PRECAUTIONS
General High and prolonged serum Tobracef (Ceftazidime and Tobramycin )combination concentrations can occur from usual dosages in patients with transient or persistent reduction of urinaryoutput because of renal insufficiency. The total daily dosage should be reduced when the combination is administered to patients with renal insufficiency. Elevated levels of Ceftazidime in these patients can lead to seizures, encephalopathy, asterixis, neuromuscular excitability, and myoclonia. Continued dosage should be determined by degree of renal impairment, severity of infection, and susceptibility of the causative organisms. As with other antibiotics, prolonged use of Tobracef may result in overgrowth of non susceptible organisms. Repeated evaluation of the patient’s condition is essential. If super infection occurs during therapy, appropriate measures should be taken. Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K may be administered as required.
OVERDOSE
Excitability and coma. Patients who receive an Tobracef (Ceftazidime and Tobramycin) over dosage may occur in patients with renal failure. Reactions may include seizure activity, encephalopathy, asterixis, neuromuscularacute overdosage should be carefully observed and given supportive treatment. Nephrotoxicity following the parenteral administration of an aminoglycoside is most closely related to the area under the curve of the serum concentration versus time graph. Patients who are elderly, have abnormal renal function, are receiving other nephrotoxic drugs, or are volume depleted are at greater risk for developing acute tubular necrosis. Auditory and vestibular toxicities have been associated with aminoglycoside overdose. In the presence of renal insufficiency, hemodialysis may aid in the removal of Ceftazidime and Tobramycin from the body.
CARCINONGENESIS Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PHARMACEUTICAL PARTICULARS Shelf Life 2 years
Special Precautions for Storage Tobracef in the dry state should be stored between 20°– 25°C and protected from light.
Presentation Each vial of Tobracef (Ceftazidime Pentahydrate and Tobramycin Sulphate) for injection with new SFI is filled in flint vial with Grey butyl plug and flip off seal in unit pack. It is available in following three strength
- 560 mg in 10ml vial,
- 1.12 g in 20ml vial and
Instructions for Use/Handling Standard aseptic technique is employed during handling.
*Research Product of Venus Remedies Ltd. Patent Under Process TM-Trademark under Registration Manufactured in India by : VENUS REMEDIES LIMITED Unit – II, Hill Top Industrial Estate Jharmajri EPIP, Phase – 1 (Extention) Bhatoli Kalan,Baddi, H.P (India).