Consumer medicine information

Alphamox

Amoxicillin

BRAND INFORMATION

Brand name

Alphamox

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Alphamox.

What is in this leaflet

This leaflet answers some common questions about ALPHAMOX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ALPHAMOX against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ALPHAMOX is used for

ALPHAMOX contains the active ingredient amoxicillin, which is an antibiotic that belongs to a group of medicines called penicillins.

ALPHAMOX is used to treat a range of infections caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.

ALPHAMOX works by killing the bacteria that causes these infections. ALPHAMOX can also be used to prevent endocarditis (heart infection) in some people.

ALPHAMOX will not work against infections caused by viruses, such as colds or flu.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor's prescription.

There is no evidence that ALPHAMOX is addictive.

Before you take ALPHAMOX

When you must not take it

Do not take ALPHAMOX if you are allergic to:

  • any medicine containing amoxicillin
  • penicillin or any other similar antibiotics such as cephalosporins
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

If you have ever had an allergic reaction (such as a rash) when taking an antibiotic, you should tell your doctor before you take ALPHAMOX.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. ALPHAMOX may be used in pregnancy. It has been used in a large number of pregnant women without any proven increase in harmful effects on the developing baby. However, your doctor will discuss with you the risks and benefits of taking ALPHAMOX during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. ALPHAMOX passes into breast milk. Your doctor will discuss the risks and benefits of taking ALPHAMOX when breastfeeding.

Tell your doctor if you have any medical conditions, especially the following:

  • kidney or liver problems. The dosage of ALPHAMOX may need to be changed or you may need to be given an alternative medicine
  • leukaemia
  • glandular fever (mononucleosis) or a blood disorder
  • you have ever had an allergic reaction (such as a rash) to any antibiotics in the past.

Tell your doctor if you plan to have surgery.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may be affected by ALPHAMOX, or may affect how well it works. These include:

  • probenecid and allopurinol, medicines used to treat gout
  • certain other antibiotics, such as tetracyclines
  • anticoagulants such as warfarin, which is used to prevent blood clots.
  • the contraceptive pill (birth control pill)
  • methotrexate, a medicine used to treat arthritis and some types of cancers

Talk to your doctor about the need for additional contraception while taking ALPHAMOX. ALPHAMOX, like other antibiotics, may reduce the effectiveness of some birth control pills.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

If you have not told your doctor about any of the above, tell them before you start taking ALPHAMOX.

How to take ALPHAMOX

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

Take ALPHAMOX as directed by your doctor or pharmacist.

For the treatment of most infections, the usual adult dose is 250 to 500 mg every 8 hours. For children, the dose may vary depending on the child's weight.

People with kidney problems may need smaller doses.

For the prevention of endocarditis (heart infection) in people undergoing dental procedures, ALPHAMOX is usually taken one hour prior to the procedure. Your doctor or dentist will advise you.

Do not change the dose without first checking with your doctor.

How to take ALPHAMOX

ALPHAMOX can be taken with or without food.

Swallow whole with a glass of water.

How long to take it

Continue taking ALPHAMOX until you finish the capsules, or for as long as your doctor tells you.

Do not stop taking ALPHAMOX even if you feel better after a few days, unless advised by your doctor. Your infection may not clear completely if you stop taking your medicine too soon.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much ALPHAMOX.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking ALPHAMOX

Things you must do

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking ALPHAMOX.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine. Some medicines may affect the way other medicines work.

If your symptoms do not improve within a few days, or if they become worse, tell your doctor.

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

If you develop itching, swelling or a skin rash when you are taking ALPHAMOX, do not take any more ALPHAMOX and tell your doctor at once.

If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking ALPHAMOX. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine such as Lomotil or Imodium without checking with your doctor.

Things you must not do

Do not use ALPHAMOX to treat any other conditions unless your doctor tells you to.

Do not give ALPHAMOX to anyone else, even if they have the same condition as you.

Things to be careful of:

Be careful driving or operating machinery until you know how ALPHAMOX affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ALPHAMOX.

