Medication info

Unique-Pem Injection 500mg (Meropenem Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Meropenem Hydrate›500mg / 1 vial
Manufacturer / importer
한국유니온제약(주)
Appearance
[For domestic use] A white to light yellow crystalline powder in a colorless transparent vial for injection [For export] A colorless transparent vial filled with a white to light yellow crystalline powder
Packaging
10 vials/box
Approval status
Active

MFDS item code 201903535 · Approved 2019.05.29 · Insurance code 665507431

Summary

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

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

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

  • Sepsis
  • superficial pyogenic infections
  • 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 is effective against various bacteria, including key strains such as Staphylococcus, Streptococcus, Enterococcus, Escherichia coli, Klebsiella, Pseudomonas, and Haemophilus influenzae. It is used to treat a variety of infections such as sepsis, superficial pyogenic infections, lymphadenitis, and infections in surgical and orthopedic areas (osteomyelitis, arthritis, wound infections). It is also effective for respiratory infections such as pneumonia, secondary infections in chronic respiratory diseases, and lung abscesses, and helps in the treatment of complicated urinary tract infections and liver/biliary infections. This drug is utilized for various infections occurring in obstetrics and gynecology as well as bacterial meningitis (in children over 3 months) and infections in patients with neutropenia. It is also used in the management of infections in patients with peritonitis and cystic fibrosis, which improves the health of these patients.

How it is given

Adult administration

As Meropenem Hydrate, administer 0.5 to 1 g (potency) daily in 2 to 3 divided doses via slow intravenous infusion over at least 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, neutropenia, or sepsis, administer 1 g (potency) every 8 hours via slow intravenous infusion. For cystic fibrosis or meningitis, administer 2 g (potency) every 8 hours via slow intravenous infusion.

Child administration

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

Precautions

This medication should not be used in certain patients. For example, patients who have previously experienced a severe allergic reaction or shock to this drug, patients currently taking valproate sodium, or patients with hypersensitivity to this drug and its components should not receive it. Patients who have a history of severe allergic reactions to other carbapenem or beta-lactam antibiotics should also exercise caution. Patients with renal or liver impairment, those with central nervous system diseases, allergic individuals, elderly patients, and infants should use this medication with caution. This drug can cause various side effects, including rare occurrences of shock, skin rashes, blood abnormalities, liver and kidney dysfunction, gastrointestinal issues, central nervous system anomalies, and respiratory problems, so any unusual symptoms that arise should be reported to a healthcare professional immediately. Regular testing of liver and kidney function should be performed during treatment to detect any abnormal signs early. To prevent the development of resistant bacteria, susceptibility testing should be conducted, and this drug should only be used for the minimum necessary duration. A thorough allergy history should be taken, and the patient's condition should be closely monitored after administration; if a rash or other abnormal reactions occur, treatment should be stopped immediately and appropriate care should be provided. This drug may interact with other medications, so it is essential to inform healthcare providers of any other medications being taken. Women who are pregnant or breastfeeding should carefully consider the risks and benefits before using this drug, and it is advisable to avoid its use while breastfeeding. The safety and efficacy of this drug have not been established in infants under 3 months, so its use is not recommended. Elderly patients may experience side effects more easily due to decreased body function, requiring dose adjustment and close observation. This medication is for intravenous injection only, and should be used as soon as possible after reconstitution; it should also be used within the defined timeframe during storage for safety. Lastly, this drug may cause cross-allergic reactions with other beta-lactam antibiotics; therefore, special caution is advised for individuals with known allergies to related medications.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, shock, anaphylactic reaction, severe rash with fever, blistering, desquamation of skin, pain in mucous membranes of the mouth/eyes, severe skin adverse reactions, jaundice, systemic malaise, liver abnormalities, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, severe neurological symptoms, markedly decreased urine output, systemic

Mild side effects

  • Wheezing
  • dizziness
  • diarrhea
  • tinnitus
  • sweating
  • warmth
  • erythema
  • itching
  • fever
  • flushing
Show 19 more
  • generalized rash
  • angioedema
  • pancytopenia
  • agranulocytosis
  • hemolytic anemia
  • hypochromic anemia
  • leukopenia
  • neutropenia
  • eosinophilia
  • thrombocytopenia or thrombocytosis
  • lymphocytosis
  • hemoglobin decrease
  • basophilia
  • atypical lymphocytosis
  • erythrocytopenia
  • hematocrit decrease
  • hypokalemia
  • hepatic impairment
  • AST

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

Storage

This drug should be stored in a sealed container that prevents air or moisture from entering, at a safe temperature between 1 to 30 degrees Celsius. Stored this way, it will maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

[For domestic use] A white to light yellow crystalline powder in a colorless transparent vial for injection [For export] A colorless transparent vial filled with a white to light yellow crystalline powder

Package unit

10 vials/box

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.