Iodine new.fa.dem. Ung Derm 1.000g 2% + 10%

NAME
IODIUM NEW.FA.DEM. 2% + 10% OIL

PHARMACOTHERAPEUTIC CATEGORY
Antiseptics and disinfectants.

ACTIVE PRINCIPLES
Iodine / potassium iodide.

EXCIPIENTS
Purified water; Vaseline and lanolin base ointment.

INDICATIONS
Disinfection of intact skin.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active ingredients or to any of the excipients; generally contraindicated in pregnancy.

DOSAGE
Apply a thin layer of ointment to the area to be treated.

STORAGE
Store at a temperature not exceeding 30 degrees C. Keep the container tightly closed and away from light and heat. Store in the original package (iodine-resistant material) to protect the medicine from direct light and heat.

WARNINGS
Do not swallow. For external use only. To avoid excessive absorption of iodine, do not cover the treated skin area with occlusive bandages. Prolonged application can cause irritation and caustication of the treated surface, therefore the medicine should not be used frequently. Since 'iodine and its iodide salts can alter the function of the thyroid gland, caution is recommended when using the medicine in patients older than 45 years or with goiter. Furthermore, the results of thyroid function tests could be altered. Premature infants treated with local iodine applications may show altered results of thyroid function tests.

INTERACTIONS
If it comes into contact with acetone, elemental iodine forms an irritating pungent compound. In evaluating the interactions with other drugs it is necessary to take into account the possible systemic effects of iodine, although when administered topically in the recommended modalities it is absorbed only in small quantities. The effects of iodine and iodides on the thyroid can be altered by other compounds including amiodarone and lithium.

SIDE EFFECTS
The undesirable effects are listed below, organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed. Immune system disorders: iodine and iodides, even when applied locally in accordance with the expected modalities, can cause hypersensitivity reactions which include urticaria, angioedema, skin bleeding or purpura, fever, arthralgia, lymphadenopathy and eosinophilia. Skin and subcutaneous tissue disorders: inhalation of iodine vapors is very irritating to the mucous membranes. Iodine, when administered locally in the recommended modalities, is absorbed only in small quantities with minimal systemic effects. However, the following are listed the adverse reactions due to systemic effects of the drug, which could occur in cases of abnormal absorption (abundant, prolonged use or with occlusion of the treated skin area). Endocrine disorders: iodine and iodides have variable effects on the thyroid gland and can cause goiter and hypothyroidism, as well as hyperthyroidism (Graves' disease). Goiter and hypothyroidism can occur in infants exposed to iodides during pregnancy. Psychiatric disorders: depression, insomnia. Nervous system disorders: headache. Gastrointestinal disorders: nausea, vomiting, diarrhea. Skin and subcutaneous tissue disorders: acneiform eruptions, iododerma. Reproductive system and breast disorders: impotence. Injury, poisoning and procedural complications: prolonged use can cause a series of adverse effects collectively called iodism, some of which may be due to hypersensitivity. These adverse effects include metallic taste, increased salivation, burning and pain in the mouth; acute rhinitis, chorionic-like syndrome, swelling and inflammation of the throat, irritation and swelling of the eyes, and increased tearing may also occur. Pulmonary edema, dyspnoea and bronchitis can develop.

PREGNANCY AND BREASTFEEDING
Iodine is only slightly absorbed when used as intended. The iodine that reaches the systemic circulation crosses the placenta. Excess iodine is harmful to the fetus: the use of potassium iodide and other iodide salts during pregnancy have been associated with goiter, hypothyroidism, respiratory problems, enlarged heart, tracheal compression and neonatal death. Iodides, even when applied topically, are generally to be avoided in pregnancy.