This medicine helps most people with treating infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

While you are taking it

Tell your doctor if you notice any of the following and they worry you:

  • nausea (feeling sick), vomiting
  • diarrhoea
  • oral thrush (white, furry sore tongue and mouth)
  • vaginal thrush (sore and itchy vagina, vaginal discharge)

The above list includes the milder side effects of your medicine.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • watery or severe diarrhoea (several loose bowel movements per day), which may also be bloody
  • indigestion
  • severe stomach cramps
  • bleeding or bruising more easily than normal
  • mouth ulcers
  • yellowing of the skin and eyes
  • dark coloured urine or pale stools
  • difficulty or pain on passing urine; decreased amount of urine

The above list includes serious side effects which may require medical attention.

If any of the following allergic reactions happen, stop taking ALPHAMOX and tell your doctor immediately, or go to Accident and Emergency at the nearest hospital:

  • any type of skin rash, itching, blistering or peeling of the skin, hives
  • swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing
  • wheezing, shortness of breath or difficulty breathing, fainting

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Remember you should tell your doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur during or after treatment with ALPHAMOX.

After you have finished taking it

Tell your doctor immediately if you notice any of the following, even if they occur several weeks after stopping treatment with ALPHAMOX:

  • watery and severe diarrhoea, which may also be bloody
  • severe stomach cramps
  • fever, in combination with one or both of the above

These are rare but serious side effects. You may need urgent medical attention. Do not take any diarrhoea medicine without checking with your doctor.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people and there may be some side effects not yet known.

After using ALPHAMOX

Storage

Keep ALPHAMOX in the packaging until it is time to take it. If you take the medicine out of the packaging they may not keep well.

Keep ALPHAMOX in a cool dry place where the temperature stays below 25°C.

Do not store ALPHAMOX or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep ALPHAMOX where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

ALPHAMOX capsules are available in 2 strengths:

  • ALPHAMOX 250: hard gelatin capsule with ivory body and green cap Size “2” filled with almost white granular powder.
  • ALPHAMOX 500: hard gelatin capsule of size “0el” having FEA ivory opaque body and FEG green opaque cap filled with white/almost white granular powder.

Each pack contains 20 capsules.

Ingredients

The active ingredient in ALPHAMOX is amoxicillin (as trihydrate).

Each ALPHAMOX 250 capsule contains 250 mg of the active ingredient amoxicillin.

Each ALPHAMOX 500 capsule contains 500 mg of the active ingredient amoxicillin.

The capsules also contain the following inactive ingredients:

  • purified talc
  • sodium starch glycollate
  • magnesium stearate
  • microcrystalline cellulose [ALPHAMOX 250 only]
  • colloidal anhydrous silica
  • sodium lauryl sulfate
  • Empty Hard Gelatin Capsule Shell Cap - Green Opaque Body - Ivory Opaque Size 2 (ARTG PI No: 12436). [ALPHAMOX 250 only]
  • Empty Hard Gelatin Capsule Shells Cap - Green Opaque Body- Ivory Opaque Size 0el (ARTG PI No: 12361). [ALPHAMOX 500 only]

Supplier

ALPHAMOX is supplied in Australia by:

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in May 2023.

Australian registration numbers:

ALPHAMOX 250 - AUST R 17678

ALPHAMOX 500 - AUST R 17679

ALPHAMOX® is a Viatris company trade mark

ALPHAMOX_cmi\May23/00

Published by MIMS July 2023

BRAND INFORMATION

Brand name

Alphamox

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin (as trihydrate).

2 Qualitative and Quantitative Composition

Each Alphamox capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg of amoxicillin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Alphamox 250.

Hard gelatin capsule with ivory body and green cap size "2" filled with almost white granular powder.

Alphamox 500.

Hard gelatin capsule of size "0e1" having FEA ivory opaque body and FEG green opaque cap filled with white/almost white granular powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of the following infections due to susceptible strains of sensitive organisms.

Note.

Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.

Skin and skin structure.

Staphylococcus, non-penicillinase producing; Streptococcus; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Respiratory (acute and chronic).

H. influenzae; Streptococcus; S. pneumoniae; Staphylococcus, non-penicillinase producing; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Genitourinary tract (complicated and uncomplicated, acute and chronic).

P. mirabilis; S. faecalis; E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology).

Gonorrhoea.

N. gonorrhoeae (non-penicillinase producing).

Prophylaxis of endocarditis.

Amoxicillin may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

4.2 Dose and Method of Administration

The following recommended doses are for patients with normal renal function.

Upper respiratory tract infections, genitourinary tract infections, skin and soft tissue infections.

Adults.

250 mg every 8 hours.

Children (under 20 kg).

20 mg/kg/day in equally divided doses every 8 hours.
In severe infections or those caused by less susceptible organisms, 500 mg every 8 hours for adults and 40 mg/kg/day in equally divided doses every 8 hours for children may be needed.

Lower respiratory tract infections.

Adults.

500 mg every 8 hours.

Children (under 20 kg).

40 mg/kg/day in equally divided doses every 8 hours.

Urethritis, gonococcal.

Adults.

3 grams as a single dose.
Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving Alphamox and monthly serological tests for a minimum of four months.

Acute, uncomplicated lower urinary tract infections in non-pregnant adult females.

Adults.

3 grams as a single dose.

Note.

Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route.
The children's dosage is intended for individuals whose weight will not cause dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.

Renal impairment.

In renal impairment, the excretion of the antibiotic will be delayed, and depending on the degree of impairment, it may be necessary to reduce the total daily dosage.
In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day. Amoxicillin may be removed from the circulation by haemodialysis.
It should be recognised that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days treatment for any infection caused by haemolytic Streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Prophylaxis of endocarditis.

See Table 1.

4.3 Contraindications

Amoxicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. penicillins, cephalosporins).

4.4 Special Warnings and Precautions for Use

Hypersensitivity (anaphylactic) reactions.

Serious, and occasionally fatal, hypersensitivity reactions (including anaphylaxis, anaphylactoid, and severe cutaneous reactions) have been reported in patients receiving beta-lactam antibiotics. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction (see Section 4.8 Adverse Effects (Undesirable Effects)). These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. Before commencing therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and Alphamox therapy discontinued.
Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin (see Section 4.8 Adverse Effects (Undesirable Effects)). DIES is an allergic reaction with the leading symptom of protracted vomiting (1-4 hours after administration of amoxicillin) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. There have been severe cases including progression to shock.

Clostridium difficile associated diarrhoea.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Clostridium difficile associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.

Oral anticoagulants.

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

Potential for microbial overgrowth or bacterial resistance.

Prolonged use of amoxicillin may occasionally result in overgrowth of non-susceptible organisms.
As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Aerobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.

Use in patients with mononucleosis.

Amoxicillin, an aminopenicillin, is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Patients with lymphatic leukaemia.

Amoxicillin should be given with caution to patients with lymphatic leukaemia, since they are especially susceptible to ampicillin induced skin rashes.

Patients with acute lower urinary tract infection.

Following single dose therapy of acute lower urinary tract infections, the urine should be cultured. A positive culture may be evidence of a complicated or upper urinary tract infection and call for a longer or larger course of therapy.
Adequate fluid intake and urinary output must be maintained in patients receiving high doses of amoxicillin.

Use in renal impairment.

Dosage should be adjusted in patients with renal impairment (see Section 4.2 Dose and Method of Administration).
In patients with reduced urine output, crystalluria (including acute renal injury) has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria. In patients with bladder catheters, a regular check of patency should be maintained (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.9 Overdose).

Use in the elderly.

No data available.

Paediatric use.

No data available (see Section 4.2 Dose and Method of Administration).

Effects on laboratory tests.

