Consumer medicine information

Ibimicyn

Ampicillin

BRAND INFORMATION

Brand name

Ibimicyn

Active ingredient

Ampicillin

Schedule

SUMMARY CMI

IBIMICYN

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 IBIMICYN?

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

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

2. What should I know before I use IBIMICYN?

Do not use if you have ever had an allergic reaction to IBIMICYN 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 IBIMICYN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with IBIMICYN 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 IBIMICYN?

IBIMICYN must only be given by a doctor or nurse.

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

5. What should I know while using IBIMICYN?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using IBIMICYN. If you develop itching with swelling or skin rash or difficulty breathing after you have been given IBIMICYN, contact your doctor immediately. If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after IBIMICYN has been stopped.
Driving or using machines	Be careful driving or operating machinery until you know how IBIMICYN affects you.
Looking after your medicine	IBIMICYN is stored in the pharmacy or on the ward. IBIMICYN 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 IBIMICYN? 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 IBIMICYN: 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

IBIMICYN

Active ingredient(s): ampicillin (as sodium)

Consumer Medicine Information (CMI)

This leaflet provides important information about using IBIMICYN. 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 IBIMICYN.

Where to find information in this leaflet:

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

1. Why am I using IBIMICYN?

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

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

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

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

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

There is no evidence that IBIMICYN is addictive.

2. What should I know before I use IBIMICYN?

Warnings

Do not use IBIMICYN 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 or swelling

Always check the ingredients to make sure you can use this medicine.

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

Check with your doctor if you:

have an allergy to IBIMICYN or any other penicillin.
have any type of allergic reaction to cephalosporin medicines.

You may have an increased chance of being allergic to IBIMICYN 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, hayfever, glandular fever (infectious mononucleosis), kidney or liver disease.

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

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 IBIMICYN during pregnancy.

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

Your doctor will discuss the risks and benefits of using IBIMICYN 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 IBIMICYN. These include:

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

These medicines may be affected by IBIMICYN, 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 IBIMICYN.

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 IBIMICYN.

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

4. How do I use IBIMICYN?

How IBIMICYN is given

IBIMICYN 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.

IBIMICYN must only be given by a doctor or nurse.

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

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

If you have too much IBIMICYN

This rarely happens as IBIMICYN is administered under the care of a highly trained doctor. However, if you are given too much IBIMICYN, 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 IBIMICYN can cause brain upsets including fits.

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

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), 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 IBIMICYN?

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 IBIMICYN, contact your doctor immediately.
If you get severe diarrhoea tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after IBIMICYN 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 IBIMICYN, 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 IBIMICYN allows fungi to grow and the above symptoms to occur. IBIMICYN does not work against fungi.
If you become pregnant while you are receiving IBIMICYN, tell your doctor.
If you have to have any tests tell your doctor you have been given IBIMICYN. IBIMICYN may affect the results of some tests.
Tell any doctor, dentist or pharmacist who is treating you that you have been given IBIMICYN.

Driving or using machines

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

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

Looking after your medicine

IBIMICYN 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. IBIMICYN is not to be given after the expiry date on the label.

Do not use IBIMICYN 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 IBIMICYN, 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 IBIMICYN. The rash will disappear after the IBIMICYN 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 IBIMICYN

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. IBIMICYN 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 IBIMICYN.

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 IBIMICYN contains

Active ingredient (main ingredient)	Ampicillin sodium 500mg or 1g
Other ingredients (inactive ingredients)	None
Potential allergens	N/A

Do not take this medicine if you are allergic to any of these ingredients.

What IBIMICYN looks like

IBIMICYN is a white crystalline powder. It is available in pack of 5* and 10 vials of 500mg or 1g.

5*- Presentations not currently marketed.

Who distributes IBIMICYN

Juno Pharmaceuticals Pty Ltd
42 Kelso Street,
Cremorne,
VIC 3121
www.junopharm.com.au

Australian Registration Numbers:

AUST R 92839 (IBIMICYN 500mg)
AUST R 92840 (IBIMICYN 1g)

This leaflet was prepared in October 2023.

Published by MIMS January 2024

BRAND INFORMATION

Brand name

Ibimicyn

Active ingredient

Ampicillin

Schedule

1 Name of Medicine

Ampicillin (as sodium).

2 Qualitative and Quantitative Composition

Ibimicyn is a white to off-white powder contained in a clear glass vial. This product contains no excipients.
It occurs as a white, crystalline powder, odourless; taste bitter, hygroscopic.
It is freely soluble in water, sparingly soluble in acetone and practically insoluble in ether, fatty oils and in liquid paraffin.
Each gram of ampicillin sodium contains approximately 2.7 mmol of sodium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ampicillin (as sodium), 500 mg powder for injection vial.
Ampicillin (as sodium), 1 g powder for injection vial.

4 Clinical Particulars

4.1 Therapeutic Indications

Ibimicyn is indicated for:
Treatment of infections due to susceptible strains of Gram positive and Gram negative organisms (see Section 5.1 Pharmacodynamic Properties, Microbiology). Bacteriological studies to determine the causative organisms and their sensitivity to ampicillin sodium should be performed.

4.2 Dose and Method of Administration

Respiratory tract infections.

Adults.

250-500 mg six hourly.

Children.

25-50 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.

500-750 mg six hourly.

Children.

50-70 mg/kg day in equally divided doses, six hourly.
It should be recognised that in the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisals are necessary.
Smaller doses than those recommended above should not be used. The usual duration of therapy is 5-10 days but in some cases therapy may be required for longer durations. Even higher doses may be needed at times. Treatment should be continued for a minimum of 48-72 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. Specific recommendations for more severe types of infections are shown below.

Bacterial meningitis.

Adults and children.

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

Septicaemia.

Adults and children.

200 mg/kg/day in equally divided doses, four to six hourly, I.V. with an upper limit of 12 g/day.
When parenteral administration is required for any of these conditions, similar doses should apply (the dosage interval for intravenous administration should be no greater than four hours).

Children's dosage.

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

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 0-7 days, 12 hourly.
Infants < 2000 g and > 7 days or > 2000 g and 0-7 days, 8 hourly.
Infants > 2000 g and > 7 days, 6 hourly.

Patients with 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 regimen has been suggested. (See Table 1).

Preparation of injections.

Shake the vial immediately after adding the diluent. Ampicillin sodium is unstable in concentrated solution and when prepared for injection should be administered immediately.
Product is for one dose in one patient only. Discard any remaining contents.

Intramuscular injection.

When the entire content of a vial is to be used, 1.5 mL of Water for Injections BP should be added to the 500 mg or 1 g vial.
When only part of a vial's content is required, the amount of Water for Injections BP which should be added to provide a convenient final concentration is shown in the following table. (See Table 2).

Intravenous injection.

Dissolve 500 mg in 5 mL of sterile water for injections BP, and administer by slow injection (3-4 minutes).
Dissolve 1 g in at least 7.4 mL of sterile water for injections and administer slowly over 10-15 minutes.

Caution.

More rapid administration may result in convulsive seizures.

Infusion.

Reconstitute as for intramuscular administration prior to diluting with intravenous solution (normal saline, Ringer's solution, M/6 lactate, 1.4% sodium bicarbonate or dextran 40 in sodium chloride. The ampicillin sodium solution should be administered as a rapid infusion over 30 to 40 minutes.

Intraperitoneal use.

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

Intrapleural use.

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

Intra-articular use.

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

Intrathecal use.

Reconstitute in normal saline to give a solution of concentration 10 mg/mL.
Children up to 2 years: 5-10 mg; 2-10 years: 10-20 mg.
Adults: 20-40 mg.

4.3 Contraindications

History of an allergic reaction to any of the penicillins or cephalosporin antibiotics.

