Consumer medicine information

LPV

Phenoxymethylpenicillin

BRAND INFORMATION

Brand name

LPV

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using LPV.

SUMMARY CMI

LPV®

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 taking LPV?

LPV contains the active ingredient, phenoxymethylpenicillin. LPV is used to treat infections in different parts of the body caused by certain bacteria.

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

2. What should I know before I take LPV?

Do not take if you have ever had an allergic reaction to LPV or any of the ingredients listed at the end of the CMI or to any medicines containing phenoxymethylpenicillin, any other penicillins.

Talk to your doctor if you have any other medical conditions, are allergic to cephalosporin antibiotics, 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 take LPV? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with LPV 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 take LPV?

  • Your doctor will decide the best dose and how often you should take LPV.
  • Follow your doctor's instructions and complete the full course of LPV prescribed by them.

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

5. What should I know while taking LPV?

Things you should do
  • Tell your doctor immediately if your symptoms do not improve within a few days, become worse or you do not feel well while taking LPV
  • Tell your doctor immediately if you become pregnant while taking LPV
  • Remind any doctor, dentist or pharmacist you visit that you are taking LPV.
Things you should not do
  • Do not stop taking LPV or change the dosage without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how LPV affects you.
Drinking alcohol
  • Drinking alcohol while taking medicines is not recommended.
Looking after your medicine
  • Store capsules below 25°C in a cool dry place.
  • Keep out of reach of children

For more information, see Section 5. What should I know while taking LPV? in the full CMI.

6. Are there any side effects?

Common side effects include diarrhoea, nausea, vomiting, stomach pain or fever or a black hairy tongue. Serious side effects include severe watery or bloody diarrhoea, and hypersensitivity and allergic reactions.

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

LPV®

Active ingredient: Phenoxymethylpenicillin

Consumer Medicine Information (CMI)

This leaflet provides important information about using LPV. 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 LPV.

Where to find information in this leaflet:

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

1. Why am I taking LPV?

LPV contains the active ingredient, phenoxymethylpenicillin. LPV is an antibiotic that belongs to a group of medicines called penicillins. These antibiotics work by killing the bacteria that are causing your infection.

LPV is used to treat infections in different parts of the body caused by certain bacteria.

LPV may also be used to prevent infections before, during and after surgery but will not work against infections caused by viruses, such as colds.

2. What should I know before I take LPV?

Warnings

Do not take LPV:

  • If you are allergic to phenoxymethylpenicillin, any other penicillins or to 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
  • Always check the ingredients to make sure you can take LPV
  • To treat any other medical conditions unless instructed by your doctor
  • If the packaging is torn or shows signs of tampering.

Check with your doctor if you:

  • Have allergies to any medicines, and in particular to cephalosporin antibiotics, foods, preservatives or dyes
  • Have previously had or currently have any health issues, such as asthma
  • Have a potassium deficiency or have high potassium blood levels. Each LPV 250 mg capsule contains 28 mg potassium and each LPV 500 mg capsule contains 55 mg potassium.
  • Take any medicines for any other condition.

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 will discuss the risks and benefits of taking LPV while pregnant and breastfeeding

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.

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

4. How do I take LPV?

How much to take:

  • Your doctor will decide the best dose and how often you should take LPV.
  • Follow your doctor's instructions and complete the full course prescribed by them, even if you begin to feel better after a few days. If you do not finish all your LPV, the bacteria causing your infection may not clear completely or your symptoms may return.
  • Swallow the capsules whole with a glass of water.

When to take LPV:

  • Take about one hour before food or two hours after food. It can be taken with food, but it may not be as effective.

If you forget to take LPV:

LPV should be taken regularly at the same time each day.

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

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

If you take too much LPV:

If you think that you have taken too much LPV, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while taking LPV?

Things you should do:

Keep all of your doctor's appointments so that your progress can be checked.

Call your doctor straight away:

  • If your symptoms do not improve within a few days, or become worse
  • If you do not feel well while taking LPV
  • If you experience any of the following, even if they occur several weeks after stopping treatment with LPV:
    - severe stomach cramps or pain
    - severe watery or bloody diarrhoea
    - with or without a fever
    Do not take any diarrhoea medication without first checking with your doctor. You may have a serious condition affecting your bowel requiring urgent medical attention
  • If you become pregnant while taking LPV.

Remind any doctor, dentist or pharmacist you visit that you are taking LPV, especially if they are about to prescribe any new medication for you.

Things you should not do:

  • Do not take LPV 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 LPV or change the dosage without checking with your doctor. LPV must be taken for the full course as prescribed by your doctor. If you stop taking LPV without completing the full course, your condition may worsen.

Driving or using machines:

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

LPV is not expected to affect your ability to drive or operate machinery. However, you should be careful with these activities until you know how LPV affects you.

Children should be careful riding bicycles or climbing on playground equipment until you know how LPV affects them.

Drinking alcohol:

Tell your doctor if you drink alcohol.

Drinking alcohol whilst taking medication is not recommended.

Looking after your medicine:

  • Store below 25°C
  • Store LPV in the blister pack until it is time to take them.

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
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine:

If you no longer need to take 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?

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.

Less serious side effects:

Less serious side effectsWhat to do
Common side effects:
  • Diarrhoea
  • Nausea
  • Vomiting
  • Stomach pain
  • Fever
  • Black hairy tongue
Other side effects:
  • Rash and itchiness
  • Sore throat, difficulty swallowing and bringing up undigested food
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects:

Serious side effectsWhat to do
  • Severe stomach cramps or pain
  • Severe watery or bloody diarrhoea
  • Fever (when associated with the above symptoms
  • Sudden signs of allergy such as skin reactions, with swelling of the face, lips, tongue or other parts of the body
  • Shortness of breath
  • Wheezing or trouble breathing
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.

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 LPV 250 mg capsules contain:

Active ingredient
(main ingredient)		Phenoxymethylpenicillin (as the potassium salt)
Other ingredients
(inactive ingredients)		Brilliant blue FCF
Carbon black
Erythrosine
Gelatin
Magnesium stearate
Opacode black A-10259
Sunset yellow FCF
Titanium dioxide
Potential allergensNone

What LPV 500 mg capsules contain:

Active ingredient
(main ingredient)		Phenoxymethylpenicillin (as the potassium salt)
Other ingredients
(inactive ingredients)		Brilliant blue FCF
Erythrosine
Gelatin
Magnesium stearate
Opacode black A-10259
Sunset yellow FCF
Titanium dioxide
Potential allergensNone

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

What does LPV looks like:

LPV 250 mg capsules: Opaque red cap and opaque grey body with "LPV250" printed in black ink on cap and body. They come in a blister pack of 50 capsules.

Registration number: AUST R 66510

LPV 500 mg capsules: Red opaque cap and pink body with "LPV500" printed in black ink on cap and body. They come in a blister pack of 50 capsules.

Registration number: AUST R 66511

Who distributes LPV:

iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056

This leaflet was prepared in December 2022.

Published by MIMS February 2023

BRAND INFORMATION

Brand name

LPV

Active ingredient

Phenoxymethylpenicillin

Schedule

S4

 

1 Name of Medicine

Phenoxymethylpenicillin.

2 Qualitative and Quantitative Composition

Phenoxymethylpenicillin potassium is a white or almost white, crystalline powder, freely soluble in water and practically insoluble in ethanol (96%).
LPV capsules contain either 250 mg or 500 mg of the active phenoxymethylpenicillin (as potassium). They also contain magnesium stearate, gelatin, erythrosine, sunset yellow FCF, brilliant blue FCF, titanium dioxide and opacode black A-10259S-1-8115 black. The 250 mg capsule also contains carbon black.

Excipients with known effects.

LPV 250 mg capsules contain 28 mg potassium per capsule and LPV 500 mg capsules contain 55 mg potassium per capsule.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

LPV phenoxymethylpenicillin 250 mg (as potassium) capsule blister pack - capsules with a opaque red cap and opaque grey body printed with "LPV250" in black ink on cap and body.
LPV phenoxymethylpenicillin 500 mg (as potassium) capsule blister pack - capsules with a red opaque top and pink body; both printed with "LPV500" in black ink.

4 Clinical Particulars

4.1 Therapeutic Indications

Penicillin V potassium is indicated in the treatment of mild to moderately severe infections due to penicillin V sensitive microorganisms. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response.

Note.

Severe pneumonia, empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with penicillin V during the acute stage.
Indicated surgical procedures should be performed.
The following infections will usually respond to adequate dosage of penicillin V.

Streptococcal infections (without bacteraemia).

Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas.

Note.

Streptococci in groups A, C, G, H, L and M are very sensitive to penicillin. Other groups, including group D (Enterococcus), are resistant.

Pneumococcal infections.

Mild to moderately severe infections of the respiratory tract.

