Medication info
Cefaclor Capsule (Cefaclor Monohydrate)

Cefaclor Capsule (Cefaclor Monohydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
경동제약(주)
Appearance
A hard capsule with an upper purple part and a lower white part containing a white to off-white crystalline powder.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 199802093 · Notified 1998.09.12 · Insurance code 648101060

Summary

Main use
Treatment of otitis media, respiratory and urinary tract infections, etc.
Who takes it
Adults · Children
Adult dose
Administer 250 mg (activity) of cefaclor orally every 8 hours. In cases of severe infections (such as pneumonia) and low-sensitivity infections, the dose may be doubled. For acute gonococcal urethritis, administer 3 g of this medication along with 1 g of probenecid as a single dose.
Child dose
Administer 20 mg (activity) per kg of body weight per day divided every 8 hours. In cases of severe infections, otitis media, and low-sensitivity infections, a maximum dosage of 40 mg (activity) per kg of body weight per day may be administered.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Treatment of otitis media, respiratory and urinary tract infections, etc.

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

This medication is effective against various bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus. It is used to treat respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also suitable for treating urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. Regarding skin infections, it aids in the treatment of abscesses, furuncles, folliculitis, soft tissue infections, infectious ulcerations, and wound infections. It is widely used for various bacterial infections and is effective in alleviating symptoms.

How to take

Adult dose

Administer 250 mg (activity) of cefaclor orally every 8 hours. In cases of severe infections (such as pneumonia) and low-sensitivity infections, the dose may be doubled. For acute gonococcal urethritis, administer 3 g of this medication along with 1 g of probenecid as a single dose.

Child dose

Administer 20 mg (activity) per kg of body weight per day divided every 8 hours. In cases of severe infections, otitis media, and low-sensitivity infections, a maximum dosage of 40 mg (activity) per kg of body weight per day may be administered.

Precautions

This medication should not be used in patients who have experienced severe allergic reactions or shock due to this medication in the past. It is also safe to refrain from administering this medication to patients who had allergic reactions to cefalosporin antibiotics. Patients with a history of allergy to penicillin antibiotics or those with a tendency to allergies, and those with severely impaired kidney function should use this medication with caution. Patients who have difficulty swallowing, elderly patients, and those with poor general health may exhibit symptoms of vitamin K deficiency, thus their condition should be closely monitored. Caution should be exercised when administering in patients with a history of gastrointestinal diseases, particularly colitis. This medication can rarely cause shock or severe allergic reactions, so symptoms should be carefully monitored during administration; stop administration immediately and seek appropriate treatment if abnormalities occur. Severe rashes, vesicles, or skin necrosis may occur, and if such symptoms appear, use should be stopped immediately. Regular laboratory tests and monitoring are necessary as blood cell counts can be affected. Liver dysfunction or renal impairment may occur, so liver and kidney function should be tested regularly, and administration should cease if abnormalities are detected. If severe gastrointestinal symptoms or diarrhea appear, consult a physician immediately, and any gastrointestinal symptoms such as nausea, vomiting, or abdominal pain should be carefully monitored. If respiratory symptoms or pneumonia symptoms develop, administration should be stopped, and appropriate treatment sought. Neurological side effects such as anxiety, insomnia, dizziness, or hallucinations may occur; caution is needed if these symptoms arise. Rarely, phenomena such as oral candidiasis or fungal overgrowth may occur. There is a rare risk of bleeding tendency due to vitamin K deficiency or symptoms of vitamin B group deficiencies; caution is warranted. It is advisable to only administer this medication for the minimum required duration to prevent the emergence of resistant bacteria. There may be interactions with other medications, so caution is especially needed when used with drugs that affect the kidneys, anticoagulants, or oral contraceptives. The administration of this medication in pregnant or breastfeeding women should be determined with caution, as it may affect the baby during breastfeeding. Its safety is not established for newborns, and thus its use is not recommended. The elderly may experience adverse effects more readily due to decreased bodily function, so the dosage and administration intervals should be adjusted and closely monitored. This medication may affect some clinical test results, so it should be considered when interpreting test results.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • edema
  • respiratory distress
  • shock
  • anaphylactic symptoms
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • jaundice
  • profound malaise
  • acute renal failure
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  • severe edema
  • severe colitis
  • interstitial pneumonia
  • eosinophilic lung infiltrates
  • asthma
  • severe allergic reactions
  • severe skin reactions
  • respiratory issues
  • liver dysfunction (jaundice)
  • and severe edema or urination issues.

Mild side effects

  • Generalized flushing
  • vascular swelling
  • sensory disturbances
  • syncope
  • hypertension
  • vasodilation
  • rash
  • itching
  • fever
  • lymphadenopathy
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  • arthralgia
  • serum sickness-like reactions
  • agranulocytosis
  • leukopenia
  • aplastic anemia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • increased serum creatinine
  • elevated AST
  • ALT
  • and ALP
  • and increased BUN.

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

Storage

This product is sensitive to light and should be stored in a special container that does not allow light in. Additionally, it is safe to store the medication at room temperature, avoiding extremes of heat or cold.

Appearance and packaging

Appearance

A hard capsule with an upper purple part and a lower white part containing a white to off-white crystalline powder.

Package unit

30 capsules/bottle, 100 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.