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, Ibimicyn 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 21G [0.8mm] 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).
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 occured in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity reactions to multiple allergens. Cross sensitivity to cephalosporins may occur.
Before commencing therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If an allergic reaction occurs, the drug should be discontinued and 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.

Pseudomembranous colitis.

Antobiotic associated pseudomembranous colitis has been reported with many antibiotics including ampicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to 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 C. difficile should be considered.
Drugs which delay peristalsis, e.g. opiate and diphenoxylate with atropine (Lomotil), may prolong and/or worsen the condition and should not be used. Fluid, electrolyte and protein replacement therapy should be provided when indicated.
Ampicillin sodium, an aminopenicillin, is not the treatment of choice in patients 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 ampicillin sodium is used. Patients with lymphatic leukaemia also appear to have a higher incidence of skin rashes when treated with ampicillin sodium.
As with any antibiotic preparation, constant observation for signs of overgrowth of nonsusceptible organisms, including fungi, is essential. Should superinfection occur (usually involving Enterobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted. It is advisable to check periodically for organ system dysfunction during prolonged therapy, including renal, hepatic and haemopoietic systems. This is particularly important in prematures, neonates and other infants.

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.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

Allopurinol may lead to an increase in ampicillin sodium induced rashes. Tetracyclines, erythromycin and chloramphenicol antagonise the action of ampicillin sodium. Gentamycin should not be mixed with ampicillin when both drugs are given parenterally (due to the inactivation which occurs). Probenecid delays the excretion of ampicillin.

Oral contraceptives.

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Australian Definition of Pregnancy Classification A: Drugs which have been taken by a large 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 fetus having been observed.
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 Ibimicyn in pregnancy should be reserved for cases considered essential by the clinician.
Concentrations can be detected in the milk of nursing mothers. Thus there is a risk of allergic sensitisation in the infant.

Use in labour and delivery.

Studies in guinea pigs have shown that intravenous administration of ampicillin sodium decreased the uterine tone, frequency of contractions, height of contractions and duration of contractions. However, it is not known whether the use of ampicillin in humans during labour or delivery prolongs the duration of labour or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

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 this registration.

4.8 Adverse Effects (Undesirable Effects)

It may be expected that untoward reactions will be limited essentially to sensitivity phenomena. These are more likely where previous hypersensitivity to penicillins has occurred and in those with a history of allergy, asthma, hay fever or urticaria. The following adverse reactions have been reported as associated with the use of ampicillin sodium.

Gastrointestinal.

Glossitis, stomatitis, black hairy tongue, nausea, vomiting and diarrhoea. These reactions are usually associated with oral dosage forms.

Hypersensitivity reactions.

An erythematous maculopapular rash has been reported fairly frequently. Urticaria and erythema multiforme have been reported occasionally. A few cases of exfoliative dermatitis have been reported. Anaphylaxis is the most serious reaction experienced.

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 sodium therapy.

Hepatic.

A moderate rise in serum aspartate aminotransferase (AST) has been noted, particularly in infants, but the significance of this finding is unknown.

Haemic and lymphatic systems.

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

Renal.

Nephropathy has been reported rarely.

CNS.

Encephalopathy can occur when the ampicillin blood level reaches 800mg/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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

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.

Treatment.

There is no specific treatment for Ibimicyn 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.

Ibimicyn is a broad spectrum semisynthetic penicillin.

Microbiology.

Ampicillin sodium is similar to benzylpenicillin in its bactericidal action against sensitive organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. It generally provides less in vitro activity against Gram positive bacteria than benzylpenicillin and differs in its in vivo spectrum from benzylpenicillin in the Gram negative spectrum. Ampicillin sodium is susceptible to beta-lactamases and is, therefore, not effective against penicillinase producing bacteria.
In vitro studies have demonstrated the susceptibility of many strains of the following organisms.

Gram negative.

