Hanmi Cefradine Capsule 500 mg

Adult dosage

(Capsules) (Dry Syrup) ○ Adults 1) Skin and soft tissue infections, and respiratory tract infections: Depending on the severity, administer 250mg～500mg (potency) per dose 4 times daily, or 500mg～1g (potency) twice daily, orally, as cefradine. 2) Urinary tract infections: For uncomplicated urinary tract infections, administer 500mg (potency) per dose twice daily. For severe urinary tract infections, administer 500mg (potency) per dose 4 times daily or 1g (potency) per dose twice daily. Severe infections may require an extended treatment period and intensive treatment. ○ Patients with renal impairment 1) For patients not undergoing hemodialysis, administer as follows: Creatinine clearance (mL/min) >20 : Dose (mg) 500, dosing interval (hours) 6～12 Creatinine clearance (mL/min) 15～20 : Dose (mg) 250, dosing interval (hours) 12～24 Creatinine clearance (mL/min) 10～14 : Dose (mg) 250, dosing interval (hours) 24～40 Creatinine clearance (mL/min) 5～9 : Dose (mg) 250, dosing interval (hours) 40～50 Creatinine clearance (mL/min) <5 : Dose (mg) 250, dosing interval (hours) 50～70 2) For patients undergoing chronic intermittent hemodialysis, administer an initial dose of 250mg (potency) at the start of hemodialysis, followed by 250mg (potency) 6～12 hours later and another 250mg (potency) 36～48 hours later. Then administer 250mg at the next hemodialysis session (only if at least 30 hours have elapsed since the most recent dose). (Injection) ○ Adults: Administer 2～4g (potency) per day as cefradine, divided into 4 doses, by intravenous or intramuscular injection. For bone infections, administer 1g (potency) per dose 4 times daily by intravenous injection. For most infections, administer 500mg (potency) per dose 4 times daily by intravenous or intramuscular injection. For severe infections (e.g., sepsis), the dose may be increased to 8g (potency) per day. ○ Patients with renal impairment 1) For patients not undergoing hemodialysis, follow the table for capsules and dry syrup. 2) For patients undergoing chronic intermittent hemodialysis, administer an initial dose of 250mg (potency) at the start of hemodialysis, followed by 250mg (potency) 6～12 hours later and another 250mg (potency) 36～48 hours later. Administer 250mg (potency) before the start of the next hemodialysis session if at least 30 hours have elapsed since the previous dose. Adjust the dose appropriately according to age and symptoms. As with administration of other antibiotics, treatment should generally continue for at least 48～72 hours after symptoms resolve or evidence of bacterial eradication appears. For group A beta-hemolytic streptococcal infections, treatment for at least 10 days is recommended to prevent the risk of rheumatic fever or glomerulonephritis.

Children's dosage

(Capsules)(Dry syrup) ○ Children: Administer orally in 2～4 divided doses at a daily dose of 25～50mg (potency) per Kg of body weight. For otitis media, administer in 2～4 divided doses at a daily dose of 75～100mg (potency) per Kg of body weight. However, do not administer more than 4g (potency) per day, and do not exceed the adult dose. Use in infants 9 months of age or younger is not recommended. (Injection) ○ Children: 50～100mg (potency) per Kg of body weight per day may be administered by intravenous or intramuscular injection in 4 divided doses, but the adult dose must not be exceeded.

This medication should not be used in patients who have experienced shock due to this drug in the past. Patients with a history of allergy to this drug or cephalosporin antibiotics should generally not be administered this medication, but it may be used very cautiously when absolutely necessary. Caution is also advised for patients with a history of allergy to penicillin antibiotics. Patients with a tendency to easily develop allergic reactions such as bronchial asthma, skin rashes, and hives in themselves or their families should exercise caution. Patients with severely reduced kidney function should be particularly careful when using this drug and should closely monitor their kidney status before and during administration. Patients who have difficulty swallowing pills, receive non-oral nutrition, are elderly, or are in poor overall health may show symptoms of vitamin K deficiency so careful observation is needed. This drug can induce shock, so patient condition should be carefully monitored during administration. If symptoms such as dizziness, vomiting, or sweating occur, administration should be immediately discontinued and appropriate treatment should be given. If allergic reactions such as rashes, hives, itching, or fever occur, administration should stop, and medical treatment should be sought. If severe gastrointestinal symptoms such as abdominal pain, diarrhea, or blood in the stool occur, the drug should be stopped immediately, and medical attention should be sought. If respiratory symptoms such as dyspnea, cough, or fever occur, treatment should be stopped, and appropriate measures such as steroid therapy should be sought. Blood tests may rarely show decreases in white blood cells, anemia, or thrombocytopenia, thus regular testing is necessary. Severe skin reactions such as erythema multiforme or Stevens-Johnson syndrome have been rarely reported; if any skin changes occur, the patient should consult a doctor immediately. Liver function abnormalities may also occur infrequently, thus liver enzyme tests should be monitored. Acute renal failure or other serious kidney problems may occur, so regular kidney function tests are advised. Oral yeast infections or candidiasis may occur, and oral hygiene should be maintained. Bleeding tendencies due to vitamin K deficiency or symptoms of vitamin B complex deficiency may occur infrequently, thus caution is warranted if symptoms arise. Symptoms such as headache, malaise, or loss of appetite may occur, so any unusual symptoms should be discussed with a healthcare provider. To prevent the occurrence of resistant bacteria, it is advisable to conduct sensitivity tests and to administer the least possible duration of therapy when using this medication. To minimize the risk of shock, thorough patient history and skin reaction assessments are recommended prior to administration. During treatment, prepare for emergencies by ensuring that emergency care is possible and observe the patient in a stable condition. Co-administration with diuretics or aminoglycoside antibiotics may increase the risk of kidney problems, thus it should be used carefully. Pregnant women or women of childbearing potential should use this medication only when the benefits outweigh the risks, as its safety has not been established. This medication may be partially excreted in breast milk; therefore, caution is necessary when administering it to nursing mothers. It is advisable not to use this medication in premature or newborn infants, particularly those under 9 months of age. Elderly patients may exhibit more frequent adverse reactions due to decreased physiological functions, thus dose and interval should be adjusted with careful monitoring. This medication may affect certain test results during urine tests, so this should be disclosed to the healthcare professional conducting the tests. When administered by injection, temporary pain or thrombophlebitis may occur at the injection site, thus caution is required.

Shock

This medication should be stored in a tightly closed container to prevent exposure to air and humidity, ideally at room temperature between 1 and 30 degrees. Storing it this way helps maintain its efficacy and safety.

Appearance

A hard capsule with a blue top and gray bottom containing a white or light yellow crystalline powder

Package unit

30 capsules/bottle, 300 capsules/bottle