Oral administration of amoxicillin will result in high urine concentrations of amoxicillin. Since high urine concentrations of amoxicillin may result in false positive reactions when testing for the presence of glucose in urine using Clinitest, Benedict's solution or Fehling's solution, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix or Testape) be used.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated oestriol, oestriol-glucuronide, conjugated oestrone and oestradiol has been noted. This effect may also occur with amoxicillin.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Alphamox may result in increased and prolonged blood levels of amoxicillin.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Similar reactions can be expected with amoxicillin.
In common with other broad-spectrum antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
In the literature, there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Methotrexate.

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Animal studies with amoxicillin have shown no teratogenic effects. Amoxicillin has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies.
Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Labour and delivery.

Oral ampicillin class antibiotics are generally poorly absorbed during labour. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions and duration of contractions. However, it is not known whether the use of amoxicillin in humans during labour or delivery has immediate or delayed adverse effects on the foetus, prolongs the duration of labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
 Ampicillin class antibiotics are excreted in the milk; therefore, caution should be exercised when amoxicillin is administered to breastfeeding women.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins.
The following adverse reactions have been reported as associated with the use of amoxicillin.

Cardiac disorders.

Kounis syndrome: not known.

Infections and infestations.

Mucocutaneous candidiasis have been reported very rarely.

Gastrointestinal.

Nausea, vomiting, diarrhoea. Intestinal candidiasis and antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported rarely. Black hairy tongue has been reported very rarely (see Section 4.4 Special Warnings and Precautions for Use).
Drug-induced enterocolitis syndrome: not known (see Section 4.4 Special Warnings and Precautions for Use).

Skin and subcutaneous tissue disorders.

Linear IgA disease: not known.

Hypersensitivity reactions.

Erythematous maculopapular rashes, urticaria and pruritus have been reported occasionally. Rarely, skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous, exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness, hypersensitivity vasculitis and interstitial nephritis have been reported rarely.
Whenever such reactions occur, Alphamox should be discontinued. (Note: urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids.) Anaphylaxis is the most serious reaction experienced (see Section 4.4 Special Warnings and Precautions for Use).

Hepatic.

A moderate rise in AST and/or ALT has occasionally been noted, but the significance of this finding is unknown. As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely.

Haemic and lymphatic system.

Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia and leucopenia (including severe neutropenia or agranulocytosis) have been reported during therapy with other penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been rarely reported.

Renal and urinary tract disorders.

Interstitial nephritis. Crystalluria (including acute renal injury): not known (see Section 4.9 Overdose).

Central nervous system effects.

CNS effects have been seen rarely. They include aseptic meningitis, hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Miscellaneous.

Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and symptoms of water/electrolyte imbalance should be treated symptomatically. During the administration of high doses of amoxicillin, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
Amoxicillin can be removed from the circulation by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology. Amoxicillin is similar to ampicillin in its bactericidal action against Gram positive and Gram negative susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of the cell wall mucopeptide.
Amoxicillin is active in vitro against most strains of Haemophilus influenzae*, Neisseria gonorrhoeae*, Neisseria meningitidis, Escherichia coli*, Proteus mirabilis* and Salmonellae. Because amoxicillin does not resist destruction by penicillinase, it is not active against penicillinase producing organisms, particularly penicillinase-producing Staphylococci.
* Activity refers only to β-lactamase negative strains.
All strains of Pseudomonas species, Klebsiella species, Enterobacter species, indole-positive Proteus species, Serratia marcescens, Citrobacter species, penicillinase producing N. gonorrhoeae and penicillinase producing H. influenzae are resistant.
In vitro studies have demonstrated the susceptibility of most strains of the following Gram-positive bacteria: alpha- and beta-haemolytic streptococci, Diplococcus pneumoniae, non-penicillinase producing Staphylococci and Streptococcus faecalis. These organisms are susceptible to amoxicillin at serum concentrations, which may be expected following the recommended doses. However, some of the organisms were susceptible to amoxicillin only at concentrations achieved in the urine (see Section 4.1 Therapeutic Indications).
Escherichia coli isolates are becoming increasingly resistant to amoxicillin in vitro due to the presence of penicillinase-producing strains.
Strains of gonococci which are relatively resistant to benzylpenicillin may be sensitive to amoxicillin.
The following in vitro data are available, but their clinical significance is unknown. See Table 2.
A positive β-lactamase test predicts resistance to penicillin, ampicillin and amoxicillin.
The following are rates of resistance to amoxicillin for common pathogens in Australia (see Table 3).
Breakpoints. Streptococcus pneumoniae: S ≤ -2 microgram/mL; I = 4 microgram/mL; R ≥ 8 microgram/mL.

