Diapamiro 370 mg/50 ml

INDICATIONS

Neuroradiology: Lumber myelography, thoraco-cervical myelography.Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocadiography, selective visceral arteriography, peripheral arteriography, digital subtraction angiography, venography, urography.Other diagnostic procedures: Contrast enhancement in CT scanning, arthrography, fistulography.

PHARMACOLOGY

Iopamidol, an organic Iodine compound and used as a non-ionic water soluble radiographic contrast medium. Iopamidol blocks X-rays as they pass through the body, thereby allowing body structures not containing Iodine to be visualized. The degree of opacity produced by Iopamidol is directly proportional to the total amount of the iodinated contrast agent in the path of the X-rays. The visualization of body structures is dependent upon the distribution and elimination of Iopamidol.

DOSAGE

Adult dosage:

Neurology: Lumber myelography: Iopamidol 370, 6-13 ml
Thoraco-cervical myelography: Iopamidol 370, 6-13 ml
Urography: Iopamidol 370, 40-80 ml IV up to 1.5 ml/kg in severe renal disease.

Children:

Usual Dose: 1-2.5 ml/kg
Other Diagnostic Procedure: Contrast enhancement in CT scanning: Iopamidol 370, 0.5-2.0 ml/kg

Angiography: Cerebral angiography: Iopamidol 370, 6-13 mlSelective coronary arteriography: Iopamidol 370, 4-8 ml/arteryPeripheral arteriography: Iopamidol 370, 20-50 mlVenography: Iopamidol 370, 24-60 mlAngiocardiography: Iopamidol 370, 30-80 mlLeft ventriculography: Iopamidol 370, 30-80 mlPercutaneous transfemoral or renal arteriography: Iopamidol 370, 30 mlSelective renal arteriography: Iopamidol 370, 5-10 mlHepatic angiography: Iopamidol 370, 70 mlCoeliac angiography: Iopamidol 370, 40-70 mlSuperior mesenteric angiography: Iopamidol 370, 25-50 mlInferior mesenteric angiography: Iopamidol 370, 5-30 mlDigital subtraction angiography: 30-50 ml (10-20 ml/sec) of Iopamidol 370, IV 25 ml (left ventricle), 2-5 ml (coronary arteries), 15 ml/sec. of Iopamidol 370 i.a for cardiac imaging

INTERACTION

Thyroid function test-use of Iopamidol 370/300 may interfere with tests or thyroid function. Biguanide oral anti-diabetic agents e.g. Metformin, are excreted unchanged through the kidneys. They therefore compete for excretion in the kidneys with contrast media and this could lead to reduction in kidney function. Patient with NIDDM who are taking Metformin or other biguanides should therefore be instructed not to take any doses of Metformin for 48 hours before or 48 hours after the x-ray examination.

SIDE EFFECTS

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, fever, sweating, asthenia, dizziness, pallor, dyspnea, and moderate hypotension. Skin reactions 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. During intracardiac and /or coronary arteriography, ventricular arrhythmia may infrequently occur. Hyperthyroidism may recur in patients previously treated for graves disease.

PREGNANCY & LACTATION

In pregnant women, Iopamidol injection should be administered only if the procedure is considered essential by the physician. Fertility and mutagenicity studies have shown that Iopamidol has no influence on these parameters. Teratogenicity studies in rats and rabbits have shown no influence of Iopamidol up to 8.2 g/kg (rat) and 4.1 g/kg (rabbit).

PRECAUTIONS & WARNINGS

Iopamidol 370/300 should not be drawn into the syringe until immediately before use. The bottle, once opened, must be used immediately. In consideration of possible serious side effect the use of organoiodinate contrast media should be limited to cases for which there is a precise need for radiographic contrast examination. This should be evaluated according to clinical status of the patient, in particular in relation to pathologies of the cardiovascular, urinary or hepatobiliary system. In particular contrast media designed for cardioangiography should be used in hospitals or clinics equipped and staffed for intensive care in emergencies. For other diagnostic procedures requiring the use of iodinised contrast media, in the public or institutions where such procedures take place, resuscitation equipment and therapeutic measures should be immediately available. 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. X-ray examination of woman should also, if possible be conducted during the pre-ovulation phage of menstrual cycle. In patients scheduled for thyroid examination with a radioactive Iodine tracer, one must take into consideration that Iodine uptake in the thyroid gland will be reduced for several days (up to two weeks) after dosing with an iodinised contrast medium that is eliminated through kidney. Biguanide oral anti diabetic agents e.g. Metformin, are excreted unchanged through the kidneys. They therefore compete for excretion in the kidneys with contrast media and this could lead to reduction in kidney function. Patient with NIDDM who are taking Metformin or other biguanides should therefore be instructed not to take any doses of Metformin for 48 hours before and 48 hours after the X-ray examination.

THERAPEUTIC CLASS

Contrast medium for diagnostic procedures

STORAGE CONDITIONS

Keep Iopamidol away from light. Store below 30°C. Exceptionally crystallization of Iopamidol injections can occur. It has been shown that such a phenomenon is caused by a damaged 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.