Penicillin Tablets 250mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Penicillin Tablets 250 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenoxymethylpenicillin 250 mg (as potassium salt)
For excipients see 6.1
3. PHARMACEUTICAL FORM
Tablet
White, creamy-white or greyish white flat, bevelled tablet scored on one side and marked MP 12 on the other side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Phenoxymethylpenicillin potassium is indicated in the treatment of mild to severe infections associated with micro organisms whose susceptibility to penicillin is within the range of serum levels attained with these dosage forms.
The drug exerts high activity in vitro against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L and M), pneumococci, Corynebacterium diphtheriae, Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacillus moniformis, Listeria monocytogenes, Leptospira, Neisseria gonorrhoeae, Treponema pallidum.
The following 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.
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.
Prophylactic usage: prophylaxis with oral Penicillin has proved effective in preventing recurrence 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.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2 Posology and method of administration
Adults and children over 12 years: 125 mg or 250 mg every four to six hours,
depending on the severity of the condition. The dose may be increased up to 1g every six hours in severe infection.
Elderly: As for adults. Reduce dosage if renal function is markedly impaired.
Children: 5 to 12 years - 250 mg every six hours
1 to 5 years - 125 mg every six hours
Up to 1 year - 62.5 mg every six hours. Use of a penicillin solution is recommended.
Prophylactic use: 125 mg twice daily is recommended for long term prophylaxis of rheumatic fever and chorea.
In all but the most serious cases, the last dose of the day may be doubled to avoid disturbing sleep. Ideally each dose should be given half-an-hour before (or at least three hours after) a meal.
To avoid late complications (rheumatic fever), infections with P-haemolytic streptococci should be treated for 10 days.
To be taken by mouth.
4.3. Contraindications
A previous 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 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).
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.
Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with Penicillin during the acute phase.
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.
Penicillins may cause false-positive urinary glucose test results when testing for reduced substances.
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 superinfection occurs, appropriate measures should be taken.
Penicillin Tablets 250mg contain lactose and are unsuitable for patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorbtion.
4.5. Interactions with other medicinal products and other forms of interaction
Concomitant use of neomycin or guar gum reduces the absorption of phenoxymethylpenicillin.
Penicillins may decrease the removal of methotrexate from the body, increasing the risk of toxicity.
Probenecid may decrease the rate of removal of penicillins from the body.
Penicillins may decrease the effectiveness of oestrogen containing contraceptive pills.
4.6. Pregnancy and lactation
Penicillins are not known to be harmful when used during pregnancy but caution should be exercised when prescribing for the pregnant patient.
Penicillin passes into the breast milk, but at normal doses it is unlikely to harm the baby.
4.7. Effects on ability to drive and use machines
No known effects
4.8. Undesirable effects
Although reactions have been reported much less frequently after oral than after parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin.
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.
4.9. Overdose
Treatment is symptomatic, but unlikely to be required.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Penicillin is bactericidal to susceptible micro-organisms during the stage of their active multiplication.
5.2. Pharmacokinetic properties
Absorption of Phenoxymethylpenicillin from the gastro-intestinal tract is usually rapid, but peak serum concentrations are variable; peak serum concentrations of about 0.7 jig per ml have been observed following a dose of 125 mg and 3 to 5 ig per ml following 250 to 500 mg. The biological half-life of Phenoxymethylpenicillin in serum is about 30 minutes and about 55%-80% is protein bound. Phenoxymethylpenicillin diffuses across the placenta; it also diffuses into ascitic, pericardial, pleural and synovial fluids. There is little diffusion into the cerebrospinal fluid unless the meninges are inflamed. Some 20%-30% of a dose appears in the urine within 24 hours. Only small concentrations are excreted in the bile.
5.3. Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Lactose Maize starch
Pregelatinised maize starch Sodium starch glycollate Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Containers: 36 months. Blister Packs: 24 Months
6.4. Special precautions for storage
Containers: Do not store above 25°C. Store in the original container and keep the container tightly closed.
Blister Packs: Do not store above 25°C. Store in the original package.
6.5. Nature and contents of container
Tablet containers: Polypropylene or high density polystyrene containers with polythene closures and polyurethane wads or polythene inserts.
Blister packs: 250pm PVC/PVDC and 20pm aluminium foil coated with heat resistant print primer on one side and heat-seal lacquer on the other.
Pack sizes of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.
6.6. Instruction for use and handling
Not Applicable.
7 MARKETING AUTHORISATION HOLDER
Metwest Pharmaceuticals Limited
15 Runnelfield
Harrow on the Hill
Middlesex
HA1 3NY
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 17521/0012
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/02/2006
10 DATE OF REVISION OF THE TEXT
19/06/2012