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PHENOXYMETHYLPENICILLIN 250MG TABLETS BP

Active substance(s): PHENOXYMETHYLPENICILLIN POTASSIUM / PHENOXYMETHYLPENICILLIN POTASSIUM

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Phenoxymethylpenicillin 250mg Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Phenoxymethylpenicillin potassium (1515 l-U/mg) BP
280.00mg

3

PHARMACEUTICAL FORM
White, flat bevelled edge tablets, engraved on one side with company logo and
with breakline and A057 on the other side

4

Clinical particulars

4.1

Therapeutic indications
Phenoxymethylpenicillin and potassium phenoxymethylpenicillin are indicated in the
treatment of mild to moderately severe infections associated with micro-organisms
whose susceptibility to penicillin is within the range of serum levels attained with
these dosage forms. The following infections will usually respond to adequate doses:
Streptococcal infections (without bacteraemia): Mild to moderate infections of the
upper respiratory tract, scarlet fever and mild erysipelas.
Pneumococcal infections: Mild to moderately severe infections of the respiratory
tract.
Staphylococcal infections sensitive to penicillin: Mild infections of the skin and soft
tissues.
Fusospirochaetosis (Vincent’s gingivitis and pharyngitis): Mild to moderately severe
infections of the oropharynx usually respond to therapy with oral penicillin.
Prophylactic use: Prophylaxis with oral penicillin has proved effective in preventing
reccurrence of rheumatic fever and chorea.
Patients with a past history of rheumatic fever receiving continuous prophylaxis may
harbour penicillin-resistant organisms. In these patients, the use of another
prophylactic agent should be considered.
Note: severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not
be treated with Phenoxymethylpenicillin during the acute phase.
Consideration should be given to official guidance on the appropriate use of
antibacterial agent.

4.2

Posology and method of administration
Adults: 125-500mg every 4-6 hours depending on the severity of the
condition.
Prophylactic use: 125mg twice daily is recommended for long term
prophylaxis of rheumatic fever.
Children:
Up to 1 year : 250 mg strength product is not suitable
1 - 5 years

: 125 mg 6 hourly

6-12 years

: 250 mg 6 hourly

The elderly: As for adults. Reduce dosage if renal function is markedly
impaired.
Each dose should be administered half an hour before or at least three hours
after a meal.
In patients with beta-haemolytic streptococcal infection, it is usual to continue
treatment at the full dosage for 10 days, in order to minimise the occurrence of
secondary complications such as acute nephritis and rheumatic fever.
Route of administration: oral

4.3

Contraindications
Hypersensitivity reaction to any penicillin

4.4

Special warnings and precautions for use
All degrees of hypersensitivity, including fatal anaphylaxis, have been
observed with oral penicillin. These reactions are more likely to occur in
individuals with a history of sensitivity to penicillins, cephalosporins and other
allergens.
Enquiry should be made for such a history before therapy with a penicillin is
begun. If an allergic reaction occurs, the drug should be discontinued and the
patient treated with the usual agents (e.g. Adrenaline and other pressor amines,
antihistamines and corticosteroids).
Oral therapy should not be relied upon in patients with severe illness, or with
nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility.
Occasionally, patients do not absorb therapeutic amounts of orally
administered penicillin.
Administer with caution in the presence of markedly impaired renal function,
as safe dosage may be lower than that usually recommended.
Streptococcal infections should be treated for a minimum of 10 days, and posttherapy 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 super-infection occurs, appropriate measures
should be taken.
Patients with rare hereditary problems of galactose intolerance, the LAPP
lactase deficiency or glucose-galactose malabsorption should not take this
medicine.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant administration of guar gum with phenoxymethylpenicillin
reduces the absorption of the latter. Concurrent use of phenoxymethylpenicillin with probenecid reduces the excretion of phenoxymethylpenicillin.
Concurrent use of oestrogen-containing oral contraceptives may decrease the
effectiveness of oral contraceptives because of stimulation of oestrogen
metabolism resulting in menstrual irregularities, intermenstrual bleeding and
unplanned pregnancies.

4.6

Pregnancy and lactation
Laboratory and clinical studies have shown no evidence of teratogenicity with
the use of phenoxymethylpenicillin potassium during pregnancy. However, as
with other drugs, caution should be exercised when prescribing to pregnant
patients. Phenoxymethylpenicillin is excreted in the milk and should be used
with caution in nursing mothers as it may cause an allergic reaction in the
offspring.

