluted to the areas to be treated.

In antiseptic topical therapy of burn wounds. Betaiodine is generally applied undiluted to the areas to be treated.

For antiseptic irrigation washes and baths Betaiodine can be diluted. The following dilutions are recommended as standard rations:

• Irrigation within the scope of wound treatment (e.g. decubitus, varicose ulcer and gangrene) and perioperative infection prophylaxis 1:2 to 1:20
• Antiseptic washes 1:2 to 1:25
• Antiseptic partial baths approx 1:25, antiseptic full baths approx 1:100

Betaiodine is intended for topical application either undiluted or diluted.

Normal tap water is suitable for dilution. Where conditions approximating isotonicity are desired, physiological saline or Ringer’s solution can be used.

For application to the eye solutions buffered with phosphate buffer solutions are recommended.

Dilutions must always be freshly prepared and used immediately.

Sufficient Betaiodine must be applied to wet the area to be treated completely. The antiseptic film that forms as it dries can be easily rinsed off with water.

Due to the possibility of skin irritations when used for preoperative disinfection of the skin the “formation of a puddle” under the patient should be avoided.

In repeated use, the frequency and duration of application depends on the indication for use. Betaiodine, freshly prepared for each use, can be applied several times daily.

Wound treatment should be continued for as long as there are signs of an infection or a marked risk of infection of the wound. Should infection reoccur after discontinuing treatment with Betaiodine, treatment can be resumed.

The brown colouration caused by Betaiodine is a property of the preparation and indicates its efficacy. Considerable decolouration indicates exhaustion of the efficacy of the preparation.

Betaiodine can cause hypersensitivity reactions and irritation of the skin and mucous membranes, although severe reactions are rare and povidone-iodine is considered to be less irritant than iodine.

The application of Betaiodine to severe burns or to large areas otherwise denuded of skin may produce the systemic adverse effects associated with iodine and metabolic acidosis, hypernatraemia, and renal impairment. Hyperthyroidism or hypothyroidism may occur after ingestion or absorption of large quantities. Hypothyroidism has occurred in neonates both as a result of absorption of iodine from Betaiodine applied to the neonate and also to the mother during pregnancy or breast feeding. Betaiodine application is contra-indicated in premature neonates or those weighing less than 1.5 kg.

Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy.

• Broken skin; renal impairment.
• In severe renal impairment, avoid regular application to inflamed or broken skin or mucosa.
• The application of Betaiodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
• Solutions of iodine applied to the skin should not be covered with occlusive dressings. The disinfectant activity of iodine is reduced by alkalis as well as by protein.
• As povidone iodine can affect the thyroid gland, its use may interfere with tests of thyroid function.

Following inadvertent oral intake of large amounts of povidone-iodine, symptoms of acute iodine in-toxication can manifest such as abdominal pain and cramps, nausea, vomiting, diarrhoea, dehydration, drop in blood pressure (persistent), tendency to collapse, epiglottitis, haemorrhagic diathesis (mucosal membranes and kidneys), cyanosis, renal damage (acute tubular necroses up to anuria [after1-3 days]), parathesias, fever and pulmonary oedemas. Following long-term excessive intake of iodine, hyperthyroidism, tachycardia, restlessness, tremor and headache can occur as symptoms.

In the literature, symptoms of intoxication after the intake of more than 10g povidone-iodine were reported.

Therapeutic measures to treat cases of intoxication

Immediate administration of foodstuffs containing starch and protein, e.g., corn flour stirred into milk or water, or gastric lavage with 5% sodium thiosulphate solution or starch suspension.

After absorption has already taken place toxic serum iodine concentrations can be reduced effectively by peritoneal dialysis or haemodialysis.

Thyroid function must be monitored carefully clinically to rule out or identify at any early stage any possible iodine-induced hyperthyroidism.

Further therapy is carried out as required to manage other possible existing symptoms such as metabolic acidosis and renal dysfunction, for example.

Treatment of iodine-induced hyperthyroidism

The treatment of iodine-induced hyperthyroidism is conducted as clinically indicated. Mild forms may require no treatment, pronounced forms may require anti-thyroid medical therapy (which is, however, effective only after a delay). In the most severe cases (thyrotoxic crisis), intensive therapy, plasmapheresis or thyroidectomy may be required.

• in hyperthyroidism or other manifest thyroid diseases;
• in herpetiform dermatitis (Duhring’s disease);
• before and after radiodine application (until the end of the treatment);
• in known cases of hypersensitivity to iodine or any of the other ingredients of the medication.

Betaiodine should only be applied after careful diagnosis

− over a prolonged period (>14 days) and on extensive areas (e.g., over 10% of the body surface area), in patients with:

• bland multimodular goitre;
• after patients have been treated for thyroid diseases;
• and in those predisposed to hyperthyroidism i.e. with autonomous adenomas and/or functional automony (especially elderly patients)
• as subsequent iodine-inducted hyperthyroidism cannot be completely ruled out. In these cases the doctor should be vigilant for early symptoms of possible hyperthyroidism for up to 3 months after therapy has been discontinued and, where necessary, thyroid function monitored;

− to an extremely limited extent in neonates and nursing infants up to the age of 6 months as the risk of hypothyroidism cannot be completely ruled out. After applying Betaiodine function should be checked. In the case of hypothyroidism, early treatment with thyroid hormones must be carried out until thyroid function becomes normal. Accidental oral intake by the nursing infant must be avoided.

Regular or prolonged use should be avoided with patients with thyroid disorders or those receiving lithium therapy.

During pregnancy and the lactation period, Betaiodine– as in all preparations containing iodine – must only be administered following a very careful assessment of the risk/benefit and in extremely limited amounts. After applying Betaiodine thyroid function must be monitored in the child. In the event of hypothyroidism, immediate treatment with thyroid hormones must be carried out until thyroid function returns to n ormal.

The accidental oral intake of Betaiodine by the nursing infant as a result of contact with the treated site of the nursing mother’s body must be avoided.

If, due to the nature and the extent of the application of Betaiodine, a marked absorption of iodine is to be expected, it must be taken into account that, as a result, the iodine content of the mother’s milk may also increase.

• It is to be expected that povidone-iodine reacts with protein and various other organic substances such as blood and pus components for example. This interaction may impair efficacy.
• As a result of oxidation, the concomitant application of Betaiodine and enzymatic wound treatment agents weakens the action of the enzyme components of both drugs. The latter is also true of hydrogen peroxide and taurolidine as well as of disinfectants containing silver (formation of silver iodide).
• Betaiodine must not be used concomitantly or immediately following disinfectants containing mercury (risk of chemical burns due to the formation of mercury iodide).
• Betaiodine must not be used concomitantly with or immediately after the application of octenidine-based antiseptics to the same or adjacent areas as transient dark discolouration can occur at the areas concerned.
• In patients receiving concomitant lithium therapy, regular application of Betaiodine should be avoided as, especially in the case of application of povidone-iodine to extensive areas, larger amounts of iodine may be absorbed. In exceptional cases, this can induce (transient) hypothyroidism. In this special situation, a synergistic effect might occur as lithium may also induce hypothyroidism.

Effect on diagnostic tests:

• Due to the oxidising action of povidone-iodine, when patients are undergoing treatment with Betaiodine various diagnostic agents can give false-positive results (inter alia toluidine and guaiac resin for the determination of haemoglobin or glucose in the stools or urine).
• During the application of povidone-iodine uptake of iodine by the thyroid gland may be reduced; this can lead to disturbances in thyroid scanning, PBI (protein-bound iodine) determination and radioiodine diagnostics and make planned radioiodine therapy impossible. A waiting period of at least 1-2 weeks should be observed after discontinuing the povidone-iodine treatment before conducting a new thyroid scan.

A brown colored liquid having a characteristic iodine odor.

Solution for topical use is filled into 30 ml, 60 ml and 100 ml plastic bottles inserted together with leaflet in cardboard box.
1, 3.6, 4 liters in plastic bottles closed with caps.

2 years.

Store in a cool and dry place, out of the reach of children. Protect from light.

To be dispensed withоut prescription.