Medication info

Orofenem 500 mg (Meropenem Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Meropenem Hydrate›500mg / 1 vial
Manufacturer / importer
한미약품(주)
Appearance
A white to pale yellow crystalline powder in a colorless, transparent vial for injection
Packaging
10 vials/box [1 vial x 10]
Approval status
Active

MFDS item code 200807608 · Notified 2008.07.09 · Insurance code 643505171

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 (potency) daily divided into 2 to 3 doses via IV infusion over more than 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, and neutropenia, administer 1 g (potency) via IV infusion every 8 hours. For cystic fibrosis and meningitis, administer 2 g (potency) via IV infusion every 8 hours.
Child administration
For bacterial meningitis in children over 3 months, administer 40 mg per kg of body weight every 8 hours via IV infusion over more than 30 minutes, depending on the pathogen's susceptibility and patient's condition.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

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

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

This medication is effective against various bacterial infections. It acts on several harmful bacteria including Staphylococcus, Streptococcus, and Enterococcus, and is used to treat respiratory and surgical infections such as pneumonia, abscess, and osteomyelitis. It is also utilized for a wide range of infection conditions including urinary tract infections, biliary tract infections, peritonitis, gynecological and ENT infections. It is effective in bacterial meningitis occurring in children over 3 months and infections in patients with neutropenia. Furthermore, it helps to prevent secondary infections in cystic fibrosis patients. Overall, it is widely used for treating various infectious diseases.

How it is given

Adult administration

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

Child administration

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

Precautions

This medication should not be administered to certain patients. For example, it should not be given to patients who have previously experienced shock related to this medication or patients taking sodium valproate alongside this medication. Additionally, patients who have had allergic reactions to this medication or its components, or those who have shown serious hypersensitivity reactions to other carbapenem antibiotics or beta-lactam antibiotics should be excluded from administration. Particular caution is required when administering to patients with impaired kidney function, those with epilepsy, liver disease, elderly patients, or those with poor general health or nutritional status. In particular, for infants under 3 months, safety and efficacy have not been established, so it must be used cautiously. During the administration of this medication, it is necessary to closely monitor the patient for various adverse reactions including shock, allergic reactions, blood abnormalities, liver or kidney function abnormalities, gastrointestinal disturbances, central nervous system symptoms, respiratory problems, and serious skin reactions. If a rash or other abnormal symptoms occur after administration, discontinue use immediately and seek appropriate treatment. To prevent the emergence of resistant bacteria, susceptibility testing should be conducted, and this medication should only be used for the minimum required duration. Furthermore, prior to administration, it is essential to check whether there has been a history of hypersensitivity to beta-lactam drugs, and during administration, liver and kidney function tests should be conducted regularly. This medication may interact with other drugs, so caution is needed, particularly when used with probenecid, antiepileptic medications, hormonal contraceptives, and warfarin. For women who are pregnant or may become pregnant, it should be administered only when the benefits of treatment outweigh the risks, and it is advisable to avoid use during breastfeeding. Elderly patients are more susceptible to side effects due to decreased physiological function, and there is a risk of bleeding due to vitamin K deficiency, so dosages and administration intervals should be adjusted carefully. This medication is for intravenous use only, and it should be used as soon as it is dissolved and should be consumed within the specified time during storage. Finally, this medication may have cross-allergic reactions with existing beta-lactam antibiotics, so caution is necessary if there is a history of drug allergy.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), shock, anaphylaxis, severe allergic reactions, severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acute generalized exanthematous pustulosis), severe liver impairment, liver failure, jaundice, acute renal failure, severe kidney impairment, severe diarrhea (pseudomembranous colitis), seizures, altered consciousness, central nervous system symptoms, asthma, difficulty breathing, severe respiratory problems, heart failure, cardiac arrest, myocardial infarction, pulmonary.

Mild side effects

  • Rash
  • warmth
  • erythema
  • itching
  • fever
  • skin reddening
  • generalized flushing
  • angioedema
  • oral abnormalities
  • wheezing
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  • dizziness
  • changes in stool
  • tinnitus
  • sweating
  • abdominal pain
  • frequent diarrhea
  • nausea
  • vomiting
  • loss of appetite
  • oral candidiasis
  • flatulence
  • bowel obstruction
  • dyspepsia
  • insomnia
  • anxiety
  • nonsensical speech
  • confusion
  • perceptual disturbances
  • hallucinations
  • drowsiness
  • anxiety
  • depression
  • weakness
  • inflammation at the injection site
  • phlebitis
  • thrombophlebitis
  • pain at the injection site
  • injection site.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to ensure that the medication retains its effectiveness.

Appearance and packaging

Appearance

A white to pale yellow crystalline powder in a colorless, transparent vial for injection

Package unit

10 vials/box [1 vial x 10]

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.