Azosephradin Capsule 500 mg (Cefradine Hydrate)

Adult dosage

(Capsules)(Dry syrup) Adults 1) Skin and soft tissue infections, respiratory tract infections: Depending on severity, administer cefradine orally at 250mg～500mg (potency) per dose 4 times daily or 500mg～1g (potency) per dose 2 times daily. 2) Urinary tract infections: For uncomplicated urinary tract infections, administer 500mg (potency) per dose 2 times daily. For severe urinary tract infections, administer 500mg (potency) per dose 4 times daily or 1g (potency) per dose 2 times 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) at the start of hemodialysis, followed by 250mg (potency) 6～12 hours later and 36～48 hours later, respectively. 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) of cefradine per day in 4 divided 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 up 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 36～48 hours later, respectively. Before the next hemodialysis session, administer 250mg (potency) if at least 30 hours have elapsed since the previous dose. Adjust the dose appropriately according to age and symptoms. As with other antibiotics, treatment should generally continue until at least 48～72 hours after symptoms have resolved or evidence of bacterial eradication has appeared. For Group A beta-hemolytic streptococcal infections, treatment for at least 10 days is advisable to prevent the risk of rheumatic fever or glomerulonephritis. <Preparation of this drug> For intravenous injection, dissolve this drug at 5mL of water for injection, 5% dextrose injection, or normal saline injection per 500mg (potency), and inject intravenously over 3～5 minutes. For intravenous infusion, dissolve in an infusion fluid such as 5% or 10% dextrose injection or normal saline injection, and administer by intravenous infusion. For intramuscular injection, dissolve this drug at 2.0mL of water for injection or normal saline injection per 500mg (potency), and inject intramuscularly.

Children's dosage

Children (capsules, dry syrup): Administer 25～50mg (potency) per kg of body weight per day orally in 2～4 divided doses. Do not exceed 4g (potency) per day or the adult dose. Otitis media: Administer 75～100mg (potency) per kg of body weight per day in 2～4 divided doses. Do not exceed 4g (potency) per day or the adult dose. It is preferable not to administer to infants 9 months of age or younger. Children (injection): 50～100mg (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 medication should not be used in patients who have had severe allergic reactions or shock due to this drug in the past. Patients who have had allergic reactions to this drug or similar classes of antibiotics should use it with caution. Patients allergic to penicillin antibiotics should also exercise caution. If there is a family history of bronchial asthma or allergic symptoms such as skin rashes or hives, it should also be administered carefully. Patients with severely impaired kidney function should be closely monitored before administration. Patients who have difficulty swallowing or older adults in poor nutritional status may experience vitamin K deficiency symptoms, so they need to be managed carefully. This medication contains a dye called Yellow No. 5 and should be used with caution in cases of allergy to this component. While taking this medication, signs of shock or allergic reaction should be closely monitored, and if discomfort, dizziness, rash, etc. appear, use should be stopped immediately, and the hospital should be notified. Gastrointestinal symptoms such as abdominal pain, diarrhea, and nausea may occur, and if severe colitis symptoms appear, immediate treatment should be sought. Respiratory symptoms such as asthma, cough, and difficulty breathing may rarely occur, and if abnormal symptoms arise, stop using the medication immediately. Routine blood tests may show leukopenia or anemia, so regular examinations are necessary. Severe skin rashes or blisters may rarely occur, so skin condition should be monitored carefully. Hepatic dysfunction may rarely occur, so liver function tests are recommended. Kidney function may deteriorate rapidly, so kidney status should be checked regularly. Oral infections like stomatitis or candidiasis may rarely occur. Signs of bleeding tendency or symptoms of vitamin B group deficiency may occur due to vitamin K deficiency, so caution is needed. Symptoms like headache, fatigue, and dyspepsia may also occur rarely. When using this drug, it is important to ensure the sensitivity of the infectious organism and administer it for only the required duration to prevent resistance. To prevent shock reactions, a thorough medical history and skin reaction tests should be conducted before administration. Post-administration, the patient should be kept in a stable condition and closely monitored. Use with diuretics or aminoglycoside antibiotics may stress kidney function, so caution is needed. Pregnant women or women who may become pregnant should use this medication only when the benefits outweigh the risks as its safety has not been established. Caution should also be exercised when administering to breastfeeding mothers, as the drug may pass into breast milk. It is advisable not to use this medication in infants, especially those under 9 months of age. Elderly patients may have reduced physiological functions and may show more side effects, so dosing and intervals should be adjusted and monitored closely. Some clinical tests may be influenced by this drug, so consider this when conducting tests. When used as an injectable, temporary pain or thrombotic phlebitis may occur at the injection site.

Shock

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius to effectively preserve the drug's efficacy.

Appearance

A hard capsule with a filling of white to pale yellow crystalline powder, with a turquoise upper part and a colorless lower part.

Package unit

30 capsules/bottle, 300 capsules/bottle