Medication info

Zempene 0.5g (Meropenem Hydrate)

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

MFDS item code 201800829 · Notified 2018.02.14

Summary

Main use
Treatment of various bacterial infections (sepsis, respiratory infections, etc.) and improvement of infections.
Who receives it
Adults · Children
Adult administration
As meropenem hydrate, administer 0.5 to 1 g (potency) daily in 2 to 3 divided doses, infused intravenously over more than 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, neutropenia, and sepsis, administer 1 g (potency) intravenously every 8 hours. In cystic fibrosis and meningitis: administer 2 g (potency) intravenously every 8 hours. After 3 days from initiation, determine if continued administration is necessary.
Child administration
For bacterial meningitis in children over 3 months, administer 40 mg per kg body weight in a droplet intravenous infusion over 30 minutes every 8 hours, depending on the pathogen's susceptibility and the patient's condition.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

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

  • Sepsis
  • superficial purulent diseases
  • 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 used to treat infections caused by a variety of bacteria. Major target bacteria include Staphylococcus, Streptococcus, Enterococcus, Escherichia coli, and various other types of bacteria. This medication effectively treats sepsis, superficial purulent diseases, infections in surgical and orthopedic areas, respiratory infections, urinary tract infections, biliary tract infections, peritonitis, infections in gynecological and otolaryngological areas. It is also used for serious infections including bacterial meningitis and suspected infections in neutropenic patients. It is helpful in managing infections in cystic fibrosis patients. This medication improves various infectious conditions and is widely used for infection treatment.

How it is given

Adult administration

As meropenem hydrate, administer 0.5 to 1 g (potency) daily in 2 to 3 divided doses, infused intravenously over more than 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, neutropenia, and sepsis, administer 1 g (potency) intravenously every 8 hours. In cystic fibrosis and meningitis: administer 2 g (potency) intravenously every 8 hours. After 3 days from initiation, determine if continued administration is necessary.

Child administration

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

Precautions

This medication should not be used in certain patients. For example, patients who have previously experienced severe allergic reactions or shock due to this medication, patients taking valproate sodium, or those with severe allergies to other antibiotics with similar ingredients should avoid taking it. Additionally, patients with a history of allergies, impaired renal function, epilepsy or central nervous system disorders, severely decreased liver function, the elderly, and infants or patients in poor general condition should use this medication with caution. Especially in cases of weak renal function, the drug concentration can increase, leading to side effects such as seizures or consciousness disturbances which may require dosage adjustments. This medication can rarely cause serious side effects during use. Shock or anaphylactic reactions, severe skin reactions, blood disorders, impaired liver function, renal dysfunction, severe colitis, central nervous system abnormal symptoms have been reported; hence the patient's condition should be closely monitored during administration. Moreover, when using this medication for a prolonged period or after 3-5 days, especially observe for side effects such as rashes or liver function abnormalities, and if any unusual symptoms occur, discontinue use immediately and seek appropriate treatment. To prevent the occurrence of resistant bacteria, susceptibility testing should be performed beforehand, and it should only be used for the minimum necessary duration. If susceptibility testing is not done, tests should be conducted within 3 days after starting treatment, and if necessary, switch to another medication. Before administration, always check for previous hypersensitivity to beta-lactam drugs such as penicillin or cephalosporins, and during treatment, be attentive to neurological symptoms such as headaches, confusion, or seizures. This medication can interact with certain drugs, so caution is necessary when taken together with probenecid, valproate, antiepileptic drugs, hormonal contraceptives, etc., and if used in conjunction with warfarin, frequent checks of blood coagulation status are required. Women who are pregnant or may become pregnant should only use this medication when the therapeutic benefit outweighs the risk, as safety during pregnancy is not established. Lactating women should avoid breastfeeding as this medication may be secreted into breast milk. Safety and efficacy have not been established for infants under 3 months old, and elderly patients may experience an increased incidence of side effects due to decreased bodily functions, thus dosage and intervals should be adjusted with caution. This medication is primarily administered via intravenous injection, and should be used as soon as possible after reconstitution. If it needs to be preserved, it should be used within 6 hours at room temperature or within 24 hours if refrigerated. This medication may have cross-allergenicity with other beta-lactam antibiotics, so patients with a history of allergy to these medications should be particularly cautious.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylactoid reactions, urticaria, angioedema, severe allergic reactions, severe skin reactions (toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, DRESS syndrome, erythema multiforme, acute generalized exanthematous pustulosis (AGEP)), jaundice, liver failure, fulminant hepatitis, acute renal failure, respiratory distress, asthma, severe respiratory abnormalities, severe edema, elevated blood pressure, seizures.

Mild side effects

  • Urticaria
  • rash
  • feeling of warmth
  • erythema
  • itching
  • fever
  • flushing
  • generalized erythema
  • angioedema
  • oral disturbances
Show 23 more
  • wheezing
  • dizziness
  • diarrhea
  • tinnitus
  • sweating
  • pancytopenia
  • agranulocytosis
  • hemolytic anemia
  • hypochromic anemia
  • leukopenia
  • neutropenia
  • eosinophilia
  • thrombocytopenia or thrombocytosis
  • lymphocytosis
  • hemoglobin reduction
  • hypokalemia
  • AST
  • ALT
  • LDH
  • ALP
  • LAP
  • γ-GTP
  • bilirubin.

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

Storage

Store this medication in a sealed container to prevent exposure to air or moisture. Additionally, it should be kept at room temperature between 1 and 30 degrees Celsius, avoiding extremely hot or cold places.

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.