Consumer medicine information

Aspecillin V Oral suspension

Phenoxymethylpenicillin benzathine

BRAND INFORMATION

Brand name

Aspecillin V Oral suspension

Active ingredient

Phenoxymethylpenicillin benzathine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Aspecillin V Oral suspension.

What is in this leaflet?

This leaflet answers some common questions about ASPECILLIN.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking ASPECILLIN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

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

Use ASPECILLIN only on the advice of your doctor and contact your doctor if you suffer from any unwanted effects.

What ASPECILLIN is used for

ASPECILLIN belongs to a group of medicines called penicillins.

ASPECILLIN 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 will not work against infections caused by viruses such as colds or the flu. Your doctor however, may have prescribed this medicine for another purpose. Ask your doctor (or pharmacist) if you have any questions about why ASPECILLIN has been prescribed for you.

The medicine brand name is:
ASPECILLIN V®

Active ingredient name:
phenoxymethylpenicillin benzathine - also called Penicillin V

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

Your doctor may have prescribed it for another reason.

ASPECILLIN is not addictive.

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

Before you take it

When you must not take it

Do not take ASPECILLIN if:

  1. you have an allergy to:
  • ASPECILLIN
  • other penicillins
  • 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.

  1. you have had an allergic reaction to cephalosporins.

You may have an increased chance of being allergic to ASPECILLIN if you are allergic to cephalosporins.

Do not take ASPECILLIN if the packaging is torn or shows signs of tampering.

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

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking ASPECILLIN, contact your doctor.

Before you start to take it

Tell your doctor if:

  1. you have any allergies to any other medicines or any other foods, preservatives or dyes
  2. you have or have ever had any other health problems/ medical conditions, including:
  • asthma
  • kidney problems
  1. you are pregnant or intend to become pregnant or are breastfeeding.

Like most medicines, ASPECILLIN is not recommended during pregnancy of breast-feeding. Your doctor will discuss the possible risks and benefits of involved.

If you have not told your doctor about any of the above, tell him/her before you start ASPECILLIN.

Taking other medicines

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

Some medicines and ASPECILLIN may interfere with each other. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking ASPECILLIN.

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

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 ASPECILLIN.

How to take it

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 box/bottle, ask your doctor or pharmacist for help.

How much to take

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.

How to take ASPECILLIN

For suspensions

Shake the bottle well before each dose and accurately measure the dose with a medicine measure.

When to take it

Take your medicine 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 long to take it

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

If you forget to take it

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 take too much (overdose)

Immediately telephone your doctor or the Poison Information Centre (telephone 13 11 26) for advice, or go the Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much ASPECILLIN. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

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 ASPECILLIN, or if they have become worse, check with your doctor.

While you are using it

Things you must 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 ASPECILLIN 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 your medication 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 ASPECILLIN, 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 ASPECILLIN allows fungi to grow and the above symptoms to occur. This medicine does not work against fungi.

If you become pregnant while taking it tell your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ASPECILLIN.

Tell your doctor that you are taking this medicine if you are about to have any blood tests.

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 must not do

Do not stop taking ASPECILLIN 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.

Do not take ASPECILLIN 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.

Things to be careful of

Be careful when drinking alcohol while you are taking this medicine.

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

Side effects

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

It 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.

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

  • skin rash
  • nausea & vomiting
  • black hairy tongue
  • diarrhoea
  • epigastric distress
  • difficulty in breathing

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
  • nausea, vomiting and diarrhoea.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare. Other side effects not listed above may also occur in some people.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

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

  • 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. ASPECILLIN 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.

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

After using it

Storage

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

Store ASPECILLIN V oral suspensions in a refrigerator, preferably between 2 to 8 oC. Do not freeze. Shake well before use.

Do not store ASPECILLIN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it

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

Disposal

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

Product description

What it looks like

ASPECILLIN V 150 mg/5 mL is a beige coloured, apricot flavoured viscous suspension.

Ingredients

Active ingredients

Phenoxymethylpenicillin as the benzathine salt is the active ingredient.

List of inactive ingredients

ASPECILLIN V 150 mg/5mL suspension contains: Butylated hydroxyanisole, Sodium methyl hydroxybenzoate, Sodium propyl hydroxybenzoate, potassium sorbate, sodium citrate, sucrose, xanthan gum, apricot flavour, polysorbate 80.

Registration Number

AUST R 151597

BRAND INFORMATION

Brand name

Aspecillin V Oral suspension

Active ingredient

Phenoxymethylpenicillin benzathine

Schedule

S4

 

1 Name of Medicine

Aspecillin V: phenoxymethylpenicillin benzathine.
Aspecillin VK: phenoxymethylpenicillin potassium.

6.7 Physicochemical Properties

Chemical structure.

The structural formula of phenoxymethylpenicillin potassium is:

CAS number.

CAS number is 132-98-9.

Chemical structure.

The structural formula of phenoxymethylpenicillin benzathine is:

CAS number.

CAS number: 63690-57-3.
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. Its chemical name is potassium (6R)-6-(2-phenoxyacetamido) penicillanate with an empirical formula of C16H17KN2O5S and a molecular weight of 388.5.
Benzathine phenoxymethylpenicillin has an empirical formula of (C16H18N2O5S)2,C16H20N2 and a molecular weight of 941.1. It is an almost white powder, almost insoluble in water and soluble in alcohol, chloroform ether and acetone.

2 Qualitative and Quantitative Composition

Aspecillin V oral suspension 150 mg/5 mL.

Contains phenoxymethylpenicillin 150 mg per 5mL as the benzathine salt.

Aspecillin V oral suspension 250 mg/5 mL.

Contains phenoxymethylpenicillin 250 mg per 5mL as the benzathine salt.

Aspecillin V oral suspension 125 mg/5 mL.

Contains phenoxymethylpenicillin 125 mg per 5mL as the benzathine salt.

Aspecillin VK capsules 250 mg.

Contains phenoxymethylpenicillin 250 mg as the potassium salt.

Aspecillin VK tablets 250 mg, 500 mg.

Contain phenoxymethylpenicillin 250 mg or 500 mg as the potassium salt.

List of excipients with known effect.

Sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate (Aspecillin V oral suspension 150 mg/5 mL).
Lactose (Aspecillin 250 mg capsules).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Aspecillin V oral suspension 150 mg/5 mL: is a beige liquid, apricot flavoured.
Aspecillin V oral suspension 250 mg/5 mL: is a white to off white liquid, coconut/vanilla flavoured.
Aspecillin V oral suspension 125 mg/5 mL: is a yellow liquid, banana flavoured (not marketed).
Aspecillin VK capsules 250 mg: are a white/yellow capsule marked with Abbott logo.
Aspecillin VK tablets 250 mg: are bright yellow, plain on both sides, smooth, round film coated tablet.
Aspecillin VK tablets 500 mg: are bright yellow, one side plain and the other side with a break bar, smooth, film coated capsule-shaped tablet.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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 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 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, 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.

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.

4.3 Contraindications

Known hypersensitivity to penicillin and/or cephalosporin.

4.4 Special Warnings and Precautions for Use

Identified precautions.

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 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 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.

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 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 hepatic impairment.

The half-life is greatly extended in patients with hepatic 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 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 breast feeding mothers unless the benefits outweigh any potential risk.

4.8 Adverse Effects (Undesirable Effects)

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.
The most common reactions are nausea, vomiting, epigastric distress, diarrhoea, pruritis 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.

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.

Renal or hepatic impairment.

The half-life is greatly extended in these patients.

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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

Aspecillin V oral suspension 150 mg/5 mL.

Butylated hydroxyanisole, sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate, potassium sorbate, sodium citrate dihydrate, sucrose, xanthan gum, Apricot Flavouring Super Alpina 58%, polysorbate 80, citric acid, purified water.

Aspecillin V oral suspension 250 mg/5 mL.

Carmellose sodium, Imitation Coconut Milk 03-5723, Imitation Vanice Flavour 10-2245, Masking Agent LN 5346, sodium cyclamate, sodium dehydroacetate, dibasic sodium phosphate heptahydrate, sorbitol, sucrose and purified water.

Aspecillin V oral suspension 125 mg/5 mL.

Carmellose sodium, Masking Agent LN 5346, Natural Banana Flavour 01-5215, quinolone yellow, saccharin sodium sodium cyclamate, sodium dehydroacetate, monobasic sodium phosphate, sorbitol solution (70%) (noncrystallising), purified water.

Aspecillin VK capsules 250 mg.

Lactose monohydrate, magnesium stearate, polacrillin potassium, povidone, quinoline yellow, sodium citrate dihydrate and titanium dioxide.

Aspecillin VK tablets 250 mg, 500 mg.

Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, magnesium stearate, Opadry AMB Yellow OY-B32904 and Opadry Clear OY-S-29019.

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

Oral suspension: store between 2 - 8°C.
Tablets/capsule: store below 30°C.

6.5 Nature and Contents of Container

Aspecillin V oral suspension.

150mg/5mL available in 100 mL (Glass Type III coloured) bottle.
250mg/5mL (not marketed) - Polypropylene bottle.
125mg/5mL (not marketed) - Polypropylene bottle.

Aspecillin VK tablets, 250 mg.

Available in plastic bottle of 25's.

Aspecillin VK tablets, 500 mg.

Available in plastic bottle of 25's.

Aspecillin VK capsules, 250 mg (not marketed).

Registered in plastic bottle of 25's, 500's.

6.6 Special Precautions for Disposal

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

Summary Table of Changes