Medication info

Gentapro Injection (Gentamicin Sulfate)

Prescription medication
Ingredient · strength
Gentamicin Sulfate›40mg / 1mL
Manufacturer / importer
(주)휴메딕스
Appearance
Colorless, odorless transparent liquid
Packaging
50 ampoules/box [(2 milliliters/ampoule)]
Approval status
Active

MFDS item code 199600433 · Notified 1996.10.22 · Insurance code 683100121

Summary

Main use
Treatment of sepsis, central nervous system infections, etc. (infections)
Who uses it
Adults · Children
Adult dosage
For adults: Administer intravenously or intramuscularly 3 mg (in terms of activity) per kg of body weight every 8 hours, and in life-threatening cases, administer 5 mg (in terms of activity) per kg of body weight split into 3-4 doses. Dosage should be reduced according to symptom improvement, with a maximum serum concentration of 12µg/mL and a minimum serum concentration (just before the next dose) not exceeding 2µg/mL. For urinary tract infections in patients with normal kidney function, a single dose of 160 mg (in terms of activity) can be administered daily.
Children's dosage
Children: Administer intravenously or intramuscularly 6-7.5 mg (in terms of activity) per kg of body weight every 8 hours. Infants: Administer intravenously or intramuscularly 7.5 mg (in terms of activity) per kg of body weight every 8 hours.

Ingredients

Manufacturer
(주)휴메딕스

Efficacy & effects

Treatment of sepsis, central nervous system infections, etc. (infections)

  • Sepsis
  • central nervous system infections
  • urinary tract infections
  • respiratory infections
  • gastrointestinal infections
  • skin infections
  • bone infections
  • soft tissue infections
  • conjunctivitis
  • keratitis
  • blepharitis
  • dacryocystitis
View approved original text

This injection is used for the treatment of various infections caused by several bacteria including Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus. It is effective for sepsis, central nervous system infections, urinary tract infections, respiratory infections, gastrointestinal infections, skin infections, bone and soft tissue infections. It is particularly used for the initial treatment of gram-negative bacterial infections, when the causative agent is unclear, and in cases of life-threatening Pseudomonas aeruginosa infections. Additionally, it is used in combination for the treatment of endocarditis, which can be administered alongside penicillin-type drugs. The eye drops are used for the treatment of infections around the eyes such as conjunctivitis and keratitis, while the ointments and creams are effective for contagious subcutaneous infections and secondary skin infections. The grafts are used to prevent and treat infections after osteomyelitis or artificial joint implantation. Overall, this drug is widely used for the treatment of various bacterial infections.

Dosage and Administration

Adult dosage

For adults: Administer intravenously or intramuscularly 3 mg (in terms of activity) per kg of body weight every 8 hours, and in life-threatening cases, administer 5 mg (in terms of activity) per kg of body weight split into 3-4 doses. Dosage should be reduced according to symptom improvement, with a maximum serum concentration of 12µg/mL and a minimum serum concentration (just before the next dose) not exceeding 2µg/mL. For urinary tract infections in patients with normal kidney function, a single dose of 160 mg (in terms of activity) can be administered daily.

Children's dosage

Children: Administer intravenously or intramuscularly 6-7.5 mg (in terms of activity) per kg of body weight every 8 hours. Infants: Administer intravenously or intramuscularly 7.5 mg (in terms of activity) per kg of body weight every 8 hours.

Precautions

Care must be taken when handling this medication as glass fragments may be mixed in if the ampoule is broken. Extra caution is needed, especially for children and the elderly. This medication should not be used if there is an allergy to this drug or similar antibiotics, or if the patient is pregnant or breastfeeding. Patients with hearing impairment or kidney dysfunction, neonates, premature infants, elderly patients, or those with muscle disorders should use this drug with caution. It may cause allergic reactions or asthma attacks, so asthmatic patients should be particularly careful. If any abnormal symptoms occur during administration, such as shock, rash, itching, hearing loss, dizziness, vomiting, or respiratory distress, the use should be immediately discontinued, and a doctor should be consulted. Regular kidney and liver function tests should be performed, and the dosage should be adjusted as necessary. Prolonged use may lead to vitamin deficiency symptoms, so attention is needed. When used in combination with other drugs that may affect the kidneys or muscle relaxants, the risk of side effects increases, so it is advisable to consult a doctor. Pregnant or breastfeeding women should refrain from using this drug or use it cautiously based on medical judgment. Dosages and administration intervals should be adjusted for children or the elderly based on their physical condition, and particularly careful considerations should be taken if kidney function is impaired. In case of overdose, serious side effects such as kidney damage, hearing loss, or respiratory paralysis may occur, necessitating immediate emergency care. Pain or induration at the injection site may occur, so it is advisable to massage the area well after injection. When using this drug as eye drops or ointments, allergic reactions or local irritation symptoms may occur, so caution is advised, and the safety for children under 6 years of age has not been established. This medication should only be used for the prescribed duration to prevent bacterial resistance, and prolonged use may lead to new infections or side effects, so discontinuation and consultation with a doctor are necessary. Finally, it is crucial to keep this medicine out of reach of children and adhere to the usage period.

Side effects and when to seek care immediately

Serious side effects

Shock (cyanosis, respiratory distress, chest discomfort, hypotension), severe allergic reactions (hives, severe swelling), asthma attacks, severe skin reactions (severe rashes with high fever, blisters, skin peeling, mucosal pain in mouth/eyes), respiratory distress, laryngeal edema, pulmonary fibrosis, liver abnormalities (jaundice, aggravated liver dysfunction), acute kidney failure, significantly reduced urine output, generalized severe swelling, hypertension accompanied by swelling, severe neurological symptoms (severe headache)

Mild side effects

Itching, rash, fever, dizziness, tinnitus, hearing loss, auditory impairment, ataxia, drowsiness, depression, visual disturbances, skin tingling, muscle cramps, vomiting, loss of appetite, excessive salivation, stomatitis, nausea, laryngeal edema, pulmonary fibrosis, eosinophilia, leukopenia, agranulocytosis, reticulocyte count changes, thrombocytopenia, anemia, granulocytopenia, mild liver dysfunction, vitamin K deficiency symptoms (hypoprothrombinemia, tendency to bleed, etc.),

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

Storage

This medication should be stored in a sealed container to prevent air and moisture ingress and should be kept in a cool room at room temperature, away from direct sunlight.

Appearance and packaging

Appearance

Colorless, odorless transparent liquid

Package unit

50 ampoules/box [(2 milliliters/ampoule)]

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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.