Orofenem Injection 1g (Meropenem Hydrate)

Adult administration

As Meropenem Hydrate, 0.5 to 1 g (potency) should be administered by intravenous infusion divided into 2 to 3 doses lasting more than 30 minutes, daily. In cases of suspected infections in patients with pathogenic pneumonia, peritonitis, or neutropenia, administer 1 g (potency) every 8 hours by intravenous infusion. For cystic fibrosis or meningitis, 2 g (potency) should be administered every 8 hours by intravenous infusion.

Child administration

For bacterial meningitis in children over 3 months, administer 40 mg per kg of body weight every 8 hours by intravenous infusion lasting more than 30 minutes, according to the sensitivity of the pathogen and the child's condition and type of infection.

This drug should not be used in patients who have experienced shock due to this drug in the past. Patients taking sodium valproate should be cautious as co-administration may lower plasma levels of valproate, leading to a recurrence of seizures. Patients who are allergic or have had hypersensitivity reactions to this medication or its ingredients should not be administered this drug. Patients who have experienced allergic reactions to other carbapenem antibiotics, especially severe skin reactions, should also avoid using this drug. Patients who have had severe allergic reactions to beta-lactam antibiotics such as penicillins or cephalosporins should refrain from using this medication. Patients with a history of allergies or family history, and those with impaired kidney function should use this drug cautiously, adjusting the dose or extending intervals accordingly. Patients with a history of seizures or central nervous system problems may also experience seizures or disturbances in consciousness, requiring caution. Patients with severely impaired liver function should use this drug with caution as it may worsen liver function. Elderly patients may experience side effects more frequently due to reduced bodily function, hence doses and intervals should be carefully adjusted. Patients who have difficulty taking medications orally or are in poor nutritional status may develop vitamin K deficiency symptoms, necessitating careful monitoring of their condition. Infants under 3 months of age should avoid using this drug as its safety and efficacy have not been established for this age group. Serious allergic reactions such as shock or anaphylaxis can occur rarely when administering this drug. Patients should be monitored closely during administration, and if unusual symptoms arise, administration should be discontinued immediately. If symptoms of hypersensitivity such as skin rashes, urticaria, or itching appear, administration of this drug should be stopped immediately, and appropriate treatment should be received. Various hematological abnormalities such as leukopenia, anemia, or platelet abnormalities may occur, so regular blood tests should be conducted, and medication should be discontinued if abnormalities are found. Liver function abnormalities or hepatitis symptoms may occur, leading to the need for regular liver function tests and discontinuation if abnormalities are found. Kidney function may deteriorate suddenly, requiring periodic kidney function tests and discontinuation if abnormalities are detected. Severe diarrhea or abdominal pain may indicate serious colitis such as pseudomembranous colitis, thus medication should be stopped immediately and treatment sought. Central nervous symptoms such as seizures or disturbances of consciousness should lead to immediate discontinuation of administration; patients with kidney or central nervous system issues need to be particularly cautious. Respiratory problems such as asthma, difficulty breathing, or pneumonia may arise, requiring immediate cessation and medical treatment if symptoms occur. Severe skin reactions such as Stevens-Johnson Syndrome or toxic epidermal necrolysis may present, necessitating careful observation of the skin condition. Rare instances of opportunistic infections like stomatitis or candidiasis may occur. Bleeding tendencies due to vitamin K deficiency or symptoms of vitamin B deficiencies should be closely monitored for bleeding symptoms or stomatitis. Cardiac issues, abnormal blood pressure, and arrhythmias may arise, hence cardiovascular status should be carefully observed. Nervous system symptoms such as insomnia, mental confusion, and dizziness may occur, requiring caution if such symptoms arise. Injection sites may experience inflammation or pain, requiring observation of the injection site. Urogenital issues such as urinary retention, vaginitis, or urinary incontinence have been reported, necessitating caution. Symptoms of rhabdomyolysis such as muscle pain, muscle weakness, or dark urine should prompt immediate discontinuation and appropriate treatment. During the use of this drug, susceptibility testing should be conducted to prevent the emergence of resistant bacteria, and the minimum necessary duration should be adhered to. If administered without susceptibility testing, susceptibility should be confirmed 3 days later to decide if continued use is warranted, and alternative medications should be considered if resistant. Before administration, allergy response should be thoroughly checked, and treatment should be prepared for emergency situations. Long-term administration may increase the risk of side effects, so when used for more than 7 days, reasons must be clearly defined, and monitoring for rash or liver function abnormalities is necessary. Liver function tests must be performed after more than one week of administration to check liver status. Past severe allergic reactions to beta-lactam antibiotics must be investigated. While on this medication, patients may experience headaches or mental symptoms; caution is advised when driving or operating machinery. If symptoms of rhabdomyolysis appear, such as muscle pain, muscle weakness, dark urine, or elevated creatine kinase, immediate cessation of treatment is required. This medication may interact with certain drugs, potentially altering concentrations or effects when used concomitantly, so consulting with a doctor or pharmacist is advised. The safety of this drug during pregnancy has not been established, thus it should only be used when the benefits outweigh the risks. During lactation, this drug may be secreted in breast milk, so it is advisable to avoid breastfeeding when administering this drug. The safety and efficacy in infants under 3 months have not been established; it is preferable not to use the drug in this age group. Elderly patients may experience side effects more frequently due to diminished bodily functions, and careful monitoring and adjustment of dosing and intervals is necessary. Certain test results may yield false positives during administration, so caution is needed in interpreting test results. After administration, the medication should be used as soon as possible; if storage is required, it should be used within 6 hours at room temperature or within 24 hours when refrigerated. This drug should only be administered by intravenous injection, and color changes after dissolution do not affect its efficacy.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash accompanied by fever, blisters, skin peeling, pain in oral and ocular mucosa, severe skin reactions, shortness of breath, asthma attacks, respiratory problems accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities, sudden and severe drops.

Mild side effects

• Discomfort
• oral mucosa abnormalities
• wheezing
• dizziness
• diarrhea
• tinnitus
• sweating
• rash
• heat sensation
• erythema

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture, preferably at room temperature between 1 degree and 30 degrees Celsius. This storage method helps maintain the drug's efficacy and prevents degradation.

Appearance

A white to light yellow crystalline powder in a colorless transparent vial for injection.

Package unit

10 vials/box [1 vial X 10]