Consumer medicine information

Noumed Amoxicillin Capsules

Amoxicillin

BRAND INFORMATION

Brand name

Noumed Amoxicillin

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Noumed Amoxicillin Capsules.

What is in this leaflet

This leaflet answers some common questions about Noumed Amoxicillin capsules.

It does not contain all 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 this medicine against the benefits they expect it will have for you.

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

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

What this medicine is used for

The name of your medicine is Noumed Amoxicillin. It contains the active ingredient amoxicillin trihydrate.

Amoxicillin is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that cause infections.

Noumed Amoxicillin is used to treat infections in different parts of the body caused by bacteria. These may be infections of the chest (pneumonia), tonsils (tonsillitis), sinuses (sinusitis), urinary and genital tract, skin and fleshy tissues.

It is also used to prevent infections before, during and after surgery.

Noumed Amoxicillin will not work against infections caused by viruses such as colds or the flu.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

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

Noumed Amoxicillin is not addictive.

Before you take this medicine

When you must not take it

Noumed Amoxicillin must not be taken if you have an allergy to:

  • amoxicillin
  • any β-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenem or monobactam)
  • 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

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:

  1. you have ever had any allergies to any antibiotics, and other medicines, foods, preservatives or dyes.
  2. you are pregnant or intend to become pregnant.
Your doctor will discuss the possible risks and benefits of using this medicine during pregnancy.
  1. you are breast-feeding or intend to breast-feed.
Noumed Amoxicillin passes into breast milk. Your doctor will discuss the risks and benefits of taking this medicine when breastfeeding.
  1. Tell your doctor if you have or have had any of the following medical conditions:
  • glandular fever (mononucleosis)
  • blood disorders
  • diabetes
  • seizures history
  • stomach or bowel problems
  • liver or kidney problems
  • asthma
  • history of allergic problems, including hayfever.

If you have not told your doctor about any of the above, tell them before you take this medicine.

Taking other medicines

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

Some medicines may interfere with this medicine. These include:

  • medicines used to treat gout (e.g. probenecid or allopurinol)
  • digoxin, a medicine used to treat heart failure
  • other antibiotics (e.g. tetracyclines)
  • anticoagulants (used to prevent blood clots) such as warfarin
  • methotrexate, a medicine used to treat arthritis and some types of cancers
  • oral contraceptives (birth control pills)

These medicines may be affected by Noumed Amoxicillin, or may affect how well it works. Your child may need different amounts of the medicine, or may need to take different medicines. Your doctor or pharmacist will advise you.

Talk to your doctor about the need for an additional method of contraception while taking Noumed Amoxicillin. Some antibiotics may decrease the effectiveness of some birth control pills.

Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while taking Noumed Amoxicillin.

How to take this medicine

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

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

How much to take

Your doctor will tell you the dose of Noumed Amoxicillin you will need to use each day. This depends on the condition being treated and whether any other medicines are being used.

In adults the usual dosage is 250-500mg three times daily.

In children, the usual dosage is 125-250mg three times daily and may vary depending on the weight of your child.

How to take it

Take the capsules with a glass of water.

When to take it

In order for Noumed Amoxicillin to be most effective, it should be taken at regular times through the day. For example, if you are taking it three times a day, take a dose every 8 hours.

Your doctor or pharmacist can advise you on a dosing schedule if you are unsure.

Noumed Amoxicillin can be taken with or without food.

How long to take it

Continue taking Noumed Amoxicillin until you finish the capsules or for as long as your doctor recommends.

Keep taking this medicine for the full course of treatment, even if you begin to feel better after a few days. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.

Check with your doctor if you are not sure how long you should be taking Noumed Amoxicillin.

If you forget to take it

If it is almost time for your next dose, skip the missed dose 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 give a double dose to make up for the dose that was missed.

If you have trouble remembering to give the doses, 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 Noumed Amoxicillin.

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

If you take too much Noumed Amoxicillin, you may experience symptoms such as diarrhoea, nausea, vomiting or stomach cramps.

While you are taking this medicine

Things you must do

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

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

If you get severe diarrhoea tell your doctor or pharmacist immediately.

Do this even if it occurs several weeks after Noumed Amoxicillin has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while taking or soon after stopping Noumed Amoxicillin, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of Noumed Amoxicillin allows fungi to grow and the above symptoms to occur. Noumed Amoxicillin does not work against fungi.

Tell your doctor if you become pregnant while taking Noumed Amoxicillin.

If you have to test your urine for sugar while you are using Noumed Amoxicillin, make sure your doctor knows which type of test you use. Noumed Amoxicillin may affect the results of some of these tests.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Noumed Amoxicillin.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Noumed Amoxicillin.

Things you must not do

Do not stop taking your medicine because you are feeling better, unless advised by your doctor. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return.

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

Do not give Noumed Amoxicillin to treat any other complaints unless your doctor tells you to.

Things to be careful of

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

Noumed Amoxicillin may cause tiredness or dizziness in some people.

Make sure you know how you react to Noumed Amoxicillin before you drive a car, operate machinery or do anything else that may be dangerous if you are affected.

Side effects

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

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.

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

  • soreness of the tongue or mouth
  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina or discharge
  • diarrhoea (several loose bowel movements per day), indigestion, feeling sick or being sick
  • discoloration of the teeth. Usually the discoloration can be removed by teeth brushing
  • headache, tiredness.

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • signs of anaemia such as looking pale, short of breath when exercising, dizziness
  • signs of frequent infections such as fever, sever chills, sore throat or mouth ulcers
  • itching, rash
  • unusual bleeding or bruising
  • yellowing of the skin or eyes
  • dark urine or pale stools
  • difficulty or pain on passing urine

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following occur, stop taking Noumed Amoxicillin and tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital:

  • wheezing, swelling of the lips/mouth, difficulty in breathing
  • any skin rash, itching or hives or blistering or peeling of the skin
  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody.

These are very serious side effects. You may need urgent medical attention or hospitalisation. Serious side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor or pharmacist if you do not understand anything in this list.

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

After giving this medicine

Storage

Keep your capsules in the pack until it is time to take them. If you take the capsules out of the pack they may not keep well.

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

Do not store Noumed Amoxicillin in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it 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

Noumed Amoxicillin Capsules - opaque yellow hard gelatin capsules.

Available in blisters packs of 20 capsules.

Ingredients

Noumed Amoxicillin Capsules contain either 250mg or 500mg of amoxicillin (as trihydrate).

The capsules also contain:

  • magnesium stearate
  • microcrystalline cellulose
  • gelatin
  • iron oxide yellow C177492
  • titanium dioxide.

Australian Registration Numbers

  • Noumed Amoxicillin 250 mg: AUST R 298258
  • Noumed Amoxicillin 500 mg: AUST R 298259

Sponsor

Avallon Pharmaceuticals Pty Ltd
Level 5, 7 Eden Park Drive
Macquarie Park NSW 2113

This leaflet was prepared in April 2020.

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Noumed Amoxicillin

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin trihydrate.

2 Qualitative and Quantitative Composition

Each Noumed Amoxicillin capsule contains 250 mg or 500 mg amoxicillin (as trihydrate). For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Noumed Amoxicillin Capsules are white to cream powder in an opaque yellow hard gelatin capsule.

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. Amoxicillin alone or in combination with another antibiotic, may be used in an emergency where the causative has not been identified.

Respiratory tract infections (acute and chronic).

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

Urogenital infections (complicated and uncomplicated, acute and chronic).

E. coli (see Section 5.1 Pharmacodynamic Properties, Microbiology), P. mirabilis and Strep. faecalis.

Gonorrhoea.

N. gonorrhoea (non-pencillinase producing).

Skin and skin structure infections.

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

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.
Infections caused by pathogens with established penicillin G susceptibility should preferentially be treated with penicillin G.

4.2 Dose and Method of Administration

Amoxicillin suspensions are unavailable in this brand, however are available in other brands. Where correct dosing requires amoxicillin suspension formulations, other brands should be used.

Normal renal function.

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

Adults.

250 mg every eight 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 eight 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 eight hours.

Children (under 20 kg).

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

Urethritis, gonococcal.

Adults.

