Ceradin Capsule (Cefradine Hydrate)

Adult dose

○ Adults 1) Skin and soft tissue infections, respiratory tract infections: Depending on the severity, administer 250mg～500mg (potency) of cefradine orally 4 times daily, or 500mg～1g (potency) twice daily. 2) Urinary tract infections: For uncomplicated urinary tract infections, administer 500mg (potency) twice daily. For severe urinary tract infections, administer 500mg (potency) 4 times daily or 1g (potency) twice daily. Severe infections may also require a longer treatment period and intensive treatment. ○ Patients with renal impairment 1) For patients not undergoing hemodialysis, administer as follows. Creatinine clearance (mL/min) / dose per administration (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 patients undergoing chronic, intermittent hemodialysis, administer an initial dose of 250mg (potency) when hemodialysis is started, followed by 250mg (potency) after 6～12 hours and again after 36～48 hours. Then administer 250mg at the next hemodialysis session (only if at least 30 hours have elapsed since the most recent dose). The dose may be adjusted as appropriate according to age and symptoms.

Child dose

○ Children Administer 25～50mg (potency) per Kg of body weight per day orally in 2～4 divided doses. Do not exceed the maximum daily dose of 4g (potency), and do not exceed the adult dose. Otitis media: Administer 75～100mg (potency) per Kg of body weight per day in 2～4 divided doses. Do not exceed the maximum daily dose of 4g (potency), and do not exceed the adult dose. Use in infants 9 months of age or younger is not recommended.

This medication should not be used in patients who have previously experienced severe allergic reactions or shock after taking it. Patients with allergies to this medication or cephalosporin antibiotics should generally not be administered this medication, but if absolutely necessary, it should be used with extreme caution. Patients with a history of allergy to penicillin antibiotics should also be administered this medication with caution. Patients who or whose family members have a tendency to frequently present allergic symptoms such as bronchial asthma, rashes, or hives should be especially careful when using this medication. Patients with severely impaired kidney function should be closely monitored for kidney status when administering this medication. Patients who have difficulty with oral intake or are receiving non-oral nutrition, the elderly, or patients with poor health conditions may have an increased risk of bleeding due to vitamin K deficiency, thus requiring careful observation. Patients with allergies to yellow No. 5 and yellow No. 203 coloring agents contained in this medication should be careful when using it. This medication can cause severe allergic reactions, including shock, so the patient's condition should be closely monitored during administration. If symptoms such as discomfort, oral abnormalities, wheezing, dizziness, diarrhea, tinnitus, or sweating occur, administration should be stopped immediately and appropriate treatment should be received. If allergic symptoms such as skin rashes, hives, erythema, itching, fever, lymphadenopathy, edema, or arthralgia occur, the medication should be discontinued and the patient should consult a doctor. If gastrointestinal abnormalities such as abdominal pain, frequent diarrhea, or severe colitis with bloody stools occur, administration of the drug should be stopped immediately. Rarely, symptoms such as nausea, vomiting, heartburn, diarrhea, abdominal pain, loss of appetite, constipation, or abdominal bloating may occur. Respiratory anomalies may present with fever, asthma, cough, and abnormal lung findings, so if such symptoms appear, administration should be discontinued and treatment should be initiated. Blood anomalies such as granulocytopenia, anemia, and thrombocytopenia may occur rarely, so regular blood tests may be necessary. Severe skin reactions such as severe rashes or Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely. Liver function abnormalities may occur, so caution should be exercised if liver enzyme elevation or hepatitis symptoms appear. Severe renal disorders such as acute kidney failure may occur rarely, so kidney function should be regularly monitored. Oral inflammation or candidiasis may develop, and bleeding tendencies due to vitamin K deficiency or symptoms of vitamin B complex deficiency may rarely appear. Headaches, general malaise, and discomfort in the upper abdomen may occur, and if symptoms are severe, consultation with a doctor is recommended. When using this medication, it is essential to conduct susceptibility testing to prevent the development of resistant bacteria and to take it only for the necessary minimum duration. Before administering, it is advisable to thoroughly check the patient's medical history and skin reaction tests to prevent severe allergic reactions. Emergency preparedness for shock should be ensured, and patients should be observed in a stable condition after administration. Caution should be taken when used in conjunction with diuretics or aminoglycoside antibiotics as renal damage may worsen. Safety has not been established during pregnancy, so it should be administered to pregnant women or women who may become pregnant only when the benefits of treatment outweigh the risks. This medication can also be passed into breast milk, so nursing women should use it cautiously. It is advisable not to administer this medication to premature infants or neonates, as safety has not been established in infants under 9 months of age. Elderly patients, whose physiology may be deteriorated, should have their dosage and administration intervals adjusted and their conditions closely monitored for adverse reactions. Some urine tests may show false positive reactions during the use of this medication, therefore caution should be exercised in interpreting test results. When used as an injection, temporary pain or thrombophlebitis at the injection site may occur, and improper injection techniques may lead to aseptic abscess formation, thus attention should be given to injection methodology. The dry syrup form should be dissolved in water to make a suspension and stored in the refrigerator, using it within two weeks.

• Shock
• discomfort
• oral dysesthesia
• wheezing
• dizziness
• bowel movement abnormalities
• tinnitus
• sweating
• rash
• hives

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, to maintain the efficacy of the drug, it is important to store it at room temperature, specifically between 1 to 30 degrees Celsius.

Appearance

A hard capsule with a white to light yellowish powder, with an upper light ocher color and a lower pale yellow color.

Package unit

30 capsules/bottle, 300 capsules/bottle