Consumer medicine information

Austrapen

Ampicillin

BRAND INFORMATION

Brand name

Austrapen

Active ingredient

Ampicillin

Schedule

SUMMARY CMI

AUSTRAPEN^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using AUSTRAPEN?

AUSTRAPEN contains the active ingredient ampicillin (as sodium). AUSTRAPEN is used to treat infections in different parts of the body caused by bacteria.

For more information, see Section 1. Why am I using AUSTRAPEN? in the full CMI.

2. What should I know before I use AUSTRAPEN?

Do not use if you have ever had an allergic reaction to AUSTRAPEN or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use AUSTRAPEN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AUSTRAPEN and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use AUSTRAPEN?

AUSTRAPEN must only be given by a doctor or nurse.

More instructions can be found in Section 4. How do I use AUSTRAPEN? in the full CMI.

5. What should I know while using AUSTRAPEN?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using AUSTRAPEN. If you develop itching with swelling or skin rash or difficulty breathing after you have been given AUSTRAPEN, contact your doctor immediately. If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after AUSTRAPEN has been stopped.
Driving or using machines	Be careful driving or operating machinery until you know how AUSTRAPEN affects you.
Looking after your medicine	AUSTRAPEN is stored in the pharmacy or on the ward. AUSTRAPEN is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using AUSTRAPEN? in the full CMI.

6. Are there any side effects?

Tell your doctor if you notice any of the following: pain or redness at the site of injection, oral thrush - white, furry, sore tongue and mouth, vaginal thrush - sore and itchy vagina and/or discharge, a mild rash.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following: a severe skin reaction, including severe rash or blisters, wheezing, irregular heart beat, feeling faint.

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after finishing treatment with AUSTRAPEN: severe abdominal cramps or stomach cramps, fever or watery and severe diarrhoea, which may also be bloody.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

AUSTRAPEN^®

Active ingredient: ampicillin (as sodium)

Consumer Medicine Information (CMI)

This leaflet provides important information about using AUSTRAPEN. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using AUSTRAPEN.

Where to find information in this leaflet:

1. Why am I using AUSTRAPEN?
2. What should I know before I use AUSTRAPEN?
3. What if I am taking other medicines?
4. How do I use AUSTRAPEN?
5. What should I know while using AUSTRAPEN?
6. Are there any side effects?
7. Product details

1. Why am I using AUSTRAPEN?

AUSTRAPEN contains the active ingredient ampicillin (as sodium). AUSTRAPEN is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

AUSTRAPEN is an antibiotic used to treat infections in different parts of the body caused by bacteria.

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

Your doctor may have prescribed AUSTRAPEN for another reason. Ask your doctor why AUSTRAPEN has been prescribed for you.

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

There is no evidence that AUSTRAPEN is addictive.

2. What should I know before I use AUSTRAPEN?

Warnings

Do not use AUSTRAPEN if:

you are allergic to ampicillin (as sodium), penicillins, cephalosporins or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:
- skin rash
- itching
- difficulty breathing
Always check the ingredients to make sure you can use this medicine.

If you are not sure whether you should be given AUSTRAPEN, talk to your doctor.

Check with your doctor if you:

have an allergy to AUSTRAPEN or any other penicillin.
have any type of allergic reaction to cephalosporin medicines.
You may have an increased chance of being allergic to AUSTRAPEN if you are allergic to cephalosporins.
have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes. This may include medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
you have or have ever had any other health problems/medical conditions, including asthma, kidney or liver disease.

If you have not told your doctor about any of the above, tell him/her before you are given AUSTRAPEN.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the risks and benefits of using AUSTRAPEN during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the risks and benefits of using AUSTRAPEN when breast-feeding.

3. What if I am taking other medicines?

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

Some medicines may interfere with AUSTRAPEN. These include:

probenecid
some antibiotics e.g. tetracyclines, erythromycin and chloramphenicol.

These medicines may be affected by AUSTRAPEN, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid whilst receiving AUSTRAPEN.

Some antibiotics may decrease the effectiveness of some birth control pills.

Talk to your doctor about the need for an additional method of contraception whilst receiving AUSTRAPEN.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect AUSTRAPEN.

4. How do I use AUSTRAPEN?

How AUSTRAPEN is given

AUSTRAPEN may be given in two ways:

as a slow injection into a vein
as a deep injection into a large muscle, a joint or the sac surrounding the lung.

AUSTRAPEN must only be given by a doctor or nurse.

