Medication info

Korea United Cephaclor Dry Syrup

Prescription medicationApproval withdrawn
Ingredient · strength
Cefaclor Hydrate›Strength being verified
Manufacturer / importer
한국유나이티드제약(주)
Appearance
Pink powder for syrup
Packaging
150mL/bottle
Approval status
Approval withdrawn

MFDS item code 199701720 · Notified 1997.11.21

This product's status changed to Approval withdrawn on 2023.05.12. 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, etc.), and urinary tract infections (pyelonephritis, cystitis, etc.)
Who uses it
Adults · Children
Adult dosage
Adult: Administer 250 mg (based on potency) of cephaclor orally every 8 hours. In cases of severe infections (such as pneumonia) and those with low sensitivity, the dosage may be doubled. In the case of acute gonococcal urethritis, administer this drug 3 g along with 1 g of probenecid in a single dose.
Children's dosage
Pediatric: Administer 20 mg per kg body weight (based on potency) divided into doses every 8 hours. In cases of severe infections, otitis media, and infections with low sensitivity, a dosage of 40 mg per kg body weight can be administered.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Treatment of otitis media, respiratory infections (pneumonia, pharyngitis, etc.), and urinary tract infections (pyelonephritis, cystitis, etc.)

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

This medication is an antibiotic effective against various bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, and Staphylococcus. It is 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 is useful in treating skin and soft tissue infections such as boils, abscesses, folliculitis, cellulitis, infectious gangrene, subcutaneous abscesses, and wound infections. This drug is very beneficial for treating various infectious diseases caused by several types of bacteria.

Dosage and Administration

Adult dosage

Adult: Administer 250 mg (based on potency) of cephaclor orally every 8 hours. In cases of severe infections (such as pneumonia) and those with low sensitivity, the dosage may be doubled. In the case of acute gonococcal urethritis, administer this drug 3 g along with 1 g of probenecid in a single dose.

Children's dosage

Pediatric: Administer 20 mg per kg body weight (based on potency) divided into doses every 8 hours. In cases of severe infections, otitis media, and infections with low sensitivity, a dosage of 40 mg per kg body weight can be administered.

Precautions

This drug is an antibiotic that kills bacteria by binding to specific proteins and interfering with the synthesis of the bacterial cell wall. This drug should not be used in patients who have experienced severe allergic reactions or shock from this drug or cephalosporin antibiotics in the past. It also contains lactose, and should not be administered to patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Caution should be exercised when using this drug in patients with a history of allergy to penicillin antibiotics or in individuals who frequently exhibit allergic symptoms like bronchial asthma, skin rashes, or urticaria. Patients with severely impaired kidney function, those who have difficulty swallowing orally, the elderly, and those in poor general condition should be monitored closely due to the risk of vitamin K deficiency. Patients with a history of gastrointestinal diseases, particularly colitis, also require caution. This drug can rarely cause shock or severe allergic reactions; therefore, symptoms should be closely observed during administration, and if abnormal signs appear, administration should be stopped immediately and appropriate treatment should be sought. Severe skin reactions may occur; therefore, if rashes, blisters, or skin peeling occur, immediate consultation with medical personnel is required. Blood abnormalities, liver function anomalies, and kidney function impairments may occur, necessitating regular tests, and administration should be stopped if any abnormalities are found. Gastrointestinal symptoms such as severe diarrhea, abdominal pain, or bloody stools should be immediately reported. Respiratory symptoms or central nervous system symptoms can also rarely occur; hence caution is advised. Prolonged use of this medication can lead to deficiencies in vitamin K and vitamin B complex, so symptoms should be carefully monitored. This drug should only be used for the minimum duration necessary to prevent antibiotic resistance, and prior to administration, a thorough check of allergy history and current status should be performed. Caution should be taken when used in conjunction with probenecid, nephrotoxic drugs, diuretics, and others as they may affect kidney function. Taking this medication with anticoagulants may increase the risk of bleeding, so regular checks of blood coagulation status are required. Using oral contraceptives concurrently may reduce their effectiveness, so it is advisable to use additional contraceptive methods. During pregnancy, safety has not been established, so it should only be administered if necessary, and caution is required for nursing mothers. Safety and efficacy have not been confirmed for infants under one month of age; therefore, it should be avoided in this population. Elderly patients may show adverse reactions more readily due to decreased physiological function, so dosage and administration intervals should be adjusted and closely monitored. Some urine tests may show false positive reactions while using this medication, so this should be considered when interpreting test results.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylactic symptoms (generalized rash, edema, difficulty breathing, angioedema, sensory disturbances, syncope, hypertension, vasodilation), Stevens-Johnson syndrome, toxic epidermal necrolysis, jaundice, acute renal failure, severe colitis (pseudomembranous colitis, etc.), interstitial pneumonia, eosinophilic pulmonary infiltration, altered consciousness, hallucinations, seizures, difficulty breathing

Mild side effects

  • Rash
  • urticaria
  • erythema
  • itching
  • fever
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reaction
  • agranulocytosis
  • granulocytopenia
Show 18 more
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • transient hepatitis
  • elevation of AST
  • ALT
  • ALP
  • reversible interstitial nephritis
  • increased BUN
  • increased serum creatinine
  • abdominal pain
  • nausea

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

Storage

This drug is sensitive to light, so it should be stored in an opaque container. Furthermore, to maintain the drug's efficacy, it is important to store it at room temperature, specifically between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Pink powder for syrup

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.