Consumer medicine information

Aspecillin VK

Phenoxymethylpenicillin

BRAND INFORMATION

Brand name

Aspecillin VK

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Aspecillin VK.

SUMMARY CMI

ASPECILLIN® VK

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 ASPECILLIN VK?

ASPECILLIN VK contains the active ingredient phenoxymethylpenicillin (as potassium). ASPECILLIN VK is used to treat infections in different parts of the body caused by bacteria.
For more information, see Section 1. Why am I using ASPECILLIN VK? in the full CMI.

2. What should I know before I use ASPECILLIN VK?

Do not use if you have ever had an allergic reaction to phenoxymethylpenicillin (as potassium) 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 ASPECILLIN VK? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ASPECILLIN VK 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 ASPECILLIN VK?

  • The usual dose for adults: 250 mg to 500 mg every four to six hours.
  • To prevent recurrence of rheumatic fever: 250 mg twice a day for as long as your doctor tells you to.

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

5. What should I know while using ASPECILLIN VK?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking ASPECILLIN VK.
  • Tell your doctor immediately if you become pregnant while taking ASPECILLIN VK.
  • If your symptoms do not improve within a few days, or if they become worse, tell your doctor immediately.
  • Tell your doctor or pharmacist immediately if you get diarrhoea, nausea or vomiting. Do this even if it occurs several weeks after you have stopped taking ASPECILLIN VK.
  • Tell your doctor that you are taking this medicine are about to have any blood or urine tests.
  • Tell your doctor if you get a sore mouth or tongue while taking or after you have stopped taking ASPECILLIN VK.
Things you should not do
  • Do not stop taking ASPECILLIN VK without checking with your doctor.
  • Do not take any medicine for diarrhoea without first checking with your doctor or pharmacist.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how ASPECILLIN VK affects you.
Looking after your medicine
  • Keep your tablets in a cool dry place where the temperature stays below 25°C.
  • Keep your tablets in the bottle until it is time to take them.
  • Keep it where young children cannot reach it.

For more information, see Section 5. What should I know while using ASPECILLIN VK? 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: skin rash, nausea or vomiting, black hairy tongue, diarrhoea, upset stomach or difficulty in breathing.
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

ASPECILLIN® VK

Active ingredient(s): phenoxymethylpenicillin (as potassium)

Consumer Medicine Information (CMI)

This leaflet provides important information about using ASPECILLIN VK. 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 ASPECILLIN VK.

Where to find information in this leaflet:

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

1. Why am I using ASPECILLIN VK?

ASPECILLIN VK contains the active ingredient phenoxymethylpenicillin as potassium. ASPECILLIN VK is a type of antibiotic that belongs to a group of medicines called penicillins.

ASPECILLIN VK is used to treat infections in different parts of the body caused by bacteria. It works by killing the bacteria that are causing the infection.

ASPECILLIN VK will not work against infections caused by viruses such as colds or the flu.

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

Your doctor may have prescribed ASPECILLIN VK for another purpose.

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

2. What should I know before I use ASPECILLIN VK?

Warnings

Do not use ASPECILLIN VK if:

  • you are allergic to phenoxymethylpenicillin, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.
  • you are allergic to any other penicillin medicines or cephalosporins.
    If you have an allergic reaction to cephalosporins, you may have an increased chance of being allergic to ASPECILLIN VK.
    Some of the symptoms of an allergic reaction may include:
    - shortness of breath
    - wheezing or difficulty breathing
    - swelling of the face, lips, tongue or other parts of the body
    - rash, itching or hives on the skin
  • Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
    If it has expired or is damaged, return to your pharmacist for disposal.

Check with your doctor if you:

  • have or have ever had any of the following medical conditions:
    - diarrhea after taking antibiotics previously
    - bleeding disorders
    - kidney problems
    - liver problems
    - asthma or have the tendency to develop allergic conditions such as hay fever or eczema
    - any other health problems
  • have any allergies to any other medicines or any other foods, preservatives or dyes

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.

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

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

The active ingredient in ASPECILLIN VK passes into breast milk and there is a possibility that your baby may be affected.

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 ASPECILLIN VK and affect how it works.

  • probenecid, a medicine used to treat gout
  • antacids, medicines used to reduce heartburn or indigestion
  • oral contraceptive pills, medicines used for contraception

You may need to use other birth control methods while you are taking ASPECILLIN VK.

  • aminoglycosides, medicines used treat some bacterial infections
  • methotrexate, a medicine used treat rheumatoid arthritis, some cancers and inflammatory conditions

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

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

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

4. How do I use ASPECILLIN VK?

How much to take

  • The usual dose is:
    Adults:
    250 mg to 500 mg every four to six hours.
  • To prevent recurrence of rheumatic fever
    250 mg twice a day for as long as your doctor tells you to.
  • The dose you take will depend on the type of treatment you are to receive. Your doctor will decide your dose and how long you take ASPECILLIN VK for.
  • Continue taking your medicine for as long as your doctor tells you.
    It is important to keep taking your medicine even if you feel well.

When to take ASPECILLIN VK

  • ASPECILLIN VK should be taken 1 hour before food.

How to take ASPECILLIN VK

  • Swallow the tablets whole with a glass of water.

If you forget to use ASPECILLIN VK

ASPECILLIN VK should be used regularly at the same time each day.

If it is less than 4 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

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

Do not take a double dose to make up for the dose you missed.

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 ASPECILLIN VK

If you think that you or anyone else may have taken too much ASPECILLIN VK, 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 ASPECILLIN VK?

Things you should do

Call your doctor straight away if you:

  • are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ASPECILLIN VK.
  • Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
  • become pregnant while taking this medicine, tell your doctor immediately.
  • If your symptoms do not improve within a few days, or if they become worse, tell your doctor immediately.
  • get diarrhoea, nausea or vomiting, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking ASPECILLIN VK.
    Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.
  • are about to have any blood or urine tests, tell your doctor that you are taking this medicine.
    It may interfere with the results of some tests.

Things you should not do

  • Do not take any medicine for diarrhoea without first checking with your doctor or pharmacist.
  • Do not take ASPECILLIN VK 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 ASPECILLIN VK without checking with your doctor.
    Your infection and symptoms may not clear completely.

Things to be careful of

Tell your doctor if you get a sore mouth or tongue while taking or after you have stopped taking ASPECILLIN VK.

This could be due to a fungal infection called thrush. This may also result in fever and irritation in your stomach.

Driving or using machines

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

Looking after your medicine

  • Keep your tablets in the bottle until it is time to take them.
    If you take the tablets out of the bottle they may not keep well.
  • Keep your tablets in a cool dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • on window sills or in the car.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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 ASPECILLIN VK.

This medicine helps most people but it may have some unwanted side effects in a few people.

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.

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

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

Less serious side effects

Less serious side effectsWhat to do
  • skin rash
  • nausea or vomiting
  • black hairy tongue
  • diarrhoea
  • upset stomach
  • difficulty in breathing
Speak to your doctor if you have any of these less serious side effects and they worry you.

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 ASPECILLIN VK contains

Active ingredient
(main ingredient)		Phenoxymethylpenicillin (as potassium)
Other ingredients
(inactive ingredients)
  • starch maize
  • magnesium stearate
  • calcium hydrogen phosphate dihydrate
  • microcrystalline cellulose
  • Opadry AMB Yellow OY-B-32904 (ARTG PI No: 3024)
  • Opadry Clear OY-S-29019 (ARTG PI No: 3025)
Potential allergensN/A

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

What ASPECILLIN VK looks like

ASPECILLIN VK 250 mg tablets are bright yellow, smooth, round film coated tablets. Odour characteristic. Free of visible contamination and imperfections. (AUST R 200136)

ASPECILLIN VK 500 mg tablets are bright yellow, smooth, film coated capsule shaped tablets. Plain on one side and a break bar on the other. Odour characteristic. Free of visible contamination and imperfections. (AUST R 200137)

Who distributes ASPECILLIN VK

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 2023.

ASPECILLIN® is a Viatris company trade mark

ASPECILLIN VK_cmi\Jun23/00

Published by MIMS July 2023

BRAND INFORMATION

Brand name

Aspecillin VK

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

1 Name of Medicine

Phenoxymethylpenicillin (as potassium).

2 Qualitative and Quantitative Composition

Each Aspecillin VK tablet contains 250 mg or 500 mg of phenoxymethylpenicillin (as potassium) as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Aspecillin VK 250 mg tablets are bright yellow, smooth, round film coated tablets. Odour characteristic. Free of visible contamination and imperfections.
Aspecillin VK 500 mg tablets are bright yellow, smooth, film-coated caplet shaped tablets. Plain on one side and a break bar on the other. Odour characteristic. Free of visible contamination and imperfections.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of mild to moderately severe infections caused by 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 childbirth.

4.2 Dose and Method of Administration

Adults.

250 mg to 500 mg every four to six hours, preferably 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.

Infants and small children.

15 mg/kg 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.

Renal or hepatic impairment.

The half-life is greatly extended in these patients.

4.3 Contraindications

Known hypersensitivity to penicillin 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.
Caution should be exercised in prescribing phenoxymethylpenicillin to patients with an allergic diathesis or with bronchial asthma.

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 of 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, cardio-spasm 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 estrogen 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.

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, phenoxymethylpenicillin should be discontinued immediately and an alternative treatment should be considered.

Use in hepatic impairment.

The half-life is greatly extended in patients with hepatic impairment.

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.

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 estrogen 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 breast feeding 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 (macropapular 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, leucopenia, thrombocytopenia, neuropathy and nephropathy are uncommon reactions usually associated with high doses of parenteral penicillin.
Anaphylaxis is a less common reaction.

Skin and other subcutaneous tissue disorders.

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.

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.

Microbiology. Phenoxymethylpenicillin 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 penicillin 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.
Pharmacology. 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 benzyl penicillin, however, it has the advantage of being acid stable and hence better absorbed from the gastrointestinal tract than benzyl penicillin. 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.

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 other body tissues and the cerebrospinal fluid.

Metabolism.

Approximately 80% of phenoxymethylpenicillin is serum protein bound. About 56% of a 500 mg oral dose of the drug is metabolised into inactive metabolite. 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.

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 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, however, 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

The tablets also contain calcium hydrogen phosphate dihydrate, magnesium stearate, maize starch, microcrystalline cellulose, Opadry AMB Yellow OY-B-32904 (ARTG PI No: 3024) and Opadry Clear OY-S-29019 (ARTG PI No: 3025).

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 below 30°C.

6.5 Nature and Contents of Container

The tablets are supplied in a HDPE bottle with a HDPE cap in packs of 25 tablets.
Some strengths, pack sizes and/or pack types may not be marketed.

Australian register of therapeutic goods (ARTG).

AUST R 200136 - Aspecillin VK phenoxymethylpenicillin 250 mg (as potassium) tablet bottle.
AUST R 200137 - Aspecillin VK phenoxymethylpenicillin 500 mg (as potassium) tablet bottle.

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

Chemical structure.


Phenoxymethylpenicillin (or penicillin V) potassium is the potassium salt of the phenoxymethyl analog of penicillin G. It is a white crystalline powder and is soluble in water and polar organic solvents but practically insoluble in vegetable oils and liquid paraffins. Chemical name: potassium (6R)-6-(2-phenoxyacetamido) penicillanate.
Molecular formula: C16H17KN2O5S.
Molecular weight: 388.5.

CAS number.

132-98-9.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes