Cefgen Capsule 500 mg (Cefradine Hydrate)

Adult dosage

(Capsules)(Dry syrup) ○ Adults 1) Skin and soft tissue infections, respiratory tract infections: Depending on severity, administer 250 mg–500 mg (potency) per dose 4 times daily, or 500 mg–1 g (potency) 2 times daily, orally, as cefradine. 2) Urinary tract infections: For uncomplicated urinary tract infections, administer 500 mg (potency) per dose 2 times daily. For severe urinary tract infections, administer 500 mg (potency) per dose 4 times daily or 1 g (potency) per dose 2 times daily. Severe infections may also require a longer treatment period and intensive treatment. ○ Patients with renal impairment 1) If hemodialysis is not being performed, administer as follows. Creatinine clearance (mL/min) Dose (mg) Dosing interval (hours) >20 500 6–12 15–20 250 12–24 10–14 250 24–40 5–9 250 40–50 <5 250 50–70 2) For chronic, intermittent hemodialysis, administer an initial dose of 250 mg (potency) when hemodialysis is started, followed by 250 mg (potency) at 6–12 hours and 36–48 hours. Then administer 250 mg at the next hemodialysis session (only if at least 30 hours have elapsed since the most recent dose). (Injection) ○ Adults: Administer 2–4 g (potency) per day of cefradine in 4 divided doses by intravenous or intramuscular injection. For bone infections, administer 1 g (potency) per dose 4 times daily by intravenous injection. For most infections, administer 500 mg (potency) per dose 4 times daily by intravenous or intramuscular injection. For severe infections (e.g., sepsis), the dose may be increased to up to 8 g (potency) per day. ○ Patients with renal impairment 1) If hemodialysis is not being performed, follow the table for capsules and dry syrup. 2) For chronic, intermittent hemodialysis, administer an initial dose of 250 mg (potency) when hemodialysis is started, followed by 250 mg (potency) at 6–12 hours and 36–48 hours. Before starting the next hemodialysis session, administer 250 mg (potency) if at least 30 hours have elapsed since the previous dose. Adjust the dose as appropriate according to age and symptoms. As with 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. <Preparation of this medicine> For intravenous injection, dissolve each 500 mg (potency) of this medicine in 5 mL of water for injection, 5% dextrose injection, or normal saline injection, and administer intravenously over 3–5 minutes. For intravenous infusion, dissolve in an infusion solution such as 5% or 10% dextrose injection or normal saline injection, and administer by intravenous infusion. For intramuscular injection, dissolve each 500 mg (potency) in 2.0 mL of water for injection or normal saline injection and administer intramuscularly.

Children's dosage

○ Children: Administer 25–50 mg (potency) per kg of body weight per day orally in 2–4 divided doses. For otitis media, administer 75–100 mg (potency) per kg of body weight per day in 2–4 divided doses. However, do not administer more than 4 g (potency) per day or exceed the adult dose. Administration to infants 9 months of age or younger is not recommended. ○ Children: 50–100 mg (potency) per kg of body weight per day may be administered in 4 divided doses by intravenous or intramuscular injection, but the adult dose must not be exceeded.

This drug should not be used in patients who have had severe allergic reactions or shock due to this drug in the past. Additionally, this drug contains lactose, and should not be administered to patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. It is generally not administered to patients who have previously shown allergic reactions to this drug or to cephalosporin antibiotics; however, if unavoidable, it should be used with extreme caution. Caution is needed for patients with allergies to penicillin antibiotics, and those with a family history of allergies such as asthma, rashes, or urticaria. Patients with severely impaired kidney function, those who have difficulties with oral intake, those receiving parenteral nutrition, elderly patients, and those in poor systemic condition should be carefully monitored, as vitamin K deficiency symptoms may arise. While using this drug, certain adverse reactions such as shock, rashes, urticaria, difficulty breathing, abdominal pain, diarrhea may occur; if these symptoms arise, discontinue administration immediately and seek appropriate treatment. Particularly, serious gastrointestinal adverse reactions such as pseudomembranous colitis can occur rarely; if diarrhea or abdominal pain worsens, consult a medical professional promptly. Respiratory adverse reactions such as interstitial pneumonia or eosinophilic pulmonary infiltrations can occur; therefore, if breathing difficulties or severe coughing occur, administration should be stopped. Hematological abnormalities such as granulocytopenia, anemia, and thrombocytopenia may arise, requiring regular blood tests. Severe skin reactions like erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis can occur rarely. Liver dysfunction may occur rarely, so regular liver function tests are advisable. Kidney function may deteriorate rapidly, thus kidney function tests should also be conducted periodically. Long-term use of this drug can lead to dysbiosis such as stomatitis or candidiasis. Due to vitamin K deficiency, bleeding tendencies may arise, hence any bleeding symptoms should be reported immediately. When using this drug, it is crucial to administer it only for the minimum duration needed based on sensitivity testing to prevent the development of resistant bacteria. Before administration, check the patient's allergy history thoroughly and prepare for emergency treatment in case of shock. Caution should be taken when used concurrently with diuretics or aminoglycoside antibiotics, as renal function impairment may worsen. For women who are pregnant or may become pregnant, careful consideration of benefits and risks should be taken before administration of this drug. For nursing mothers, caution should be exercised as the medication may be transmitted through breast milk. It is advisable to avoid use in premature infants or infants under 9 months due to uncertain safety. In elderly patients, the likelihood of adverse reactions may be increased due to decreased physiological function, thus dosage and intervals should be adjusted, and close monitoring is advised. Care is needed in interpreting test results, as some clinical tests may be affected. When used as an injection, pain at the injection site or thrombophlebitis may occur, requiring observation, and subcutaneous injections should be deep intramuscular to prevent sterile abscess formation. After being made into a suspension, it should be refrigerated and used within two weeks for safety.

• shock
• discomfort
• dysgeusia
• wheezing
• dizziness
• diarrhea
• tinnitus
• sweating
• rash
• urticaria

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1°C and 30°C room temperature to preserve the drug's efficacy and safety for a long time.

Appearance

Hard capsule with light yellow contents, upper and lower blue.

Package unit

30 capsules/bottle, 100 capsules/bottle