Drugs List

Therapeutic Indications

Uses

Treatment of mild to moderate infections associated with micro-organisms whose susceptibility to penicillin is within the range of serum levels attained with the dosage form.

The following types of infections will usually respond to treatment:
Streptococcal infections (without bacteraemia) - mild to moderate upper respiratory tract infection, scarlet fever, mild erysipelas
Pneumococcal infections - mild to moderate respiratory tract infection
Sensitive staphylococcal infection - mild skin and soft tissue infections
Fusospirochaetosis (Vincent's gingivitis and pharyngitis) - mild to moderate infections of the oropharynx
Otitis media

Prophylaxis against recurrence of rheumatic fever and chorea
Prophylaxis against pneumococcal infection in asplenia or in patients with sickle cell disease
Prevention of secondary case of group A streptococcal infection

Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with phenoxymethylpenicillin during the acute phase.

Oral penicillin should not be used as adjunctive prophylaxis for genito-urinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy and child birth.

Administration

For oral administration.

Dose should be taken 30 minutes before or at least 3 hours after food.

Contraindications

None known

Precautions and Warnings

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Severe renal impairment - see Dosage; Renal Impairment
In patients undergoing long-term treatment the complete and differential blood count, as well as the liver and kidney function, should be monitored.

Penicillin should only be used with caution in those patients with a history of sensitivities to the related group of cephalosporins and other allergens. Hypersensitivity reactions including fatal anaphylaxis are more likely to occur in these individuals and those with a history of allergy (including asthma, eczema, hay fever). Enquiries should be made for such a history before therapy is begun.
If any allergic reaction occurs, the drug should be discontinued and the patient treated with the appropriate agents.

Oral therapy should not be relied upon in patients with severe illness, or with nausea, vomiting, diarrhoea, gastric dilation, cardiospasm or intestinal hypermotility. Occasionally patients do not absorb therapeutic amounts of orally administered penicillin.

Consider pseudomembranous colitis if patient presents with severe diarrhoea. Discontinue at once if pseudomembranous colitis occurs.

Streptococcal infections should be treated for a minimum of 10 days. Post therapy cultures should be performed to confirm the eradication of the organisms.

Prolonged use of antibiotics may promote the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate measures should be taken.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Some formulations contain potassium. Caution is advised in low potassium diets.
Some formulations contain sodium. Caution is advised in low sodium diets.
Some formulations contain sucrose.
Some formulations contain lactose.
Caution is advised in patients with hereditary fructose intolerance or galactosaemia.

May affect results of some laboratory tests. See Laboratory Tests section.

Pregnancy and Lactation

Pregnancy

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing to the pregnant patient.

Briggs (2011) considers use of phenoxymethylpenicillin during pregnancy to be low risk.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Phenoxymethylpenicillin is excreted in breast milk and should be used with caution in nursing mothers as the neonate may experience an allergic reaction. Due to the prematurity of the blood brain barrier its use during breastfeeding may present the risk of central nervous system toxicity.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Hypersensitivity reactions
Anaphylaxis
Rash
Skin eruption
Maculopapular rash
Exfoliative dermatitis
Urticaria
Angioedema
Serum sickness-like reactions
Interstitial nephritis
Neutropenia
Chills
Fever
Oedema
Arthralgia
Prostration
Laryngeal oedema
Gastro-intestinal symptoms
Nausea
Vomiting
Abdominal pain
Diarrhoea
Coagulation disorders
Prolonged bleeding
Impaired platelet function
CNS toxicity
Convulsions
Paraesthesia
Sore mouth
Black tongue
Joint pain
Eosinophilia
Haemolytic anaemia
Leucopenia
Thrombocytopenia
Neuropathy
Nephropathy
Antibiotic-associated colitis
Encephalopathy
Hepatitis
Cholestatic jaundice
Pseudomembranous colitis
Erythematous rash
Stomatitis
Glossitis
Agranulocytosis
Erythema multiforme
Anaphylactoid reaction
Asthma
Purpura

Presentation

Powder for oral solution containing 125mg/5ml phenoxymethylpenicillin as phenoxymethylpenicillin potassium
Powder for oral solution containing 250mg/5ml phenoxymethylpenicillin as phenoxymethylpenicillin potassium
Sugar free powder for oral solution containing 125mg/5ml phenoxymethylpenicillin as phenoxymethylpenicillin potassium
Sugar free powder for oral solution containing 250mg/5ml phenoxymethylpenicillin as phenoxymethylpenicillin potassium

Tablets containing 250mg phenoxymethylpenicillin as phenoxymethylpenicillin potassium

Drugs List

Therapeutic Indications

Uses

Treatment of mild to moderate infections associated with micro-organisms whose susceptibility to penicillin is within the range of serum levels attained with the dosage form.

