Amoxicilin Tablets 625 mg (Amoxicillin Monohydrate · Clavulanate Potassium)

Adult dose

Adults and children aged 12 years or older or weighing more than 40 kg should take amoxicillin/clavulanate potassium as 250 mg/125 mg once every 8 hours orally. In severe cases and respiratory infections, dosage may be increased to 500 mg/125 mg once. In cases of renal impairment, dosage should be adjusted according to creatinine clearance. - Creatinine clearance of 10-30 mL/min: 250-500 mg of amoxicillin per dose every 12 hours.

Child dose

For children under 12 years or weighing less than 40 kg, dose should be adjusted similarly.

This drug is a beta-lactam antibiotic that belongs to the penicillin class. It should not be administered to patients with a history of hypersensitivity to this drug or to patients allergic to beta-lactam antibiotics. Caution should be exercised for patients with viral diseases like infectious mononucleosis or lymphocytic leukemia due to a higher risk of rash. Patients who have had liver dysfunction or jaundice from this drug or penicillin in the past should avoid administration as recurrence may occur. Patients with impaired liver function may experience worsening liver conditions when using this medication, so it should be administered with caution. Patients with moderate to severe renal impairment may retain the drug longer in their system leading to higher concentrations, thus dosage adjustments or lengthening of dosing intervals may be necessary. Patients with bronchial asthma or allergic predispositions may experience allergic reactions more readily during the use of this drug. Patients suffering from severe vomiting or diarrhea, the elderly, and those in poor nutritional status may develop vitamin K deficiency and require careful use. This drug may cause gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain; in severe cases, serious enteritis like pseudomembranous colitis can occur, and patients should inform their doctor immediately if these symptoms arise. Elevated liver enzymes or rare manifestations of hepatitis and jaundice may occur; particularly with prolonged use, regular liver function tests are necessary. Rarely, skin reactions such as rashes, urticaria, and in severe instances, Stevens-Johnson syndrome may occur; if abnormal symptoms appear, use should be stopped immediately. Blood tests may show anomalies such as leukopenia, thrombocytopenia, and anemia, so regular blood tests are necessary in prolonged use. Central nervous system disturbances such as anxiety, restlessness, drowsiness, and seizures may occur rarely, especially in patients with impaired renal function or those on high doses. Cases of sudden and severe worsening of kidney function with acute kidney failure or nephritis have been reported, necessitating regular kidney function tests. Fungal infections like candidiasis may develop due to antibiotic use; if symptoms arise, consultation with a physician is advised. There may be a tendency for bleeding due to vitamin K deficiency; thus, any bleeding symptoms should be reported immediately. This drug may interact with other medications; any other medications being taken should be reported to a doctor or pharmacist. Pregnant women or those who may become pregnant should not take this drug, especially during the first three months of pregnancy. Nursing mothers must also be cautious due to potential adverse reactions in the infant. It is not recommended for children under 12 years of age or those weighing less than 40 kg. The elderly may experience more adverse reactions due to declines in kidney and liver function; careful dosage and administration intervals should be adjusted accordingly. In cases of overdose, gastrointestinal symptoms and neurological disturbances may occur, and immediate medical attention should be sought.

Serious side effects

• Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
• Severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe cutaneous adverse reactions
• Asthma attacks, respiratory issues with cough and fever
• Skin or eyes turning yellow (jaundice), extreme lethargy, liver dysfunction (jaundice)
• Sudden and severe headache, lightning strike headache, seizures

Mild side effects

• Diarrhea
• pseudomembranous colitis
• dyspepsia
• stomatitis
• gastritis
• glossitis
• black hairy tongue
• nausea
• vomiting
• loss of appetite

This medicine should be placed in a tightly sealed container to prevent moisture and stored in a dry place below 25 degrees Celsius. Care should be taken as its effectiveness may decrease in high humidity or high-temperature areas.

Appearance

This medicine is a white or almost white oval film-coated tablet.

Package unit

40 tablets (4 tablets/PTPX10)