Consumer medicine information

Cilamox

Amoxicillin

BRAND INFORMATION

Brand name

Cilamox

Active ingredient

Amoxicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cilamox.

What is in this leaflet

This leaflet answers some common questions about CILAMOX. 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 CILAMOX 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 CILAMOX is used for

This medicine is used to treat infections in different parts of the body caused by bacteria, such as:

  • upper and lower respiratory tract infections - chest infections (pneumonia), tonsillitis, sinusitis
  • urinary and genital tract infections
  • skin and fleshy tissue infections

This medicine belongs to a group of medicines called penicillins.

This medicine works by killing the bacteria that are causing the infection. It can also be used to prevent infection.

CILAMOX will not work against infections caused by viruses, such as the common cold or the 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.

Before you take CILAMOX

When you must not take it

Do not take CILAMOX if you have an allergy to:

  • any medicine containing amoxicillin
  • any medicine containing 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

Tell your doctor if you have suffered from any allergic conditions due to the use of penicillin.

Do not take this medicine if you have had ever had liver problems as a result of taking penicillins.

Do not breast-feed if you are taking this medicine. The active ingredient in CILAMOX passes into breast milk and there is a possibility that your baby may be affected.

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, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

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

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

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

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 and CILAMOX may interfere with each other. These include:

  • medicines used to treat gout such as probenecid or allopurinol
  • oral contraceptive pills (you may need to use other birth control methods such as condoms, while you are taking CILAMOX)
  • other antibiotics (these may interfere with the way CILAMOX works in the body)
  • anticoagulants (used to prevent blood clots) such as warfarin

These medicines may be affected by CILAMOX or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take CILAMOX

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 box, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much you need to take each day, and for how long you will need to take CILAMOX for.

The dose varies from person to person, and it will depend on the condition being treated and your response to the treatment.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Take your medicine at about the same time each day. Space the doses as evenly as possible throughout the day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. For example, if you are taking CILAMOX three times a day, take a dose about every eight hours.

It does not matter if you take this medicine before or after food.

How long to take it

Continue taking your medicine for as long as your doctor tells you. It is important to keep taking your medicine even if you feel well.

If you forget to take it

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 that you missed.

This may increase the chance of you getting an unwanted side effect.

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

While you are using CILAMOX

Things you must do

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

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked.

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

Tell your doctor immediately if you develop any form of skin rash and/or itching, swelling or difficulty in breathing while taking CILAMOX.

Tell your doctor or pharmacist immediately if you get severe diarrhoea. Do this even if it occurs several weeks after you have stopped using CILAMOX. 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 or pharmacist.

Tell your doctor if you get a sore mouth or tongue, vaginal itching or discharge while taking or after you have stopped taking CILAMOX. This could be due to a fungal infection called thrush. This may also result in fever and irritation in the stomach. Sometimes the use of this medicine allows fungi to grow, as CILAMOX is ineffective against fungi.

Tell your doctor, if for any reason, you have not taken CILAMOX exactly as prescribed. Otherwise, your doctor may think that the medicine was not effective and change your treatment unnecessarily.

Things you must not do

Do not take CILAMOX to treat any other complaints unless your doctor tells you to.

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

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your infection may return and your condition may worsen..

Things to be careful of

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

Side effects

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

This medicine helps most people with bacterial 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 attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

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

  • nausea and vomiting
  • diarrhoea (several loose bowel movements per day)
  • indigestion
  • oral thrush (white, furry, sore tongue and mouth)
  • vaginal thrush (sore, itchy vagina sometimes with irregular discharge)

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • rash or itching
  • bleeding or bruising more easily than normal
  • yellowing of the skin and eyes
  • dark urine or pale stools
  • difficulty in passing urine
  • severe diarrhoea

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

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

  • lumpy rash (hives) itching, blistering or peeling of the skin
  • swelling of the face, lips, mouth or throat
  • wheezing, shortness of breath or difficulty breathing

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

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

Other side effects not listed above may also occur in some people.

After using CILAMOX

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 CILAMOX or any other medicine 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

CILAMOX capsules come in two strengths, 250 mg and 500 mg, and are available in blister packs of 20 capsules. They are hard gelatin capsules and are opaque white in colour.

