Medication info
CMG Cefaclor Capsule (Cefaclor Hydrate)

CMG Cefaclor Capsule (Cefaclor Hydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(주)씨엠지제약
Appearance
Oral use: Hard capsule with upper purple and lower white containing light yellow powder Export 1: Hard capsule with upper dark purple and lower light yellow containing light yellow powder Export 2: Hard capsule with upper purple and lower containing light yellow powder
Packaging
Bottle - 30 capsules/bottle, Bottle - 300 capsules/bottle
Approval status
Active

MFDS item code 199602411 · Notified 1996.10.18 · Insurance code 648601050

Summary

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

Ingredients

Manufacturer
(주)씨엠지제약

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
  • furuncles
  • abscesses
  • folliculitis
  • soft tissue infections
View approved original text

This medication is effective against various bacteria including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella, and Neisseria gonorrhoeae. It is mainly used for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also effective for urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. It helps treat skin and soft tissue infections like furuncles, abscesses, folliculitis, soft tissue infections, infectious granulomas, subcutaneous abscesses, human bite wounds, and wound infections. This drug contributes to the recovery of patients' health by improving various types of bacterial infections.

How to take

Adult dose

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

Child dose

Administer 20 mg/kg body weight per day divided every 8 hours. In cases of severe infections, otitis media, or infections with lower sensitivity, a dose of 40 mg/kg body weight per day may be administered, with a maximum dose of

Precautions

This drug should not be used in patients who have experienced severe allergic reactions or shock due to this medication or any cephalosporin antibiotics in the past. Patients allergic to penicillin antibiotics, or those with a tendency for asthma, rash, hives, or other allergy symptoms in themselves or their families, should exercise caution when using this medication. Patients with severely reduced kidney function, difficulty in oral intake, elderly patients, or those with poor general health should be carefully monitored for symptoms of vitamin K deficiency. Patients with a history of gastrointestinal diseases, especially colitis, should also use this medication with caution. This medication can rarely cause shock or severe allergic reactions; therefore, if symptoms occur, administration should be stopped immediately, and appropriate treatment must be provided. Serious reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis can occur, so skin condition should be closely monitored. Blood tests may show abnormalities such as leukopenia, anemia, or thrombocytopenia, so regular testing should be performed, and administration should be discontinued if abnormal symptoms appear. Liver dysfunction or kidney impairment may occur; therefore, liver and kidney functions should be regularly monitored, and administration should be stopped if abnormalities arise. In the gastrointestinal system, severe colitis symptoms such as pseudomembranous colitis may occasionally occur, so if abdominal pain or diarrhea worsens, medication should be stopped immediately. Adverse reactions in the respiratory system can rarely occur, so if symptoms such as fever, cough, or difficulty breathing develop, patients should consult healthcare professionals. Central nervous system symptoms such as anxiety, agitation, dizziness, drowsiness may rarely occur, so caution is advised. Flora shifts such as stomatitis or candidiasis may occur, so monitoring oral condition is advisable. Bleeding tendencies due to vitamin K deficiency or symptoms of vitamin B complex deficiency may appear; thus, special caution is needed for the elderly or patients with poor health. Interactions may occur when used with other drugs, especially with anticoagulants, diuretics, probenecid, or oral contraceptives; therefore, patients should inform healthcare professionals for management. Pregnant women or those who might become pregnant should use this drug only if the benefits outweigh the risks, as safety during pregnancy has not been firmly established. Breastfeeding women should use this drug carefully as it may be present in breast milk in small amounts, and monitoring of the infant's condition is required. It is advisable to avoid use in neonates under 1 month of age as safety and efficacy have not been established. Elderly patients with compromised physiological functions are more likely to experience adverse reactions, so dose and frequency should be adjusted carefully, and their condition should be monitored. It is important to confirm susceptibility to prevent the emergence of resistant bacteria during treatment, and to administer the drug for the minimum necessary period only. During administration, always closely observe for the occurrence of adverse symptoms, and if any problems arise, consult healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylactic reactions (difficulty breathing, angioedema), Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, aplastic anemia, hemolytic anemia, reversible neutropenia, hepatitis, jaundice, increased AST, ALT, ALP, reversible interstitial nephritis, increased BUN, increased serum creatinine, acute kidney failure, seizures, pseudomembranous colitis, and hematochezia

Mild side effects

  • Rash
  • itching
  • fever
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reactions
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
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  • discomfort in the stomach
  • heartburn
  • loss of appetite
  • agitation
  • anxiety
  • muscle tension
  • restlessness
  • insomnia
  • dizziness
  • hallucinations
  • drowsiness
  • stomatitis
  • candidiasis
  • headache
  • genital itching
  • vaginitis
  • vaginal moniliasis
  • anxiety
  • arthralgia
  • asthma
  • bronchitis
  • chest pain
  • chills
  • conjunctivitis
  • constipation
  • dysmenorrhea
  • indigestion
  • urinary difficulty

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 or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Oral use: Hard capsule with upper purple and lower white containing light yellow powder Export 1: Hard capsule with upper dark purple and lower light yellow containing light yellow powder Export 2: Hard capsule with upper purple and lower containing light yellow powder

Package unit

Bottle - 30 capsules/bottle, 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.