Medication info

Cefaclor Capsule 250 mg (Cefaclor Hydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Cefaclor Hydrate›Strength being verified
Manufacturer / importer
(주)퍼슨
Appearance
Hard capsule with a purple upper part and a white lower part containing a pale yellow powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 201507857 · Approved 2015.11.24

This product's status changed to Approval withdrawn on 2023.04.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of otitis media, respiratory and urinary tract infections
Who uses it
Adults · Children
Adult dosage
For cefaclor hydrate, 250 mg (potency) should be taken orally every 8 hours. In cases of severe infections (such as pneumonia) and low susceptibility infections, the dosage can be doubled. For acute gonococcal urethritis, this drug 3 g should be combined with 1 g of probenecid in a single dose.
Children's dosage
Administer 20 mg (potency) per kg of body weight every 8 hours. In cases of severe infections, otitis media, and low susceptibility infections, 40 mg (potency) per kg of body weight can be administered daily, with the maximum dose being

Ingredients

Manufacturer
(주)퍼슨

Efficacy & effects

Treatment of otitis media, respiratory and urinary tract infections

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

This medication is effective for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also used for treating urinary tract infections like pyelonephritis, cystitis, and gonococcal urethritis. It is widely used for various skin and soft tissue infections including abscesses, boils, folliculitis, cellulitis, infectious gangrene, subcutaneous abscess, skin ulcers, and wound infections. This drug is effective against various types of bacteria including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and Escherichia coli, aiding in the treatment of numerous infectious diseases. Overall, it is used for the treatment of various respiratory, urinary, and skin soft tissue infections.

Dosage and Administration

Adult dosage

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

Children's dosage

Administer 20 mg (potency) per kg of body weight every 8 hours. In cases of severe infections, otitis media, and low susceptibility infections, 40 mg (potency) per kg of body weight can be administered daily, with the maximum dose being

Precautions

This drug is an antibiotic that treats infections by destroying the cell walls of certain bacteria. Before using this drug, it is essential to inform whether you have previously experienced serious allergic reactions or shock from this drug or similar medications. Individuals with a history of allergies, or those who easily exhibit symptoms like asthma, rashes, or hives should use this drug with caution. Patients with severely impaired kidney function should exercise greater caution when using this drug, and dosage adjustments may be necessary. Older adults or patients in poor overall condition should be closely monitored for the risk of bleeding due to vitamin K deficiency. Patients with gastrointestinal disorders, especially those with a history of colitis, should immediately consult healthcare providers if abnormal symptoms such as abdominal pain or diarrhea occur during use of this drug. While taking this medication, serious allergic reactions, skin rashes, blood abnormalities, liver or kidney dysfunction may rarely occur, so immediate medical attention should be sought if symptoms arise. In particular, if symptoms such as breathing difficulties, swelling, severe rashes, or high fever appear, the administration should be stopped immediately, and appropriate treatment must be received. This drug may interact with other medications, so it is essential to inform healthcare providers of any currently taken medications. Caution is particularly needed when used together with medications that affect blood clotting or may burden the kidneys. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this drug, and breastfeeding mothers should be cautious as this drug may be excreted in small amounts in breast milk. Use of this drug in newborns, especially infants under one month old, is not recommended as its safety and efficacy have not been established. When using this drug, it is important to administer it only for the minimal necessary duration to prevent the development of resistant bacteria. During administration, regular kidney and liver function tests, blood tests, etc., should be conducted to monitor for any issues. While taking this drug, careful observation for unexpected side effects or unusual symptoms is essential, and immediate consultation with healthcare providers should be sought if any suspected symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylactic symptoms (including difficulty breathing), hives, Stevens-Johnson syndrome, toxic epidermal necrolysis, liver abnormalities (including jaundice), reversible interstitial nephritis, acute renal failure, severe colitis, interstitial pneumonia, eosinophilic pulmonary infiltration, asthma, breathing difficulties, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), severe swelling or urination problems

Mild side effects

Generalized flushing, vascular swelling, sensory abnormalities, fainting, hypertension, vasodilation, rash, itching, fever, lymphadenopathy, arthralgia, erythema multiforme, arthritis, serum sickness-like reactions, blood abnormalities (agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, eosinophilia, lymphocytosis, leukocytopenia, aplastic anemia, hemolytic anemia, reversible neutropenia), transient hepatitis, elevated AST/ALT/ALP,

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

Storage

This medication may be sensitive to air and moisture, so the bottle should be tightly closed during storage. It is best to store it at room temperature between 1°C and 30°C. This helps maintain the drug's effectiveness for a longer time.

Appearance and packaging

Appearance

Hard capsule with a purple upper part and a white lower part containing a pale yellow 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.