Consumer medicine information

Cilicaine V

Phenoxymethylpenicillin

BRAND INFORMATION

Brand name

Cilicaine V

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Cilicaine V.

SUMMARY CMI

CILICAINE® V

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 CILICAINE V?

CILICAINE V contains the active ingredient phenoxymethylpenicillin benzathine. CILICAINE V is used to treat infections in different parts of the body caused by bacteria.

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

2. What should I know before I use CILICAINE V?

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

3. What if I am taking other medicines?

Some medicines may interfere with CILICAINE V 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 CILICAINE V?

  • Your doctor will tell you how much CILICAINE V you need to take.
  • This will depend on the type of infection you have.

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

5. What should I know while using CILICAINE V?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using CILICAINE V.
  • 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 of skin rash or difficulty breathing while you are taking CILICAINE V do not take any more and contact your doctor immediately.
Things you should not do
  • Do not take CILICAINE V 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 because you are feeling better, unless advised by your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how CILICAINE V affects you.
Drinking alcohol
  • Be careful when drinking alcohol while you are taking this medicine.
Looking after your medicine
  • Store CILICAINE V oral suspension in a refrigerator, between 2°C to 8°C. Do not freeze. Shake well before use.
  • Keep your suspension in the bottle until it is time to take it.

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

6. Are there any side effects?

Tell your doctor or pharmacist if you notice any of the following and they worry you: nausea & vomiting, black hairy tongue, diarrhoea, or pain or discomfort right below your ribs (epigastric distress). If any of the following happen, tell your doctor immediately or go the Accident and Emergency at your nearest hospital: 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.

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

CILICAINE® V

Active ingredient(s): phenoxymethylpenicillin benzathine

Consumer Medicine Information (CMI)

This leaflet provides important information about using CILICAINE V. 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 CILICAINE V.

Where to find information in this leaflet:

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

1. Why am I using CILICAINE V?

CILICAINE V contains the active ingredient phenoxymethylpenicillin benzathine. CILICAINE V belongs to a group of medicines called penicillins. It works by killing the bacteria that are causing the infection. It will not work against infections caused by viruses such as colds or the flu.

CILICAINE V is used to treat infections in different parts of the body caused by bacteria.

Ask your doctor or pharmacist if you have any questions about why CILICAINE V has been prescribed for you.

Your doctor may have prescribed this medicine for another purpose.

This medicine is not addictive.

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

2. What should I know before I use CILICAINE V?

Warnings

Do not use CILICAINE V if:

  • you are allergic to any medicine containing phenoxymethylpenicillin benzathine, other penicillins, cephalosporins as you may have an increased chance of being allergic to CILICAINE V if you are allergic to this or 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
    - nausea, vomiting and diarrhoea

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

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, contact your doctor.

Check with your doctor if you:

  • have any allergies to any other medicines, foods, preservatives or dyes
  • have or have had any of the following medical conditions:
    - asthma
    - kidney problems

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

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

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

Like most medicines, CILICAINE V is not recommended during pregnancy of 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 and CILICAINE V may interfere with each other.

Tell your doctor or pharmacist if you are taking any oral contraceptive pills.

You may need to use other birth control methods while you are taking CILICAINE V.

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

4. How do I use CILICAINE V?

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 bottle, ask your doctor or pharmacist for help.

How much to take

  • Follow the instructions provided when CILICAINE V was prescribed, including the number of days it should be taken.
  • Adults: 250 mg to 500 mg every four to six hours, preferable one hour before food.
  • Prevention of recurrence following rheumatic fever: 250 mg twice a day continuously.
  • Children: the dose varies depending on their age, weight and how sick they are.
  • Your doctor may adjust your dose depending on the type and severity of the infection.

When to take CILICAINE V

  • CILICAINE V should be taken at about the same time each day.
  • Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
  • Your medicine is best taken on an empty stomach (one hour before meals and at bedtime), unless otherwise directed by your doctor

How to take CILICAINE V

  • Shake the bottle well before each dose and accurately measure the dose with a medicine measure.
  • Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can buy a medicine measure from your pharmacist.

How long to take it

  • Continue taking your medicine for as long as your doctor tells you.

What if I am feeling better?

  • The whole course of antibiotics should be taken, even if you are feeling better. If you stop taking antibiotics too soon the infection may start up again because not all the infection has been killed.
  • If your symptoms do not improve within a few days of starting CILICAINE V, or if they have become worse, check with your doctor.

If you forget to take CILICAINE V

CILICAINE V should be taken regularly at the same time each day.

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

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

Do not take double dose to make 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 use too much CILICAINE V

If you think that you have taken too much CILICAINE V, 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 CILICAINE V?

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 of skin rash or difficulty breathing while you are taking CILICAINE V do not take any more and contact your doctor immediately.
  • If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after CILICAINE V has been stopped.
    Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
  • If you get a sore white mouth or tongue while taking or soon after stopping CILICAINE V, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
    This may mean you have a fungal infection called thrush. Sometimes the use of CILICAINE V allows fungi to grow and the above symptoms to occur. CILICAINE V does not work against fungi.
  • If you become pregnant while taking CILICAINE V tell your doctor.
  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CILICAINE V.
  • If you are about to have any blood tests, tell your doctor that you are taking this medicine.
    It may interfere with the results of some tests.
  • Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Things you should not do

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

Driving or using machines

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

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Avoid drinking alcohol while taking CILICAINE V and for several days after completing a course of treatment with CILICAINE V.

Looking after your medicine

Keep your suspension in the bottle until it is time to take it.

Store CILICAINE V oral suspension in a refrigerator, between 2°C to 8°C. Do not freeze. Shake well before use.

Keep it where children cannot reach it

Getting rid of any unwanted medicine

If your doctor tells you to stop using CILICAINE V or it has passed its expiry date, ask your pharmacist what to do with any CILICAINE V left over.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using CILICAINE V.

CILICAINE V helps most people with infections, but it may have some 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.

Less serious side effects

Less serious side effectsWhat to do
  • nausea & vomiting
  • black hairy tongue
  • diarrhoea
  • pain or discomfort right below your ribs in the area of your upper abdomen (epigastric distress)

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

Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • 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

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

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.
  • 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. CILICAINE V can change bacteria, which is normally present in the bowel and normally harmless, to multiply and therefore cause the above symptoms. You may need urgent medical attention. However, this side effect is rare.

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with CILICAINE V

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

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

Other side effects not listed here may occur in some people.

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 CILICAINE V contains

Active ingredient
(main ingredient)		CILICAINE V contains 40.27 mg per mL of Phenoxymethylpenicillin benzathine as the active ingredient (equivalent to 30 mg per mL of phenoxymethylpenicillin).
Other ingredients
(inactive ingredients)
  • Apricot Flavouring Super Alpina 58% (ARTG PI No: 106680)
  • Butylated hydroxyanisole
  • Citric acid
  • Polysorbate 80
  • Potassium sorbate
  • Purified water
  • Sodium citrate dihydrate
  • Sodium methyl hydroxybenzoate
  • Sodium propyl hydroxybenzoate
  • Sucrose
  • Xanthan gum
Potential allergensCILICAINE V contains hydroxybenzoates, sorbates, sugars and soya bean products.

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

What CILICAINE V looks like

CILICAINE V is a beige, dense, viscous creamy suspension and apricot flavoured. (AUST R 151598)

Sponsor

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 June 2022.

CILICAINE® is a Viatris company trade mark

CILICAINE V_cmi\Jun22/00

Published by MIMS August 2022

BRAND INFORMATION

Brand name

Cilicaine V

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

1 Name of Medicine

Phenoxymethylpenicillin (as benzathine).

2 Qualitative and Quantitative Composition

Each 5 mL of oral liquid suspension contains 150 mg of phenoxymethylpenicillin (as benzathine) as the active ingredient.

Excipients with known effect.

Hydroxybenzoates, sorbates, sugars and soya bean products.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cilicaine V 150 mg/5 mL oral liquid suspension is a beige, dense, viscous creamy suspension and apricot flavoured.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response.
For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation.

Note.

Oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

4.2 Dose and Method of Administration

Adults.

250 mg to 500 mg every four to six hours, preferable one hour before food. The dosage should be determined according to sensitivity of the organisms and severity of the infection.

Prevention of recurrence following rheumatic fever.

250 mg twice a day continuously.

Children.

Infants and small children. 15 to 50 mg/kg in three to six divided doses. If not calculated by bodyweight the following dosage schedule may be used.

Up to 1 year.

60 mg every six hours.

1 to 5 years.

120 mg every six hours.

6 to 12 years.

120 to 270 mg every six hours.

4.3 Contraindications

Hypersensitivity to penicillins and/or cephalosporin.

4.4 Special Warnings and Precautions for Use

Risk-benefit should be considered when the following medical problems exist.

History of sensitivity (allergy to penicillins/ cephalosporins).

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, the drug 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.

Gastrointestinal disease (pseudomembranous colitis).

Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including phenoxymethylpenicillin. A toxin produced with 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, 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.
Phenoxymethylpenicillin is not recommended for chronic, severe or deep seated infections as therapeutic concentrations may not be achieved in the relevant tissues.
Oral administration should not be relied upon to achieve therapeutic levels in some patients with severe illness or with nausea, vomiting, gastric dilation, cardiospasm or intestinal hypermotility. Occasionally patients will not absorb therapeutic amounts of oral penicillin. Parenteral administration of suitable antibiotics is recommended in these patients.
In a streptococcal infection, therapy should continue for a minimum of ten days. Cultures should be taken following completion of treatment to determine whether Streptococci have been eradicated.
Use of an alternative or additional method of contraception is strongly recommended if an oestrogen containing contraceptive is taken concurrently (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

History of bleeding disorders.

Some penicillins may cause platelet dysfunction and haemorrhage.

Prolonged use.

Prolonged use of penicillins may lead to the development of oral candidiasis.

Use in hepatic impairment.

The half-life is greatly extended in these patients.

Use in renal impairment.

Because most penicillins are excreted through the kidneys, a reduction in dosage, or increase in dosing interval, is recommended in patients with renal function impairment; and the potassium content of high doses of phenoxymethylpenicillin potassium, should be considered in patients with severe renal function impairment.
The half-life is greatly extended in these patients.

Use in the elderly.

There are no age specific problems documented with the use of phenoxymethylpenicillin. However, the elderly are more likely to have age-related renal function impairment, which may require dosage adjustment.

Paediatric use.

The half-life of phenoxymethylpenicillin is prolonged in premature infants and neonates up to 3 months of age. Consequently, only three doses a day may be adequate to maintain plasma levels in these infants.

Effects on laboratory tests.

With diagnostic test results:

Glucose, urine.

High urinary concentrations of penicillin may produce false positive or elevated test results with copper sulfate tests (Benedict's, Clinitest or Fehling's).

Direct antiglobulin (Coombs') tests.

False positive results may occur during therapy with any penicillin.

White blood cell count.

Leukopenia or neutropenia is associated with the use of all penicillins; the effect is more likely to occur with prolonged therapy and severe hepatic function impairment.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Bacteriostatic drugs may antagonise the effect of penicillin.
Probenecid reduces the tubular excretion of penicillin, thereby increasing concentrations in the blood stream of concomitantly administered penicillin.
Food has a variable effect, generally delaying absorption.
Antacids may reduce absorption of the drug.
When used concurrently with an oestrogen containing oral contraceptive, the effectiveness of the oral contraceptive may be decreased because of stimulation of oestrogen metabolism or reduction of enterohepatic circulation of oestrogens, resulting in menstrual irregularities, intermenstrual bleeding and unplanned pregnancies. This interaction may be of greater clinical significance with long-term use of this penicillin; patients should be advised to use an alternative or additional method of contraception while taking this penicillin.

Aminoglycosides.

Mixing penicillins with aminoglycosides in vitro has resulted in substantial mutual inactivation.

Methotrexate.

Concurrent use with penicillins has resulted in decreased clearance of methotrexate toxicity; probably due to competition for renal tubular secretion; patients should be closely monitored.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Reproductive studies performed in the mouse, rat and rabbit have revealed no evidence of impaired fertility due to phenoxymethylpenicillin.
(Category A)
Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, penicillin should be used during pregnancy only if clearly needed.
 The drug is excreted in breast milk in concentrations lower than plasma levels. As safety to newborn infants has not been established, it is not recommended for breastfeeding mothers unless the benefits outweigh any potential risk.

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)

The most common reactions are nausea, vomiting, epigastric distress, diarrhoea, pruritus ani, black hairy tongue, allergic skin reactions, urticaria and other serum sickness reactions.
The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum sickness-like reactions, laryngeal oedema and anaphylaxis. Fever and eosinophilia may frequently be the only reaction observed.
Haemolytic anaemia, leukopenia, thrombocytopenia, neuropathy and nephropathy are uncommon reactions usually associated with high doses of parenteral penicillin.
Anaphylaxis is a less common reaction.

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

Phenoxymethylpenicillin has low toxicity. However, if there is gross renal impairment, the drug may accumulate in the blood, and the dose should be reduced accordingly.

Treatment.

Management of overdose should include monitoring of electrolyte balance, cardiovascular status and renal function. Penicillins are generally not readily removed by dialysis.
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.

Phenoxymethylpenicillin produces a bactericidal effect on penicillin sensitive organisms during the stage of active multiplication through inhibition of biosynthesis of cell wall mucopeptides. The antibacterial spectrum of phenoxymethylpenicillin is similar to that of benzylpenicillin, however, it has the advantage of being acid stable and hence better absorbed from the gastrointestinal tract than benzylpenicillin. It is resistant to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when given on an empty stomach. Average blood levels are two to five times higher than the levels following the same dose of oral penicillin G and show much less individual variation.

Microbiology.

Penicillin V exerts a bactericidal action against penicillin sensitive microorganisms during the stage of active multiplication. It is not active against the penicillinase producing bacteria, which include many strains of Staphylococci.
Sensitive organisms include the following:
Gram-positive cocci, e.g. Streptococci (groups A, C, G, H, L and M), and non-penicillinase producing Staphylococcus pyogenes.
Gram-positive bacilli, e.g. Clostridium tetani, Cl. perfringens, Corynebacterium diphtheriae and Bacillus anthracis.
Gram-negative bacteria: some isolates of both Neisseria meningitidis and N. gonorrhoeae remain sensitive to penicillins while most strains of Haemophilus influenzae and Moraxella catarrhalis are now resistant. Other aerobic Gram negative bacilli are highly resistant.
Treponema pallidum is sensitive, but treatment of syphilis with oral penicillins is not recommended.

Susceptibility test.

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, clinical 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.

Usually, up to 60% of the drug is absorbed into the blood stream after oral administration. Absorption is usually rapid and may produce peak serum concentrations within 30 minutes and demonstrable levels are maintained for 4 hours.

Distribution.

Penicillin levels are highest in the kidney tissues with lesser amounts in the liver, skin and intestines. Small amounts are found in all other body tissues and the cerebrospinal fluid.
Approximately 80% of phenoxymethylpenicillin is serum protein bound.

Metabolism.

About 56% of a 500 mg oral dose of the drug is metabolised into inactive metabolite and about 23 to 36% of the drug is rapidly excreted in the unchanged form in the urine. Bile excretion depends on renal function, being low in normal renal function and high in renal impairment. The oral plasma half-life is about 30 minutes in healthy adults and about 1 to 3 hours in neonates. The half-life is greatly extended in patients with renal or hepatic impairment.

Excretion.

The drug is excreted as rapidly as it is absorbed in individuals with normal kidney function; however, recovery of the drug from the urine indicates that only about 25% of the dose given is absorbed. In neonates, young infants and individuals with impaired kidney function, excretion is considerably delayed.

5.3 Preclinical Safety Data

Genotoxicity.

The genotoxic potential of phenoxymethylpenicillin has not been examined.

Carcinogenicity.

Long-term studies have not been performed in animals.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cilicaine V 150 mg/5 mL: Apricot flavouring super alpina 58% (ARTG PI No: 106680), butylated hydoxyanisole, citric acid, polysorbate 80, potassium sorbate, purified water, sodium citrate dihydrate, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, sucrose, xanthan gum.

6.2 Incompatibilities

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

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store at 2 to 8°C. Refrigerate. Do not freeze.

6.5 Nature and Contents of Container

Container type: Bottle glass type III coloured.
Pack size: 100 mL.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG).

AUST R 151598 - Cilicaine V phenoxymethylpenicillin (as benzathine) 150 mg/5 mL oral liquid, suspension bottle.

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.


Chemical name: phenoxymethylpenicillin benzathine.
Molecular formula: (C16H18N2O5S)2,C16H20N2.
Molecular weight: 941.1.

CAS number.

63690-57-3.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes