Betadine 10% Mylan Cutaneous Solution 10 Disposable Vials 5ml

Betadine 10% Cutaneous Solution in Disposable Vials - Medical Device

PHARMACOTHERAPEUTIC CATEGORY

Antiseptics and disinfectants, iodine derivatives.

ACTIVE PRINCIPLES

This drug 10% cutaneous solution 100 ml contain: povidone iodine (10% iodine) 10 g.

EXCIPIENTS

This medicine 10% cutaneous solution: glycerol, macrogol laurilete re, dibasic sodium phosphate dihydrate, citric acid monohydrate, sodium hydroxide, purified water.

INDICATIONS

Disinfection and cleaning of damaged skin (wounds, sores, etc.).

CONTRAINDICATIONS / SECONDARY EFFECT

Hypersensitivity to the active substance or to any of the excipients.
Hyperthyroidism.
Do not use in children younger 'less than six months.

DOSAGE

It is applied twice a day directly on small wounds and skin infections.
A quantity of 5 ml of solution (containing 50 mg of iodine) is sufficient to treat an area of about 15 cm per side.
For skin antisepsis: apply a protective layer of the brown color solution until a medium intensity color is obtained: a superficial film is formed that does not stain.

STORAGE

Betadine 10% cutaneous solution: store at a temperature not exceeding 25 degrees C.

WARNINGS

Do not use for prolonged treatments.
Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of this drug on damaged skin.
For external use only.
The use, especially if prolonged, can give rise to sensitization phenomena.
In this case, interrupt the treatment and adopt suitable therapeutic measures.
Patients with goiter, thyroid nodules or other acute and non-acute thyroid disease are at risk of developing thyroid hyperfunction (hyperthyroidism) following the administration of large amounts of iodine.
In this patient population, povidone iodine solution should not be used for an extended period of time and on large body surfaces unless strictly indicated.
Even after the end of treatment, early symptoms of possible hyperthyroidism must be sought and, if necessary, thyroid function must be monitored.
Do not use at least 10 days before performing a scan or after radioactive iodine scintigraphy or in the treatment with radioactive iodine of thyroid cancer.
The pediatric population has an increased risk of developing hypothyroidism following applications of high doses of iodine.
Due to the permeability of the skin and their high sensitivity to iodine, the use of suitable iodopov should be minimized in children.
A check of the child's thyroid function (eg T4 and TSH levels) may be necessary.
Any oral ingestion of povidium iodine by the child should be avoided.
In pediatric age use only under strict control and in cases of real necessity.
The accidental ingestion or inhalation of some disinfectants can have serious and sometimes fatal consequences.
Avoid contact with eyes.

INTERACTIONS

Avoid the simultaneous use of other antiseptics and detergents.
The polyvinylpyrrolidone-iodine complex is effective at pH values between 2.0 and 7.0.
It is possible that the complex reacts with proteins or other unsaturated organic compounds, and that this determines a reduction in its effectiveness.
The concomitant use of preparations with enzymatic components for the treatment of wounds leads to a weakening of the effects of both substances.
Povidone iodine should not be used at the same time as products containing mercury salts or benzoin compost, carbonates, tannic acid, alkali, hydrogen peroxide, taurolidine and silver.
The use of povidone-containing products concomitantly with other antiseptics containing octedin in the same or adjacent sites can cause a momentary darkening of the affected areas.
The oxidative effect of the preparations based on povidone iodone can cause false positive results of some laboratory diagnostic tests (for example tests with toluidine or guaiac gum for the determination of hemoglobin or glucose in stool or urine) .
Avoid habitual use in patients on concurrent lithium treatment.
Absorption of iodine from povidone-iodine solution may reduce thyroid iodine uptake.
This may interfere with various tests (thyroid scintigraphy, determination of iodine binding proteins, radioactive iodine diagnostics) and may make planned thyroid and iodine treatment (radioactive iodine therapy) impossible.
After the end of the treatment, before performing a new scintigraphy it is necessary that you have an adequate period of time.

SIDE EFFECTS

Undesirable effects are classified according to their frequency: very common (> = 1/10); common (> 1/100 to <1/10); uncommon (> = 1 / 1,000 to <1/100); rare (> = 1 / 10,000 to <1 / 1,000); very rare (<1 / 10.0 00); not known (frequency cannot be estimated from available data).
Disorders of the immune system.
Rare: Hypersensitive ta '; very rare: Anaphylactic reaction.
Endocrine pathologies.
Very rare: Hyperthyroidism (sometimes with symptoms such as tachycardia or agitation); not known: hypothyroidism.
Metabolism and nutrition disorders .
Not known: electrolyte imbalance, metabolic acidosis.
Skin and subcutaneous tissue disorders.
Rare: contact dermatitis (with symptoms such as erythema, microvesicles and itching); very rare: angioedem a; not known: exfoliative dermatitis.
Renal and urinary disorders.
Not known: acute renal failure, abnormal blood osmolarity.
In patients with a history of thyroid disease following high iodine uptake, for example after long-term use of povidone-iodine solution for the treatment of wounds and burns on large skin areas.
It can occur following the uptake of large amounts of povidone iodine (for example in the treatment of burns).
Hypothyroidism following prolonged or extensive use of povidone iodine Reporting of suspected adverse reactions.
The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov .it / content / how-to-report-a-suspected-adverse reaction.

PREGNANCY AND BREASTFEEDING

During pregnancy and lactation, povidone iodine solution should be used only if strictly necessary and at the minimum if possible, due to the ability of iodine to pass through the lacenta and to be secreted into breast milk and for the high sensitivity of the fetus and newborn to iodine.
Furthermore, iodine is more concentrated in breast milk than serum, therefore it can cause transient hypothyroidism with an increase in TSH (thyroid stimulating hormone) in the fetus or newborn.

FORMAT

Pack of 10 disposable 5 ml falcons.