Medication info
Icivefa Capsule (Cefaclor Hydrate)

Icivefa Capsule (Cefaclor Hydrate)

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
신신제약(주)
Appearance
A hard capsule with a purple upper part and white lower part containing a white to light yellow powder.
Packaging
① 300 capsules/bottle, ② 30 capsules/bottle
Approval status
Active

MFDS item code 201403436 · Approved 2014.07.28 · Insurance code 643802370

Summary

Main use
Treatment of respiratory infections (pneumonia, pharyngitis) and urinary tract infections (pyelonephritis, cystitis)
Who takes it
Adults · Children
Adult dose
For Cefaclor Hydrate, administer 250mg (potency) orally every 8 hours. For severe infections (such as pneumonia) and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, administer this medication 3g along with probenecid 1g in a single combined dose.
Child dose
Administer 20mg (potency) per kilogram of body weight divided every 8 hours. For severe infections, otitis media, and infections with low susceptibility, 40mg (potency) per kilogram of body weight may be administered, with a maximum dosage of 1.

Ingredients

Manufacturer
신신제약(주)

Efficacy & effects

Treatment of respiratory infections (pneumonia, pharyngitis) and urinary tract infections (pyelonephritis, cystitis)

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

This medication is effective against various harmful bacteria including Streptococcus pneumoniae, Influenza bacteria, and Staphylococcus. It is used for respiratory infections such as otitis media, pneumonia, pharyngitis, and tonsillitis, as well as urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. It is also effective for the treatment of skin and soft tissue infections such as boils, abscesses, and folliculitis. This medication helps improve infections caused by a variety of bacteria, contributing to symptom relief and recovery for patients. It is widely used for the treatment of various infectious diseases.

How to take

Adult dose

For Cefaclor Hydrate, administer 250mg (potency) orally every 8 hours. For severe infections (such as pneumonia) and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, administer this medication 3g along with probenecid 1g in a single combined dose.

Child dose

Administer 20mg (potency) per kilogram of body weight divided every 8 hours. For severe infections, otitis media, and infections with low susceptibility, 40mg (potency) per kilogram of body weight may be administered, with a maximum dosage of 1.

Precautions

This medication is an antibiotic that kills bacteria by binding to specific proteins and disrupting bacterial cell wall synthesis. It should not be used in patients who have experienced severe allergic reactions or shock from this medication or similar classes of antibiotics. Patients allergic to penicillin antibiotics or those predisposed to allergic symptoms such as asthma, rashes, and hives should use this medication with caution. Patients with severely impaired kidney function, those who cannot take medications orally, the elderly, or those in poor overall health should be closely monitored for the risk of bleeding due to vitamin K deficiency. Patients with a history of gastrointestinal diseases, especially colitis, should also be administered this medication with caution. Rarely, serious allergic reactions such as shock and anaphylaxis may occur, and if symptoms arise, administration should be stopped immediately, and appropriate treatment should be provided. Severe rashes on the skin or serious skin reactions such as Stevens-Johnson syndrome may occur; therefore, skin condition should be closely monitored. Regular checks should be conducted as blood tests may reveal abnormalities such as leukopenia, anemia, or thrombocytopenia. Liver function abnormalities or renal function deterioration may also rarely occur, thus periodic testing of liver and kidney status is essential, and administration should be stopped if abnormalities are found. Gastrointestinal adverse effects may include diarrhea, abdominal pain, nausea, and vomiting, and if severe colitis symptoms occur, the medication should be stopped immediately. Respiratory inflammatory symptoms or pneumonia may rarely develop, so any symptoms such as cough or difficulty breathing should be reported to medical personnel. Occasional central nervous system symptoms such as anxiety, agitation, dizziness, and drowsiness may occur. This medication may lead to phenomena such as oral candidiasis or stomatitis, so oral condition should be monitored as well. There is a risk of bleeding due to vitamin K deficiency; therefore, signs of bleeding should be taken seriously, and symptoms of vitamin B deficiency have also been reported, though rarely. There may be interactions with other medications, thus caution is needed when taken with probenecid, nephrotoxic drugs, diuretics, anticoagulants, and oral contraceptives. Especially when taken with anticoagulants, the risk of bleeding may increase, thus regular blood coagulation checks are necessary. Women who are pregnant or may become pregnant should only use this medication when safety has not been firmly established, and only when necessary. Nursing mothers should also use this medication cautiously as it may be secreted in small amounts in breast milk. Safety and efficacy have not been established for neonates under 1 month, therefore it is advisable not to use it in this age group. Elderly individuals may experience adverse reactions more easily due to reduced bodily function; therefore, dosage and administration intervals should be adjusted with caution. During the administration of this medication, it may affect some clinical test results, thus care should be taken in interpreting the results.

Side effects and when to seek care immediately

Serious side effects

Shock, anaphylaxis symptoms (difficulty breathing), hives, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, granulocytopenia, pancytopenia, anemia, thrombocytopenia, aplastic anemia, hemolytic anemia, hepatitis, jaundice, elevation of AST, ALT, ALP, reversible interstitial nephritis, acute kidney injury, pseudomembranous colitis, severe colitis, interstitial pneumonia, eosinophilic lung infiltrates, seizures, confusion, hallucinations, reversible hyperfunction

Mild side effects

  • Systemic 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
  • gastric discomfort
  • heartburn
  • loss of appetite
  • restlessness
  • anxiety
  • muscle tension
  • irritability
  • insomnia
  • confusion
  • dizziness
  • hallucinations
  • drowsiness
  • stomatitis
  • candidiasis
  • hypoprothrombinemia
  • tendency to bleed
  • glossitis
  • neuritis
  • headache

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

Storage

This medication should be stored in a sealed container to prevent air and moisture intrusion and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

A hard capsule with a purple upper part and white lower part containing a white to light yellow powder.

Package unit

① 300 capsules/bottle, ② 30 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.