Your doctor will decide what dose and for how long you will receive AUSTRAPEN. This depends on your infection and other factors, such as your weight. For most infections, AUSTRAPEN is usually given in divided doses throughout the day.

To reduce microbial contamination, each AUSTRAPEN vial is used only once. Any remaining contents must be discarded.

If you have too much AUSTRAPEN

This rarely happens as AUSTRAPEN is administered under the care of a highly trained doctor. However, if you are given too much AUSTRAPEN, you may experience some of the side effects listed under Section 6 'Are there any side effects?'. Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns. A very large overdose of AUSTRAPEN can cause brain upsets including fits.

If you think that you have used too much AUSTRAPEN, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using AUSTRAPEN?

Things you should do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you develop itching with swelling or skin rash or difficulty breathing after you have been given AUSTRAPEN, contact your doctor immediately.
If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after AUSTRAPEN 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.
An illness consisting of a rash, swollen glands, joint pains and fever may occur about a week after the treatment.
If you get a sore white mouth or tongue after you have been given AUSTRAPEN, tell your doctor.
Tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of AUSTRAPEN allows fungi to grow and the above symptoms to occur. AUSTRAPEN does not work against fungi.
If you become pregnant while you are receiving AUSTRAPEN, tell your doctor.
If you have to have any tests tell your doctor you have been given AUSTRAPEN. AUSTRAPEN may affect the results of some tests.
Tell any doctor, dentist or pharmacist who is treating you that you have been given AUSTRAPEN.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how AUSTRAPEN affects you.

AUSTRAPEN generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, AUSTRAPEN may cause dizziness, drowsiness or tiredness in some people.

Looking after your medicine

AUSTRAPEN will be stored in the pharmacy or on the ward. Store it in a cool dry place, protected from light, where the temperature stays below 25°C. AUSTRAPEN is not to be given after the expiry date on the label.

Do not use AUSTRAPEN if:

the packaging is torn or shows signs of tampering
the expiry date on the pack has passed. If you take it after the expiry date, it may have no effect at all, or worse, an unexpected effect.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Check with your doctor as soon as possible if you have any problems whilst receiving AUSTRAPEN, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
pain or redness at the site of injection oral thrush - white, furry, sore tongue and mouth vaginal thrush - sore and itchy vagina and/or discharge a mild rash	Tell your doctor if you notice any of the following.

Serious side effects

Serious side effects	What to do
a severe skin reaction, including severe rash or blisters wheezing irregular heart beat feeling faint If you are suffering from glandular fever or some other more serious blood complaints, it is very common to develop a rash if you are given AUSTRAPEN. The rash will disappear after the AUSTRAPEN is stopped.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

After finishing AUSTRAPEN

Serious side effects	What to do
severe abdominal cramps or stomach cramps watery and severe diarrhoea, which may also be bloody fever, in combination with one or both of the above These are rare but serious side effects. AUSTRAPEN can change bacteria (which are normally present in the bowel and normally harmless) to multiply and therefore cause the above symptoms. You may need urgent medical attention.	Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after finishing treatment with AUSTRAPEN.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

This is not a complete list of all possible side effects. Other side effects not listed above may also occur in some patients. These include very rare cases of brain, blood and kidney disease.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

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

What AUSTRAPEN contains

Active ingredient (main ingredient)	Ampicillin sodium 1000 mg
Other ingredients (inactive ingredients)	None
Potential allergens	N/A

Do not take this medicine if you are allergic to the above ingredient.

What AUSTRAPEN looks like

AUSTRAPEN is a white to almost white powder which has to be dissolved in water before it is injected (AUST R 29354).

Available in packs of 5 x 1000 mg vials.

Who distributes AUSTRAPEN

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.

AUSTRAPEN^® is a Viatris company trade mark

AUSTRAPEN_cmi\May23/00

Published by MIMS June 2023

BRAND INFORMATION

Brand name

Austrapen

Active ingredient

Ampicillin

Schedule

1 Name of Medicine

Ampicillin (as sodium).

2 Qualitative and Quantitative Composition

Each Austrapen 1000 mg powder for injection contains 1000 mg of ampicillin (as sodium) as the active ingredient.
Each 1 gram of monograph substance represents 2.7 mmol of sodium.

3 Pharmaceutical Form

Powder for injection.
Austrapen powder for injection is a white to almost white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of infections due to susceptible strains of Gram positive and Gram negative organisms (see Section 5.1 Pharmacodynamic Properties, Mechanism of action, Microbiology). Bacteriological studies to determine the organism and its sensitivity should be undertaken.

