Medication info

Unicupem 1g (Meropenem Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Meropenem Hydrate›1000mg / 1 vial
Manufacturer / importer
한국유니온제약(주)
Appearance
[For Domestic Use] A powder for injection, crystalline and white to pale yellow, contained in a colorless and transparent vial. [For Export] A colorless and transparent vial filled with a crystalline powder, white to pale yellow.
Packaging
10 vials/box
Approval status
Active

MFDS item code 201605417 · Approved 2016.09.05 · Insurance code 665506881

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 daily (as potency) divided into 2 to 3 doses by intravenous infusion lasting over 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, or neutropenia, administer 1 g (as potency) intravenously every 8 hours. For cystic fibrosis and meningitis, administer 2 g (as potency) intravenously every 8 hours. Assess the necessity of continued administration based on 3 days after commencement of dosing.
Child administration
In children over 3 months with bacterial meningitis, administer 40 mg per kg body weight by intravenous infusion lasting over 30 minutes every 8 hours, depending on the pathogen's susceptibility and the patient's condition and type of infection. In severe cases,

Ingredients

Manufacturer
한국유니온제약(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 a variety of bacteria such as staphylococci, streptococci, and enterococci, treating bacteria that cause respiratory and urinary tract infections like Escherichia coli and Streptococcus pneumoniae. Major indications include sepsis, superficial purulent infections, lymphadenitis, perianal abscesses, and osteomyelitis, arthritis, and wound infections occurring in surgery and orthopedics. It is also used for respiratory infections such as pneumonia, secondary infections of chronic respiratory diseases, lung abscess, empyema, urinary tract infections including pyelonephritis and complicated cystitis, and hepatic biliary infections such as cholecystitis and cholangitis, and liver abscesses. Additionally, it can be applied to peritonitis, gynecological infections, otitis media, sinusitis, bacterial meningitis, infection prevention in neutropenic patients, and infection treatment in cystic fibrosis patients. Overall, this drug is broadly used for the treatment of various bacterial infections.

How it is given

Adult administration

As Meropenem Hydrate, administer 0.5 to 1 g daily (as potency) divided into 2 to 3 doses by intravenous infusion lasting over 30 minutes. For suspected infections in patients with pathogenic pneumonia, peritonitis, or neutropenia, administer 1 g (as potency) intravenously every 8 hours. For cystic fibrosis and meningitis, administer 2 g (as potency) intravenously every 8 hours. Assess the necessity of continued administration based on 3 days after commencement of dosing.

Child administration

In children over 3 months with bacterial meningitis, administer 40 mg per kg body weight by intravenous infusion lasting over 30 minutes every 8 hours, depending on the pathogen's susceptibility and the patient's condition and type of infection. In severe cases,

Precautions

This medication should not be used in patients who have experienced severe allergic reactions or shock to this drug or its components in the past. Patients taking valproate should be cautious as this medication can lower the blood concentration of valproate, leading to seizures. Patients who have had severe allergic reactions to other carbapenem or beta-lactam antibiotics should avoid this drug. Patients with allergic tendencies such as asthma and easy development of allergy symptoms like rash should use this medication with caution. Patients with impaired renal function may have increased concentrations of the drug, leading to central nervous system side effects, so dosage adjustment or increased intervals may be necessary. Patients with epilepsy or central nervous system disorders may experience seizures or consciousness disturbances when using this drug, thus caution is needed. Patients with severely impaired liver function, the elderly, infants, and those with poor nutritional status or difficulty in oral intake also require special caution. This drug can rarely cause shock, severe allergic reactions, blood abnormalities, liver or kidney dysfunction, gastrointestinal issues, central nervous system disorders, respiratory and skin reactions, thus patients must be monitored closely during administration. If rash or liver function abnormalities occur, discontinue use immediately and seek appropriate treatment. To reduce the occurrence of resistant bacteria, it should only be used for the minimum period necessary after susceptibility testing, and if susceptibility is not confirmed, discontinuation or switching to another drug is advisable. Prior to administration, always check the patient's history of allergy to beta-lactam antibiotics. Caution is required when driving or operating machinery as symptoms like headache, dizziness, and mental confusion may occur. If muscle pain, muscle weakness, or dark urine are observed, they may indicate muscle damage, and the healthcare provider should be informed immediately. This medication may interact with specific drugs, so patients should inform their healthcare provider if they are taking other medications. Pregnant women or those who may become pregnant should carefully consider the benefits and risks of this medication before use, and breastfeeding mothers are advised to avoid use. It is advisable not to use this drug in infants under 3 months as safety and efficacy have not been established. In the elderly, body functions decline and side effects may easily occur, hence dosage adjustment and monitoring of the condition are necessary. This medication should only be administered intravenously, and it should be used quickly after dissolution and stored for the prescribed time.

Side effects and when to seek care immediately

Serious side effects

Shock, severe allergic reactions, anaphylaxis, serious skin reactions, toxic epidermal necrolysis, Stevens-Johnson syndrome, DRESS syndrome, erythema multiforme, acute generalized exanthematous pustulosis, liver failure, jaundice, fulminant hepatitis, acute renal failure, severe kidney impairment, severe diarrhea (pseudomembranous colitis), seizures, consciousness disturbances, central nervous system symptoms, asthma, respiratory distress, pleural effusion, pulmonary edema, seizure pneumonia, pulmonary embolism, heart failure.

Mild side effects

  • Hives
  • rash
  • warmth
  • erythema
  • itching
  • fever
  • flushing
  • generalized erythema
  • angioedema
  • oral discomfort
Show 28 more
  • wheezing
  • dizziness
  • changes in bowel movements
  • tinnitus
  • sweating
  • nausea
  • vomiting
  • loss of appetite
  • oral candidiasis
  • flatulence
  • intestinal obstruction
  • dyspepsia
  • insomnia
  • anxiety
  • delirium
  • mental confusion
  • dizziness
  • hyperexcitability
  • sensory disturbances
  • hallucinations
  • drowsiness
  • anxiety
  • depression
  • asthenia
  • inflammation at the injection site
  • phlebitis
  • thrombophlebitis
  • pain at the injection site.

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

Storage

This drug should be stored in a tightly sealed container to prevent air entry and kept at room temperature between 1°C and 30°C. This will help maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

[For Domestic Use] A powder for injection, crystalline and white to pale yellow, contained in a colorless and transparent vial. [For Export] A colorless and transparent vial filled with a crystalline powder, white to pale yellow.

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.