Fluconazole and amoxicillin

The injectable formulations can also be used for the treatment and prevention of endocarditis.

The CHMP also agreed that Amoxil should no longer be used to treat female genital infections, because not enough clinical data are available to support this indication.

Additionally, Amoxil should no longer be used in several other indications (treatment of bronchitis, acute lung disease, urethritis (inflammation of the urethra, amoxicillin making me tired the tube that carries urine from the bladder out of the body), gonococcal infections, male genital infections, gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae ), enteritis (inflammation of the small intestine) with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, and serious infections caused by Haemophilus

influenzae

This is either because antibiotics are no longer used to treat these conditions, or amoxicillin trihydrate 500 because other antibiotics have been shown to be more effective than amoxicillin.

Having harmonised the indications, the CHMP also harmonised the recommendations on

how

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 of excipients 6.2 Incompatibilities 6.3 Shelf life 6.4 Special precautions for storage 6.5 Nature and contents of container 6.6 Special precautions for disposal and other handling 7.

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

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

Acute cystitis may be treated with 3 g use of amoxicillin capsules 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

*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 breakpoint S ? 0.5 mg/L. 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

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

In addition,

all

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.

In the range 250 to 3000 mg the bioavailability is linear in proportion to dose (measured as C max and AUC). The absorption is not influenced by simultaneous food intake. Haemodialysis can be used for elimination of amoxicillin.

About 18% of total plasma amoxicillin is bound to protein and the apparent volume of distribution is around 0.3 to 0.4 l/kg. Following intravenous administration, amoxicillin has been found in gall bladder, abdominal tissue, skin, fat, muscle tissues, synovial and peritoneal fluids, bile and pus.

Amoxicillin does not adequately distribute into the cerebrospinal fluid. From animal studies there is no evidence for significant tissue retention of drug-derived material.

Amoxicillin, like most penicillins, can be detected in breast milk (see section 4.6). Amoxicillin has been shown to cross the placental barrier (see section 4.6).

Amoxicillin is partly excreted in the urine as the inactive penicilloic acid in quantities equivalent to up to 10 to 25% of the initial dose.

The major route of elimination for amoxicillin is via the kidney. Amoxicillin has a mean elimination half-life of approximately one hour and a mean total clearance of approximately 25 l/hour in healthy subjects. Approximately 60 to 70% of the amoxicillin is excreted unchanged in urine during the first 6 hours after administration of a single 250 mg or 500 mg dose of amoxicillin.

Various studies have found the urinary excretion to be 50-85% for amoxicillin over a 24 hour period.

Concomitant use of probenecid delays amoxicillin excretion (see section 4.5).

The elimination half-life of amoxicillin is similar for children aged around 3 months to 2 years and older children and adults.

For very young children (including preterm newborns) in the first week of life the interval of administration should not exceed twice daily administration due to immaturity of the renal pathway of elimination. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Following oral administration of amoxicillin/ to healthy males and female subjects, gender has no significant impact on the pharmacokinetics of amoxicillin. The total serum clearance of amoxicillin decreases proportionately with decreasing renal function (see sections 4.2 and 4.4).

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals.

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. Carcinogenicity studies have not been conducted with amoxicillin. This leaflet is for parents and carers about how to use this medicine in children. Our information sometimes differs from that provided by the manufacturers, because their information is usually aimed at adults. Keep it somewhere safe so that you can read it again. If your child has ever had a reaction to any medicine, tell your doctor before giving amoxicillin.

Amoxicillin (sometimes spelt amoxycillin) Common brands: Amoxil®, Amix®, Amoram®, Amoxident®, Galenamox®, Rimoxallin® Why is it important for my child to take this medicine?

It is important that your child takes this medicine in the way that your doctor has told you to so that it kills the harmful bacteria and gets rid of their infection. Capsules: 250 mg and 500 mg Liquid medicine (suspension): 125 mg or 250 mg in 5 mL and 125mg in 1.25ml: these may contain a small amount of sugar.

This should be first thing in the morning, early afternoon and at bedtime.