4.2 Dose and Method of Administration

Austrapen may be given by intramuscular injection, by intravenous infusion or by slow intravenous injection.

Respiratory tract infections.

Adults.

250 to 500 mg six hourly.

Children.

25 to 50 mg/kg/day in equally divided doses, six hourly.

Chronic bronchitis.

Adults.

500 mg six hourly. (High dosage therapy - 1 g six hourly).

Urinary tract infections.

Adults.

500 mg six hourly.

Children.

50 mg/kg/day in equally divided doses, six hourly.

Gastrointestinal tract infections.

Adults.

500 to 750 mg six hourly.

Children.

50 to 70 mg/kg/day in equally divided doses, six hourly.
The children's dosage is intended for individuals whose weight will not cause a dosage to be calculated greater than that recommended for adults. Children weighing more than 20 kg should be dosed according to the adult recommendations. It should be recognised that frequent bacteriological and clinical appraisals are necessary in the treatment of chronic urinary tract and intestinal infections.
Smaller doses than those recommended above should not be used. Higher doses may be needed at times. The usual duration of therapy is 5 to 10 days but in some cases therapy may be required for longer durations. 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 help prevent the occurrence of acute rheumatic fever or glomerulonephritis.

Bacterial meningitis and septicaemia.

Adults and children.

200 mg/kg/day in equally divided doses, four to six hourly, intravenously, with an upper limit of 12 g daily.

Intraperitoneal use.

At least 500 mg per 10 mL water for injections daily.

Intrapleural use.

500 mg in 5 to 10 mL water for injections daily.

Intra-articular use.

500 mg daily, dissolved in up to 5 mL of water for injections, or 0.5% procaine hydrochloride.

Intrathecal use.

Not recommended.

Neonatal dosage.

The half-life of ampicillin sodium varies inversely with age in neonates. The recommended dosage is 25 mg/kg (50 mg/kg for meningitis) at the following intervals.

Infants < 2000 g and 0 to 7 days.

Every 12 hr.

Infants < 2000 g and > 7 days.

Every 8 hr.

Infants > 2000 g and 0 to 7 days.

Every 8 hr.

Infants > 2000 g and > 7 days.

Every 6 hr.

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 dosage. The following dosage schedule is recommended.
Glomerular filtration rate 10 to 50 mL/minute, dose normal, dosage interval 6 to 12 hours.
Glomerular filtration rate < 10 mL/minute, dose normal, dosage interval 12 to 16 hours.

Preparation of injections.

Use a 21 G [0.8 mm] needle for reconstitution. It is recommended to slice the bung with the bevelled edge facing upwards and avoid a stabbing action when inserting the needle of the syringe into the vial, through the rubber stopper (see Section 4.4 Special Warnings and Precautions for Use, Identified precautions).
Ampicillin sodium is unstable in concentrated solutions and contains no anti-microbial preservative. When Austrapen is reconstituted with water for injections, it must be administered immediately to reduce microbiological hazard. Shake the vial immediately after adding the diluent.
Following reconstitution, Austrapen may be held in certain intravenous fluids as described in Table 2 (see Section 6.4 Special Precautions for Storage). Each Austrapen vial should be used in one patient on one occasion only and any residue discarded.

Intramuscular administration.

(a) When the entire contents of a vial are to be used, 1.5 mL water for injections should be added to the 1 g vial.
(b) When only part of a vial's content is required, the amount of water for injections which should be added to provide a convenient final concentration is shown in Table 1. The remaining contents of the vial should be discarded.

Direct intravenous administration.

Reconstitute in 10 to 20 mL of water for injections and inject slowly over 3 to 5 minutes.
Caution - more rapid administration may result in convulsive seizures.

Intravenous infusion.

Reconstitute as for intramuscular administration prior to diluting with intravenous solution. The ampicillin solution should be administered as a rapid infusion over 30 to 40 minutes.

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, Austrapen should be discontinued immediately and an alternative treatment should be considered.

Identified precautions.

Coring has been reported during reconstitution. It is strongly advised that a 21 G [0.8 mm] diameter size needle is used during reconstitution. It is important that the correct needle size is used to avoid coring.
As further precaution, avoid stabbing action when inserting the needle of the syringe into the vial, through the rubber stopper; it is recommended to slice the bung with the bevelled edge facing upwards. (See Section 4.2 Dose and Method of Administration, Preparation of injections).

Hypersensitivity reactions.

