The package insert of the medicine Cetaz Im/iv

the package insert of the medicine Cetaz Im/iv. Active principles Ceftazidime.

what For?

it Is indicated in the treatment of infections, single or multiple caused by susceptible bacteria that include infections of the respiratory tract, urinary tract, infections in the joints and bones, gynaecological infections, intra-abdominal infections and soft tissue infections in the skin, in cases of septicaemia and meningitis.

In virtue of its action spectrum widened, especially against agents, gram-negative, is also indicated in infections resistant to other antibiotics, including aminoglycosides and cephalosporins. Nevertheless, when necessary, can be administered in combination with aminoglycoside or other beta-lactam antibiotics, such as, for example, in the face of severe neutropenia.

Contraindications

When should I not use?

The product is contraindicated to patients with hypersensitivity to the components of the formula and to antibiotics cefalosporínicos.

Dosage

How to use?

The product should be used via exclusively parenteral, varying the dose according to the severity, sensitivity and type of infection, as well as the age, weight and renal function of the patients.

Adults:
The dose varies from 1 to 6 g daily, for example, 500mg, 1g or 2g, administered every 8 or 12 hours, by injection intravenously or intramuscularly. For infections of the urinary tract and those of lower severity, the dose of 500mg or 1g of 12/12 hours is generally satisfactory. For most infections, the optimal dosages are 1g 8/8 hours or 2g of 12/12 hours. In more serious infections, especially in patients with immunosuppression, including the neutropênicos, should be administered the dose of 2g every 8 or 12 hours. In patients fibrocísticos adults with normal renal function and patients with lung infection by Pseudomonas, will be necessary scores high, that is, from 100 to 150mg/kg/day, divided into three doses (doses of 9g/day have been employed with safety in such cases).

newborns and infants up to 2 months of age:
25 to 60 mg/kg/day divided in two applications. In newborn infants the half-life serum concentrations of Ceftazidime can be 3 to 4 times higher than that of the adult.

Infants and older children:
Dosage usual for children older than 2 months is 30 to 100 mg/kg/day, divided into two or three doses. Doses greater than 150mg/kg, three times a day, up to a maximum of 6 g/day may be administered to children with impaired immunity, with cystic fibrosis or meningitis.

elderly Patients:
Due to the reduced clearance of Ceftazidime in elderly patients severe, the daily dose of Ceftazidime should not normally exceed 3g, especially in those with more than 80 years.

Dosing before the impairment of renal function:
The product is excreted by the kidneys almost exclusively by glomerular filtration. Thus, in patients with kidney function compromised, it is recommended that the dose be reduced, unless the impairment is of mild intensity, that is, speed of glomerular filtration (VFG) greater than 50ml/min. In patients with suspicion of renal failure can be instituted at an initial dose of 1g of the product. In these cases, it is recommended to estimate the VFG in order to determine the correct dose. The doses recommended maintenance are:
Creatinine clearance (ml/min) serum Creatinine approximately mmol/l (mg/dl) unit Dose recommended (g) Frequency of doses (hours)
>50 5,6) 0,5 48
In patients with severe infection, especially in the neutropênicos, the dose unit may be increased by 50% or the frequency of administration increased appropriately. In such patients it is recommended to monitor serum levels of Ceftazidime so that they do not exceed 40 mg/l. In the case of having only the values of serum creatinine, you can use the following formula (the Equation of Cockcroft) to estimate the clearance rate. The serum creatinine would represent, then, a state is maintained in the kidney function.

Men:
Creatinine clearance (ml/min)= weight (kg) x (140 – age in years)
72 x serum creatinine (mg/dl)
Women:
0.85 x the value obtained for the men (above)
To convert serum creatinine from mmol/l to mg/dl, divide by 88,4.

In children, the creatinine clearance should be adjusted in function of body surface area or lean muscle mass, reducing, as in adults, the frequency of doses in cases of renal failure. The half-life serum concentrations of Ceftazidime during haemodialysis ranges from 3 to 5 hours; the maintenance dose appropriate should be repeated after each section. The Ceftazidime can also be used in dialysis (peritoneal, both injecting as incorporated into the liquid of dialysis (usually 125 and 250 mg/2 liters).

Administration:
The product can be administered via intravenous or intramuscular deep. The solution should be prepared as specified below:
Bottle Use Volume of diluent to be added(ml) Concentration approximate (mg/ml)
1g Intramuscular 3,0 260
1g Intravenous 1,0 90
1g Infusion Intravenous 50 20
After addition of the diluent, it is recommended to shake the bottle well and wait until getting the clear solution (1 to 2 minutes); it is expected, in this period, the release of a small amount of carbon dioxide. The solutions for intravenous use may be injected directly into the vein or introduced into the rubber of the team, if the patient is receiving fluids parenteral.

Ceftazidime is compatible with the majority of the parenteral solutions in common use (see Precautions pharmacy-technical below).

the Preparation of solutions for injections intramuscular and intravenous:
1) Introduce the syringe needle through the cap of the vial and inject the recommended volume of diluent;
2) Remove the needle and shake the vial to form a clear solution;
3) Invert the bottle. With the syringe plunger fully depressed, insert the needle in the solution. Withdraw the total volume of the solution inside of the syringe ensuring that the needle aspirate only the solution. Small bubbles of carbon dioxide should be neglected.

the Preparation of solutions for iv infusion injection:
1) Introduce the syringe needle through the cap of the vial and inject 10 ml of diluent;
2) Remove the needle and shake the vial to form a clear solution;
3) Insert a second needle in the lid of the jar to remove the gas and release the pressure in the interior of the vial;
4) With the bottle free of gas, add the remainder of the diluent. Remove both the needle; shake the vial and prepare the infusion in the normal way.

Note: To preserve the sterility of the product it is important not to insert the second needle for releasing the gas before the product to be dissolved.

Side Effects

What are the evils that can cause me?

clinical experience has shown that Ceftazidime is generally well tolerated. Adverse reactions are infrequent, including phlebitis or thrombophlebitis after administration, intravenous; pain and/or inflammation after intramuscular administration; rash máculo-papular, or urticariforme, fever, pruritus and, more rarely, angioedema and anaphylaxis (bronchospasm and/or hypotension); diarrhea, nausea, vomiting, abdominal pain and, more rarely, inflammation of the mouth or colitis; as with other cephalosporins, colitis may be associated with Clostridium difficile and present as pseudomembranous colitis; candidiasis, vaginitis; headache, dizziness, paresthesia and sensation of unpleasant taste. Have been reported rare cases of seizures that occurred in patients with renal dysfunction, in whom the dose of Ceftazidime has not been appropriately reduced.

Overdose

what to do if someone use a larger amount than is recommended?

The serum levels of Ceftazidime is reduced by haemodialysis or peritoneal dialysis. The overdose can lead to neurological complications including encephalopathy, convulsions and coma. Can occur especially in patients with renal dysfunction when it is not done to adjust the dose.