The following types of infections will usually respond to treatment:
Streptococcal infections (without bacteraemia) - mild to moderate upper respiratory tract infection, scarlet fever, mild erysipelas
Pneumococcal infections - mild to moderate respiratory tract infection
Sensitive staphylococcal infection - mild skin and soft tissue infections
Fusospirochaetosis (Vincent's gingivitis and pharyngitis) - mild to moderate infections of the oropharynx
Otitis media

Prophylaxis against recurrence of rheumatic fever and chorea
Prophylaxis against pneumococcal infection in asplenia or in patients with sickle cell disease
Prevention of secondary case of group A streptococcal infection

Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with phenoxymethylpenicillin during the acute phase.

Oral penicillin should not be used as adjunctive prophylaxis for genito-urinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy and child birth.

Dosage

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

For oral administration.

Dose should be taken 30 minutes before or at least 3 hours after food.

Contraindications

None known

Precautions and Warnings

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section

Severe renal impairment - see Dosage; Renal Impairment
In patients undergoing long-term treatment the complete and differential blood count, as well as the liver and kidney function, should be monitored.

Penicillin should only be used with caution in those patients with a history of sensitivities to the related group of cephalosporins and other allergens. Hypersensitivity reactions including fatal anaphylaxis are more likely to occur in these individuals and those with a history of allergy (including asthma, eczema, hay fever). Enquiries should be made for such a history before therapy is begun.
If any allergic reaction occurs, the drug should be discontinued and the patient treated with the appropriate agents.

Oral therapy should not be relied upon in patients with severe illness, or with nausea, vomiting, diarrhoea, gastric dilation, cardiospasm or intestinal hypermotility. Occasionally patients do not absorb therapeutic amounts of orally administered penicillin.

Consider pseudomembranous colitis if patient presents with severe diarrhoea. Discontinue at once if pseudomembranous colitis occurs.

Streptococcal infections should be treated for a minimum of 10 days. Post therapy cultures should be performed to confirm the eradication of the organisms.

Prolonged use of antibiotics may promote the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, appropriate measures should be taken.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Some formulations contain potassium. Caution is advised in low potassium diets.
Some formulations contain sodium. Caution is advised in low sodium diets.
Some formulations contain sucrose.
Some formulations contain lactose.
Caution is advised in patients with hereditary fructose intolerance or galactosaemia.

May affect results of some laboratory tests. See Laboratory Tests section.

Pregnancy and Lactation

Pregnancy

Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing to the pregnant patient.

Briggs (2011) considers use of phenoxymethylpenicillin during pregnancy to be low risk.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Phenoxymethylpenicillin is excreted in breast milk and should be used with caution in nursing mothers as the neonate may experience an allergic reaction. Due to the prematurity of the blood brain barrier its use during breastfeeding may present the risk of central nervous system toxicity.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

None known.

Side Effects

Hypersensitivity reactions
Anaphylaxis
Rash
Skin eruption
Maculopapular rash
Exfoliative dermatitis
Urticaria
Angioedema
Serum sickness-like reactions
Interstitial nephritis
Neutropenia
Chills
Fever
Oedema
Arthralgia
Prostration
Laryngeal oedema
Gastro-intestinal symptoms
Nausea
Vomiting
Abdominal pain
Diarrhoea
Coagulation disorders
Prolonged bleeding
Impaired platelet function
CNS toxicity
Convulsions
Paraesthesia
Sore mouth
Black tongue
Joint pain
Eosinophilia
Haemolytic anaemia
Leucopenia
Thrombocytopenia
Neuropathy
Nephropathy
Antibiotic-associated colitis
Encephalopathy
Hepatitis
Cholestatic jaundice
Pseudomembranous colitis
Erythematous rash
Stomatitis
Glossitis
Agranulocytosis
Erythema multiforme
Anaphylactoid reaction
Asthma
Purpura

Effects on Laboratory Tests

Penicillins may cause false-positive urinary glucose (if testing for reducing substances).

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Oral solutions
Store in a dry place below 25 degrees C. Protect from light.
Reconstituted solutions - Store for 7 days in a refrigerator.

Tablets
Protect from heat, light and moisture

Further Information

Last Full Review Date: June 2012

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics for Phenoxymethylpenicillin Elixir BP (Ospen) 125mg/5ml. Kent Pharma Ltd. June 2012.
Summary of Product Characteristics for Phenoxymethylpenicillin Elixir BP (Ospen) 250mg/5ml. Kent Pharma Ltd. June 2012.
Summary of Product Characteristics for Phenoxymethylpenicillin Oral Solution 125mg/5ml. Kent Pharma Ltd. June 2012.
Summary of Product Characteristics for Phenoxymethylpenicillin Oral Solution 250mg/5ml. Kent Pharma Ltd. June 2012.
Summary of Product Characteristics for Penicillin VK Tablets. Kent Pharma Ltd. June 2012.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 September 2017