Iopamiro 370 Warnings

The use of organic iodine compounds may cause untoward side effects and manifestations of anaphylaxis. The symptoms include nausea, vomiting, widespread erythema, generalized heat sensation, headache, coryza or laryngeal edema, fever, sweating, asthenia, dizziness, pallor, dyspnea and moderate hypotension. Skin reactions may occur in the form of various types of rash or diffuse blister formation. More severe reactions involving the cardiovascular system such as peripheral vasodilation with pronounced hypotension, tachycardia, dyspnea, agitation, cyanosis and loss of consciousness, may require emergency treatment. For these reasons the use of organic iodine contrast media must be limited to cases for which the diagnostic procedure is definitely indicated, as suggested by the patient's clinical status with special attention to existing pathology of the cardiovascular, urinary or hepatobiliary system. In particular, contrast media designed for cardioangiographic procedures should be used in hospitals or clinics equipped and staffed for intensive care in emergencies. For other more common diagnostic procedures calling for the use of iodinized contrast media, the public or private institutions, where such procedures take place, should be supplied at all times with all equipment and drugs that experience has shown to be suitable in case of an accident: the Ambu balloon, oxygen bottles, antihistamines, vasopressor drugs, cortisones. Never mix other drugs with contrast medium solutions. When examining small children or babies, do not limit fluid intake before administering a hypertonic contrast solution; also, correct any existing water and electrolyte imbalance. Pregnant women and patients with hyperthyroidism should receive iodinized contrast media only if the attending physician finds it absolutely necessary.
Iopamiro like all other iodinated contrast media, may induce changes in thyroid function in some patients. Transient hyperthyroidism or hypothyroidism has been reported following iodinated contrast media administration to adults and paediatric patients.
Decreased levels of thyroxine (T4) and triiodothyronine (T3) and increased level of TSH were reported after exposure to iodinated contrast media in infants, especially preterm infants, which remained for up to a few weeks or more than a month (see ADVERSE REACTIONS). Hypothyroidism in infants may be harmful for growth or development, including mental development, and may require treatment. Thyroid function in infants exposed to iodinated contrast media should therefore be evaluated and monitored until thyroid function is normalised.
In patients scheduled for thyroid examination with a radioactive iodine tracer, bear in mind that iodine uptake in the thyroid gland will be reduced for several days (sometimes up to 2 weeks) after dosing with an iodinized contrast medium that is eliminated through the kidneys.
General Adverse reactions: Endocrine disorders.
Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and paediatric patients, including infants. Some patients were treated for hypothyroidism.
Keep Iopamiro solutions away from strong light. Exceptionally, the event of crystallization of Iopamiro solutions could occur. It has been shown that such a phenomenon is caused by a damaged or defective container and therefore the product should not be used in this case. The bottle, once opened, must be used immediately. Any residue of contrast medium must be discarded. Iopamiro, as other iodinated contrast media, can react with metallic surfaces containing copper (e.g. brass), therefore the use of equipment, in which the product comes into direct contact with such surfaces, should be avoided.