Medication info
Cefaclor Capsule 250mg (Cefaclor Hydrate)

Cefaclor Capsule 250mg (Cefaclor Hydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
에이치엘비제약(주)
Appearance
A 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
Active

MFDS item code 200401908 · Notified 2004.07.09 · Insurance code 647300790

Summary

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

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Treatment of otitis media, respiratory and urinary tract infections.

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

This medication is effective against various bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Group A beta-hemolytic streptococci, and Escherichia coli. It is used for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also utilized for urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. It is effective in treating skin and soft tissue infections, for example, boils, abscesses, folliculitis, soft tissue infections, infectious necrosis, subcutaneous abscesses, infected wounds. This medication is used to improve bacterial infections in various parts of the body.

How to take

Adult dose

As cefaclor hydrate, 250mg per dose should be administered orally every 8 hours. For severe infections (such as pneumonia) and infections with low sensitivity, the dose may be doubled. For acute gonococcal urethritis, this medication is administered in a single dose of 3g alongside probenecid 1g.

Child dose

Administer 20mg per kg of body weight once daily, divided every 8 hours. In cases of severe infections, otitis media, and infections with low sensitivity, 40mg per kg of body weight may be administered. The maximum dosage is

Precautions

This drug acts by binding to specific proteins to disrupt bacterial cell wall synthesis, thereby killing bacteria. It should not be administered to patients with a history of shock due to this drug or to patients who have experienced allergic reactions to this drug or to cephalosporin antibiotics. Caution is required for patients allergic to penicillin antibiotics or those with a predisposition to allergies inducing asthma, rashes, or hives, as well as for patients with severely impaired renal function, those unable to take oral medication, elderly patients, and those in poor overall condition, as symptoms of vitamin K deficiency may appear, necessitating close monitoring. Patients with gastrointestinal diseases, particularly those with a history of colitis, also require caution. This drug may rarely cause shock, severe allergic reactions, serious skin rashes, or necrotizing diseases; if symptoms occur, discontinue administration immediately and seek appropriate treatment. Regular monitoring is necessary for potential changes in blood cell counts, and if issues arise, administration should be terminated. Abnormal liver function or renal dysfunction may appear, so regular testing is required to monitor these conditions, and dosage adjustments may be necessary for patients with severe renal impairment. If severe colitis symptoms such as pseudomembranous colitis, abdominal pain, or diarrhea arise, discontinue administration immediately. If respiratory issues or pneumonia symptoms manifest, administration should be stopped, and appropriate treatment should be sought. The central nervous system may be affected, causing anxiety, agitation, dizziness, hallucinations, and drowsiness, necessitating caution. Oral infections like stomatitis or candidiasis may develop. Symptoms of vitamin K and B deficiencies may rarely occur, requiring attention to bleeding tendencies and neurological symptoms. Miscellaneous side effects such as headache, itching, vaginitis, fever, and rash have been reported rarely. To prevent resistant bacteria, it is advisable to administer the drug only for the minimal necessary duration after susceptibility testing. Detailed inquiries about past drug allergy history must be conducted to prevent reactions like shock. Consider the possibility of superinfection by resistant bacteria when selecting appropriate therapies. Caution is needed when administering with probenecid, as blood concentrations may be prolonged. When combined with nephrotoxic drugs or diuretics, renal function may be compromised, thus careful use is warranted. The risk of bleeding may increase when combined with anticoagulants, necessitating regular checks on coagulation status and potential adjustments in dosage. When taken with oral contraceptives, contraceptive efficacy may be reduced, so additional contraceptive methods should be used. Caution is needed, as the effectiveness of this drug may decrease when used with certain antibiotics. Safety during pregnancy has not been established; it should be used cautiously when necessary, and nursing women should be aware that this drug may be excreted in small amounts in breast milk. Safety for newborns, particularly infants under one month old, has not been confirmed. Dosage and administration intervals should be adjusted carefully for the elderly, as side effects may appear more easily due to decreased physiological function. This drug may affect test results, hence caution is advised when interpreting urine glucose tests or direct Coombs tests.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • swelling
  • difficulty breathing
  • shock
  • anaphylactic symptoms
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • agranulocytosis
  • granulocytopenia
  • pancytopenia
Show 18 more
  • anemia
  • thrombocytopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • jaundice
  • hepatitis
  • reversible interstitial nephritis
  • acute renal failure
  • seizures
  • headache
  • asthma
  • difficulty breathing
  • severe colitis
  • cough
  • eosinophilia
  • interstitial pneumonia
  • eosinophilic pulmonary infiltration.

Mild side effects

  • Generalized flushing
  • vascular edema
  • sensory disturbances
  • fainting
  • hypertension
  • vasodilation
  • rash
  • itching
  • fever
  • lymphadenopathy
Show 27 more
  • arthralgia
  • serum sickness-like reactions
  • occasional increases in AST
  • ALT
  • ALP
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • discomfort in the epigastric region
  • heartburn
  • loss of appetite
  • fever
  • abdominal bloating
  • gastritis
  • infection
  • insomnia
  • vaginal discharge
  • fatigue
  • menstrual irregularities
  • myalgia
  • sore throat
  • irritability
  • nocturia
  • otitis media
  • pain
  • palpitations.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage can help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

A 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.