3 g as a single dose.
Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving amoxicillin and monthly serological tests for a minimum of 4 months.

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

3 g as a single dose.

Prophylaxis of endocarditis.

Dental Procedures.

Prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues, who are not having general anaesthetic, and who have not received a penicillin in the previous month. (Note: Patients with prosthetic heart valves should be referred to hospital.)

Adults (including elderly).

3 g orally, 1 hour before procedure. A second does may be given 6 hours later if considered necessary.

Children: Under 10 years.

Half adult dose.

Under 5 years.

Quarter adult dose.
(Note: Prophylaxis with alternative antibiotics should be considered if the patient has received penicillin within the previous month, or is allergic to penicillin.).

Use in neonates.

Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route.

Use in children.

The children's dosage is intended for individuals whose weight will not cause dosage greater than that recommended for adults. Children receiving amoxicillin every 8 hours and weighing more than 20 kg should receive the adult recommended doses.

Impaired renal function.

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 doses.
In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day.
Amoxicillin may be removed from the circulation by haemodialysis.

Chronic urinary tract infections.

Frequent biological and clinical appraisals are recommended for patients under treatment for chronic urinary tract infections. Doses smaller than those recommended should not be used.
Therapy for stubborn infections may have to be extended for several weeks.
Bacteriological and clinical appraisals may have to be continued for several months following cessation of treatment.

Duration of treatment.

Treatment should be continued for a minimum of 48 to 72 hours beyond the time when patients become asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be a minimum of 10 days treatment for any infection caused by haemolytic streptococci to prevent occurrence of acute rheumatic fever or glomerulonephritis.

4.3 Contraindications

Amoxicillin is a penicillin and should not be given to patients with a known history of hypersensitivity or suspected hypersensitivity to β-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenem or monobactam). Potential cross allergy to other beta-lactams such as cephalosporins should be taken into account.
Known hypersensitivity to the active substance, to any of the penicillins or to any of the excipients.
Antibiotics have no place in trivial infections.

4.4 Special Warnings and Precautions for Use

Hypersensitivity reactions.

Serious, and occasionally fatal, hypersensitivity (anaphylactoid) reactions have been reported in patients receiving penicillin therapy. These reactions are more frequently associated with parenteral therapy but have been reported for patients receiving oral penicillins. Careful assessment should be made prior to administration of amoxicillin to determine any previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. Amoxicillin therapy should be immediately discontinued if hypersensitivity reactions occur. Patients should be told about the potential occurrence of allergic reactions and instructed to report them.
If allergic reactions occur, the drug should be discontinued and the usual treatment with adrenaline, antihistamines and corticosteroids should be instituted, as necessary.
Serious anaphylactoid reactions should be treated with adrenaline. Oxygen, intravenous steroids and airways management, including intubation should be administered as necessary.

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. This particularly applies when considering the treatment of patients with urinary tract infections and severe infections of the ear, nose and throat.
Amoxicillin should not be used for the treatment of bacterial infections in patients with viral infections, presenting with sore throat, pharyngitis or infectious mononucleosis, as a high incidence of amoxicillin induced erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Overgrowth of non-susceptible microorganisms.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. 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 eg. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the conditions and should not be used.

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.

Prolonged therapy.

As with any potent drug, periodic assessment of renal, hepatic and haematopoietic function should be made during prolonged therapy. The possibility of superinfection with mycotic or bacterial pathogens should be kept in mind. If superinfection occurs (usually involving Aerobacter, Pseudomonas or Candida) discontinue the drug and/or institute appropriate therapy.

Lymphatic Leukaemia.

Amoxicillin should be given with caution to patients with lymphatic leukaemia as they are susceptible to amoxicillin induced skin rashes.

Skin reactions.

The occurrence of a generalized erythema with fever and pustules at the beginning of treatment should make suspect a generalized acute exanthematic pustulosis; this necessitates the interruption of therapy and contraindicated any further administration of amoxicillin.

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. Special caution should be exercised in patients with allergic diatheses or bronchial asthma and hay fever.

Crystalluria.

The presence of high urinary concentrations of amoxicillin can cause precipitation of the product in urinary catheters. Therefore, catheters should be visually inspected at intervals. At high doses, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria.

Monitoring.

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 higher dose or prolonged course of treatment may be appropriate.
As with other beta-lactams, the blood formula should be checked regularly during high-dose therapy. Elevated liver enzymes and changes in blood counts have been reported.

Convulsions.

High dose therapy with beta-lactams for patients with renal insufficiency or seizures history, treated epilepsy and meningeal affection, could exceptionally lead to seizures. Dosage should be adjusted in patients with renal impairments (see Section 4.2 Dose and Method of Administration).

Use in renal impairment.

See Section 4.2 Dose and Method of Administration.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.
Precaution should be taken in premature children and during neonatal period: renal, hepatic and haematological functions should be monitored.

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 enzyme-based 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

Allopurinol.

Concomitant ingestion of allopurinol and ampicillin may promote the occurrence of skin rashes. The underlying mechanism is still poorly understood. Similar reactions can be expected with amoxicillin.

Digoxin.

An increase in the absorption of digoxin is possible on concurrent administration with amoxicillin. A dose adjustment of digoxin may be necessary.

Anticoagulants.

Concomitant administration of amoxicillin and anticoagulants from the coumarin class, may prolong the bleeding time. A dose adjustment of anticoagulants may be necessary (see section 4.4 Special Warnings and Precautions for Use). If coadministration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.
A large number of cases showing an increase of oral anticoagulant activity has been reported in patients receiving antibiotics. The infectious and inflammatory context, age and the general status of the patient appear as risk factors. In these circumstances, it is difficult to know the part of the responsibility between the infectious disease and its treatment in the occurrence of INR disorders. However, some classes of antibiotics are more involved, notably fluoroquinolones, macrolides, cyclines, cotrimoxazole and some cephalosporins.

Probenecid.

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin.

Tetracyclines.

Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

Methotrexate.

Interaction between amoxicillin and methotrexate leading to methotrexate toxicity has been reported. Serum methotrexate levels should be closely monitored in patients who receive amoxicillin and methotrexate simultaneously (see section 4.4 Special Warnings and Precautions for Use). Amoxicillin decreases the renal clearance of methotrexate, probably by competition at the common tubular secretion system.

Caution is recommended when amoxicillin is given concomitantly with.

Oral hormonal contraceptives.

Administration of amoxicillin can transiently decrease the plasma level of oestragens and progesterone, and may reduce the efficacy of oral contraceptives. It is therefore recommended to take supplemental non-hormonal contraceptive measures.

Other forms of interactions.

Forced diuresis leads to a reduction in blood concentrations by increased elimination of amoxicillin; amoxicillin may decrease the amount of urinary estriol in pregnant women; at high concentrations, amoxicillin may diminish the results of serum glycemia levels; amoxicillin may interfere with protein testing when colormetric methods are used.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals have shown no effects on fertility.
(Category A)
Drugs which have been taken by a lage number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Animal studies with amoxicillin have shown no teratogenic effects. The product 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.

Use in 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 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 breast milk and caution should be exercised when amoxicillin is administered to nursing mothers. So far no detrimental effects for the breast-fed infant have been reported after taking Amoxicillin. Amoxicillin can be used during breast-feeding. However, breast-feeding must be stopped if gastrointestinal disorders (diarrhoea, candidosis or skin rash) occur in the newborn.

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 most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash.
The following adverse reactions have been reported as associated with the use of amoxicillin.

Gastrointestinal.

Nausea, vomiting, diarrhoea. Intestinal candidiasis, antibiotic associated colitis (including pseudomembranous colitis and haemorrhagic colitis), superficial discoloration of the teeth have been reported rarely (see Section 4.4 Special Warnings and Precautions for Use). Usually the discoloration can be removed by teeth brushing. If severe and persistent diarrhoea occurs, the very rare possibility of pseudomembranous colitis should be considered. The administration of anti-peristaltic drug is contraindicated. Black hairy tongue and haemorrhagic colitis have been reported very rarely.

Hypersensitivity.