Ingredients

CILAMOX contains either 250 mg or 500 mg of amoxicillin (as amoxicillin trihydrate) as the active ingredient.

The capsules also contain the following inactive ingredients:

  • gelatin
  • magnesium stearate
  • purified talc
  • titanium dioxide

Distributor

CILAMOX is distributed in Australia by:

Viatris Pty Ltd
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 January 2022.

250 mg: AUST R 286257

500 mg: AUST R 286258

cilamox_cmi\jan22/00

Published by MIMS March 2022

BRAND INFORMATION

Brand name

Cilamox

Active ingredient

Amoxicillin

Schedule

S4

 

1 Name of Medicine

Amoxicillin trihydrate.

2 Qualitative and Quantitative Composition

Each Cilamox capsule contains 250 mg or 500 mg of amoxicillin (as trihydrate) as the active ingredient.
Cilamox Sugar Free Syrup powder for oral liquid contains 125 mg/5 mL or 250 mg/5 mL of amoxicillin (as trihydrate) as the active ingredient.

Excipients of known effect (powder for oral liquid only).

Saccharin, benzoates and sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cilamox 250 mg capsules are size 1 hard gelatin capsules that are opaque white in colour.
Cilamox 500 mg capsules are size 0 hard gelatin capsules that are opaque white in colour.
Cilamox Sugar Free Syrup 125 mg/5 mL and 250 mg/5 mL powder for oral liquid is a white to off-white free flowing powder with characteristic fruity odours.

4 Clinical Particulars

4.1 Therapeutic Indications

Cilamox is indicated for the treatment of infections due to susceptible strains of the sensitive organisms.

Gram negative.

H. influenzae, E. coli, Pr. mirabilis and N. gonorrhoeae.

Gram positive.

Streptococcus species, S. pneumoniae, non-penicillinase producing Staphylococci and Bacillus anthracis.

Note 1.

Cilamox may be useful in instituting therapy prior to bacteriology; however, bacteriological studies to determine the causative organisms and their sensitivity to Cilamox should be performed.

Note 2.

Penicillins are now generally regarded only as adjunctive to some other established first line antibiotic therapy in the treatment and post-exposure prophylaxis of anthrax, because of concerns of constitutive and inducible beta-lactamase in Bacillus anthracis. If use of amoxicillin is contemplated, appropriate bacteriological studies must be performed by a reliable and established test method. Amoxicillin may then be suitable if the specific B. anthracis strain has been shown definitively to be sensitive to penicillin/amoxicillin.

4.2 Dose and Method of Administration

The following recommended doses are for patients with normal renal function. The dosage in patients with renal impairment may need to be adjusted (see Section 4.4 Special Warnings and Precautions for Use, Use in renal impairment).

Upper respiratory tract infections (due to streptococci, pneumococci, non-penicillinase producing staphylococci and H. influenzae), genito-urinary tract infections (due to E. coli, Proteus mirabilis and Strep. faecalis), skin and skin structure infections (due to streptococci, sensitive staphylococci and E. coli.).

Adults.

250 mg every eight hours.

Children (under 20 kg).

25 mg/kg/day in equally divided doses every eight hours.
In severe infections or those caused by less susceptible organisms, 500 mg every eight hours for adults and 50 mg/kg/day in equally divided doses every eight hours for children may be needed.

Lower respiratory tract infections (due to streptococci, pneumococci, nonpenicillinase producing staphylococci, and H. influenzae).

Adults.

500 mg every eight hours.

Children (under 20 kg).

50 mg/kg/day in equally divided doses every eight hours.

Urethritis (due to N. gonorrhoeae).

Adults.

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

Acute, uncomplicated lower urinary tract infections (due to E. coli, Proteus mirabilis, Strep. faecalis and nonpenicillinase producing staphylococci).

Adults.

3 grams as a single dose.
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.

Cutaneous anthrax.

Cutaneous anthrax (due to nonpenicillinase producing B. anthracis) proven to be susceptible to amoxicillin and without systemic symptoms and not located on the head or neck and not associated with extensive oedema. For more complicated cases, the advice of an infectious disease specialist should be sought.

Adults.

500 mg every eight hours.

Children (under 20 kg).

80 mg/kg/day in equally divided doses every eight hours.

Post-exposure anthrax prophylaxis (due to nonpenicillinase producing B. anthracis) proven to be susceptible to amoxicillin.

