Medication info
Cefaclor Capsule (Cefaclor Hydrate)

Cefaclor Capsule (Cefaclor Hydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(주)텔콘알에프제약
Appearance
Hard capsules with a green upper part and pale yellow lower part containing a yellowish powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201403147 · Approved 2014.07.15 · Insurance code 625500130

Summary

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

Ingredients

Manufacturer
(주)텔콘알에프제약

Efficacy & effects

Treatment of otitis media and respiratory (pneumonia, pharyngitis) infections

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

This drug is effective against various bacteria, including Streptococcus pneumoniae, Influenza Bacillus, Staphylococcus, Streptococcus pyogenes, and Escherichia coli. It is used for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis, as well as for urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. It is also helpful in treating skin and soft tissue infections like abscesses, furuncles, folliculitis, and soft tissue infections, and acts effectively in wound infections to prevent and treat infections at the wound site. This medicine is used to improve symptoms and treat infections in patients with various bacterial infectious diseases.

How to take

Adult dose

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

Child dose

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

Precautions

This drug should not be used in patients who have previously experienced serious allergic reactions or shock due to this drug or cephalosporin antibiotics. It should be used cautiously in patients allergic to penicillin antibiotics or those prone to allergic symptoms such as bronchial asthma, rash, or urticaria. Patients with severely impaired renal function or those who have difficulty taking orally, elderly patients, or patients in poor general health should be carefully monitored as they might develop vitamin K deficiency. Patients with a history of gastrointestinal diseases, particularly colitis, should also be administered with caution, and those allergic to the Yellow No. 5 dye included in this drug should also take care. If serious allergic reactions such as generalized rash, shortness of breath, urticaria, or severe skin eruptions occur during use, discontinue use immediately and seek treatment. Regular blood tests are necessary as abnormalities such as leukopenia, anemia, and thrombocytopenia may appear, and if any abnormal signs are observed, discontinuation of the drug should be considered. Liver dysfunction or decreased renal function can occur, so liver and kidney conditions should be checked periodically, and in severe cases, drug discontinuation may be necessary. In case of gastrointestinal symptoms like abdominal pain, diarrhea, or bloody stools, consult a physician immediately and consider stopping the medication. Rarely, effects on the central nervous system may manifest as anxiety, restlessness, dizziness, or hallucinations, so caution should be taken if such symptoms arise. Antibiotic use can lead to oral thrush or candidiasis, hence the oral condition should also be monitored. Bleeding tendency due to vitamin K deficiency or symptoms of vitamin B complex deficiency may develop, so these symptoms should be carefully observed. When using this drug, it is advisable to administer only for the necessary duration after susceptibility testing to prevent the emergence of resistant bacteria. Using with other nephrotoxic drugs or diuretics can affect kidney function, so it should be used cautiously. The risk of bleeding may increase when used in combination with anticoagulants, thus regular assessment of coagulation status is required. Taking with oral contraceptives may reduce contraceptive effectiveness, so it is recommended to use additional contraceptive methods. During pregnancy, safety has not been established, so it should only be used cautiously when necessary, and nursing women should also be cautious as the drug may pass into breast milk in small amounts. Safety for neonates or infants under 1 month has not been confirmed, so it is advisable to avoid use in such cases. In elderly patients, there is a risk of reduced physical function and bleeding due to vitamin K deficiency, so dosage and intervals should be adjusted and closely monitored.

Side effects and when to seek care immediately

Serious side effects

Urticaria, shock, anaphylactic reactions (including difficulty breathing), angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatitis, jaundice, elevated AST, ALT, ALP, reversible interstitial nephritis, acute renal failure, severe colitis (with bloody stools), interstitial pneumonia, eosinophilic lung infiltration, seizures, severe headaches, confusion, consciousness disturbances, nervous system abnormalities, severe edema

Mild side effects

Generalized rash, vascular edema, sensory abnormalities, syncope, hypertension, vasodilation, rash, itching, fever, lymph node enlargement, arthralgia, erythema multiforme, arthritis, serum sickness-like reactions, hematologic abnormalities (agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, eosinophilia, lymphocytosis, leukopenia, aplastic anemia, hemolytic anemia, reversible neutropenia), nausea, vomiting, diarrhea, abdominal pain, gastrointestinal discomfort, chest discomfort

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

Storage

This drug should be stored in a closed container that can block light and kept at a temperature between 1°C and 30°C. This helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Hard capsules with a green upper part and pale yellow 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.

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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.