Haemophilus influenzae; Neisseria meningitidis; Escherichia coli; Proteus mirabilis; Salmonella and Shigella species.

Gram positive.

Streptococcus pyogenes (group A, β-haemolytic Strep.); Streptococcus pneumoniae (D. pneumoniae); Streptococcus viridans; Streptococcus faecalis (enterococcus, group D Strep.); nonpenicillinase producing Staphylococci (methicillin resistant strains are resistant to ampicillin); Listeria monocytogenes.

Note.

(i) An increasing number of strains of H. influenzae and E. coli have become resistant due to their beta-lactamase producing ability.
(ii) Because of an increasing incidence of ampicillin resistant H. influenzae, ampicillin sodium is not recommended for the empirical treatment of meningitis as a single agent.
(iii) All strains of Pseudomonas, indole positive Proteus, Serratia marcescens, Enterobacter, Klebsiella, Citrobacter and penicillinase producing N. gonorrhoeae are resistant.

Susceptibility testing.

Dilution or diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. NCCLS). Standardised susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of 'susceptible' indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of ‘intermediate’ indicates that the result should be considered equivocal and if the microorganism is not fully susceptible to 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.

5.2 Pharmacokinetic Properties

Absorption.

Intramuscular injection of 500 mg and 1 g of ampicillin (as the sodium salt) results in peak plasma concentrations of about 7 and 10 microgram/mL respectively at one hour. Intravenous injection of 500 mg of ampicillin sodium yields a peak plasma concentration of 17 microgram/mL at 15 minutes.

Distribution.

Ampicillin sodium diffuses readily into most body tissues except ocular fluids, prostate, brain and spinal fluid. Penetration into brain and CSF is increased when meninges are inflamed, although maximum CSF levels are very much lower than peak serum levels. Thoracic lymph levels parallel serum levels. Ampicillin sodium crosses the placenta and is present in foetal serum and amniotic fluid at delivery.

Metabolism.

Ampicillin sodium is approximately 20% serum bound and in patients with normal renal function has a serum half-life of approximately 60 minutes. This is increased two to three times in the newborn, and may extend up to 20 hours in anuric patients. Ampicillin sodium crosses the placental barrier and with appropriate dosage achieves therapeutic levels in both cord blood and amniotic fluid.
Ampicillin sodium appears in the bile in higher concentrations than found in the serum and undergoes enterohepatic circulation. Concentrations in the bile are variable. In subjects with a nonfunctioning gall bladder biliary concentrations of ampicillin sodium are low. In the presence of common bile duct obstruction, ampicillin sodium is not detectable in the bile.

Excretion.

In patients with normal renal function, 60% of an injected dose and 30% of an oral dose is excreted in the urine within 6 hours of administration. Higher ampicillin sodium serum levels may be achieved by the simultaneous use of a renal blocking agent, such as probenecid. In adults, probenecid in a dose of either 1 g twice daily or 500 mg four times daily results in a one and a half to two fold increase in the Ibimicyn serum levels.
Urinary concentrations of ampicillin sodium at 0-6 hours are 0.9-2.2 mg/mL after a 500 mg IM dose, 0.1-0.6 mg/mL after 500 mg IV.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ibimicyn 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

Dry powder.

Store below 25°C. Protect from moisture. Protect from light.

Solutions for intramuscular injection.

Use within 30 minutes of preparation. Ampicillin sodium is unstable in concentrated solution. All ampicillin sodium solutions for injection or infusion should be prepared immediately before use.
Do not add to infusion bottles of 5% glucose, glucose saline or dextran 40 in glucose injection. Ampicillin sodium may be given into the drip tubing of those infusions.

6.5 Nature and Contents of Container

Clear glass vial containing a white or almost white substance sealed with a rubber closure and a flip off top.

Pack size.

500 mg, 1 g (5* and 10' vials). 5*: Not currently marketed.

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

Chemical name: (2S, 5R, 6R)-6- [[(2R)-2-amino- 2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylate.

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