Adults. 500 mg every eight hours.
Children (under 20 kg). 80 mg/kg/day in equally divided doses every eight hours.
The recommended treatment period for cutaneous anthrax and post-exposure anthrax prophylaxis should be 60 days. Periodic assessment of organ system functions is advisable (see Section 4.4 Special Warnings and Precautions for Use). In the case of cutaneous anthrax which is clearly and unequivocally the result of a zoonotic mode of transmission and in which there are no systemic symptoms, treatment for shorter periods of time may still be an option.

Note.

The children's dosage is intended for individuals whose weight will not cause the dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations.

4.3 Contraindications

Individuals with a history of an allergic reaction to the penicillins. It is also contraindicated in patients with a history of amoxicillin associated hepatic dysfunction or jaundice.

4.4 Special Warnings and Precautions for Use

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics, including Cilamox. 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.
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 organ system functions, including renal, hepatic and hematopoietic function, is advisable.

Superinfections.

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.

Infectious mononucleosis.

Cilamox, 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.

Lymphatic leukaemia.

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

Use in hepatic impairment.

Cholestatic hepatitis, which may be severe but is usually reversible, has been reported. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Hepatic events subsequent to Cilamox have occurred predominantly in adults and elderly patients.
Cilamox should be used with care in patients with evidence of hepatic dysfunction.

Use in renal impairment.

The dosage should be adjusted in patients with moderate or severe 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.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

Oral administration of Cilamox results in high concentrations of amoxicillin in the urine. Since high urine concentrations of ampicillin may yield false reactions when testing for the presence of glucose in urine using *Clinitest*, Benedict's solution or Fehling's solutions it is therefore recommended that tests based on enzymatic glucose oxidase reactions such as *Clinistix* or *Tes-Tape* should be used.
A transient decrease in plasma concentration of total conjugated oestriol, oestriol-glucuronide, conjugated oestrone and oestradiol was observed following administration of ampicillin to pregnant women. This effect may also occur with amoxicillin.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid.

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Cilamox may result in increased and prolonged blood levels of amoxicillin.

Allopurinol.

The concurrent administration of allopurinol and ampicillin causes substantial increases in the incidence of rashes compared to administration of ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricaemia present in these patients.
Similar reactions can be expected with amoxicillin.

Oral contraceptives.

In common with other broad-spectrum antibiotics, patients should be warned that Cilamox may reduce the effectiveness of oral contraceptives.

Warfarin.

In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ration should be carefully monitored with the addition or withdrawal of amoxicillin.

Tetracyclines.

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
No teratogenic effects were observed in animal studies using oral or parenteral preparations of amoxicillin. Extensive clinical use since 1972 and suitability in human pregnancy has been well documented in clinical studies.

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 uterine tone, frequency, height, and duration of contractions. However, it is not known whether the use of Cilamox 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 obstetric intervention or resuscitation of the newborn will be necessary.
 Amoxicillin is excreted in breast milk; therefore, caution should be exercised if Cilamox is administered to a breast-feeding mother.

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 reactions have been reported as associated with the use of Cilamox:

Infections and infestations.

Mucocutaneous candidiasis have been reported very rarely.

Gastrointestinal effects.

Diarrhoea, nausea, vomiting. 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).

Hypersensitivity reactions.

Erythematous maculopapular rashes, pruritus and urticaria have been reported occasionally. Rarely, skin reactions such as erythema multiforme and Steven-Johnsons 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, Cilamox should be discontinued.

Note.

Urticaria, other skin rashes and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids.

Hepatic effects.

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

Haematological effects.

Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, 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.

Renal and urinary tract disorders.

Interstitial nephritis, crystalluria (see Section 4.9 Overdose).

CNS 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. Amoxycillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special Warnings and Precautions for Use).
If a large overdose is ingested, the patient should be kept under observation and appropriate treatment should be given as considered necessary.
Amoxicillin may 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.