Fusospirochetosis (Vincent's gingivitis and pharyngitis).

Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin.

Note.

Necessary dental care should be accomplished in infections involving the gum tissue.

Medical conditions in which oral penicillin therapy is indicated as prophylaxis.

For the prevention of recurrence following rheumatic fever and/or chorea. Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions. To prevent bacterial endocarditis in patients with congenital and/or rheumatic heart lesions who are to undergo dental procedures or minor upper respiratory tract surgery or instrumentation, prophylaxis should be instituted on the day of the procedure and for 2 or more days following. Patients who have a past history of rheumatic fever and are receiving continuous prophylaxis may harbour increased numbers of penicillin resistant organisms; use of another prophylactic anti-infective agent should be considered. If penicillin is to be used in these patients at surgery, the regular rheumatic fever program should be interrupted 1 week prior to the contemplated surgery. At the time of surgery, penicillin may be reinstituted as a prophylactic measure against the hazards of surgically induced bacteraemia.

Note.

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

4.2 Dose and Method of Administration

The dosage of penicillin V should be determined according to the sensitivity of the causative microorganisms and the severity of infection, and adjusted to the clinical response of the patient.
The usual dosage recommendations for adults and children 12 years and over are as follows.

Streptococcal infections.

Mild to moderately severe, of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg every 6 to 8 hours for 10 days.

Pneumococcal infections.

Mild to moderately severe, of the respiratory tract, including otitis media: 250 to 500 mg every 6 hours until the patient has been afebrile for at least 2 days.

Fusospirochetosis (Vincent's gingivitis) of the oropharynx.

Mild to moderately severe infections: 250 to 500 mg every 6 to 8 hours.

For the prevention of recurrence following rheumatic fever and/or chorea.

125 to 250 mg twice daily on a continuing basis.

To prevent bacterial endocarditis in patients with rheumatic or congenital heart lesions who are to undergo dental or upper respiratory tract surgery or instrumentation.

Adults.

2 gram orally 30 minutes to 1 hour prior to the procedure and then 500 mg orally every 6 hours for 8 doses.

Children.

For those weighing 25 kg or more, use adult dose recommendations (see above). For those weighing less than 25 kg, use 1 gram orally 30 minutes to 1 hour prior to the procedure and then 250 mg orally every 6 hours for 8 doses.

4.3 Contraindications

A previous hypersensitivity reaction to any penicillin.

4.4 Special Warnings and Precautions for Use

Warnings.

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 apt to occur in individuals with a history of sensitivity to multiple allergens.
There have been well documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Before therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If an allergic reaction occurs, the drug should be discontinued and the patient treated with the usual agents e.g. pressor amines, antihistamines and corticosteroids.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including LPV. A toxin produced by 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 (e.g. Lomotil), may prolong and/or worsen the condition and should not be used.

Precautions.

Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. The oral route of administration should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility.
Occasional patients will not absorb therapeutic amounts of orally administered penicillin. In streptococcal infections, therapy must be sufficient to eliminate the organism (10 day minimum), otherwise the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether Streptococci have been eradicated.
Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
No data available.
 No data available.

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)

Although the incidence of reactions to oral penicillins has been reported with much less frequency than following parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been reported with oral penicillin.
The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhoea and black hairy tongue. 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 infrequent reactions and are usually associated with high doses of parenteral penicillin.

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

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.

Penicillin V exerts a bactericidal action against penicillin sensitive microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. It is not active against the beta-lactamase producing bacteria, which include many strains of Staphylococci. The drug exerts high in vitro activity against Staphylococci (except beta-lactamase producing strains), Streptococci (groups A, C, G, H, L and M) and pneumococci. Other organisms sensitive in vitro to penicillin V are Corynebacterium diphtheriae, Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacillus moniliformis, Listeria monocytogenes, Leptospira and Neisseria gonorrhoeae. Treponema pallidum is extremely sensitive.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

The potassium salt of penicillin V has the distinct advantage over penicillin G in resistance to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when the drug is 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 also show much less individual variation. Once absorbed, penicillin V is about 80% bound to serum protein. Tissue levels are highest in the kidneys, and the cerebrospinal fluid. 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.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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 25°C.

6.5 Nature and Contents of Container

250 mg.

Pack of 50.

500 mg.

Pack of 50.

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.


Chemical name: potassium salt of (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[(phenoxyacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid.
Molecular formula is C16H17KN2O5S (molecular weight: 388.5).

CAS number.

54-35-3.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes