Disinfectant vials for small wounds and skin infections.
Indications
Betadine 10% Alcoholic Cutaneous Solution contains iodopovidone, a disinfectant for local use.
Betadine 10% Alcoholic Cutaneous Solution is indicated for disinfecting damaged skin (wounds, sores) of adults and children over 6 months of age.
Ingredients
Active ingredients: 100 ml of cutaneous solution contains 10 g of iodopovidone (10% iodine).
Excipients: Glycerol, Macrogol lauryl ether, Sodium phosphate dibasic dihydrate, Citric acid monohydrate, Sodium hydroxide, Purified water.
Directions for use and Dosage
Apply twice a day directly to small wounds and skin infections.
A quantity of 5 ml of solution (containing 50 mg of iodine) is sufficient to treat an area of approximately 15 cm on each side.
For skin antisepsis: apply a protective layer of the brown solution until a medium intensity color is obtained (a superficial film forms that does not stain).
Warnings
Do not use for prolonged treatments.
Particular caution should be used in patients with pre-existing renal insufficiency who require regular applications of Betadine on damaged skin.
For external use only.
Use, especially if prolonged, may cause side effects. give rise to sensitization phenomena.
In this case, discontinue treatment and adopt appropriate therapeutic measures.
Patients with goiter, thyroid nodules or other acute and non-acute thyroid diseases 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 a prolonged period of time and on large body surfaces unless strictly indicated.
Even after the end of treatment, early symptoms of possible hyperthyroidism should be sought and, if necessary, thyroid function should be monitored.
Do not use at least 10 days before or after a scintigraphy with radioactive iodine or in the treatment of thyroid cancer with radioactive iodine.
The pediatric population is at greater risk of developing hypothyroidism following the application of high doses of iodine.
Due to the permeability of the skin and Due to their high sensitivity to iodine, the use of povidone-iodine should be reduced to the minimum necessary in children.
A check of the child's thyroid function (e.g. T4 and TSH levels) may be necessary.
Any oral ingestion of povidone-iodine by the child should be avoided.
In pediatric age, use only under strict supervision and in cases of real need.
Accidental ingestion or inhalation of some disinfectants can cause serious eye problems. have serious, sometimes fatal, consequences.
Avoid contact with eyes.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Hyperthyroidism.
Do not use in children under six months of age.
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 this leads to 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 simultaneously with products containing mercury salts or mercury compounds. benzoin, carbonates, tannic acid, alkalis, hydrogen peroxide, taurolidine, and silver.
The use of povidone-iodine-containing products in conjunction with other antiseptics containing octedine on the same or adjacent sites may cause temporary darkening of the affected areas.
The oxidative effect of povidone-iodine-based preparations may cause false-positive results in some laboratory diagnostic tests (e.g., toluidine or guaiac gum tests for the determination of hemoglobin or glucose in stool or urine).
Avoid routine use in patients receiving concomitant lithium treatment.
The absorption of iodine from povidone-iodine solution may reduce thyroid iodine uptake.
This may cause a decrease in the thyroid gland's ability to absorb iodine. interfere with various tests (thyroid scintigraphy, determination of iodine-binding proteins, radioiodine diagnostics) and may make planned treatment of the thyroid with iodine (radioactive iodine therapy) impossible.
After the end of treatment, an adequate period of time must elapse before a new scintigraphy is performed.
Side effects
Side 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 (<1/10,000);
- Not known (frequency cannot be estimated from the available data). available).
Immune system disorders
Rare: Hypersensitivity;
Very rare: Anaphylactic reaction.
Endocrine disorders
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 pruritus);
Very rare: Angioedema;
Not known: Exfoliative dermatitis.
Renal and urinary disorders
Not known: Acute renal failure **, Abnormal blood osmolarity **.
*In patients with a history of thyroid disease (see section Warnings and special precautions for use) following high iodine uptake, for example after long-term use of povidone-iodine solution for the treatment of wounds and burns on large areas of skin.
**May 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.
Overdose
In case of overdose, whether intentional or accidental, hypothyroidism or hyperthyroidism may occur.
Systemic absorption of iodine after repeated applications of the product to large wounds or severe burns may cause serious complications. produce a series of symptoms such as: metallic taste, increased salivation, burning or stinging pain in the mouth and throat, irritation or swelling of the eyes, fever, skin rash, diarrhea and gastrointestinal disturbances, hypotension, tachycardia, metabolic acidosis, hypernatremia, renal failure, pulmonary edema and shock.
In case of accidental ingestion of large quantities of the product, institute symptomatic and supportive treatment with particular attention to electrolyte balance and renal and thyroid function.
Pregnancy and breastfeeding
During pregnancy and breastfeeding, povidone-iodine solution should be used only if strictly necessary and at the lowest possible dose, due to the ability of iodine to cross the placenta and be secreted into breast milk and due to the high sensitivity of the fetus and newborn to iodine.
Furthermore, iodine is more concentrated in breast milk than in serum, therefore it can be harmful to the fetus and newborn. cause transient hypothyroidism with increased TSH (thyroid-stimulating hormone) in the fetus or newborn.
Storage
Store at a temperature not exceeding 25°C.
Format
10 single-use vials of 10 ml
Product Code:FRCM155839
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