Natronem Special Precautions

Special Precautions: The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitivity to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken.
Patients with severe renal impairment; Patients who have a history of epilepsy and CNS impairment. (Symptoms of CNS with seizures and decreased consciousness have infrequently been reported during treatment with meropenem); Patients with severe hepatic impairment; Elderly.
General Precautions: As with other β-lactam antibiotics, strains of Pseudomonas aeruginosa may develop resistance on treatment with meropenem. Development of resistance has been reported in pseudomonal hospital-acquired lower respiratory tract infections. In such cases, meropenem should be used with caution and repeat sensitivity testing is recommended.
As with other antibiotics, caution may be required in using with meropenem as monotherapy with critically ill patients with known or suspected Pseudomonas aeruginosa lower respiratory tract infection.
Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.
Pseudomembranous colitis has been observed with practically all antibiotics may vary in severity from slight to life-threatening. Therefore, antibiotics should be prescribed with care for individuals with a history of gastrointestinal complaints, particularly colitis. It is important to consider the diagnosis of pseudomembranous in the case of patients who develop diarrhea when using an antibiotic. Although studies indicate that a toxin produced by Clostridium difficile is one of the main causes of antibiotic-associated colitis, other causes should be considered. Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy eg. oral antibiotic agents effective against Clostridium difficile should be considered.
Fluids, electrolyte and protein replacement should be provided when indicated. Drugs that delay peristalsis, e.g. opiates and diphenoxylate with atropine may prolong and or worsen the condition and should not be used.
Neurological sequelae were reported following treatment of severe meningitis with meropenem. In clinical trials, these adverse events were reported in 23 out of 148 patients treated with meropenem and in 17 of 144 patients treated with comparator antibiotics.
A positive or indirect Coomb's test may develop.
Patients with Liver Disease: Patients with preexisting liver disorder should have liver function monitored during treatment with meropenem for injection.
Effects on ability to drive and use machines: No studies on the effect on the ability to drive and use machines have been performed.
Use in children: Efficacy and tolerability in infants less than 3 months have not been established. Therefore, this drug is not recommended for use in children below this age.
Use in elderly: No dose adjustment is required in elderly patients with normal renal function or creatinine clearance values more than 50 mL per minute.