Serious, and occasionally fatal, hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy it has occurred in patients on oral therapy. Before commencing therapy with any beta-lactam antibiotic, careful enquiries should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If a hypersensitivity reaction occurs, appropriate therapy should be instituted and Austrapen therapy discontinued.
Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.

Pseudomembranous colitis.

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including ampicillin. 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). 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, electrolyte and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine may prolong and/or worsen the condition and should not be used.

Allergic diathesis.

Caution should be exercised in the treatment of patients with an allergic diathesis.
Austrapen is not the treatment of choice in patients presenting with sore throat or pharyngitis. This is because the underlying cause may be infectious mononucleosis, in the presence of which there is a high incidence of rash if ampicillin is used. Patients with lymphatic leukaemia also appear to have a higher incidence of skin rashes when treated with ampicillin.

Renal, hepatic and haematopoietic function.

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 Enterobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Indwelling urethral catheters should be checked regularly as the high concentrations of ampicillin in the urine may cause it to precipitate out of solution at room temperature. The risk of crystalluria should be avoided by maintaining a high urinary output.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

As administration of Austrapen will result in high ampicillin concentrations in the urine, false positive reactions may be elicited when testing the urine for glucose with Clinitest, Benedict's solution or Fehling's solution. Tests based on enzymatic glucose oxidase reactions such as Testape or Clinistix should be used instead.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol glucuronide, conjugated estrone and estradiol has been noted.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid.

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

Tetracyclines, erythromycin and chloramphenicol.

Tetracyclines, erythromycin and chloramphenicol antagonise the action of ampicillin.

Gentamicin.

Gentamicin should not be mixed with ampicillin when both drugs are given parenterally as inactivation occurs.

Allopurinol and ampicillin.

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 hyperuricaemia present in these patients.

Oral contraceptives.

In common with other antibiotics, patients should be warned that Austrapen may reduce the effectiveness of oral contraceptives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No information is available.
(Category A)
Ampicillin diffuses across the placenta into the foetal circulation. Animal studies with ampicillin have shown no teratogenic effects. The product has been in clinical use for nearly 30 years and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effect. The use of Austrapen in pregnancy should be reserved for cases considered essential by the clinician.

Use in labour and delivery.

Studies in guinea pigs have shown that intravenous administration of ampicillin decreases uterine tone and the frequency, strength and duration of contractions. However, it is not known whether the use of ampicillin in humans during labour or delivery has any immediate or delayed adverse effects, prolongs the duration of the labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
Ampicillin is excreted in breast milk. An alternative feeding method is recommended to avoid any possible sensitisation of 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 all penicillins, the possibility of allergic reactions should always be considered. Reactions are more likely to occur in those with an allergic diathesis. Anaphylactic shock is most likely to occur with injected penicillins (see Section 4.4 Special Warnings and Precautions for Use).
The following adverse reactions have been reported as associated with the use of ampicillin.

Gastrointestinal.

Glossitis, stomatitis, black hairy tongue, nausea, vomiting and diarrhoea. These reactions are usually associated with oral dosage forms (see Section 4.4 Special Warnings and Precautions for Use).

Hypersensitivity reactions.

An erythematous maculopapular rash has been reported fairly frequently. A macular rash, which is not believed to be a hypersensitivity reaction, occurs predominantly in patients with infectious mononucleosis 4 to 5 days after beginning therapy with ampicillin.
Urticaria and erythema multiforme have been reported occasionally. A few cases of exfoliative dermatitis have been reported. Anaphylaxis is the most serious reaction experienced (see Section 4.4 Special Warnings and Precautions for Use).

Note.

Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, ampicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life threatening and amenable only to ampicillin therapy.

Hepatic.

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

Haematological.

Anaemia, thrombocytopenia, haemolytic anaemia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy, and are believed to be sensitivity reactions.

Renal.

Nephropathy has been reported rarely.

CNS.

Encephalopathy can occur when the ampicillin blood level reaches 800 mg/L. As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of ampicillin in patients with meningitis. This can result in drowsiness, hyper-reflexia, myoclonic twitches, convulsions and coma.

Injection site.

Pain may be experienced at the site of intramuscular injection and phlebitis at the site of intravenous injection.

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.

Other.

Vaginal or oral moniliasis may occur following the use of antibiotics.
Seventy two percent of all adverse events to ampicillin recorded in the Australian Adverse Drug Reaction System include rash as a symptom.

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

Symptoms.

Treatment.