Ideally, these times should be at least 4 hours apart. Your doctor will work out the amount of amoxicillin (the dose) that is right for your child.

It is important that you follow your doctor’s instructions about how much to give. Capsules should be swallowed whole with a glass of water, milk or squash (but not juice).

Measure out the right amount

using

Do not use a kitchen teaspoon as it will not give the right amount.

You can also dilute the right amount of medicine (measured with a medicine spoon) in a small amount of water or milk.

Your child should start to get better after taking the medicine for 2 days.

It is important that they take the whole course of the medicine that has been prescribed.

If your child is sick less than 30 minutes about amoxicillin after having a dose of amoxicillin, give them the same dose again. If your child is sick more than 30 minutes after having a dose of amoxicillin, you do not need to give them another dose.

If your child is sick again, seek advice from your family doctor, pharmacist, hospital doctor or nurse. If you remember up to 1 hour after you should have given a dose, give the missed dose.

If you remember after this time, do not give the missed dose. You are unlikely to cause harm if you give an extra dose of amoxicillin by mistake.

If you think you may have given your child too much amoxicillin, contact your doctor or local NHS services (details at end of leaflet). Have the medicine container or packet with you if you telephone for advice. We use medicines to make our children better, but sometimes they have other effects that we don’t want (side-effects).

Side-effects are rare with amoxicillin and do not usually last for long.

They will get better after a day or two as your child’s body gets used to the medicine, and should go away when the treatment course is finished. If your child is short of breath or is wheezing, or their face, lips or tongue start to swell, or they develop a rash, they may be allergic to amoxicillin. Take your child to hospital or phone for an ambulance straight away. If your child develops a lumpy red rash, tell your doctor, as your child may have glandular fever or another viral infection. Your child may have diarrhoea, stomach pains, feel sick or be sick (vomit) when they first start to take amoxicillin. Encourage them to drink water to replace any fluid they have lost.

Contact your doctor or local NHS services (details at end of leaflet) or take your child to hospital if they: - have diarrhoea that lasts for more than 4 days or it is severe, watery or contains blood. Do not give your child any medicine to stop the diarrhoea, unless your doctor has told you to.

You may see white patches inside your child’s mouth and throat, and girls may get itching or soreness around the vagina.

This is caused by a fungal infection called thrush. If you think your child may have thrush, contact your doctor or pharmacist for advice.

There may, sometimes, be other side-effects that are not listed above.

If you notice anything unusual and are concerned, contact your doctor.

You can report any suspected side-effects to a UK safety scheme at www.mhra.gov.uk/ yellowcard. It is important that your child completes the course of antibiotic.

This means that they must take the medicine for the number of days that the doctor has told them to, or until all the medicine has been taken.

If you stop giving the antibiotic too soon, the bacteria that are left may start to multiply again, and may cause another infection.

In the past, doctors may have prescribed antibiotics for many types of infection. However, this practice is now changing with the growing concern about the risk of antibiotic resistance.

Bacteria that become “resistant” to a common antibiotic are no

longer

It is therefore important that antibiotics are used only when needed.

Many common illnesses,

such

Try to give the antibiotic at about the same times each day, to help you remember, and to make sure that there is the right amount of medicine in your child’s body to kill amoxicillin 1500 mg the bacteria. Only give this medicine to your child for their current infection. Give old/unused antibiotics to your pharmacist to dispose of.

Only give the antibiotic to the child it was prescribed for. Never give it to anyone else, even if their condition appears to be the same, as it could do harm. If you think someone else may have taken the medicine by accident, contact your doctor for advice. Can other medicines be given at the same time as amoxicillin?

You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to. Check with your doctor or pharmacist before giving any other medicines to your child.

Is there anything else I need to know about amoxicillin?

Amoxicillin is a type of antibiotic called penicillin. Your child should not have amoxicillin if they are allergic to any penicillin antibiotic.

If your child has ever had an allergic reaction or other reaction to any medicine, tell your doctor before giving amoxicillin. Keep this medicine in a cupboard, away from heat, direct sunlight and excess moisture (do not keep it in the bathroom).