Medication info

Ospenem 500 mg (Meropenem Hydrate)

Prescription medication정맥
Ingredient · strength
Meropenem Hydrate›500mg / 1 vial
Manufacturer / importer
(주)오스코리아제약
Appearance
A colorless, transparent vial filled with crystalline powder ranging from white to light yellow.
Packaging
10 vials/
Approval status
Active

MFDS item code 201902797 · Approved 2019.04.30

Summary

Main use
Treatment of various bacterial infections (sepsis, respiratory infections, etc.)
Who receives it
Adults · Children
Adult administration
As Meropenem Hydrate, administer 0.5 to 1 g (activity) daily divided into 2 to 3 doses via intravenous infusion for at least 30 minutes. In cases of suspected infection in patients with pathogenic pneumonia, peritonitis, or neutropenia, infuse 1 g (activity) every 8 hours. For cystic fibrosis and meningitis, infuse 2 g (activity) every 8 hours.
Child administration
For bacterial meningitis in children older than 3 months, based on the pathogen's sensitivity and the patient's condition, administer 40 mg per kg of body weight via intravenous infusion for at least 30 minutes every 8 hours. Additionally

Ingredients

Manufacturer
(주)오스코리아제약

Efficacy & effects

Treatment of various bacterial infections (sepsis, respiratory infections, etc.)

  • Sepsis
  • superficial purulent diseases
  • lymphadenitis
  • perianal abscess
  • osteomyelitis
  • arthritis
  • wound infections
  • pneumonia
  • peritonsillar abscess
  • secondary infections in chronic respiratory diseases
  • lung abscess
  • empyema
View approved original text

This medication effectively acts against various bacteria to treat several infections. It is typically used for sepsis, superficial purulent diseases, lymphadenitis, and perianal abscess. It is also effective against surgical and orthopedic infections such as osteomyelitis, arthritis, and wound infections. For respiratory infections, it is beneficial in treating pneumonia, peritonsillar abscess, secondary infections in chronic respiratory disease, lung abscess, and empyema. It can apply to urinary tract infections, biliary tract infections, peritonitis, infections in gynecological areas, and otorhinolaryngological infections. Furthermore, it is used for bacterial meningitis (in children older than 3 months), suspected infections in patients with neutropenia, and treatment of cystic fibrosis. Overall, it is widely utilized in the treatment of various infections.

How it is given

Adult administration

As Meropenem Hydrate, administer 0.5 to 1 g (activity) daily divided into 2 to 3 doses via intravenous infusion for at least 30 minutes. In cases of suspected infection in patients with pathogenic pneumonia, peritonitis, or neutropenia, infuse 1 g (activity) every 8 hours. For cystic fibrosis and meningitis, infuse 2 g (activity) every 8 hours.

Child administration

For bacterial meningitis in children older than 3 months, based on the pathogen's sensitivity and the patient's condition, administer 40 mg per kg of body weight via intravenous infusion for at least 30 minutes every 8 hours. Additionally

