Medication info
Cefacline Capsule (Cefaclor Hydrate)

Cefacline Capsule (Cefaclor Hydrate)

Prescription medicationHard capsule
Ingredient · strength
Cefaclor Hydrate›262mg / 1 capsule
Manufacturer / importer
지엘파마(주)
Appearance
A hard capsule with a blue opaque upper part and a white opaque lower part filled with a pale yellow powder
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201902534 · Approved 2019.04.23 · Insurance code 649702110

Summary

Main use
Treatment of respiratory and urinary tract infections such as otitis media and pneumonia
Who uses it
Adults · Children
Adult dosage
For cefaclor hydrate, administer 250mg (potency) every 8 hours orally. In severe infections (such as pneumonia) and infections with low susceptibility, the dosage may be doubled. In cases of acute gonococcal urethritis, administer 3g of this drug combined with 1g of probenecid as a single dose.
Children's dosage
Administer 20mg (potency) per kg of body weight every 8 hours. In cases of severe infections, otitis media, and infections with low susceptibility, a dose of 40mg (potency) per kg of body weight may be used, with a maximum dose of

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Treatment of respiratory and urinary tract infections such as otitis media and pneumonia

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

This medication is effective against various bacteria including Streptococcus pneumoniae, Influenza bacillus, Staphylococcus aureus, and Escherichia coli. It is primarily 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. It is utilized to treat skin infections such as abscesses, boils, folliculitis, soft tissue infections, infectious necrosis, subcutaneous abscesses, and wound infections. Thus, it is widely used for various bacterial infection symptoms and diseases, helping to improve patient symptoms.

Dosage and Administration

Adult dosage

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

Children's dosage

Administer 20mg (potency) per kg of body weight every 8 hours. In cases of severe infections, otitis media, and infections with low susceptibility, a dose of 40mg (potency) per kg of body weight may be used, with a maximum dose of

Precautions

This medication should not be used in patients who have experienced severe allergic reactions or shock after taking this drug or similar class antibiotics in the past. It contains lactose, so it should not be administered to patients with a genetic disorder that affects lactose digestion. Caution is advised for individuals allergic to penicillin or with a family history of such allergies, as well as for those prone to asthma or allergic skin reactions. Patients with severely impaired renal function, those unable to take oral medications, and the elderly should be closely monitored due to the risk of vitamin K deficiency symptoms. Patients with a history of gastrointestinal disorders should also be cautious when taking this medication. Rarely, serious side effects such as shock, anaphylaxis, skin rash, blood abnormalities, hepatitis, renal abnormalities, gastrointestinal disturbances, pneumonia, and central nervous system disorders may occur; if symptoms arise, discontinue the medication immediately and seek appropriate treatment. To prevent antibiotic resistance, it is recommended to use the drug only for the minimum required duration based on susceptibility testing. Be careful of interactions when combining with other medications, especially probenecid, antacids, nephrotoxic drugs, anticoagulants, and oral contraceptives. Women who are pregnant or nursing should carefully consider the risks and benefits of using this medication and monitor any effects it may have on the infant during breastfeeding. Safety for neonates and children, especially those under 1 month old, has not been established; therefore, caution is warranted when administering the drug. The elderly are at higher risk of side effects due to decreased bodily function, so dosage and administration intervals should be adjusted, with careful monitoring. This medication may affect certain clinical test results, so inform the physician about its use when undergoing tests. In cases of overdose, symptoms such as nausea, vomiting, abdominal discomfort, and diarrhea may occur; immediate medical attention is required in such instances. This drug is an antibiotic that works by inhibiting bacterial cell wall synthesis.

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, pancytopenia, aplastic anemia, hemolytic anemia, jaundice, acute renal failure, acute kidney injury, pseudomembranous colitis, severe colitis, interstitial pneumonia, eosinophilic pulmonary infiltrates, asthma attacks, confusion, severe headache, hallucinations, seizures, altered consciousness, vision changes, paralysis, severe systemic reactions accompanied by hypertension

Mild side effects

  • Generalized flushing
  • angioedema
  • sensory disturbances
  • fainting
  • hypertension
  • vasodilation
  • rash
  • erythema
  • pruritus
  • fever
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  • lymphadenopathy
  • arthralgia
  • serum sickness-like reactions
  • erythema multiforme
  • arthritis
  • agranulocytosis
  • neutropenia
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • transient hepatitis
  • elevated AST
  • elevated ALT
  • elevated ALP

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

Storage

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Furthermore, it should be kept at a normal room temperature between 1 and 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance and packaging

Appearance

A hard capsule with a blue opaque upper part and a white opaque lower part filled with 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.

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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.