Medication info
Amocla Tablet 375 mg (Amoxicillin and Clavulanate Potassium)

Amocla Tablet 375 mg (Amoxicillin and Clavulanate Potassium)

Prescription medicationTablet경구
Ingredient · strength
Amoxicillin Hydrate›250mg / 1 tabletDilute Potassium Clavulanate›212.73mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
White or almost white oval film-coated tablet
Packaging
100 tablets/box [(10 tablets/PTP x 10)]
Approval status
Active

MFDS item code 202000354 · Approved 2020.01.21 · Insurance code 060500460

Summary

Main use
Treatment of respiratory (bronchitis, pneumonia) and urinary (cystitis, urethritis) infections.
Who takes it
Adults · Children
Adult dose
For adults and children over 12 years or weight over 40 kg, the dosage is 250 mg/125 mg of amoxicillin/clavulanate potassium taken orally three times a day every 8 hours, which can be increased to 500 mg/125 mg per dose in cases of severe and respiratory infections. In cases of renal impairment, dosage should be adjusted based on creatinine clearance. - Patients with creatinine clearance above 30 mL/min: dosage adjustment is not necessary.
Child dose
For children under 12 years or weight below 40 kg, use the same method as for adults with weight-adjusted dosing.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment of respiratory (bronchitis, pneumonia) and urinary (cystitis, urethritis) infections.

  • Acute and chronic bronchitis
  • lobar pneumonia
  • bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • renal pelvis infection
  • pelvic infection
View approved original text

This medication is effective against various bacterial infections. It is used for respiratory diseases such as acute and chronic bronchitis, lobar and bronchopneumonia, empyema, and lung abscesses, tonsillitis, sinusitis, and otitis media. It is also helpful in treating urinary tract infections like cystitis, urethritis, renal pelvis infections, pelvic infections, and gonorrhea. It is effective against infections like furuncles, abscesses, soft tissue infections, wound infections, as well as osteomyelitis and dental infections. It acts on various strains of bacteria that cause infections, including Staphylococcus aureus, Escherichia coli, and Neisseria gonorrhoeae, improving overall bacterial infections.

How to take

Adult dose

For adults and children over 12 years or weight over 40 kg, the dosage is 250 mg/125 mg of amoxicillin/clavulanate potassium taken orally three times a day every 8 hours, which can be increased to 500 mg/125 mg per dose in cases of severe and respiratory infections. In cases of renal impairment, dosage should be adjusted based on creatinine clearance. - Patients with creatinine clearance above 30 mL/min: dosage adjustment is not necessary.

Child dose

For children under 12 years or weight below 40 kg, use the same method as for adults with weight-adjusted dosing.

Precautions

This drug should not be used in patients with a history of hypersensitivity to beta-lactam drugs, including penicillin-type antibiotics. It can be dangerous for patients who have previously experienced allergic symptoms such as anaphylaxis, severe skin reactions, or shock from this drug’s components or similar medications. Patients with viral infections such as infectious mononucleosis or lymphocytic leukemia should be cautious as they are at higher risk of developing rash-related side effects. Patients with a history of liver function problems should also be careful as there is a risk of recurrence of liver damage when taking this drug. Patients with liver impairment or those with reduced kidney function may experience increased drug concentration, leading to side effects, so dosage and administration intervals need adjustment. Patients with allergic constitution or symptoms of asthma, urticaria, etc., should use the drug with caution. Those with gastrointestinal diseases or severe vomiting and diarrhea may experience inadequate absorption of the medication, so caution is required. This medication can cause various gastrointestinal side effects, including diarrhea, vomiting, abdominal pain, and particularly severe diarrhea or abdominal pain should result in immediate discontinuation of the drug and consultation with a physician. Symptoms of liver dysfunction may also occur, which are especially more common in older adults and males, and symptoms may persist for weeks after discontinuation of treatment. Rarely, hypersensitivity reactions such as skin rash, itching, severe dermatitis, difficulty breathing may occur, so immediate discontinuation is advised if such symptoms arise. Effects on blood may occur, as leukopenia, anemia, and thrombocytopenia have been rarely reported, so tests may be necessary if any abnormal signs are identified. Neurological symptoms such as anxiety, drowsiness, and seizures may arise, and if these symptoms occur, the physician should be notified. Kidney function may rapidly deteriorate, so regular monitoring is necessary, and drug discontinuation should occur if any issues are detected. While using this medication, there is a risk of bleeding due to vitamin K deficiency, so careful monitoring of blood coagulation status is essential. This drug may interact with other medications, so if currently taking other drugs, it is essential to inform the physician or pharmacist for consultation. Women who are pregnant or may become pregnant should preferably avoid the use of this drug, especially during the first three months, and caution is advised during breastfeeding as side effects may occur in infants. It is not recommended for children under 12 years of age or those weighing less than 40 kg. Elderly patients may experience side effects more easily due to reduced physical function, so dosage and intervals should be adjusted and used carefully. In case of overdose, gastrointestinal symptoms, renal failure, and seizures may occur, so immediate contact with a medical institution is necessary for appropriate care. This medication should be stored in a dry container to prevent moisture and should be kept at a cool temperature between 1°C and 25°C. This ensures the medication's effectiveness is maintained safely for an extended period.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, shedding of skin, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, breath abnormality accompanied by cough and fever, breathing problems, yellowing of skin or eyes, jaundice, extreme lethargy, liver abnormalities, sudden and severe symptoms.

Mild side effects

  • Diarrhea
  • pseudomembranous colitis
  • dyspepsia
  • stomatitis
  • gastritis
  • glossitis
  • nausea
  • vomiting
  • appetite loss
  • abdominal pain
Show 21 more
  • abdominal distension
  • constipation
  • colonic pain
  • hyperacidity
  • soft stools
  • xerostomia
  • acute pancreatitis
  • candidiasis
  • antibiotic-associated colitis
  • elevated AST
  • ALT
  • ALP
  • LDH
  • serum bilirubin
  • hepatitis
  • cholestatic jaundice
  • itching
  • erythema multiforme
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • vesicular exfoliative dermatitis.

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

Storage

This drug is to be kept in a sealed container to prevent moisture. When stored, it should be maintained at a cool temperature between 1°C and 25°C. This will help preserve the medication's effectiveness safely for a longer period.

Appearance and packaging

Appearance

White or almost white oval film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP 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.