Product Name:Amoxicillin capsule
Nombre del Producto:Amoxicilina capsula
Specification: 250mg, 500mg
Package: 10capsules/blister, 10blisters/box, 50blisters/box
Standard: USP & BP& CP
• Acute bacterial sinusitis
• Acute Otitis media
• Acute streptococcal tonsillitis and pharyngitis
• Acute exacerbations of chronic bronchitis
• Community acquired pneumonia
• Acute cystitis
• Asymptomatic Bacteriuria in pregnancy
• Acute pyelonephritis
• Typhoid and paratyphoid fever
• Dental abscess with spreading cellulitis
• Prosthetic joint infections
• Helicobacter pylori eradication
• Lyme disease
Amoxicillin is also indicated for the prophylaxis of endocarditis
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology and method of administration
The dose of Amoxicillin that is selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to antibacterial agents
• The severity and the site of the infection
• The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible. Some infections require longer periods of treatment
Adults and children ≥40 kg
Acute bacterial sinusitis 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours
For severe infections 750 mg to 1 g every 8 hours
Acute cystitis may be treated with 3 g twice daily for one day
Asymptomatic bacteriuria in pregnancy
Dental abscess with spreading cellulitis
Acute otitis media 500 mg every 8 hours, 750 mg to 1 g every 12 hours
For severe infections 750 mg to 1 g every 8 hours for 10 days
Acute streptococcal tonsillitis and pharyngitis
Acute exacerbations of chronic bronchitis
Community acquired pneumonia 500 mg to 1 g every 8 hours
Typhoid and paratyphoid fever 500 mg to 2 g every 8 hours
Prosthetic joint infections 500 mg to 1 g every 8 hours
Prophylaxis of endocarditis 2 g orally, single dose 30 to 60 minutes before procedure
Helicobacter pylori eradication 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole) for 7 days
Lyme disease Early stage: 500 mg to 1 g every 8 hours up to a maximum of 4 g/day in divided doses for 14 days (10 to 21 days)
Late stage (systemic involvement): 500 mg to 2 g every 8 hours up to a maximum of 6 g/day in divided doses for 10 to 30 days
*Consideration should be given to the official treatment guidelines for each indication
Children <40 kg
Children weighing 40 kg or more should be prescribed the adult dosage.
Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients listed in section 6.1.
History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).
Special warnings and precautions for use
Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agencts
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin therapy must be discontinued and appropriate alternative therapy instituted.
Amoxicillin is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with amoxicillin (see section 5.1). This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.
Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders
In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly
The Jarisch-Herxheimer reaction has been seen following amoxicillin treatment of Lyme disease .It results directly from the bactericidal activity of amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.