Medication info

Caspinem Injection 1 gram (Meropenem Hydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Meropenem Hydrate›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
A colorless, transparent vial filled with crystalline powder that is white to pale yellow.
Packaging
10 vials
Approval status
Approval withdrawn

MFDS item code 201804297 · Approved 2018.10.30

This product's status changed to Approval withdrawn on 2023.07.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of various bacterial infections (such as sepsis, respiratory and urinary tract infections)
Who uses it
Adults · Children
Adult dosage
As Meropenem Hydrate, administer 0.5 to 1 g (potency) by intravenous drip divided into 2 to 3 doses for more than 30 minutes per day. In suspected infections in patients with pathogenic pneumonia, peritonitis, and neutropenia, administer 1 g (potency) by intravenous drip every 8 hours. For cystic fibrosis and meningitis, administer 2 g (potency) by intravenous drip every 8 hours.
Children's dosage
For bacterial meningitis in children over three months old, administer by intravenous drip 40 mg per kg of body weight every 8 hours, over a period of more than 30 minutes, according to the pathogen's sensitivity and the patient's condition, and the type of infection. In severe cases,

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Treatment of various bacterial infections (such as sepsis, respiratory and urinary tract 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 various types of bacterial infections. It is effective against various pathogenic strains such as Staphylococcus, Streptococcus, and Escherichia coli. It is used for systemic infections like sepsis as well as local infections such as superficial purulent diseases, lymphadenitis, and perianal abscesses. It is also effective in infections within the surgical and orthopedic fields, including osteomyelitis, arthritis, and wound infections. For respiratory infections, it is used for pneumonia, peritonsillar abscess, secondary infections of chronic respiratory diseases, lung abscesses, and empyema, and is applicable for urinary tract infections and liver biliary tract infections. Additionally, it is effectively used for peritonitis, gynecological infections, middle ear infections and sinusitis in the otolaryngology field, bacterial meningitis, suspected infections in neutropenic patients, and the management of infections in cystic fibrosis patients. This drug is used to improve and treat a variety of infections.

Dosage and Administration

Adult dosage

As Meropenem Hydrate, administer 0.5 to 1 g (potency) by intravenous drip divided into 2 to 3 doses for more than 30 minutes per day. In suspected infections in patients with pathogenic pneumonia, peritonitis, and neutropenia, administer 1 g (potency) by intravenous drip every 8 hours. For cystic fibrosis and meningitis, administer 2 g (potency) by intravenous drip every 8 hours.

Children's dosage

For bacterial meningitis in children over three months old, administer by intravenous drip 40 mg per kg of body weight every 8 hours, over a period of more than 30 minutes, according to the pathogen's sensitivity and the patient's condition, and the type of infection. In severe cases,

