Medication info
Ceclor Capsule 250mg (Cefaclor Hydrate)

Ceclor Capsule 250mg (Cefaclor Hydrate)

Prescription medicationHard capsule
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(주)보령바이오파마
Appearance
A hard capsule with a light blue opaque upper part and a white opaque lower part filled with white or pale yellow crystalline powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201804385 · Approved 2018.11.05 · Insurance code 670501140

Summary

Main use
Treatment of respiratory infections (bronchitis, pharyngotonsillitis), urinary tract infections (cystitis, urethritis), and skin infections.
Who uses it
Adults · Children
Adult dosage
As Cefaclor, an oral dosage of 250mg (potency) every 8 hours is recommended. For severe infections and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, this drug is administered in a single dose of 3g along with 1g of probenecid. The extended-release formulation is taken orally twice daily at a dose of 375mg (potency) each. For the treatment of Streptococcus pyogenes infections, it should be continued for more than 10 days.
Children's dosage
Administer 20mg (potency) per Kg body weight per day, divided every 8 hours. For severe infections, otitis media, and infections with low susceptibility, a dosage of up to 40mg (potency) per Kg body weight can be administered, with a maximum dose of 1.

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Treatment of respiratory infections (bronchitis, pharyngotonsillitis), urinary tract infections (cystitis, urethritis), and skin infections.

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

This medication is available in capsule, syrup, and granule forms and is effective against various bacterial infections including Streptococcus pneumoniae, Influenza bacillus, and Staphylococcus. It is used for respiratory infections such as otitis media, pneumonia, pharyngotonsillitis, and bronchitis, as well as urinary tract infections like pyelonephritis, cystitis, and gonococcal urethritis. It is also suitable for treating skin and soft tissue infections such as abscesses, furuncles, folliculitis, and cellulitis. The extended-release formulation is effectively used for the recurrence of acute and chronic bronchitis, pharyngitis, tonsillitis, lower urinary tract infections, and skin and soft tissue infections. This medication helps improve symptoms and promote recovery in the treatment of various infectious diseases.

Dosage and Administration

Adult dosage

As Cefaclor, an oral dosage of 250mg (potency) every 8 hours is recommended. For severe infections and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, this drug is administered in a single dose of 3g along with 1g of probenecid. The extended-release formulation is taken orally twice daily at a dose of 375mg (potency) each. For the treatment of Streptococcus pyogenes infections, it should be continued for more than 10 days.

Children's dosage

Administer 20mg (potency) per Kg body weight per day, divided every 8 hours. For severe infections, otitis media, and infections with low susceptibility, a dosage of up to 40mg (potency) per Kg body weight can be administered, with a maximum dose of 1.

Precautions

This drug works by binding to specific proteins, disrupting bacterial cell wall synthesis and killing bacteria. Before using this medication, it is essential to inform whether you have ever experienced severe allergic reactions or shock caused by this medication or cephalosporin antibiotics. If you have an allergy to penicillin antibiotics or a tendency to show allergic symptoms such as asthma, rash, or urticaria, you should use this medication with caution. Patients with severely impaired renal function, the elderly, or those in poor nutritional status should also use this medication carefully, as vitamin K deficiency symptoms may occur, and monitoring of their condition is necessary. Patients with a history of gastrointestinal diseases, particularly colitis, should also use this medication with caution, and if symptoms like abdominal pain or diarrhea occur, they should consult medical personnel immediately. This medication may rarely cause severe allergic reactions, skin rashes, blood abnormalities, liver or kidney dysfunction, severe colitis, respiratory problems, and neurological abnormalities; if any unusual symptoms occur, discontinue administration immediately and seek appropriate treatment. Using this medication for extended periods or unnecessarily can lead to the development of resistant bacteria, so it is crucial to confirm the susceptibility of the infecting bacteria and take it for the minimum required duration. When used with other drugs, there may be interactions, especially with medications that put a burden on the kidneys, anticoagulants, or oral contraceptives, so it is essential to inform the medical staff of any such medications being taken. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of using this drug, and nursing mothers should also be cautious as this medication may be transmitted in small amounts through breast milk. The safety and efficacy of this medication have not been established for neonates under one month of age, so its use should be avoided. Elderly patients are at higher risk for adverse reactions due to decreased physiological function, and there is also a risk of bleeding due to vitamin K deficiency; therefore, dosage and administration intervals should be adjusted and administered cautiously. This drug may affect urine tests or blood test results, so caution is needed when interpreting test results.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, shock, anaphylactic symptoms (generalized flushing, swelling, difficulty breathing, angioedema, sensory disturbances, fainting, hypertension, vasodilation), Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, aplastic anemia, hemolytic anemia, liver abnormalities (including jaundice), hepatitis, elevated AST, ALT, ALP, acute renal failure, renal impairment.

Mild side effects

  • Rash
  • itching
  • fever
  • lymphadenopathy
  • joint pain
  • serum sickness-like reaction
  • skin rash
  • nausea
  • vomiting
  • diarrhea
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  • abdominal pain
  • stomach discomfort
  • heartburn
  • loss of appetite
  • anxiety
  • agitation
  • insomnia
  • dizziness
  • hallucination
  • drowsiness
  • stomatitis
  • candidiasis
  • headache
  • genital itching
  • vaginitis
  • vaginal candidiasis
  • loss of appetite
  • insomnia
  • vaginal discharge
  • malaise
  • menstrual irregularities
  • myalgia
  • throat pain
  • irritability
  • nocturia
  • otitis media
  • pain
  • palpitations.

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

Storage

This medication may be sensitive to light, so it should be stored in a container that effectively blocks light. Additionally, the drug should be stored at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with a light blue opaque upper part and a white opaque lower part filled with white or pale yellow crystalline 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.