Medication info
Donggu Cefaclor Hydrate Sustained-release Tablet 375mg

Donggu Cefaclor Hydrate Sustained-release Tablet 375mg

Prescription medicationTablet경구
Ingredient · strength
Cefaclor Hydrate›375mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Blue rectangular sustained-release tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200611033 · Notified 2006.11.28 · Insurance code 657300650

Summary

Main use
Treatment of respiratory infections (bronchitis, pharyngitis), urinary tract infections (cystitis, urethritis), and skin infections
Who takes it
Adults
Adult dose
Administer 375mg (potency) of cefaclor hydrate orally twice daily. For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), continued administration for more than 10 days is required. Tablets must be taken whole and should not be crushed, broken, or chewed. It can be administered orally regardless of meals, but absorption increases when taken with food.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment of respiratory infections (bronchitis, pharyngitis), urinary tract infections (cystitis, urethritis), and skin infections

  • Otitis media
  • pneumonia
  • pharyngitis
  • tonsillitis
  • bronchitis
  • pyelonephritis
  • cystitis
  • gonococcal urethritis
  • abscesses
  • boils
  • folliculitis
  • cellulitis
View approved original text

This medication is used to treat various bacterial infections. It is effective for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis, and is also used for urinary tract infections including pyelonephritis, cystitis, and gonococcal urethritis. Additionally, it helps treat skin and soft tissue infections such as abscesses, boils, folliculitis, cellulitis, infectious necrosis, and wound infections. The sustained-release formulation is effective against recurrent acute and chronic bronchitis, pharyngitis, tonsillitis, lower urinary tract infections, and skin soft tissue infections. It treats a broad range of bacterial infections targeting several strains and rapidly improves symptoms caused by infections. This drug is used to treat various infections.

How to take

Adult dose

Administer 375mg (potency) of cefaclor hydrate orally twice daily. For the treatment of infections caused by Streptococcus pyogenes (Group A beta-hemolytic), continued administration for more than 10 days is required. Tablets must be taken whole and should not be crushed, broken, or chewed. It can be administered orally regardless of meals, but absorption increases when taken with food.

Precautions

This drug works by binding to specific proteins to interfere with bacterial cell wall synthesis, thereby killing bacteria. Before using this drug, it should never be used by those who have previously experienced severe allergic reactions or shock from this drug or cephalosporin antibiotics. It should be used cautiously in individuals who are allergic to penicillin antibiotics or have a tendency to develop allergic symptoms such as asthma, rash, or urticaria. Patients with severely impaired kidney function, those who have difficulty with oral administration, elderly patients, or those in poor general condition should be closely monitored due to the risk of bleeding associated with vitamin K deficiency. Patients with a history of gastrointestinal diseases, particularly colitis, should also be cautious when using this drug. Severe allergic reactions or shock can rarely occur during the administration of this drug; therefore, if symptoms appear, administration must be stopped immediately and appropriate treatment sought. Symptoms such as severe rashes or blisters may indicate Stevens-Johnson syndrome, so skin conditions should be closely monitored. Regular blood tests are necessary as there may be abnormalities such as decreased white blood cell or platelet counts. This drug may affect liver and kidney function, so any unusual symptoms should be reported immediately to healthcare providers, and dosage adjustments may be needed for patients with poor kidney function. Gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal pain may occur, particularly severe colitis with blood in the stool should be watched for. Respiratory symptoms such as interstitial pneumonia or eosinophilic pulmonary infiltrates may rarely occur, so immediate notification is required if there is worsening of cough or breathing difficulties. Central nervous system effects such as anxiety, agitation, dizziness, hallucinations, or drowsiness may occur. Rarely, alterations in normal flora can lead to oral inflammation or candidiasis. The risk of bleeding may increase due to vitamin K deficiency, so signs of bleeding should be observed, and vitamin B deficiency symptoms may also appear. This drug can interact with other medications, so consultation with healthcare providers is crucial, particularly when taken with probenecid, antacids, nephrotoxic drugs, anticoagulants, and oral contraceptives. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this drug, and it should be used cautiously during breastfeeding. Safety for use in children, particularly neonates under one month or children using sustained-release formulations, has not been established, so caution is advised. Elderly patients may experience adverse reactions more easily due to decreased bodily function, so dosage and administration intervals should be carefully adjusted and used with caution. In cases of overdose, symptoms such as nausea, vomiting, and diarrhea may occur, and immediate medical attention is required. During the use of this medication, follow the doctor's instructions and use it only for the minimum necessary duration to prevent the development of resistant bacteria. If any unusual symptoms occur during the use of this drug, it is important to inform healthcare providers immediately and receive appropriate care.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, shock, anaphylactic symptoms (generalized flushing, swelling, dyspnea, angioedema, sensory disturbances, syncope, hypertension, vasodilation), Stevens-Johnson syndrome, toxic epidermal necrolysis, liver abnormalities (jaundice), acute renal failure, severe colitis such as pseudomembranous colitis, interstitial pneumonia, eosinophilic pulmonary infiltrates, severe neurological symptoms (seizures, altered consciousness, visual disturbances, paralysis),

Mild side effects

  • Rash
  • itching
  • fever
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reaction
  • agranulocytosis
  • granulocytopenia
  • anemia
  • thrombocytopenia
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  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • transient hepatitis
  • elevated AST
  • ALT
  • ALP
  • increased BUN
  • elevated serum creatinine
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • gastrointestinal discomfort
  • heartburn
  • loss of appetite
  • fever

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Blue rectangular sustained-release tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.