Consumer medicine information

Phenoxymethylpenicillin-AFT

Phenoxymethylpenicillin

BRAND INFORMATION

Brand name

Phenoxymethylpenicillin-AFT

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Phenoxymethylpenicillin-AFT.

What is in this leaflet

This leaflet contains some common questions about Phenoxymethylpenicillin-AFT. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to refer to it again.

What the medicine is used for

Phenoxymethylpenicillin-AFT is an antibiotic that belongs to the group of medicines called penicillins. It 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. It will not work against viruses such as colds or the flu.

Your doctor may have prescribed Phenoxymethylpenicillin-AFT for another reason. Ask your doctor or pharmacist if you have any questions about why phenoxymethylpenicillin has been prescribed for you.

Before you take this medicine

When you must not take it

You must not take Phenoxymethylpenicillin-AFT if:

  • You have had an allergic reaction to any penicillin
  • You have had an allergic reaction to a cephalosporin
  • You have an allergy to any of the ingredients listed at the end of this leaflet

Do not take if the packaging shows signs of tampering.

Do not take if the expiry date printed on the pack has passed.

If you are uncertain whether you should take Phenoxymethylpenicillin-AFT, talk to your doctor first.

Before you start to take the medicine

Tell your doctor if:

  • You have any allergies to any medicines, foods, preservatives, colours
  • You have or have had any other health problems/medical conditions including asthma and kidney problems.
  • You are pregnant, intend to become pregnant or are breastfeeding
  • You are taking any other medicines including any that you get without a prescription from a pharmacy, supermarket or health food shop.

How to use the Medicine

Take the dose prescribed by your doctor. It may vary depending upon the type and severity of the infection. The dose will also vary for children depending upon their age and weight.

Use a medicine measure to ensure that you take the correct dose.

Phenoxymethylpenicillin-AFT is best taken on an empty stomach (one hour before meals and at bedtime) unless directed otherwise by your doctor.

Take Phenoxymethylpenicillin-AFT for as long as your doctor tells you, even if you are feeling better.

If you forget to take a dose:

  • If it is almost time for the next dose, skip the missed dose and take the next dose when you are meant to
    Otherwise take it as soon as you remember and then go back to taking the medicine as you would normally
  • Do not take a double dose to make up for the dose that you missed.
    This may increase the chance of you getting an unwanted side effect

Avoid drinking alcohol while taking and for several days after completing a course of Phenoxymethylpenicillin-AFT.

Tell you doctor or pharmacist if you are taking an oral contraceptive pill. You may need to use other birth control methods while you are taking Phenoxymethylpenicillin-AFT.

You must take the whole course of Phenoxymethylpenicillin-AFT 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 Phenoxymethylpenicillin-AFT or if they become worse, check with your doctor.

If you are going to start a new medicine or have blood tests, remind your doctor or pharmacist you are taking this medicine.

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

Do not take this medicine 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Phenoxymethylpenicillin-AFT. While Phenoxymethylpenicillin-AFT helps most people, it may have unwanted side effects in some people. 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 get any of them.

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

  • Skin rash
  • Nausea or vomiting
  • Black hairy tongue
  • Diarrhoea
  • Epigastric distress
  • Difficulty breathing

Tell your doctor if you get a sore white mouth or tongue while taking or soon after stopping Phenoxymethylpenicillin-AFT. Also tell you doctor if you get vaginal itching or discharge. You may have a fungal infection called thrush which will need treatment with another medicine.

If any of the following happen tell you doctor immediately or go to the Accident and Emergency at the nearest hospital. They are serious side effects and you may need urgent medical attention.

  • 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 or diarrhoea
  • Severe diarrhoea even if it occurs several weeks after stopping taking Phenoxymethylpenicillin-AFT

Overdose

If you or somebody else takes too much Phenoxymethylpenicillin-AFT, telephone your doctor or the Poisons Information Centre (Telephone 13 11 26) for advice or go the Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Storage

Keep Phenoxymethylpenicillin-AFT Oral Liquid in the refrigerator. Do not freeze.

If your doctor tells you to stop using Phenoxymethylpenicillin-AFT or it has passed its expiry date, ask your pharmacist what to do with the left over medicine.

Other ingredients

Phenoxymethylpenicillin-AFT also contains sucrose, sodium benzoate, saccharin sodium and orange colour and flavour.

If you want to know more

Ask your doctor or pharmacist. They will have additional information available.

Phenoxymethylpenicillin-AFT, powder for oral liquid BP, 125 mg/5 mL, 100 mL, AUST R 159753

Phenoxymethylpenicillin-AFT, powder for oral liquid BP, 250 mg/5 mL, 100 mL, AUST R 159754

Distributor

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde
Sydney, NSW 2113
Email: [email protected]

Date: May 2022

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Phenoxymethylpenicillin-AFT

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

1 Name of Medicine

Phenoxymethylpenicillin potassium.

2 Qualitative and Quantitative Composition

When reconstituted, each bottle of Phenoxymethylpenicillin-AFT contains phenoxymethylpenicillin (as potassium) 125 mg per 5 mL, or 250 mg per 5 mL.

Excipients with known effect.

Benzoates, sugars and saccharin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for oral liquid.
Phenoxymethylpenicillin-AFT, powder for oral liquid is a pale orange granular powder which when reconstituted with purified water forms Phenoxymethylpenicillin-AFT oral solution which is a clear orange coloured solution with an orange odour and flavour which contains phenoxymethylpenicillin potassium equivalent to phenoxymethylpenicillin 125 mg/5 mL or 250 mg/5 mL respectively.

4 Clinical Particulars

4.1 Therapeutic Indications

When oral therapy is required in the treatment of mild to moderately severe infections due to penicillin sensitive organisms such as penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci. 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.
For the prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation.
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

Dilution instructions.

125 mg/5 mL.

Add 63 mL of purified water and shake well.

250 mg/5 mL.

Add 60 mL of purified water and shake well.

Adults.

250-500 mg every 4 to 6 hours, preferably 1 hour before food. Dosage should be determined according to the sensitivity of the organisms and severity of the infection. Prevention of recurrence following rheumatic fever: 250 mg every 12 hours.

Children.

Infants and small children.

15-50 mg/kg in 3 to 6 divided doses. If not calculated by bodyweight the following dosage schedule may be used.

Up to 1 year.

60 mg every 6 hours.

1 to 5 years.

120 mg every 6 hours.

6 to 12 years.

120-270 mg every 6 hours.

4.3 Contraindications

Hypersensitivity to penicillin and/or cephalosporin.

4.4 Special Warnings and Precautions for Use

Risk/ benefit should be considered when the following medical conditions 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 medicine 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 medicine discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered.

History of bleeding disorders.

Some penicillins may cause platelet dysfunction and haemorrhage.

Prolonged use.

Prolonged use of penicillins may lead to development of oral candidiasis.
Fluids, electrolytes and protein replacement should be provided when indicated.
Agents 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.
Use with caution in individuals with a history of allergy and/or asthma.
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).

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 of phenoxymethylpenicillin is extended in these patients therefore consideration should be given to increasing the dosing interval or reducing the dosage.

Use in renal impairment.

Because most penicillin are excreted through the kidneys, a reduction in dosage or increase in dosing interval is recommended in patients with renal function impairment. The potassium content of high doses of phenoxymethylpenicillin potassium should be considered in patients with severe renal function impairment. The half-life of phenoxymethylpenicillin is extended in these patients therefore consideration should be given to increasing the dosing interval or reducing the dosage.

Use in the elderly.

There are no specific age related problems known with the use of phenoxymethylpenicillin. However elderly patients with age related renal impairment 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 3 doses/day may be adequate to maintain plasma levels in these infants.

Effects on laboratory tests.

Diagnostic test results.

Glucose, urine. High urinary concentrations of penicillin may produce false positive or elevated test results with copper sulphate tests, e.g. Benedict's, Clinitest or Fehling's.

Direct antiglobulin (Coombs') tests.

False positive tests may occur during therapy with any penicillin.

White cell count.

Leucopenia 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 medicine.
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.
Mixing penicillins with aminoglycosides in vitro has resulted in substantial mutual inactivation.
Concurrent use of penicillins with methotrexate 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 not revealed any evidence of impaired fertility due to phenoxymethylpenicillin.
(Category A)
Pregnancy Category 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.
 Phenoxymethylpenicillin is excreted in breast milk in concentrations lower than plasma levels. As safety in 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.
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.
Anaphylaxis is a less common reaction.
Haemolytic anaemia, leucopenia, thrombocytopenia, neuropathy and nephropathy are uncommon reactions usually associated with high doses of parenteral penicillin.

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.

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 medicine 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 exerts a bactericidal action against penicillin sensitive microorganisms 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 benzylpenicillin and show much less individual variation.

Microbiology.

Phenoxymethylpenicillin potassium exerts bactericidal action against penicillin sensitive microorganisms during the stage of active multiplication. It is not active against penicillinase producing bacteria which includes many strains of staphylococci.
Sensitive organisms include:
Gram positive cocci e.g. Streptococci (groups A, C, G, H, L and M) and nonpenicillinase 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. Clinical and Laboratory Standards Institute (CLSI formerly NCCLS). Standardised susceptibility test procedures require the use of laboratory control organisms 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 organism 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 the 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 phenoxymethylpenicillin 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 medicine is metabolised into inactive metabolite and about 23 to 36% is excreted unchanged in the urine.

Excretion.

Bile excretion is dependent upon 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.
The medicine is excreted rapidly in individuals with normal kidney function however recovery of the medicine 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

Carcinogenicity.

Long term studies have not been performed in animals.

Genotoxicity.

The genotoxic potential of phenoxymethylpenicillin has not been studied.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sucrose, sodium benzoate, sodium saccharin, 175788 Euroblend Orange PI (105922), Trusil Orange Flavour 10814413 PI (106046).

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.
Reconstituted oral solution: 10 days.

6.4 Special Precautions for Storage

The unreconstituted powder should be stored below 25°C. The reconstituted oral liquid should be stored under refrigeration (2-8°C). The product should be protected from light and moisture.

6.5 Nature and Contents of Container

Phenoxymethylpenicillin-AFT is supplied in HDPE bottles containing phenoxymethylpenicillin potassium powder for oral liquid equivalent to 125 mg/5 mL or 250 mg/5 mL on reconstitution.

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

Phenoxymethylpenicillin potassium is a white or to almost white crystalline powder which is freely soluble in water but practically insoluble in ethanol.
Phenoxymethylpenicillin (as potassium) has the chemical name potassium (6R)-6-(2- phenoxyacetamido) penicillinate. It has the chemical formula C16H17KN2O5S with a molecular weight of 388.5.

Chemical structure.


CAS number.

132-98-09.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes