Medication info
Cephalon Capsule 250 mg (Cefaclor Hydrate)

Cephalon Capsule 250 mg (Cefaclor Hydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(주)한국피엠지제약
Appearance
A hard capsule with a purple upper part and a white lower part containing a yellowish powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201404437 · Approved 2014.09.29 · Insurance code 697100590

Summary

Main use
Treatment of otitis media, respiratory infections (pneumonia, pharyngitis), and urinary tract infections (pyelonephritis, cystitis).
Who takes it
Adults · Children
Adult dose
For cefaclor hydrate, the oral dosage is 250 mg (potency) every 8 hours. In cases of severe infections (such as pneumonia) and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, administer 3 g of this drug combined with 1 g of probenecid in a single dose.
Child dose
Administer 20 mg (potency) per kg of body weight divided every 8 hours. In cases of severe infections, otitis media or infections with low susceptibility, a dosage of 40 mg (potency) per kg of body weight may be administered daily, with a maximum dosage of

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

Treatment of otitis media, respiratory infections (pneumonia, pharyngitis), and urinary tract infections (pyelonephritis, cystitis).

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

This medication is effective against various bacteria such as streptococcus pneumoniae, Haemophilus influenzae, staphylococcus, and Escherichia coli, and is used to treat a variety of bacterial infections. It helps to treat respiratory infections like otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also effective for urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. It is used for skin and soft tissue infections like abscesses, furuncles, folliculitis, and cellulitis. It helps improve symptoms of infections such as wound infections or subcutaneous abscesses. In summary, this medication is used for the treatment of bacterial infections in various parts of the body, including respiratory, urinary, and skin infections.

How to take

Adult dose

For cefaclor hydrate, the oral dosage is 250 mg (potency) every 8 hours. In cases of severe infections (such as pneumonia) and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, administer 3 g of this drug combined with 1 g of probenecid in a single dose.

Child dose

Administer 20 mg (potency) per kg of body weight divided every 8 hours. In cases of severe infections, otitis media or infections with low susceptibility, a dosage of 40 mg (potency) per kg of body weight may be administered daily, with a maximum dosage of

Precautions

This drug is an antibiotic that kills bacteria by binding to specific proteins and inhibiting the synthesis of their cell walls. Before using this drug, patients who have previously experienced severe allergic reactions or shock from this drug or similar antibiotics should never take it. Furthermore, patients with allergies to penicillin antibiotics or those prone to allergy symptoms such as asthma or skin rashes should use this drug cautiously. Patients with severely impaired kidney function, older adults, or patients with poor nutritional status or difficulty with oral intake should be particularly monitored as vitamin K deficiency symptoms may occur. Patients with a history of gastrointestinal diseases, especially colitis, should also exercise caution when using this drug. This drug may rarely cause severe allergic reactions such as shock or anaphylaxis, so symptoms should be closely observed during administration, and if symptoms arise, drug use should be immediately discontinued and appropriate treatment sought. Serious skin diseases, such as Stevens-Johnson syndrome, may also rarely occur, so any abnormal skin symptoms should be reported to a healthcare provider promptly. Regular blood tests are necessary as there may be anomalies such as leukopenia, anemia, or thrombocytopenia; if abnormalities are detected, drug use may need to be terminated. As this drug may also affect liver and kidney function, any signs of hepatitis or suspected kidney function decline should be immediately brought to the attention of a healthcare provider. Gastrointestinal symptoms may include abdominal pain, diarrhea, and vomiting; if there is any blood in stools or severe diarrhea, drug use should be immediately stopped. Respiratory symptoms may rarely include pneumonia; if there are respiratory difficulties or cough, it should be reported immediately. CNS symptoms may include anxiety, restlessness, dizziness, and drowsiness, although these are rare. This drug can cause dysbiosis, such as stomatitis or candidiasis, so oral hygiene should be maintained. There may also be rare occurrences of bleeding tendencies or vitamin B deficiencies due to vitamin K deficiency, so patients should be vigilant for symptoms of bleeding or neurological abnormalities. Drug interactions may occur, so especially in cases where anticoagulants, diuretics, or oral contraceptives are taken, consultation with a healthcare provider is essential. Women who are pregnant or breastfeeding should consider the risks and benefits adequately before taking this drug, as its safety has not been fully established. Use in newborns less than one month old should be avoided as safety and efficacy have not been confirmed. Older adults may experience adverse reactions more easily due to declining physiological function, so dosage and administration intervals should be adjusted and used cautiously. During the use of this drug, regular clinical tests are recommended, and precaution should be taken in interpreting test results as false positives may occur in urine glucose tests or direct Coombs tests.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylactic symptoms (generalized flushing, swelling, difficulty breathing, angioedema, sensory disturbances, fainting, hypertension, vasodilation), urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, aplastic anemia, hemolytic anemia, reversible neutropenia, transient hepatitis, jaundice, elevated AST, ALT, ALP, reversible interstitial nephritis, elevated BUN.

Mild side effects

  • Rash
  • itching
  • fever
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reactions
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
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  • upper gastrointestinal discomfort
  • heartburn
  • loss of appetite
  • restlessness
  • anxiety
  • muscle hypertonicity
  • nervousness
  • insomnia
  • confusion
  • dizziness
  • hallucinations
  • drowsiness
  • stomatitis
  • candidiasis
  • hypoprothrombinemia
  • bleeding tendency
  • glossitis
  • stomatitis
  • neuritis
  • headache
  • genital itching
  • vaginitis
  • vulvovaginal candidiasis
  • accidental injuries
  • loss of appetite
  • anxiety.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. Proper storage will help safely maintain the medication's efficacy.

Appearance and packaging

Appearance

A hard capsule with a purple upper part and a white lower part containing a yellowish powder.

Package unit

30 capsules/bottle, 300 capsules/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.