There is no specific treatment for Austrapen overdosage. Ampicillin is removed by haemodialysis. Patients usually recover as the penicillin blood level decreases.
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.

Ampicillin is bactericidal and is active against a wider range of organisms than benzylpenicillin. It is less active than benzylpenicillin against Gram positive organisms but is active in vitro against Streptococcus pyogenes (Group A, β-haemolytic Streptococci) and many strains of Streptococcus pneumoniae (D. pneumonia), Streptococcus viridans, non-penicillinase producing Staphylococci and Enterococcus faecalis (Group D Streptococci). There are strains of Escherichia coli that are sensitive to ampicillin, but isolates are becoming increasingly resistant in vitro due to the presence of penicillinase producing strains. Some of the above organisms are sensitive to ampicillin only at concentrations achieved in the urine. Many strains of Haemophilus influenzae, Neisseria meningitidis, Proteus mirabilis and Salmonellae are sensitive to ampicillin, although the increasing incidence of beta-lactamase activity in H. influenzae and E. coli are reducing the capacity of ampicillin to treat diseases caused by these organisms.
Ampicillin is not effective against penicillinase producing bacteria, particularly resistant Staphylococci, which are now common. All strains of Pseudomonas, indole positive Proteus, Serratia marcescens, Enterobacter, Klebsiella, Citrobacter and penicillinase producing Neisseria gonorrhoeae are resistant.
Like benzylpenicillin, ampicillin is bactericidal to sensitive organisms during the stage of active cell division. It is believed to act through the inhibition of cell wall synthesis.

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 technique 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 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 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption and distribution.

Ampicillin sodium diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid. Intramuscular injections of 500 mg and 1 g of ampicillin sodium result in peak plasma concentrations of around 7 and 10 mg/L respectively at one hour. Intravenous injection of 500 mg of ampicillin sodium yields a peak plasma concentration of 17 mg/L at 15 minutes. Some penetration occurs through inflamed meninges but maximum CSF levels are very much lower than peak serum levels. Ampicillin is excreted mainly via the urine where it exists at 0 to 6 hours at a concentration of 0.9 to 2.2 g/L following a 500 mg intramuscular dose and 0.1 to 0.6 g/L after 500 mg given intravenously.

Metabolism.

Ampicillin is not highly protein-bound; 29 + 12% is reported to be protein-bound in the serum.
The amount to be found in bile is variable. Approximately 0.1% is excreted unchanged in the bile.
The half-life of ampicillin is approximately 1 hour with normal renal function and up to 20 hours in the total absence of renal function. Renal clearance of ampicillin is slower than that of benzylpenicillin.

Excretion.

Ampicillin is excreted in the urine both unchanged and as penicilloic acid. About 66% of a 500 mg intramuscular dose and 73% of a 500 mg intravenous dose is excreted in the urine in 6 hours in the presence of normal renal function.
Excretion of ampicillin can be delayed by concurrent administration of probenecid, thus prolonging its therapeutic effect.

5.3 Preclinical Safety Data

Genotoxicity.

No available information.

Carcinogenicity.

No available information.

6 Pharmaceutical Particulars

6.1 List of Excipients

Austrapen powder for injection contains no antiseptic or buffering agent nor are there any excipients.

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

Austrapen should be stored below 25°C, protected from light.

Dry powder.

If stored below 25°C, potency is maintained until the expiry date on the container label.

Solution.

Ampicillin is unstable in concentrated solution and when prepared for injection or infusion, should be administered immediately.

Intravenous fluids.

To reduce microbiological hazard, use as soon as practicable after reconstitution/ dilution. If required, Austrapen may be held at 2-8°C in certain intravenous fluids following reconstitution. See Table 2.

Reconstituted Austrapen Powder for Injection should not be added to infusion bottles containing 10% Rheomacrodex in 5% glucose (Dextran 40 Injection BP in Glucose Injection), 5% glucose or glucose saline, but may be injected into the drip tubing of such an infusion (see Section 4.2 Dose and Method of Administration, Preparation of injections, Direct intravenous administration).

6.5 Nature and Contents of Container

Container type.

Glass type 1 clear vial with a dark grey bromobutyl rubber stopper and aluminium flip-off seal in boxes of 5 vials.

Australian Register of Therapeutic Goods (ARTG).

AUST R 29354 - Austrapen ampicillin 1 g (as sodium) powder for injection vial.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Ampicillin (as sodium) is freely soluble in water, practically insoluble in acetone, in fatty oils and in liquid paraffin.

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