Prefipen Injection (Acetaminophen)

Adult administration

Adults weighing over 50 kg: 4 doses per day, 1 dose of acetaminophen 1000 mg, with a minimum interval of 4 hours. Maximum daily dose 4 grams is prohibited. For children weighing over 33 kg and adults weighing under 50 kg: 1 dose of acetaminophen approximately 15 mg/kg, with a minimum interval of 4 hours. Maximum daily dose 60 mg/kg or 4 grams is prohibited. For patients with severe renal impairment: recommended interval of at least 6 hours. Administration

Child administration

Pediatric patients weighing 33 kg (approximately 11 years) or more: 1 dose of acetaminophen approximately 15 mg/kg, with a minimum interval of 4 hours. Maximum daily dose 60 mg/kg or exceeding 4 grams is prohibited. Method of administration: Intravenously over 15 minutes.

Care should be taken not to confuse the dosage units of milligrams and milliliters when administering this medicine. Confusion leading to overdose can result in severe toxicity or even death. It is advisable to switch to an appropriate oral analgesic as soon as possible after the patient can take oral medication. Check whether any other medications contain the active ingredient of this medicine to avoid excess intake. Exceeding the recommended dosage can cause serious liver damage, so the prescribed dosage must be strictly observed. Symptoms of liver damage typically appear between 2 to 6 days after intake, and immediate treatment should be sought if symptoms are suspected. Patients with liver impairment or liver function issues must consult a physician before taking this medicine. Those who frequently consume alcohol daily must consult healthcare personnel before taking this medicine, to avoid a heightened risk of liver damage. Rarely, severe rashes or allergic reactions may occur; if skin rash, itching, or hives develop after taking the medication, it should be stopped immediately, and medical attention should be sought. Patients with hypersensitivity to this medicine or an allergy to the active ingredient must not take it. Patients with peptic ulcers, severe liver impairment, kidney disorders, or decreased cardiac function should also refrain from use. Patients with aspirin-induced asthma, those taking certain antidepressants, barbiturates, or frequent alcohol users should also avoid this medication. Patients with liver impairment, renal impairment, peptic ulcers, blood abnormalities, bleeding tendencies, cardiac dysfunction, hypersensitivity, asthma, the elderly, children, pregnant or nursing women, and those taking specific medications should use this medicine cautiously and in consultation with a physician. Rare adverse reactions during use may include hypotension, shock, increased liver enzymes, reduced blood cell counts, neurological disorders, acute renal failure, skin rashes, etc. This medicine may interact with certain drugs, so it is imperative to inform healthcare personnel of any other medications being taken. Caution is particularly needed when taken with probenecid, salicylamide, enzyme-inducing substances, phenytoin, oral anticoagulants, or flucloxacillin. It does not affect driving or machinery operations but should not be mixed with other medications. Children and the elderly should take the minimum effective dose and be closely monitored for adverse reactions. This medication can mask symptoms of infection, so patients with infections should receive appropriate treatment according to their physician's instructions. The use of this medication during pregnancy is limited; however, if necessary, it should be used cautiously after consultation with a physician, and while breastfeeding, a small amount may pass into breast milk without reported adverse reactions. Children have pharmacokinetic differences from adults; hence, dosage adjustments may be needed, and they should follow the guidance of an expert. The elderly do not require dosage adjustment as drug metabolism does not significantly change, but their condition should be well monitored. Patients with markedly reduced kidney function should increase the intervals of administration and must consult healthcare personnel. Overdose may result in symptoms such as nausea, vomiting, loss of appetite, abdominal pain, and in severe cases, may lead to liver damage and brain disorders, requiring immediate emergency treatment. This medicine should not be stored at temperatures above 30 degrees Celsius, and refrigeration or freezing should be avoided; prior to administration, ensure there is no discoloration or foreign matter. Any unused solution must be discarded, and it is for single use only.

Serious side effects

Hypersensitivity reactions, shock, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, neurological disorders, coma, acute renal failure, Lyell's syndrome, acute general rash with pustules, toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatitis, liver necrosis, liver failure, increased liver enzymes, angioedema, anaphylactic shock, anaphylaxis, hypersensitivity reactions requiring cessation of treatment, anaphylactic shock

Mild side effects

Fatigue, hypotension, increased liver transaminase levels, spot rashes, injection site reactions, papular rashes, similar to dermatitis herpetiformis reactions, pustular rashes, thrombocytopenia, tachycardia, nausea, vomiting, erythema, flushing, pruritus, rashes, urticaria, high ion metabolic acidosis, dizziness, headache, constipation, sputum, sensory disturbances, anemia, urinary disturbances

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is safe to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a longer time.

Appearance

A transparent colorless to pale yellow solution in a plastic container for infusion.

Package unit

100mL/package