Kimoxil amoxicillin

This is either because antibiotics are no longer used to treat these conditions, or because other antibiotics have been shown to be more effective than amoxicillin.

Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Amoxil. The recommended dose of Amoxil varies depending on the infection it is used to treat, the way it is given, and the age and weight of the patient.

Doses range from 250 mg to 2 g two or three times a day for adults and children weighing more than 40 kilograms, and from 20 to 200 mg per kilogram per day for children weighing less than 40 kilograms.

The CHMP agreed that Amoxil must not be used in patients who are hypersensitive (allergic) to amoxicillin or any other ingredients of Amoxil, and to any of the penicillins. Additionally, Amoxil must not be used in patients who have had severe allergic reactions to another type of beta-lactam antibiotic (e.g. The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), and 4.8 (side effects).

A decision on this opinion was issued by the European Commission on 20/08/2015. The pharmaceutical company has decided to discontinue this product. Other preparations of this medicine may still be available.

This information has been left on emc for reference purposes. Report Side Effect Related Medicines Same active ingredients Same company Bookmark Email.

Clinical particulars 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction 4.6 Fertiliy, pregnancy and lactation 4.7 Effects on ability to drive and use machines 4.8 Undesirable effects 4.9 Overdose 5.

Pharmacological properties 5.1 Pharmacodynamic properties 5.2 Pharmacokinetic properties 5.3 Preclinical safety data 6.

Pharmaceutical particulars 6.1

List

Date of first authorisation/renewal of the authorisation 10.

This information is intended for use by health professionals. Each hard capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin.

Amoxil is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): • Acute bacterial sinusitis. Amoxil is also indicated for the prophylaxis of endocarditis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

The dose of Amoxil that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) • 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 (see section 4.4 regarding prolonged therapy). 250 mg to 500 mg every 8 hours or 750 mg to 1 g every 12 hours. Acute cystitis may be treated with 3 g twice daily for one day.

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.

2 g orally, single dose 30 to 60 minutes before procedure. 750 mg to 1 g twice daily in combination with a proton pump inhibitor (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. Lyme disease (see section 4.4) 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 MIC) is considered to be the major determinant of efficacy for amoxicillin. The main mechanisms of resistance to amoxicillin are: • Inactivation by bacterial beta-lactamases.

• Alteration of PBPs, which reduce the affinity of the antibacterial agent for the

target

Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria. MIC breakpoints for amoxicillin are those of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) version 5.0.

MIC breakpoint (mg/L) Susceptible ? Staphylococcus spp. 1 Wild type Enterobacteriaceae are categorised as susceptible to aminopenicillins. Some countries prefer to categorise wild type isolates of E.

When this is the case, use the

MIC

2 Most staphylococci are penicillinase producers, which are resistant to amoxicillin. Methicillin resistant isolates are, with few exceptions, resistant to all beta-lactam agents.

3 Susceptibility to amoxicillin can be inferred from ampicillin. 4 The susceptibility of streptococcus groups A, B, C and G to penicillins is inferred from the benzylpenicillin susceptibility. 5 Breakpoints relate only to non-meningitis isolates. For isolates categorised as intermediate to ampicillin avoid oral treatment with amoxicillin.

Susceptibility inferred from the MIC of ampicillin.

6 Breakpoints are based on intravenous administration.

Beta-lactamase positive isolates should be reported resistant. 7 Beta lactamase producers should be reported resistant.

8 Susceptibility to amoxicillin can be inferred from benzylpenicillin.

9 The breakpoints are based on epidemiological cut-off values (ECOFFs), which distinguish wild-type isolates from those with reduced susceptibility. 10 The non-species related breakpoints are based on doses of at least 0.5 g x 3or 4 doses daily (1.5 to 2 g/day). The prevalence of resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

In vitro susceptibility of micro-organisms to Amoxicillin.

Beta-hemolytic streptococci (Groups A, B, C and G) Listeria monocytogenes.

Species for which acquired resistance may be a problem. Inherently resistant organisms † Enterococcus faecium † Acinetobacter spp. (many strains of Bacteroides fragilis are resistant). † Natural intermediate susceptibility in the absence of acquired mechanism of resistance.

? Almost all S.aureus are resistant to amoxilcillin due to production of penicillinase. In addition, all methicillin-resistant strains are resistant to amoxicillin.

Amoxicillin fully dissociates in aqueous solution at physiological pH. It is rapidly and well absorbed by the oral route of administration.

Following oral administration, amoxicillin is approximately 70% bioavailable.

The time to peak plasma concentration (T max ) is approximately one hour. The pharmacokinetic results for a study, in which an amoxicillin dose of 250 mg three times daily was administered in the fasting state to groups of healthy volunteers are presented below.