Precautions

This medication should not be used in patients who have previously experienced shock due to this drug. Patients taking sodium valproate with this drug should not be treated as the blood concentration of valproate may decrease, leading to the recurrence of seizures. Patients with allergies or a history of hypersensitivity to this drug or its components should not be treated. Patients who have had severe allergic reactions to other carbapenems or beta-lactam antibiotics should also refrain from using this medication. Patients with a tendency for allergy or those who easily show symptoms such as bronchial asthma and rashes should use this drug cautiously. In patients with compromised renal function, the drug may accumulate in the body leading to central nervous system side effects, so the dosage should be reduced or the dosing interval increased. Patients with epilepsy or central nervous system disorders may also experience seizures or disturbances of consciousness, requiring caution. Patients with very poor liver function should use this drug carefully as liver function may worsen with its use. Elderly patients may experience easier side effects due to decreased bodily function, and the risk of bleeding due to vitamin K deficiency may be higher, requiring close monitoring. Patients who cannot eat well or are in poor overall condition may also present symptoms of vitamin deficiency, and thus need observation. It is advisable not to use this drug in infants under three months of age as safety and efficacy have not been established. While administering this drug, severe allergic reactions such as shock or anaphylaxis may rarely occur, so patients should be monitored closely after administration. If symptoms of hypersensitivity such as rashes, hives, pruritus, or fever appear, administration should be immediately stopped and appropriate treatment should be administered. Regular blood tests should be conducted as blood-related abnormalities such as decreased blood cell counts or anemia may occur, and if any abnormalities are found, administration should be discontinued. Regular liver function tests must be conducted as indications of impaired liver function, jaundice, or hepatitis may occur, and if abnormalities are found, administration should be discontinued. Severe renal disorders such as acute renal failure may rarely occur, so kidney function tests should be performed to monitor the condition. Gastrointestinal side effects such as abdominal pain, diarrhea, nausea, or vomiting may occur, and if symptoms of severe diarrhea or colitis manifest, administration should be stopped immediately. Should central nervous system symptoms such as seizures or disturbances of consciousness arise, administration must be ceased, and treatment must be undertaken. Respiratory symptoms such as difficulty breathing, asthma, pneumonia, etc., may rarely occur, so immediate measures are required if respiratory symptoms develop. Serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome may occur, necessitating careful observation of the skin condition. Rare occurrences of microbial shift such as oral thrush or candidiasis may arise. Symptoms related to vitamin K deficiency causing bleeding tendencies or vitamin B deficiencies might occur, necessitating monitoring of vitamin status. Cardiovascular breakdowns such as heart failure, arrhythmias, or blood pressure changes have been reported, so cardiac health should be closely monitored. Neuropsychiatric symptoms such as insomnia, anxiety, hallucinations, or dizziness may surface; any abnormal symptoms should be reported. Inflammation, pain, or swelling at the injection site may occur, so the injection site should be observed. This drug may interact with other medications; hence, particular care is needed when taken together with sodium valproate, probenecid, antiepileptic drugs, hormonal drugs, warfarin, etc. During pregnancy, safety is not established, and it should only be administered when the therapeutic benefits outweigh the risks; during lactation, it is advised to avoid breastfeeding as this drug may be secreted in breast milk. This medication should be used promptly after dissolution, and it should be used within the designated time if preserved. It is administered only by intravenous injection, and prior to administration, the history of hypersensitivity to beta-lactam drugs must be thoroughly checked. Symptoms such as headache or confusion may manifest during driving or operating machinery; hence caution is required.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylaxis, acute liver failure, liver dysfunction, jaundice, acute renal failure, severe kidney impairment, severe colitis, pseudomembranous colitis, seizures, disturbances of consciousness, central nervous system symptoms, asthma, difficulty breathing, pulmonary edema, interstitial pneumonia, toxic epidermal necrolysis, Lyell syndrome, mucocutaneous syndrome, Stevens-Johnson syndrome, DRESS syndrome, erythema multiforme, acute generalized exanthematous pustulosis, AGEP, bleeding tendencies due to vitamin K deficiency,

Mild side effects

  • Rash
  • hives
  • warmth
  • redness
  • itching
  • fever
  • erythema
  • generalized flushing
  • angioedema
  • discomfort
Show 30 more
  • oral abnormalities
  • wheezing
  • dizziness
  • changes in bowel movements
  • tinnitus
  • sweating
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • loss of appetite
  • oral candidiasis
  • flatulence
  • bowel obstruction
  • indigestion
  • tachycardia
  • hypertension
  • heart failure
  • cardiac arrest
  • myocardial infarction
  • pulmonary embolism
  • bradycardia
  • hypotension
  • syncope
  • peripheral edema
  • hypoxia
  • insomnia
  • anxiety
  • delirium
  • confusion

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

Storage

This medication should be stored in sealed containers to prevent air or moisture from entering and is recommended to be kept at room temperature between 1 to 30 degrees Celsius. Storing in this manner helps to maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A colorless, transparent vial filled with crystalline powder that is white to pale 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.