Medication info

Fronclor Dry Syrup 125 mg/5 mL (Cefaclor Hydrate)

Prescription medicationSyrupApproval withdrawn
Ingredient · strength
Cefaclor Hydrate›3.75g / 100g
Manufacturer / importer
한화제약(주)
Appearance
Pink dry syrup to be dissolved when used
Packaging
150 mL/bottle
Approval status
Approval withdrawn

MFDS item code 201401447 · Notified 2014.03.27

This product's status changed to Approval withdrawn on 2025.03.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of otitis media, respiratory (pneumonia, pharyngitis) infections
Who uses it
Adults · Children
Adult dosage
As Cefaclor, administer 250 mg (potency) every 8 hours orally. For severe infections (such as pneumonia) and infections with reduced susceptibility, the dose may be doubled. In cases of acute gonococcal urethritis, administer 3 g of this drug along with 1 g of probenecid as a single dose.
Children's dosage
Administer 20 mg (potency) per kg of body weight divided every 8 hours. In cases of severe infections, otitis media, or infections with reduced susceptibility, it may be increased to 40 mg (potency) per kg of body weight per day, with a maximum dose of

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Treatment of otitis media, respiratory (pneumonia, pharyngitis) infections

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

This medication is used to treat infections caused by various bacteria including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and Escherichia coli. It is primarily effective for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also used for urinary infections such as pyelonephritis, cystitis, and gonococcal urethritis. Additionally, it is helpful in treating skin and soft tissue infections such as boils, abscesses, folliculitis, cellulitis, subcutaneous abscesses, and wound infections. This medication helps to treat diverse bacterial infections and promotes rapid recovery.

Dosage and Administration

Adult dosage

As Cefaclor, administer 250 mg (potency) every 8 hours orally. For severe infections (such as pneumonia) and infections with reduced susceptibility, the dose may be doubled. In cases of acute gonococcal urethritis, administer 3 g of this drug along with 1 g of probenecid as a single dose.

Children's dosage

Administer 20 mg (potency) per kg of body weight divided every 8 hours. In cases of severe infections, otitis media, or infections with reduced susceptibility, it may be increased to 40 mg (potency) per kg of body weight per day, with a maximum dose of

Precautions

This drug works by binding to certain proteins and disrupting bacterial cell wall synthesis, leading to bacterial death. This drug should not be used in patients who have previously experienced severe allergic reactions or shock due to this medication. Patients who are allergic to this drug or to cephalosporin class antibiotics should also avoid its use. This drug contains lactose, thus individuals with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take it. Patients allergic to penicillin antibiotics or with allergic predisposition, severe renal diseases, those who have difficulty swallowing medications, elderly patients, and those with a history of gastrointestinal disease should use this drug cautiously. This drug may rarely cause severe allergic reactions, skin rashes, blood abnormalities, liver or kidney dysfunction, gastrointestinal issues, respiratory symptoms, central nervous system abnormalities, and others; thus, any abnormal symptoms during treatment should be discussed immediately with healthcare personnel. To prevent the emergence of resistant bacteria, the susceptibility of the infectious bacteria should be confirmed, and it should only be used for the necessary minimum duration. Caution is needed as this drug can interact with other medications, especially those affecting the kidneys, anticoagulants, and oral contraceptives. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this drug; those who are breastfeeding should also exercise caution. Safety and efficacy in newborns less than 1 month old have not been established, so its use should be avoided. Elderly patients have decreased bodily functions, thus the risk of side effects is higher; therefore, dosage and administration intervals should be adjusted and observed cautiously. Some urine tests may show false positive results when using this medication, so care should be taken in interpreting test results.

Side effects and when to seek care immediately

Serious side effects

  • Shock
  • urticaria
  • edema
  • dyspnea
  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • agranulocytosis
  • pancytopenia
  • aplastic anemia
Show 14 more
  • hemolytic anemia
  • hepatitis
  • jaundice
  • acute kidney failure
  • severe renal impairment
  • pseudomembranous colitis
  • severe colitis
  • interstitial pneumonia
  • eosinophilic pulmonary infiltrates
  • seizures
  • confusion
  • hallucinations
  • headaches
  • dizziness

Mild side effects

  • Generalized flushing
  • sensory disturbances
  • syncope
  • hypertension
  • vasodilation
  • rash
  • itching
  • fever
  • lymphadenopathy
  • arthralgia
Show 20 more
  • serum sickness-like reactions
  • erythema multiforme
  • arthritis
  • agranulocytosis
  • granulocyte reduction
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • increases in AST
  • ALT
  • ALP
  • BUN
  • and serum creatinine
  • and others

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

Storage

This medication is sensitive to light; therefore, it should be stored in a container that does not allow light exposure, at room temperature between 1 to 30 degrees Celsius. It is important to avoid direct sunlight and maintain appropriate temperature until the medication is used.

Appearance and packaging

Appearance

Pink dry syrup to be dissolved when used

Package unit

150 mL/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.