Erythematous maculopapular rash, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme exsudativum, acute generalised pustulosis, Lyell’s syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous and exfoliative dermatitis acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS) and Jarisch-Herxheimer reaction have been reported. As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness, hypersensitivity vasculitis and interstitial nephritis (crystalluria) have been reported rarely. Whenever such reactions occur, amoxicillin 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 systems.

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 reported rarely.

Central Nervous System (CNS) effects.

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

Infections and infestations.

Mucocutaneous candidiasis have been reported very rarely.

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria have been reported very rarely.

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

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Signs of overdosage of amoxicillin would predominately be gastrointestinal related. The symptoms may include abdominal or stomach cramps and pain, severe nausea, vomiting or diarrhoea. Treatment of penicillin overdosage should be symptomatic and supportive.
Haemodialysis may aid in the removal of penicillins from the blood.
Please see Section 4.4 Special Warnings and Precautions for Use and Section 4.8 Adverse Effects (Undesirable Effects).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of Action.

Microbiology.

Amoxicillin trihydrate is a broad-spectrum penicillin similar to ampicillin in its bactericidal action. It is believed to act through the inhibition of biosynthesis of cell wall mucopeptide. It is active against both gram-positive and gram-negative microorganisms. Amoxicillin is active in vitro against beta-lactamase negative strains of Proteus mirabilis, and Haemophilus influenza. In vitro studies have also demonstrated activity against most strains of alpha- and beta-haemolytic strepococci. Streptococcus pneumoniae, and beta-lactamase negative strains of staphylococci, Neisseria gonorrhoeae, Neisseria meningitidis and Enterococcus faecalis. However, some of the organisms are sensitive to amoxicillin only at concentrations achieved in the urine. Strains of gonococci which are relatively resistant to benzyl penicillin may also be resistant to amoxicillin. Amoxicillin is not effective against penicillinase producing bacteria, particularly resistant staphylococci which now have a high prevalence. All strains of Pseudomonas, Klebsiella, Enterobacter, indole positive Proteus, Serratia marcescens, Citrobacter, penicillinase producing N. gonorrhoeae and penicillinase producing H. influenzae are also resistant. Escherichia coli isolates are becoming increasingly resistant to amoxicillin in vitro due to the presence of penicillinase-producing strains. See Table 1.

Disc Susceptibility Testing.

Dilution of diffusion techniques.

Either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (eg. 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 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 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 may 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.

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. Peak serum levels are reached within one or two hours after ingestion.
Orally administered doses of amoxicillin 250 and 500 mg result in average peak serum levels one to two hours after administration of 5 microgram/mL and 10.25 microgram/mL respectively. Detectable serum levels of amoxicillin are present eight hours after ingestion of a single dose.

Distribution.

Amoxicillin readily distributes in most body tissues and fluids with the exception of brain and spinal fluid except when the 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. Concentrations in the bile may vary and are dependent upon normal biliary function.
Amoxicillin is only 17% protein bound in serum.

Excretion.

Amoxicillin is eliminated with a half-life of 61.3 minutes with normal renal function and up to 16-20 hours in the absence of renal function.
Amoxicillin is excreted in the urine as unchanged drug and as penicilloic acid. Approximately 75% of a 1g dose is excreted in the urine within six hours with normal renal function. However, there is a proportional difference in the amount excreted following different doses, due to lack of linearity in the rate of absorption with higher doses.
Elimination of amoxicillin can be delayed by concurrent administration of probenecid.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Magnesium stearate, microcrystalline cellulose, gelatin, iron oxide yellow and titanium dioxide.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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, protect from moisture.

6.5 Nature and Contents of Container

Noumed Amoxicillin Capsules are white to cream powder in an opaque yellow hard gelatin capsule available in a PVC/PVDC/Al blister pack of 20 capsules. Each capsule contains 250 mg or 500 mg amoxicillin (as trihydrate).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Amoxicillin trihydrate is a white or almost white, crystalline powder. It is slightly soluble in water and in ethanol (96%); practically insoluble in chloroform, in ether and in fatty oils.
Chemical Name: (2S, 5R, 6R)-6-[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate.
Molecular Formula: C16H19N3O5S.3H2O.
Molecular Weight: 419.4.

Chemical Structure.



CAS number.

61336-70-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes