Each capsule contains Amoxicillin 500 mg (as trihydrate).
Pharmacology: Pharmacodynamics: Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Pharmacokinetics: Absorption: Tmax, Oral: 1 to 2 hours.
Effects of food: No effect when administered at the start of a light meal.
Distribution: Protein binding: 20%.
Excretion: Renal: approximately 60% (mostly unchanged).
Elimination Half Life: 61.3 minutes.
Treatment of susceptible bacterial infections (accordance with local official antibiotic prescribing guidelines) such as: Ear, nose, and throat infections (pharyngitis/tonsillitis, otitis media, rhinosinusitis).
Lower respiratory tract infections (including community-acquired pneumonia).
Genitourinary tract infections.
Helicobacter pylori eradication (in combination with other drugs).
Skin and skin structure infections.
Prophylaxis of bacterial endocarditis.
Other infections.
Adults and children ≥ 40 kg: Standard dose: 500 mg every 12 hours or 250 mg every 8 hours in mild to moderate infection, increased if necessary up to 875 mg every 12 hours or 500 mg every 8 hours in severe infection.
Lower respiratory tract infection: 875 mg every 12 hours or 500 mg orally every 8 hours.
Community-acquired pneumonia: 1 g orally 3 times daily for a maximum of 5 days; use in combination with a macrolide or doxycycline.
Simple acute urinary tract infection: Two 3 g doses with 10-12 hours between the doses.
Gonorrhea: Single 3 g dose.
Helicobacter pylori gastrointestinal tract infection: 1 g twice daily, in combination with a proton pump inhibitor (PPI) and clarithromycin or metronidazole (triple therapy) or a PPI, clarithromycin, and metronidazole (quadruple therapy) for 14 days: use of triple therapy should be reserved for areas where clarithromycin resistance is low (<15%) or eradication rates are high (>85%).
Prophylaxis of bacterial endocarditis: 2 g 30 to 60 minutes before procedure.
Children < 40 kg: Standard dose: 125 mg every 8 hours in mild to moderate infection, increased if necessary up to 250 mg every 8 hours in severe infection.
Prophylaxis of bacterial endocarditis: 50 mg/kg 30 to 60 minutes before procedure.
Renal impairment: GFR ≥ 30 mL/min: No dosage adjustment necessary.
GFR 10 to 30 mL/min: 250 to 500 mg every 12 hours.
GFR less than 10 mL/min: 250 to 500 mg every 24 hours.
Hemodialysis: 250 to 500 mg every 24 hours after dialysis.
Hepatic impairment: No specific recommendations are available.
Overdose and Treatment: Mild to moderate toxicity: Nausea, vomiting, abdominal pain and diarrhea may develop with ingestion. Skin rashes and urticaria may develop, especially with amoxicillin and ampicillin ingestions. Hematuria, crystalluria and transient renal insufficiency have been reported after amoxicillin overdose.
Treatment is symptomatic and supportive. Treat significant vomiting and diarrhea with IV fluids; administer antiemetics, as needed. Administer antihistamines, with or without inhaled beta agonists, corticosteroids or epinephrine for hypersensitivity reaction.
Severe toxicity: Agitation, confusion, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy may occur following massive doses of IV penicillins (40 to 100 million units/day). Cardiac arrest and death have been associated with inadvertent intravenous administration of penicillin G (benzathine and procaine). Hyperkalemia may also develop.
Acute anaphylaxis is more likely to occur after parenteral exposure, but may develop with all routes. Administer oxygen, aggressive airway management, antihistamines, epinephrine, corticosteroids, ECG monitoring, and IV fluids. Dysrhythmias should be treated with standard antiarrhythmic drugs, if necessary.
Seizures: Initially treat with IV benzodiazepines.
Serious hypersensitivity reactions, such as anaphylaxis and Stevens-Johnson syndrome, to amoxicillin or other beta-lactam antibiotics (eg, penicillins, cephalosporins).
Based on Thai Ministry of Public Health Announcement: 1. Do not use in patients with history of hypersensitivity to this drug.
2. This drug may cause an allergic reaction and life threatening.
3. If rash, irritation, or swelling occur, discontinue this drug and consult a doctor.
4. If rash or flu-like symptoms occur, discontinue this drug and consult a doctor immediately.
5. If rash, flu-like symptoms, blistering, skin and mucous areas such as the oral cavity, throat, nose, genital organs and membranes peeling off, and conjunctivitis occur, discontinue this drug and consult a doctor immediately as these symptoms may be Stevens-Johnson syndrome.
Endocrine and metabolic: False positive readings for glucose urine tests may occur with Clinitest(R), Benedict Solution, or Fehling Solution; enzymatic glucose oxidase reaction-type tests recommended.
Gastrointestinal: Clostridium difficile-associated diarrhea, including mild diarrhea to fatal colitis, has been reported and may occur over 2 months from last dose; discontinuation of antibiotics not directed against C. difficile may be required if suspected or confirmed.
Immunologic: Severe anaphylactic reactions, including fatalities, have been reported, especially in patients with a history of penicillin hypersensitivity or sensitivity to multiple allergens; discontinue if allergic reaction occurs.
Mononucleosis: Avoid use due to a high risk of developing an erythematous skin rash.
Renal: Severe renal impairment (ie, GFR less than 30 mL/min) or hemodialysis; dose adjustment is recommended.
Adverse events have not been observed in animal reproduction studies. Amoxicillin crosses the placenta. Maternal use of amoxicillin has generally not resulted in an increased risk of adverse fetal effects; however, a possible association with cleft lip with cleft palate has been observed in some studies.
Amoxicillin is excreted in breast milk. Caution be exercised when administering amoxicillin to nursing women.
Common: Dermatologic: Rash (> 1%).
Gastrointestinal: Diarrhea (overall, greater than 1%;
Helicobacter pylori therapy, 7% to 8%), Nausea (> 1%), Vomiting (> 1%).
Neurologic: Headache (
Helicobacter pylori therapy, 6% to 7%).
Reproductive: Vulvovaginitis.
Serious: Dermatologic: Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis.
Gastrointestinal: Clostridium difficile diarrhea.
Immunologic: Anaphylaxis, Hypersensitivity reaction.
Avoid concomitant use of amoxicillin with any of the following: BCG (intravesical); Cholera vaccine.
Amoxicillin may increase the levels/effects of: methotrexate; vitamin K antagonists.
The levels/effects of amoxicillin may be increased by: allopurinol; probenecid.
Amoxicillin may decrease the levels/effects of: BCG (intravesical); BCG vaccine (immunization); Cholera vaccine; lactobacillus and estriol; mycophenolate; sodium picosulfate; Typhoid vaccine.
The levels/effects of amoxicillin may be decreased by: tetracycline derivatives.
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Moxicap 500 cap 500 mg
10 × 10's
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