Bielmeropenem Injection 1 Gram (Meropenem Hydrate)

Adult administration

As meropenem hydrate, administer 0.5 to 1 g (potency) daily in 2 to 3 divided doses by intravenous infusion over more than 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, or neutropenia, administer 1 g (potency) by intravenous infusion every 8 hours. For cystic fibrosis or meningitis, administer 2 g (potency) by intravenous infusion every 8 hours.

Child administration

For bacterial meningitis in children over 3 months old, administer by intravenous infusion of 40 mg per kg body weight every 8 hours for more than 30 minutes, depending on pathogen susceptibility and the patient’s condition.

This drug should not be administered to patients who have experienced shock from this medication in the past. Additionally, patients taking a medication called sodium valproate should be cautious as co-administration with this drug can lower valproate blood levels, leading to the recurrence of seizures. Patients who have had allergic reactions to this drug or its components should also avoid use, and it should not be administered to those with severe allergies to other carbapenem antibiotics or beta-lactam antibiotics (penicillin, cephalosporins, etc.). Patients with allergic predispositions or those who frequently exhibit symptoms of allergies such as bronchial asthma or rashes should use this medication with caution. Patients with reduced kidney function may experience increased concentrations of this drug, which can lead to central nervous system symptoms such as seizures or altered consciousness, thus requiring dosage adjustments or extended intervals between doses. Patients with a history of seizures or central nervous system disorders may be at greater risk for seizure symptoms, necessitating careful monitoring. Patients with severely compromised liver function should use this drug cautiously as their liver condition may worsen. Elderly patients have a higher risk of side effects due to decreased physical function and should have their dosage and administration intervals adjusted while closely monitoring their condition. Patients who have difficulty eating or are receiving non-oral nutrition should be closely monitored for signs of vitamin K deficiency. Use in infants under 3 months of age should be approached with caution as safety and efficacy have not been established. While administering this drug, serious allergic reactions like shock or anaphylaxis may occur rarely, hence patients should be closely monitored, and the treatment should be immediately discontinued if any unusual symptoms arise and appropriate care should be undertaken. Hypersensitivity reactions such as skin rashes, hives, itching, fever, or flushing may occur, requiring immediate cessation of administration and treatment if these symptoms appear. Various blood abnormalities, including leukopenia, anemia, and platelet irregularities, may show up in blood tests, necessitating regular blood status checks. Symptoms of liver damage, such as abnormal liver function tests, jaundice, or hepatitis, may arise, mandating regular liver function tests and a discontinuation of treatment if any abnormalities are detected. Rapid deterioration of kidney function may occur; therefore, renal function tests should be conducted periodically, and treatment should be stopped if any issues are found. Severe diarrhea or pseudomembranous colitis, which are serious gastrointestinal side effects, may occur, mandating immediate cessation of treatment if abdominal pain or frequent diarrhea is noted. Central nervous system symptoms such as seizures or altered consciousness may arise, so special caution is necessary, especially in patients with renal or central nervous system disorders. Respiratory issues like asthma, dyspnea, or pneumonia may rarely occur; hence, if respiratory distress occurs, treatment should be ceased and managed accordingly. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may happen, requiring immediate cessation of treatment if any skin abnormalities are observed. Alternations in flora such as stomatitis or candidiasis may occur. There may be signs of bleeding tendencies due to vitamin K deficiency, necessitating close attention to any bleeding symptoms and the observation of vitamin B group deficiency symptoms as well. Cardiovascular anomalies such as heart failure, arrhythmias, and blood pressure changes may arise, requiring careful monitoring of the heart's health. Peripheral edema or hypoxia may occur, while the mental and nervous system can show symptoms like insomnia, delirium, and dizziness, necessitating reporting of any abnormal symptoms. Inflammation, pain, or swelling at the injection site may occur; hence injection sites must be monitored closely. Symptoms in the genitourinary system may include urination issues or vaginal candidiasis. If symptoms of rhabdomyolysis, such as myalgia, muscle weakness, or dark urine are present, treatment must be immediately ceased and managed. This drug should only be administered for the minimal required duration to prevent the emergence of resistant bacteria, and if sensitivity is not demonstrated, tests should be conducted within 3 days from the start of administration, and changes to other medicines should be made if necessary. Before administration, it is crucial to thoroughly investigate the patient's allergy history and risk of shock. During administration, patients should be maintained in a stable condition, responding immediately to any adverse reactions that occur. Long-term administration necessitates special attention for rashes and liver function abnormalities, with regular liver function testing being mandatory. Symptoms such as headaches or mental confusion may arise during driving or operating machinery, demanding caution. Due to various interactions with other drugs, especially with probenecid, valproate, antiepileptic agents, hormonal contraceptives, and warfarin, close monitoring of serum concentration and effect is warranted when used together. During pregnancy, safety has not been established, and it should only be given if the therapeutic benefits are deemed to outweigh risks. Nursing mothers should avoid breastfeeding as this drug may be secreted in breast milk. Elderly patients have an elevated risk of side effects due to decreased physiological functions and should have their dosages and intervals adjusted while being closely monitored. Lastly, this drug should only be administered as an intravenous injection and should be used as soon as possible after reconstitution, with storage at room temperature for 6 hours or within 24 hours if refrigerated.

Serious side effects

Hives, shock, anaphylactic-like reactions, rash, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme, acute generalized exanthematous pustulosis (AGEP), severe edema, severe skin adverse reactions, liver dysfunction, jaundice, acute renal failure, severe renal impairment, pseudomembranous colitis, severe colitis, seizures, altered consciousness, asthma.

Mild side effects

• Dizziness
• diarrhea
• tinnitus
• sweating
• warm sensation
• erythema
• itching
• fever
• flushing
• generalized flushing

This drug should be stored in a sealed container to prevent contact with air, and the temperature should be kept between 1 degree and 30 degrees Celsius. Such storage will maintain the drug's efficacy and ensure safety in its use.

Appearance

A crystalline powder that is white to pale yellow in color, contained in a colorless and transparent vial for injection.

Package unit

10 vials per box [(1,208 milligrams per vial)]