Medication info
Penclara Tablet 375 mg (Amoxicillin-Clavulanate Potassium (2:1))

Penclara Tablet 375 mg (Amoxicillin-Clavulanate Potassium (2:1))

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›215.52mg / 1 tablet
Manufacturer / importer
(주)펜믹스
Appearance
White or almost white oval film-coated tablets
Packaging
100 tablets/PTP (10 tablets x 10)
Approval status
Active

MFDS item code 200404803 · Notified 2004.03.12 · Insurance code 677100250

Summary

Main use
Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children over 12 years or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally, 3 times a day every 8 hours. In cases of severe and respiratory infections, it may be increased to 500 mg/125 mg per dose. In patients with renal impairment, dosage should be adjusted based on creatinine clearance. - For creatinine clearance 10 to 30 mL/min: 250 mg
Child dose
For adults and children over 12 years or weighing 40 kg or more, the dosing regimen is the same, but in cases of renal impairment, the dose is adjusted accordingly.

Ingredients

Manufacturer
(주)펜믹스

Efficacy & effects

Treatment of respiratory and urogenital infections (bronchitis, pneumonia, cystitis, etc.)

  • Acute bronchitis
  • chronic bronchitis
  • lobar pneumonia
  • bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
View approved original text

This medicine is effective in treating various bacterial infections. It is primarily used for respiratory infections such as acute and chronic bronchitis, pneumonia, empyema, tonsillitis, sinusitis, and otitis media. It is also effective for urinary infections such as cystitis, urethritis, and pyelonephritis, as well as gynecological and urological infections like pelvic inflammatory disease and gonorrhea. It treats skin and soft tissue infections such as boils, abscesses, and wound infections, and is also used for osteomyelitis and dental infections. It helps to facilitate the rapid recovery of patients from various infectious diseases.

How to take

Adult dose

Adults and children over 12 years or weighing 40 kg or more: Amoxicillin/Clavulanate Potassium 250 mg/125 mg orally, 3 times a day every 8 hours. In cases of severe and respiratory infections, it may be increased to 500 mg/125 mg per dose. In patients with renal impairment, dosage should be adjusted based on creatinine clearance. - For creatinine clearance 10 to 30 mL/min: 250 mg

Child dose

For adults and children over 12 years or weighing 40 kg or more, the dosing regimen is the same, but in cases of renal impairment, the dose is adjusted accordingly.

Precautions

This medicine should not be used in patients who are allergic to certain components or have experienced hypersensitivity to beta-lactam antibiotics. It is advisable to avoid administration in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia due to a high risk of rash. Patients who have previously experienced jaundice or liver dysfunction due to this drug or penicillin-class medications should not receive it because of the risk of recurrence. Caution should be taken in patients with diminished liver function as this drug can exacerbate liver function. Patients with moderate to severe kidney impairment should adjust the dosing interval carefully due to the potential for side effects due to prolonged retention in the body. Patients who are prone to allergic reactions or have symptoms such as bronchial asthma, skin rashes, or hives need to take precautions when using this drug. Patients who find oral ingestion difficult or are receiving non-oral nutrition, elderly patients, or those in poor overall condition should be cautious as vitamin K deficiency symptoms may occur. In patients with gastrointestinal diseases that cause vomiting or diarrhea, caution should be exercised as drug absorption may be insufficient. This drug may cause gastrointestinal side effects such as gastric disturbances, diarrhea, nausea, and vomiting; if symptoms are severe, consultation with a doctor is advised. Symptoms such as abnormal liver function or jaundice may appear, especially reported more frequently in older adults and males, which may require liver function testing. Although rare, serious skin reactions or allergic symptoms may develop, and if symptoms such as rash, itching, or difficulty breathing occur, the medication should be stopped immediately and medical assistance sought. Hematologic abnormalities such as leukopenia and thrombocytopenia may occur, so any unusual symptoms should be assessed. Rarely, central nervous system effects such as anxiety, confusion, and seizures may arise, so these symptoms should be reported immediately. Deterioration of kidney function or acute renal failure may occur, requiring kidney function testing. Long-term use may lead to the development of resistant bacteria, so it is important to administer it only for the necessary duration. It may affect blood coagulation, so patients taking anticoagulants should be cautious. Administration should be avoided during early pregnancy, and women who are pregnant or breastfeeding should use it cautiously after consulting their physician. It is not recommended for children, especially those under 12 years of age or weighing less than 40 kg, as there is limited experience with its use in this population. Elderly patients may exhibit more pronounced side effects due to decreased body function, so careful observation and adjustments in dosing and intervals are necessary. In cases of overdose, symptoms such as vomiting, diarrhea, and abdominal pain may occur, and medical personnel should be notified immediately, with emergency treatment administered as necessary. This medicine should be stored in a dry place below 25 degrees Celsius in a tightly closed container to avoid moisture. Proper use as directed by a physician will help maintain its efficacy.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions (anaphylaxis, anaphylactic shock), high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, serum sickness-like syndrome), difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, bronchospasm,

Mild side effects

Diarrhea, pseudomembranous colitis, dyspepsia, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, abdominal bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-associated colitis, liver function test changes, hepatitis, cholestatic jaundice, itching, erythema multiforme, dermatitis, serum sickness-like syndrome, skin rash, hematologic abnormal reactions (leukopenia, thrombocytopenia, hemolysis

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

Storage

This medicine should be kept in a tightly closed container to avoid moisture and stored in a dry place at or below 25 degrees Celsius. Proper storage helps maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

White or almost white oval film-coated tablets

Package unit

100 tablets/PTP (10 tablets x 10)

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.