Archifar 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 eg, severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria.
As with all β-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see Contraindications and Adverse Reactions).
Patients who have a history of hypersensitivity to carbapenems, penicillins or other β-lactam antibiotics may also be hypersensitive to meropenem. Before initiating therapy with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to β-lactam antibiotics.
If a severe allergic reaction occurs, Archifar should be discontinued and appropriate measures taken.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including meropenem, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see Adverse Reactions). Discontinuation of therapy with meropenem and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Seizures have infrequently been reported during treatment with carbapenems, including meropenem (see Adverse Reactions).
Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see Adverse Reactions).
A positive direct or indirect Coombs test may develop during treatment with meropenem.
The concomitant use of valproic acid/sodium valproate and Archifar is not recommended (see Interactions).
Archifar may reduce serum valproic acid levels. Subtherapeutic levels may be reached in some patients.
Archifar contains sodium. Archifar contains approximately 2 mEq of sodium per 500 mg dose, which should be taken into consideration by patients on a controlled sodium diet.
Effects on the Ability to Drive or Operate Machinery: No studies on the ability to drive and use machines have been performed. However when driving or operating machines, it should be taken into account that headache, paraesthesia and convulsions have been reported for meropenem.
Hepatic Impairment: Patients with preexisting liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary (see Dosage & Administration).
Use in pregnancy: The safety of meropenem in human pregnancy has not been evaluated. Animal studies have not shown any adverse effect on the developing foetus. The only adverse effect observed in animal reproductive studies was an increased incidence of abortions in monkeys at 13 times the expected exposure in man.
Archifar should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus. In every case, it should be used under the direct supervision of the physician.
Use in lactation: Meropenem is detectable at very low concentrations in animal breast milk. Archifar should not be used in breastfeeding women unless the potential benefit justifies the potential risk to the baby.
Use in children: Efficacy and tolerability in infants <3 months have not been established; therefore, Archifar is not recommended for use below this age. There is no experience in children with altered hepatic or renal function.
Keep all medicines away from children.