Ospenem Injection 1g (Meropenem Hydrate)

Adult administration

As meropenem hydrate, administer 0.5 to 1 g (potency) divided into 2 to 3 doses via intravenous infusion over at least 30 minutes daily. For suspected infections in patients with pathogenic pneumonia, peritonitis, and neutropenia, administer 1 g (potency) via intravenous infusion every 8 hours. For cystic fibrosis and meningitis, administer 2 g (potency) via intravenous infusion every 8 hours. Continue treatment based on the assessment of the need for ongoing treatment after 3 days of the initial dose.

Child administration

For bacterial meningitis in children over 3 months, administer 40 mg per kg of body weight via intravenous infusion over at least 30 minutes, every 8 hours, depending on the pathogen's susceptibility and the patient's condition.

This drug should not be used in patients who have previously experienced shock symptoms from this drug. Additionally, it is advisable not to use this drug with patients taking sodium valproate because it can lower the blood concentration of valproate and lead to a recurrence of seizure episodes. Patients who have had allergic reactions to this drug or its ingredients, and those who have shown severe allergic reactions to other carbapenem or beta-lactam antibiotics should not be administered this drug. Care should be taken when using this drug in patients with a history of allergies, bronchial asthma, skin rashes, and other frequent symptoms of allergy. Patients with impaired renal function may have this drug's concentration remaining in their bodies for longer, potentially leading to central nervous system abnormal symptoms like seizures or consciousness disturbances, so the dosage should be reduced or the dosing interval increased. Patients with a history of epilepsy are also at risk of seizures, so caution is advised. Patients with severely compromised liver function or elderly patients, and those with poor nutritional status, and infants under 3 months old require special caution. While administering this drug, it is important to closely monitor for shock or allergic symptoms, rashes, blood abnormalities, changes in liver and kidney function, severe diarrhea, abdominal pain, and symptoms of central nervous system abnormalities. Especially severe adverse effects such as severe skin reactions or liver injury, acute renal failure, and pseudomembranous colitis may occur, so if symptoms arise, the drug should be stopped immediately and medical attention sought. This drug should only be used for the minimal required period based on susceptibility testing to prevent resistant bacteria, and if susceptibility is not confirmed, it should be quickly switched to another medication. Before administration, it is essential to confirm any history of allergy to beta-lactam drugs. Symptoms of headache, confusion, and perceptual disturbances may occur, so caution is advised when driving or operating machinery. If symptoms of rhabdomyolysis such as muscle pain, muscle weakness, or dark urine occur, the drug should be discontinued immediately. This drug may interact with other medications, so especially when taking with probenecid, valproate, anticonvulsants, hormonal contraceptives, etc., consultation with a physician is necessary. Women who are pregnant or may become pregnant should only use this drug when the therapeutic benefits are deemed to outweigh the risks. Breastfeeding women should avoid breastfeeding since this drug can be excreted in breast milk. It is advisable not to administer this drug to infants under 3 months old as safety and efficacy have not been established. Elderly patients should have their dosage and intervals adjusted carefully due to decreased body function and increased susceptibility to side effects. This drug may affect test results, so caution is needed during tests, and it should be used as soon as possible after preparation. Lastly, this drug must only be administered intravenously, and it should also be used within the prescribed time during storage.

Serious side effects

Shock, anaphylaxis, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, DRESS syndrome, erythema multiforme, acute generalized exanthematous pustulosis), severe colitis, liver failure, jaundice, acute renal failure, asthma, respiratory distress, pulmonary edema, epileptic pneumonia, pulmonary embolism, heart failure, cardiac arrest, hypertension, myocardial infarction, hypotension, urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor,

Mild side effects

• Rash
• urticaria
• feeling of warmth
• erythema
• itching
• fever
• redness
• generalized flushing
• angioedema
• oral discomfort

This drug must be stored in a sealed container to prevent exposure to air, maintaining storage temperatures between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's efficacy and safety.

Appearance

Colorless and transparent vial filled with crystalline powder that is white to light yellow.

Package unit

10 vials/