Cilamox differs in vitro from benzylpenicillin in the Gram negative spectrum and has the same Gram positive and Gram negative spectrum as ampicillin.
In vitro, most strains of Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis and Salmonellae are sensitive to Cilamox at serum concentrations which may be expected following the recommended doses.
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 Cilamox.
In vitro studies have demonstrated the sensitivity of most strains of the following Gram positive bacteria: alpha- and beta-haemolytic Streptococci, Streptococcus pneumoniae, nonpenicillinase producing Staphylococci, Streptococcus faecalis and Bacillus anthracis. However, some of the organisms were sensitive to Cilamox only at concentrations achieved in the urine.
Cilamox is not effective against penicillinase producing bacteria, particularly resistant Staphylococci, which now have high prevalence. All strains of Pseudomonas and most strains of Klebsiella and Aerobacter are resistant.
Like benzylpenicillin, Cilamox is bactericidal against sensitive organisms during the stage of active multiplication. It is believed to act through the inhibition of biosynthesis of cell wall mucopeptide.
A commonly used method involving flooding culture plates with a large inoculum of organisms has demonstrated that a 15 mm or greater inhibition zone represents sensitivity using a 25 microgram disc of amoxicillin.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Cilamox is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food. It diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed.

Distribution.

Cilamox is not highly protein-bound, being only 17% protein-bound in serum as compared to 59% for benzylpenicillin. The average peak serum levels resulting from the oral administration of Cilamox are approximately double those compared to the same dose of ampicillin. Peak serum levels of amoxicillin are approximate following intramuscular administration of the same dose of ampicillin. Oral peak serum levels are reached after 1 to 2 hours. Measurable serum levels of Cilamox are present even at 8 hours after administration. The area under the curve (AUC) for Cilamox is twice that of ampicillin given in the same dose and by the oral route. About 60 to 70% of an oral dose of Cilamox is excreted in the urine as compared to 30 to 40% with ampicillin given by the same route and in the same dose.

Excretion.

Cilamox has been shown to diffuse into sputum and saliva and is excreted mainly via the urine where it exists in high concentration. The amount to be found in the bile is variable depending on normal biliary secretory function.
The half-life of Cilamox is approximately one hour (61.3 minutes) with normal renal function and in the absence of renal function 16 to 20 hours.
Cilamox is excreted in the urine both unchanged and as penicilloic acid. With normal renal function, about 75% of a 1 gram dose is excreted in the urine in 6 hours (60% is biologically active and 15% is penicilloic acid). However, about 32% of a 3 gram 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 the 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.
Following oral administration, the finding of higher peak serum concentrations, larger AUC and greater urinary excretion of Cilamox, with identical half-lives for the two antibiotics, all reflect much better absorption of Cilamox.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity and mutagenicity.

Long-term carcinogenicity or mutagenicity studies have not been carried out in animals to determine carcinogenic or mutagenic potential of Cilamox.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cilamox 250 mg and 500 mg capsules contain the following inactive ingredients: gelatin, titanium dioxide, magnesium stearate and purified talc.
Cilamox Sugar Free Syrup powder for oral liquid contain the following inactive ingredients: colloidal anhydrous silica, disodium edetate, saccharin sodium, silicon dioxide, sodium benzoate, sorbitol, xanthan gum and the following flavours - Banana 51464 AP0572 (ARTG PI No: 2737) and Forest Berry 502874 AP0572 (ARTG PI No: 2738) [125 mg/5 mL] and Sonaflo Passion Fruit 171011 (ARTG PI No: 108517) and Sonaflo Vanilla 080911 (ARTG PI No: 108516) [250 mg/5 mL].

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

Capsules.

Store below 25°C.

Powder for oral liquid.

Store below 25°C. Protect from light, heat and moisture.

6.5 Nature and Contents of Container

Container type.

Capsules: blister pack (PVC/PVDC/Al).
Powder for oral liquid: HDPE bottle with polypropylene child resistant cap.

Pack sizes.

Capsules: 3, 20.
Powder for oral liquid: 100 mL.
Some strengths, pack sizes and/or pack types may not be marketed.

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

Chemical structure.


Chemically amoxicillin trihydrate is D-(-)-α-amino-ρ-hydroxybenzylpenicillin trihydrate which is susceptible to hydrolysis by β-lactamases.
Molecular formula: C16H19N3O5S.3H2O.
Molecular weight: 419.5.
Solubility: slightly soluble in water and ethanol (96%); practically insoluble in chloroform, ether and fixed oils. It dissolves in dilute solutions of acids and of alkali hydroxides.

CAS number.

61336-70-7.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes