Withers Cephalexin Capsule 500 mg (Cephalexin Hydrate)

Adult dose

○ Adults 1) Skin and soft tissue infections, respiratory tract infections: Depending on the severity, administer 250mg～500mg (potency) of cefradine per dose 4 times daily, or 500mg～1g (potency) 2 times daily, orally. 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. In addition, severe infections 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) 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). Adjust the dose appropriately 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. For otitis media, administer 75～100mg (potency) per Kg of body weight per day in 2～4 divided doses. However, do not administer more than 4g (potency) per day or exceed the adult dose. It is preferable not to administer to infants 9 months of age or younger.

This medication should not be used in patients who have previously experienced shock from it. Patients who have had an allergy to this drug or cephalosporins should avoid administration, but if necessary, it should be used very cautiously. Patients with a history of allergic reactions to penicillin antibiotics should also administer it with caution. Caution should be taken in patients with a family history of easy occurrence of allergic symptoms such as bronchial asthma, rash, and urticaria. Patients with severely impaired kidney function require special care when administering this medication. Patients who have difficulty in oral intake, those receiving parenteral nutrition, elderly individuals, or those with poor general health may experience symptoms of vitamin K deficiency, so careful monitoring is necessary. This medication contains a dye called Yellow No. 5, so patients with allergies or hypersensitivity to this ingredient should be administered cautiously. If symptoms such as discomfort, oral abnormalities, wheezing, dizziness, constipation, tinnitus, sweating, etc. occur during the administration of this medication, it should be immediately discontinued and a healthcare professional should be consulted. If allergic reactions occur such as rash, urticaria, erythema, itching, fever, lymphadenopathy, edema, or arthralgia, the medication should be discontinued and appropriate treatment sought. If abdominal pain, frequent diarrhea, or blood in the stool occurs, it may indicate severe colitis; thus, the medication should be immediately stopped, and the patient should go to the hospital. Gastrointestinal symptoms such as nausea, vomiting, heartburn, diarrhea, stomachache, loss of appetite, abdominal bloating may occur, so patients need to be vigilant regarding these symptoms. Rarely, inflammation of the lungs may occur, so if fever, asthma, cough, or shortness of breath occurs, the medication should be discontinued, and professional treatment is needed. Blood tests may show leukopenia, anemia, or thrombocytopenia, so regular testing is necessary. Severe skin rash or blistering has been reported as a rare side effect, so if any skin abnormalities are observed, they should be reported immediately. Liver function levels may rise, and rare cases of hepatitis or jaundice may occur, so liver health should be checked periodically. Kidney function may deteriorate, requiring regular kidney function tests; if there are signs of trouble, the medication should be stopped. Oral infections such as stomatitis or candidiasis may occur, so oral health should be well managed. Vitamin K deficiency may lead to bleeding tendencies, hence attention should be paid to bleeding symptoms. Headache, general fatigue, epigastric discomfort, glossitis, and sensory abnormalities may rarely occur. When using this medication, it is important to check the sensitivity of the infecting bacteria and administer it for only the necessary minimum duration to prevent resistant bacteria from developing. To prevent shock reactions, it is recommended to thoroughly investigate the patient's medical history and perform skin reaction tests. For emergency situations, it is essential to prepare first aid measures and observe the patient adequately after administration in a stable condition. Combining with diuretics or aminoglycoside antibiotics may increase stress on the kidneys, so care is necessary when administering. Safety has not been established during pregnancy, so women who are pregnant or may become pregnant should use it only when the therapeutic advantage outweighs the risks. This medication can be transmitted through breast milk, so lactating women should take it cautiously. It is preferable to avoid administration in premature or newborn infants due to the lack of established safety, and it is recommended not to use it in infants under 9 months of age. The elderly may experience adverse reactions more easily due to declining physiological functions; hence, dosage and administration intervals should be adjusted, and conditions should be closely monitored. Some urinary glucose tests may yield false positive results, so caution should be exercised in interpreting test results. A direct Coombs test may also show a positive reaction, so test results should be carefully evaluated.

• Shock
• discomfort
• oral dysgeusia
• wheezing
• dizziness
• diarrhea
• tinnitus
• sweating
• rash
• urticaria

This medication should be stored in a closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule filled with crystalline powder that is white to pale yellow, with a light green upper part and a colorless lower part.

Package unit

30 capsules/bottle, 300 capsules/bottle