Medication info

Donghwa Cefaclor Dry Syrup 125mg/5mL (Cefaclor Monohydrate)

Prescription medicationSyrup경구Approval withdrawn
Ingredient · strength
Cefaclor Hydrate›3.75g / 100g
Manufacturer / importer
동화약품(주)
Appearance
Pink to reddish cefaclor syrup to be dissolved before use
Packaging
150mL/bottle
Approval status
Approval withdrawn

MFDS item code 199700943 · Notified 1997.11.17

This product's status changed to Approval withdrawn on 2025.03.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
동화약품(주)

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

This medication is effective against various pathogens including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus, Group A beta-hemolytic Streptococcus, Escherichia coli, Proteus mirabilis, Klebsiella, and Neisseria. It is used to treat 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. Additionally, it is utilized for treating infections of the skin and soft tissue such as abscesses, furuncles, folliculitis, soft tissue infections, infected gangrene, subcutaneous abscesses, hand infections, and wound infections. It is widely used to improve the symptoms of bacterial infections.

How to take

Adult dose

For cefaclor, administer 250mg (potency) every 8 hours orally. For severe infections (such as pneumonia) and infections with low susceptibility, the dose can be doubled. In the case of acute gonococcal urethritis, administer 3g of this medication along with 1g of probenecid as a single dose.

Child dose

Administer 20mg (potency) per kg body weight divided every 8 hours. In the case of severe infections, otitis media, and infections with low susceptibility, up to 40mg (potency) per kg body weight can be administered, with a maximum dosage of

Precautions

This medication should not be used in patients who have experienced severe allergic reactions or shock related to this medication or cephalosporin antibiotics in the past. Caution is advised for patients with a history of allergic reactions to penicillin antibiotics or those with an allergy disposition, severely impaired renal function, difficulty swallowing, elderly patients, and those with a history of gastrointestinal disorders. This medication can rarely cause acute allergic reactions such as severe shock or anaphylaxis, so patient status should be closely monitored during administration. Serious skin reactions may occur, so if symptoms like rash, urticaria, or severe dermatitis appear, administration should be stopped immediately and appropriate treatment should be sought. Regular blood tests are necessary as leukopenia, anemia, thrombocytopenia, and other abnormalities may appear in blood tests, and administration should be stopped if there are abnormal findings. Hepatic dysfunction or renal function impairment may occur, thus liver and kidney function tests should be conducted periodically, and administration should be discontinued if abnormalities are found. Gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain may occur, especially severe colitis, and medical staff should be informed immediately if these symptoms arise. Respiratory symptoms such as interstitial pneumonia may rarely occur; therefore, administration should be ceased if symptoms such as respiratory distress or cough appear. Central nervous system symptoms such as agitation, anxiety, dizziness, hallucinations, or drowsiness may occur; hence, if any abnormal symptoms appear, consult medical staff. This medication can cause dysbiosis such as stomatitis or candidiasis, so oral hygiene should be maintained. Observe symptoms indicative of bleeding tendencies due to vitamin K deficiency or vitamin B complex deficiency closely. To prevent the development of resistant bacteria, it is important to conduct susceptibility tests and administer the medication for the minimum necessary duration. Interactions with other medications may occur, especially caution is needed when combined with probenecid, nephrotoxic drugs, diuretics, anticoagulants, and oral contraceptives. The safety of this medication during pregnancy has not been established, so it should only be administered when necessary and should be used cautiously during breastfeeding, as a small amount may be secreted in breast milk. The safety of this medication in newborns under one month old is not confirmed, so administration should be avoided if possible. Elderly patients may experience adverse reactions more easily due to declining bodily functions, hence it is essential to adjust the dosage and administration intervals and use with caution. Certain clinical tests may be affected by this medication, so caution is warranted during the interpretation of test results.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • shortness of breath
  • shock
  • generalized flushing
  • edema
  • dyspnea
  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
Show 7 more
  • jaundice
  • acute renal failure
  • severe colitis
  • interstitial pneumonia
  • eosinophilic pulmonary infiltrates
  • asthma
  • seizures

Mild side effects

  • Generalized flushing
  • vascular swelling
  • sensory disturbances
  • syncope
  • hypertension
  • vasodilation
  • rash
  • erythema
  • pruritus
  • fever
Show 19 more
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reactions
  • agranulocytosis
  • granulocytopenia
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • transient hepatitis
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated BUN

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

Storage

This medication is sensitive to light, so it should be stored in a place protected from light. It is best to store it at room temperature between 1°C and 30°C. Additionally, it should be stored in a well-sealed container to prevent air and moisture from entering.

Appearance and packaging

Appearance

Pink to reddish cefaclor syrup to be dissolved before use

Package unit

150mL/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.