4.7

Effects on ability to drive and use machines
None reported

4.8

Undesirable effects
The most common reactions to oral penicillin are nausea, vomiting, epigastric
distress, diarrhoea and black, hairy tongue. The hypersensitivity reactions
noted are skin eruptions (ranging from maculopapular to exfoliative
dermatitis); urticaria; reactions resembling serum sickness, including chills,
fever, oedema, arthralgia and prostration; laryngeal oedema; and anaphylaxis.
Fever and eosinophilia may frequently be the only reactions observed.
Haemolytic anaemia, leucopenia, thrombocytopenia, neuropathy and
nephropathy are infrequent reactions and are usually associated with high
doses of parenteral penicillin.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
A large oral overdose of penicillin may cause nausea, vomiting, stomach pain,
diarrhoea and rarely, major motor seizures. If other symptoms are present,
consider the possibility of an allergic reaction. No specific antidote is known.
Symptomatic and supportive therapy is recommended. Activated charcoal with
a cathartic, such as sorbitol, may hasten drug elimination. Penicillin may be
removed by haemodialysis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Phenoxymethylpenicillin has a mainly bactericidal action against many grampositive bacteria and some gram-negative cocci, and against some spirochaetes
and actinomycetes.
It is considered to act through interference with the final stage of synthesis of
the bacterial cell wall. The action depends upon phenoxymethylpenicillin's
ability to reach and bind to certain membrane bound proteins, known as
penicillin-binding proteins (PBP's), that are located beneath the cell wall.
These proteins are involved in maintaining cell wall structure, in cell wall
synthesis, and in cell division, and appear to possess transpeptidase and
carboxypeptidase activity.
Bacterial surface enzymes called autolysins also appear to be involved in the
lethal effect of penicillins particularly for gram-positive bacteria. In gramnegative bacilli, osmotic rupture of cells may occur once the cell wall is
weakened. Phenoxymethylpenicillin can also produce morphological changes
in vitro including the formation of long filaments or abnormally shaped cells.
Bacteria that are not growing and dividing are generally not killed by
phenoxymethylpenicillin.
Its action is inhibited by penicillinase and other beta-lactamases that are
produced during the growth of certain micro-organisms. The sensitivity of
bacteria to phenoxymethylpenicillin varies widely, even among the general
that are normally susceptible, especially as the incidence of beta-lactamaseproducing organisms is increasing.

5.2

Pharmacokinetic properties
Following oral administration, phenoxymethylpenicillin potassium is more
resistant to the action of gastric acid and is better absorbed than
benzylpenicillin. The absorption is rapid and approximately 60% of the oral
dose is absorbed.

Peak serum concentrations of 3-6 microgram per ml have been attained
following a dose of 250-500 mg. The effect of food on absorption appears to
be slight and variable. The plasma half-life is about 30 minutes and can be
increased up to 4 hours in renal failure. Approximately 80% of the drug is
bound to protein. It is widely distributed at varying concentrations in body
tissues and fluids. It appears in pleural, pericardial, peritoneal and synovial
fluids but diffusion is only to a small extent into abscess cavities, avascular
areas, the eye, the middle ear and the CSF.
It is metabolised in the liver; several metabolites have been identified
including penicilloic acid. The unchanged drug and metabolites are eliminated
rapidly in the urine. Minute concentrations are excreted in the bile.

5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Ingredient
Maize Starch BP
Lactose BP
Pregelatinised Maize Starch BP
Potable Water HSE
Magnesium Stearate BP

6.2

Incompatibilities
None reported

6.3

Shelf life
24 Months

6.4

Special precautions for storage
Keep out of the reach of children. Protect from heat, light and moisture.

6.5

Nature and contents of container
1) Opaque plastic containers (securitainers) fitted with snap-on plastic
closures in pack sizes of 9, 10, 14, 15, 20, 21, 28, 30, 50, 56, 84, 100, 250,
500 and 1000 tablets.
2) Opaque plastic containers composed of either high density polypropylene
or high density polyethylene with a tamper evident or child resistant

tamper evident closure composed of high density polyethylene with a
packing inclusion of standard polyether foam or polyethylene-or
polypropylene-made filler in pack sizes of 9, 10, 14, 15, 20, 21, 28, 30,
50, 56, 84,100, 250, 500 and 1000 tablets.
3) Blister packs of aluminium opaque PVC in pack sizes of 9, 10, 14, 15, 20,
21, 28, 30, 56, 84 and 500 tablets.

6.6

Special precautions for disposal
No special instructions for use/handling

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
Units 3 and 4, Quidhampton Business Units
Polhampton lane
Overton
Hampshire
RG25 3ED

8

MARKETING AUTHORISATION NUMBER
PL 20416/0126

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/11/2003

10

/

23/01/2009

DATE OF REVISION OF THE TEXT
10/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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