Medication info
Cephaclam Capsule (Cefaclor Hydrate)

Cephaclam Capsule (Cefaclor Hydrate)

Prescription medicationHard capsule
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(주)킴스제약
Appearance
A hard capsule with a blue opaque upper part and a white opaque lower part filled with a light yellow powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201907596 · Approved 2019.10.31

Summary

Main use
Treatment of otitis media, respiratory infections (pneumonia, pharyngitis), and urinary tract infections (pyelonephritis, cystitis)
Who uses it
Adults · Children
Adult dosage
As cefaclor, administer 250mg (based on potency) orally every 8 hours. In cases of severe infections (such as pneumonia) and low-sensitive infections, the dosage may be doubled. For acute gonococcal urethritis, this medication is administered in a single dose of 3g along with probenecid 1g.
Children's dosage
Administer 20mg (based on potency) per kg of body weight divided into doses every 8 hours. In cases of severe infections, otitis media, and low-sensitive infections, it may be administered at 40mg (based on potency) per kg of body weight, with a maximum dosage of

Ingredients

Manufacturer
(주)킴스제약

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
  • boils
  • folliculitis
  • cellulitis
View approved original text

This medication is effective against various bacterial infections, including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and Escherichia coli. It is primarily 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 aids in the treatment of skin-related infections such as abscesses, boils, folliculitis, cellulitis, infectious gangrene, subcutaneous abscesses, hand infections, and wound infections. It is widely used for treating various infections caused by different bacteria.

Dosage and Administration

Adult dosage

As cefaclor, administer 250mg (based on potency) orally every 8 hours. In cases of severe infections (such as pneumonia) and low-sensitive infections, the dosage may be doubled. For acute gonococcal urethritis, this medication is administered in a single dose of 3g along with probenecid 1g.

Children's dosage

Administer 20mg (based on potency) per kg of body weight divided into doses every 8 hours. In cases of severe infections, otitis media, and low-sensitive infections, it may be administered at 40mg (based on potency) per kg of body weight, with a maximum dosage of

Precautions

This medication should not be administered to certain patients. For instance, individuals who have previously experienced severe allergic reactions or shock due to this medication, or those who are allergic to this medication or similar classes of antibiotics, should not use it. Additionally, because it contains lactose, patients with lactose intolerance or specific genetic metabolic disorders should not take it. This medication should be used cautiously in certain situations, particularly for individuals allergic to penicillin antibiotics or those with asthma or skin rashes, as they may have heightened sensitivity. Special monitoring is required for patients with severely impaired kidney function, the elderly, or those in poor overall health when taking this medication. While taking this medication, various side effects may occur such as rare instances of shock, anaphylaxis, skin disorders, blood abnormalities, liver or kidney dysfunction, gastrointestinal issues, respiratory problems, and neurological anomalies. If any of these symptoms arise, it is essential to discontinue the medication immediately and consult healthcare professionals. To prevent the emergence of resistant bacteria, it is important to confirm the sensitivity of the infecting bacteria and to take the medication for the minimum necessary duration. Caution should be exercised when taking this medication with other drugs as interactions may occur, particularly with probenecid, antacids, medications that affect the kidneys, anticoagulants, and oral contraceptives. Pregnant or breastfeeding women should only take this medication when absolutely necessary, as the safety during pregnancy has not been fully established, and care should be taken to consider the potential effects on the infant during breastfeeding. The safety for infants under 1 month old has not been established, and some formulations have not been sufficiently validated for efficacy and safety in children. Elderly patients may have reduced bodily functions and a higher risk of side effects, necessitating careful observation and adjustments to dosage and administration intervals. This medication may affect certain clinical test results, so patients should inform healthcare professionals about this prior to testing. In case of overdose, symptoms such as nausea, vomiting, abdominal discomfort, and diarrhea may occur, and in severe cases, treatment may be necessary to cleanse the stomach or reduce drug absorption. This medication is an antibiotic that exerts a bactericidal effect by inhibiting bacterial cell wall synthesis, thus requiring proper usage and precautions.

Side effects and when to seek care immediately

Serious side effects

Shock, urticaria, edema, dyspnea, vascular edema, symptoms of anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, jaundice, acute renal failure, seizures, severe headache, altered consciousness, visual disturbances, paralysis, asthma attacks, dyspnea, elevated blood pressure, severe edema, severe colitis accompanied by bloody stools, severe renal impairment, interstitial pneumonia, eosinophilic pulmonary infiltration

Mild side effects

  • General flushing
  • sensory disturbances
  • syncope
  • hypertension
  • vasodilation
  • rash
  • erythema
  • itching
  • fever
  • lymphadenopathy
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  • arthralgia
  • serum sickness-like reactions
  • agranulocytosis
  • granulocytopenia
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • transient hepatitis
  • elevated AST
  • ALT
  • ALP
  • elevated BUN
  • elevated serum creatinine

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

Storage

This medication is sensitive to light; therefore, it must be stored in a container that protects it from light. In addition, it is important to maintain a room temperature between 1 and 30 degrees Celsius during storage. Proper storage will help maintain the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

A hard capsule with a blue opaque upper part and a white opaque lower part filled with a light yellow powder

Package unit

30 capsules/bottle, 100 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.