Precautions

This medication should not be used in patients with a history of shock resulting from this medication. Additionally, it should not be used in patients taking sodium valproate, as it may lower the blood concentration of valproate, posing a risk of recurrent seizures. Patients who have previously shown allergic reactions to this medication or its components should also avoid receiving this medication. Patients who have had allergic reactions to other carbapenem antibiotics, as well as those who have experienced severe allergic reactions to beta-lactam antibiotics such as penicillin or cephalosporins, should use caution. Careful administration is needed for patients with a history of allergies or family history of bronchial asthma, rashes, or other allergic symptoms. Patients with decreased kidney function may need reduced dosages or extended administration intervals, as this medication may linger in the body causing central nervous system side effects. Patients with epilepsy or central nervous system diseases may experience seizures or consciousness disturbances and should be monitored closely. For patients with severely impaired liver function, use cautiously due to the risk of worsening liver function. Elderly patients may have decreased physiological functions, increasing the potential for side effects, requiring adjustments to dosage and administration intervals while monitoring their condition. Patients who cannot take oral medications or have poor overall health should be monitored closely for vitamin K deficiency symptoms. Children under 3 months of age should avoid using this medication as safety and effectiveness have not been established. This medication can rarely cause severe allergic reactions such as shock or anaphylaxis, necessitating close observation of the patient's condition during administration. If allergy symptoms such as rashes, hives, itching, or fever occur, the administration should be immediately stopped and appropriate treatment received. Various blood abnormalities such as leukopenia, anemia, and thrombocytopenia may occur, requiring regular blood tests with cessation of use if any abnormalities are detected. Liver function abnormalities, acute hepatitis, or jaundice may develop, so regular liver function testing should be conducted, and administration stopped if issues arise. Kidney function may rarely decline or acute renal failure may occur; regular assessment of kidney function is advised, with cessation of use if abnormalities exist. Gastrointestinal side effects such as severe diarrhea or pseudomembranous colitis may arise; if abdominal pain or frequent diarrhea occurs, administration should be stopped immediately. Central nervous system symptoms such as seizures or disturbances in consciousness can occur, especially in patients with kidney or central nervous system disorders, requiring caution. Respiratory side effects may include asthma, dyspnea, or interstitial pneumonia; if symptoms arise, administration should be halted and treatment applied. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may rarely occur; administration should cease immediately if skin abnormalities develop. Phenomena such as oral mucositis or candidiasis may occur. Vitamin K deficiency may lead to bleeding tendencies, so careful observation for bleeding symptoms is important. Cardiovascular side effects such as heart failure, arrhythmias, or blood pressure changes have been reported, necessitating appropriate treatment for observed symptoms. Neurological symptoms may include insomnia, hallucinations, or delirium; if any unusual symptoms occur, special attention is required. Local inflammation, pain, or swelling may occur at injection sites, so monitoring of the injection site is necessary. This medication has many drug interactions; special caution is needed when co-administered with probenecid, anticonvulsants, contraceptives, warfarin, etc., and blood concentration should be monitored. For women who are pregnant or may become pregnant, the safety of this medication has not been established, so it should only be administered if the therapeutic benefits outweigh the risks. Breastfeeding women are advised to avoid breastfeeding while on this medication as it can be secreted into breast milk. This medication is ideally not used in infants under 3 months due to unestablished safety and efficacy. After reconstitution, it should be used as soon as possible; if storage is needed, it should be used within 6 hours at room temperature or within 24 hours when refrigerated. This medication is administered only via intravenous injection; prior to administration, it is essential to confirm any past allergic reactions to beta-lactam antibiotics. Additionally, this medication may cause symptoms of rhabdomyolysis, such as muscle pain, muscle weakness, or dark urine; it should be stopped immediately and treated if those symptoms appear.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing → severe allergic reaction
  • Rash, blisters, skin peeling, mucosal pain in the mouth/eyes → severe skin abnormal reactions
  • Asthma attacks, respiratory issues accompanied by cough and fever, shortness of breath or difficulty breathing → respiratory problems
  • Yellowing of the skin or eyes (jaundice), extreme lethargy → liver abnormalities (jaundice)
  • Sudden and severe headaches, thunderclap headache, seizures

Mild side effects

  • Rash
  • hives
  • warmth
  • erythema
  • itching
  • fever
  • redness
  • flushing
  • angioedema
  • malaise
Show 20 more
  • oral dysesthesia
  • wheezing
  • dizziness
  • altered bowel movement
  • tinnitus
  • sweating
  • pancytopenia
  • agranulocytosis
  • hemolytic anemia
  • hypochromic anemia
  • leukopenia
  • granulocytopenia
  • eosinophilia
  • thrombocytopenia or thrombocytosis
  • lymphocytosis
  • hemoglobin decrease
  • basophilia
  • atypical lymphocytosis
  • erythrocytopenia
  • hematocrit decrease

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to avoid exposure to air and is best kept at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A colorless, transparent vial filled with crystalline powder ranging from white to light yellow.

Package unit

10 vials/

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.