Shinpoong Gentamicin Injection 80 mg

Adult administration

For adults, administer 3 mg (potency) per kg of body weight intravenously or intramuscularly every 8 hours. In life-threatening situations, administer 5 mg (potency) per kg of body weight split into 3 or 4 doses. Dosage should be reduced according to symptom improvement, ensuring that peak serum concentration does not exceed 12 µg/mL, and trough concentration (just before the next dose) does not exceed 2 µg/mL. Dosages based on body weight in cases of severe infection are presented in tables.

Child administration

For children, administer 6 to 7.5 mg (potency) per kg of body weight intravenously or intramuscularly every 8 hours. For infants, administer 7.5 mg (potency) per kg of body weight intravenously or intramuscularly every 8 hours.

This medication should be handled very carefully when using ampoules as glass fragments may be mixed in. Special care is needed when used in children and the elderly. It should not be used in patients allergic to aminoglycosides or those with hypersensitivity to bacitracin, and in pregnant or nursing women. It should be administered with caution in patients with a history of hearing loss, or with kidney or liver problems, newborns, and premature infants, as well as elderly patients with poor general health or muscle disorders. This medication can cause allergic reactions, particularly in asthma patients where the symptoms may worsen. During administration, adverse effects such as shock, allergic reactions, neurological symptoms (dizziness, tinnitus, hearing loss, etc.), gastrointestinal symptoms, difficulty breathing, blood abnormalities, and changes in liver and kidney functions may occur, hence careful monitoring is required. Long-term use or high doses may increase the risk of hearing loss and kidney function decline, thus the duration of use should preferably not exceed 10 days, and hearing tests and kidney function tests should be conducted if necessary. It is especially important to measure serum drug levels in elderly patients or those with impaired kidney function to adjust the dosage and administration intervals. Adequate hydration should be maintained during administration to prevent dehydration, and caution should be exercised when combined with certain blood substitutes, diuretics, anesthetics, or muscle relaxants, as renal toxicity or respiratory depression risks may increase. It is safest not to use this medication in pregnant or nursing women, as administration during pregnancy may result in serious side effects such as hearing loss in newborns. Newborns and premature infants should be administered with care as their kidney function may be immature, potentially leading to elevated drug levels. In cases of overdose, renal dysfunction, hearing impairment, neuromuscular blockade, and respiratory paralysis may occur requiring appropriate treatment and dialysis. Pain or induration may occur at the injection site, hence it is advisable to sufficiently massage the local area post-injection. This medication may interact with other antibiotics or drugs, hence it should only be used after consulting with medical personnel.

Serious side effects

Shock, cyanosis, difficulty breathing, chest discomfort, hypotension, severe allergic reactions, laryngeal edema, pulmonary fibrosis, liver dysfunction, acute renal failure, edema, oliguria, hematuria, electrolyte imbalances, vitamin K deficiency symptoms (bleeding tendency), anaphylaxis, severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, difficulty breathing, asthma attacks.

Mild side effects

• Itching
• rarely rash
• fever
• dizziness
• tinnitus
• hearing loss
• loss of hearing
• ataxia
• numbness in limbs
• hallucinations

This medication is stored in a light-blocking sealed container. Store at room temperature, maintaining a temperature between 1 and 30 degrees Celsius. Ampoule forms of the medication should also be stored in a sealed container, and it is likewise important to keep it at room temperature.

Appearance

A brown vial containing a colorless transparent liquid or a colorless transparent ampoule injection.

Package unit

2 mL/ampoule x 50