Medication info
Sepacool Capsule (Cefaclor Hydrate)

Sepacool Capsule (Cefaclor Hydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(유)한풍제약
Appearance
A hard capsule with a purple upper part and white lower part containing a pale yellow powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201906146 · Approved 2019.08.29 · Insurance code 658107380

Summary

Main use
Treatment of otitis media, respiratory infections (pneumonia, pharyngitis, etc.), and urinary tract infections (pyelonephritis, cystitis, etc.).
Who takes it
Adults · Children
Adult dose
As cefaclor hydrate, administer 250mg per dose every 8 hours orally. In cases of severe infections, the dosage can be increased twofold. For acute gonococcal urethritis, this drug (3g) should be administered in a single dose in combination with probenecid (1g).
Child dose
Administer 20mg per kg of body weight divided every 8 hours. In the case of severe infections, otitis media, and infections with lower susceptibility, 40mg per kg of body weight can be administered daily, with a maximum dosage of

Ingredients

Manufacturer
(유)한풍제약

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

This medication is effective against various bacteria, including Streptococcus pneumoniae, influenza bacteria, and Staphylococcus. It is used for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. Additionally, it helps with urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. It is also used for the treatment of skin abscesses, boils, folliculitis, soft tissue infections, infectious necrosis, subcutaneous abscesses, infected wounds, and wound infections. It improves symptoms by effectively addressing a wide range of infectious diseases.

How to take

Adult dose

As cefaclor hydrate, administer 250mg per dose every 8 hours orally. In cases of severe infections, the dosage can be increased twofold. For acute gonococcal urethritis, this drug (3g) should be administered in a single dose in combination with probenecid (1g).

Child dose

Administer 20mg per kg of body weight divided every 8 hours. In the case of severe infections, otitis media, and infections with lower susceptibility, 40mg per kg of body weight can be administered daily, with a maximum dosage of

Precautions

This medication should not be used in patients who have previously experienced shock due to this drug or who are allergic to this drug or cephalosporin antibiotics. It should be used cautiously in patients with a history of allergy to penicillin antibiotics or with a tendency to show allergic symptoms such as bronchial asthma, rash, and hives. Patients with very poor kidney function, those who have difficulty taking medications orally, the elderly, or patients in poor overall condition should be carefully monitored for vitamin K deficiency symptoms. Particular caution is required for patients with a history of gastrointestinal disorders, especially colitis. This medication can rarely cause shock or severe allergic reactions; if symptoms occur, it should be immediately discontinued, and appropriate treatment should be initiated. Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis can occur, so caution is advised. Blood abnormalities can manifest as agranulocytosis, anemia, and thrombocytopenia, necessitating regular blood tests. There may be temporary liver function impairment, hepatitis, or jaundice symptoms, so liver status should be carefully monitored. Kidney function may be affected, leading to acute renal failure; therefore, regular kidney function tests are required, with immediate discontinuation if abnormalities occur. Gastrointestinal issues, including pseudomembranous colitis, diarrhea, nausea, or vomiting, may arise, so immediate consultation with a physician is necessary if severe abdominal pain or diarrhea occurs. Respiratory symptoms such as pneumonia or eosinophilia can rarely occur, and treatment should be discontinued if severe coughing or breathing difficulties arise. CNS symptoms such as anxiety, agitation, dizziness, drowsiness, and hallucinations can also rarely occur. Oral infections like stomatitis or candidiasis may occasionally occur as well. Vitamin K deficiency could lead to bleeding tendencies, so caution is advised for bleeding symptoms, and signs of vitamin B deficiency may also arise. To prevent the development of resistant bacteria, susceptibility tests should be performed, and the drug should only be administered for the necessary minimum duration. There may be interactions with other medications; caution is especially required when used concurrently with probenecid, nephrotoxic drugs, diuretics, anticoagulants, or oral contraceptives. Pregnant women or those who may become pregnant should carefully consider the risks and benefits of using this medication, and breastfeeding women should also use it cautiously. The safety of this medication in neonates, especially those under 1 month old, has not been established, so caution is warranted. Elderly individuals may experience adverse reactions more easily due to diminished bodily functions and higher risks of bleeding from vitamin K deficiency, thus dosage adjustment and monitoring of their condition are necessary. This drug works by binding to specific cell wall proteins and disrupting bacterial cell wall synthesis, thereby killing bacteria.

Side effects and when to seek care immediately

Serious side effects

Shock, symptoms of anaphylaxis such as difficulty breathing, vascular edema, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, aplastic anemia, hemolytic anemia, hepatitis, jaundice, elevated AST, ALT, ALP, reversible interstitial nephritis, increased BUN, elevated serum creatinine, acute renal failure, seizures, pseudomembranous colitis, severe colitis, cough, respiratory distress, convulsions.

Mild side effects

  • Generalized flushing
  • vascular edema
  • sensory abnormalities
  • syncope
  • hypertension
  • vasodilation
  • rash
  • itching
  • fever
  • lymphadenopathy
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  • arthralgia
  • serum sickness-like reactions
  • erythema multiforme
  • arthritis
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • gastrointestinal discomfort
  • heartburn
  • loss of appetite
  • agitation
  • anxiety
  • muscular hypertonia
  • nervousness
  • insomnia
  • confusion
  • dizziness
  • hallucinations
  • drowsiness
  • stomatitis
  • candidiasis
  • hypoprothrombinemia
  • bleeding tendencies
  • glossitis
  • neuropathy
  • genital.

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug's effectiveness.

Appearance and packaging

Appearance

A hard capsule with a purple upper part and white lower part containing 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.

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.