Medication info

NeoPhem Injection 500 mg (Meropenem Hydrate)

Prescription medication정맥
Ingredient · strength
Meropenem Hydrate›500mg / 1 vial
Manufacturer / importer
구주제약(주)
Appearance
A colorless transparent vial filled with white to pale yellow crystalline powder
Packaging
604 mg/vial X 10 vials
Approval status
Active

MFDS item code 201708387 · Approved 2017.12.18

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) per day divided into 2 to 3 infusions over at least 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, and neutropenia, administer 1 g (potency) via infusion every 8 hours. For cystic fibrosis and meningitis, administer 2 g (potency) every 8 hours.
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 sensitivity of the pathogen and the patient's condition, and type of infection.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

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

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

This medication is effective against various bacteria and is used to treat several infections. It is effective for sepsis and superficial purulent diseases, lymphadenitis, perianal abscess, and skin and lymphatic infections. Additionally, it treats surgical and orthopedic infections, respiratory infections such as pneumonia, urinary tract infections, and hepatic biliary infections. It is also used for severe infections such as peritonitis, gynecological infections, otolaryngological infections, and bacterial meningitis. Particularly, it is helpful in managing infections in patients with neutropenia and preventing secondary infections in cystic fibrosis patients. This drug is used for the treatment of a wide range of infections.

How it is given

Adult administration

As meropenem hydrate, administer 0.5 to 1 g (potency) per day divided into 2 to 3 infusions over at least 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, and neutropenia, administer 1 g (potency) via infusion every 8 hours. For cystic fibrosis and meningitis, administer 2 g (potency) every 8 hours.

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 sensitivity of the pathogen and the patient's condition, and type of infection.

Precautions

This medication should not be administered to patients with shock symptoms or a history of hypersensitivity to this drug. Additionally, it should not be used in patients who are taking valproate sodium, as this drug can lower the blood concentration of valproate, potentially leading to recurrent seizures. Patients who have had severe allergic reactions to other carbapenem or beta-lactam antibiotics should be cautioned. Patients with allergic tendencies, renal or liver function issues, a history of epilepsy, the elderly, and infants should use this drug with caution. In particular, in cases of reduced renal function, drug concentrations may rise, leading to central nervous system symptoms; therefore, dosage or intervals should be adjusted. Various adverse reactions such as shock, rash, urticaria, hematologic abnormalities, liver or kidney dysfunction, severe diarrhea, seizures, respiratory distress, and severe skin reactions may occur during treatment; thus patients should be closely monitored. If any adverse symptoms occur, treatment should be immediately discontinued, and appropriate care should be sought. To prevent the emergence of resistant bacteria, administer the drug for only the minimum necessary duration, and conduct sensitivity tests before use. If sensitivity is not confirmed, testing should be conducted within three days, and if necessary, switch to another drug. Prepare for rapid shock responses by equipping emergency treatment, and observe the patient in a stable condition after administration. Due to concerns of liver function abnormalities, if administered for more than one week, liver function tests should be performed regularly, and previous hypersensitivity reactions to beta-lactam agents should be verified. Caution is advised when driving or operating machinery due to reported side effects such as headaches and mental confusion. If symptoms like muscle pain, muscle weakness, or dark urine appear, rhabdomyolysis may occur; discontinue use immediately and seek treatment. This drug interacts with many other medications; thus, caution is needed when used in combination, especially with probenecid, valproate, anti-epileptic medications, and hormonal contraceptives. Women who are pregnant or may become pregnant should use this drug only when benefits outweigh the risks, as its safe use has not been established, and breastfeeding should be avoided during treatment. The safety and efficacy in infants younger than three months have not been established, so use should be cautious. Older adults may experience side effects more easily due to diminished physiological functions and should carefully adjust doses and intervals due to the risk of bleeding from vitamin K deficiency. This drug is for intravenous injection only, and after reconstitution, it should be used as soon as possible, adhering to temperature and time guidelines during storage. Previous drug histories should be checked carefully, as cross-reactivity with existing beta-lactam antibiotics may occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, shock, anaphylaxis-like reaction, severe skin adverse reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction (DRESS syndrome), erythema multiforme, acute generalized exanthematous pustulosis), severe rashes, blisters, skin sloughing, oral/ocular mucosal pain, respiratory issues (asthma, increased cough, dyspnea, pleural effusion, interstitial pneumonia).

Mild side effects

  • Rash
  • urticaria
  • flushing
  • erythema
  • itching
  • fever
  • redness
  • generalized flushing
  • angioedema
  • oral abnormalities
Show 19 more
  • wheezing
  • dizziness
  • changes in bowel movements
  • tinnitus
  • sweating
  • pancytopenia
  • agranulocytosis
  • hemolytic anemia
  • hypochromic anemia
  • leukopenia
  • neutropenia
  • eosinophilia
  • thrombocytopenia or thrombocytosis
  • lymphocytosis
  • decreased hemoglobin
  • increased basophils
  • atypical lymphocytosis
  • decreased erythrocytes
  • decreased hematocrit.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air, with storage temperatures maintained between 1 and 30 degrees Celsius. Proper storage will ensure the drug's effectiveness is safely maintained.

Appearance and packaging

Appearance

A colorless transparent vial filled with white to pale yellow crystalline powder

Package unit

604 mg/vial X 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.