Note.

Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin are fully susceptible to amoxicillin.
Susceptibility tests.

Dilution or diffusion techniques.

Either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of "susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to the alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of the drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections. This information gives only an approximate guidance on probabilities whether organisms will be susceptible to amoxicillin.
Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing performed where necessary.

Cross resistance.

Other β-lactams, β-lactam/β-lactamase inhibitor combinations and cephalosporins.

Resistance mechanisms.

Production of penicillinase, altered penicillin binding proteins.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Amoxicillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food.

Distribution.

Amoxicillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed.
Amoxicillin has been shown to diffuse into sputum and saliva and is excreted mainly via the urine where it exists in a high concentration.
The amount to be found in the bile is variable depending on normal biliary secretory function.

Excretion.

The half-life of amoxicillin is 61.3 minutes with normal renal function, and in the absence of renal function, 16 to 20 hours.
Amoxicillin is excreted in the urine both unchanged and as penicilloic acid. About 75% of a 1 g dose is excreted in the urine in 6 hours in the presence of normal renal function (60% as amoxicillin and 15% as penicilloic acid). However, only 32% of a 3 g dose is excreted via the urine as the biologically active component in 8 hours (by which time most of the urinary excretion is complete). This proportional difference in the amount excreted from the different doses reflects a lack of linearity between doses and extent of absorption with a levelling off at higher doses of oral amoxicillin.
Excretion of amoxicillin can be delayed by concurrent administration of probenecid, thus prolonging its therapeutic effect.
Amoxicillin is not highly protein bound, being only 17% protein bound in serum as measured by ultrafiltration or equilibrium dialysis. The average peak serum levels resulting from the oral administration of 250 mg and 500 mg amoxicillin are 5 microgram/mL and 6.6 to 10.8 microgram/mL respectively, occurring one to two hours after administration. Measurable serum levels of amoxicillin are present eight hours after ingestion of a single oral dose.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The capsules contain colloidal anhydrous silica, magnesium stearate, purified talc, sodium lauryl sulfate, and sodium starch glycollate.
Alphamox 250 mg also contains microcrystalline cellulose and empty hard gelatin capsule shell cap - green opaque body - ivory opaque size 2 (ARTG PI No: 12436).
Alphamox 500 mg also contains empty hard gelatin capsule shells cap - green opaque body - ivory opaque size 0e1 (ARTG PI No: 12361).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Container type.

Blister pack (PVC/PVDC/Al).

Pack sizes.

Blister pack - 6 (500 mg), 20, 28 (500 mg), 30 capsules.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).


AUST R 17678 - Alphamox 250 amoxicillin 250 mg (as trihydrate) capsule blister pack.
AUST R 17679 - Alphamox 500 amoxicillin 500 mg (as trihydrate) capsule blister pack.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

6.7 Physicochemical Properties

Amoxicillin trihydrate is a white or almost white, crystalline powder, which is slightly soluble in water and in ethanol (96%) and is practically insoluble in chloroform, in ether, and in fixed oils.

Chemical structure.


Chemical name: (2S,5R,6R)-6- [[(2R)-2-amino-2- (4-hydroxyphenyl)acetyl]amino]- 3,3-dimethyl-7-oxo-4- thia-1- azabicyclo[3.2.0] heptane-2-carboxylic acid.
Molecular formula: C16H19N3O5S, 3H2O.
Molecular weight: 419.5.

CAS number.

61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes