Amoxicillin Capsules

Amoxicillin Capsules

Treatment of infection: Amoxillin capsules is indicated for the treatment of the following infections in adults and children

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Details

Amoxicillin capsules

Indications

Product Name:Amoxicillin capsule

Nombre del Producto:Amoxicilina capsula

Specification: 250mg, 500mg

Package: 10capsules/blister, 10blisters/box, 50blisters/box

Standard: USP & BP& CP

Oral indications

• 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

Posology

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

Indication* Dose*

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 

Acute pyelonephritis 

Dental abscess with spreading cellulitis 

Acute cystitis 

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 

 

Indication* Dose*

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.

 

Contraindications

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

Hypersensitivity reactions

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.

Non-susceptible microorganisms

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

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 

Renal impairment

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

Jarisch-Herxheimer reaction

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.


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