PHENOXYMETHYLPENICILLIN

Posology Adults: 125 – 500 mg every 4 – 6 hours depending on the severity of the condition. Prophylactic use: 125 mg twice daily is recommended for long term prophylaxis of rheumatic fever. 5 mg 6 hourly 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 2 hours after a meal. To avoid late complications (rheumatic fever), infections with beta-haemolytic streptococcal infection, should be for 10 days, The treatment of acute otitis media with penicillin V should be limited to five days.

However, 5-10 days treatment may be recommended in patients with potential for complications. 6.

The most common reactions to oral penicillin are gastrointestinal effects and hypersensitivity reactions. Although hypersensitivity reactions have been reported much less frequently after oral than after parenteral therapy, it should be remembered that all forms of hypersensitivity, including fatal anaphylaxis have been observed with oral penicillin.

Hypersensitivity reactions of all intensities - to the point of anaphylactic shock- have also been observed after oral penicillin use. Severe anaphylactoid reactions, which occur significantly less often after oral administration of penicillin than after intravenous or intramuscular administration, may necessitate appropriate emergency management.

The following convention has been utilised for the classification of undesirable effects: Very common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).

Infections and infestations Not known Pseudomembranous colitis Very rare Changes in blood counts, including, thrombocytopenia, granulocytopenia, agranulocytosis neutropenia, leucopenia, pancytopenia eosinophilia and haemolytic anaemia.

These changes are reversible on discontinuation. Coagulation disorders have also been reported. Blood and lymphatic disorders Not known Coagulation disorders (including prolongation of bleeding time and defective platelet function) Common Gastric discomfort, flatulence, nausea, vomiting, abdominal pain, diarrhoea glossitis, stomatitis.

These disorders are usually light and abate during or at the latest after discontinuing treatment Uncommon Sore mouth and black hairy tongue (discolouration of tongue) Rare Dry mouth Gastrointestinal disorders Very rare tooth discolouration Very rare Hepatitis, cholestatic jaundiceHepatobiliary disorders Rare Transiently raised liver enzymes Common Allergic reactions (typically manifest as skin reactions (See Skin and subcutaneous disorders).

Urticarial, erythematous or mobilliform rash, pruritus may occur Immune disorders Very rare Serious allergic reactions including drug fever, arthralgia, eosinophilia, angioneurotic oedema, laryngeal oedema, bronchospasm, tachycardia, dyspnoea, serum sickness, allergic vasculitis and dropping of blood pressure up to life threatening shock.

Unknown Central nervous system toxicity including convulsions (especially with high doses or in severe renal impairment); paraesthesia may occur with prolonged use, Neuropathy (usually associated with high doses of parenteral penicillin) Nervous system disorders Rare Taste alteration Very rare Interstitial nephritisRenal and urinary disorders Uncommon Nephropathy (usually associated with high doses of parenteral penicillin) Common Urticarial, erythematous or mobilliform rash and pruritus, exanthema Rare Exfoliative dermatitis, Toxic epidermal necrolysis, allergic vasculitis Skin and subcutaneous disorders Very Rare Severe skin reactions such as Stevens- Johnson syndrome Metabolism and Nutrition Disorders Very common Loss of appetite Investigations Rare blood pressure decreased Frequently fever and eosinophilia will be the only manifestations of penicillin hypersensitivity.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Before initiation of penicillin therapy, careful enquiry should be made concerning previous hypersensitivity reaction to penicillin, cephalosporins or other drugs. Fatal anaphylaxis has been observed with oral penicillin. Patients suffering from severe gastrointestinal impairments accompanied by vomiting and diarrhoea should not be treated with penicillin V, because sufficient absorption is not ensured.

g. with benzyl penicillin or another adequate antibiotic). Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. 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. Enquiries should be made for such a history before therapy with a penicillin is begun. g. Adrenaline and other pressor amines, antihistamines and corticosteroids).

Oral therapy should not be relied upon for patients with severe illness, or with nausea, vomiting, gastric dilation, achalasia 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 the usually recommended doses. Streptococcal infections should be treated for a minimum of 10 days, and post-therapy cultures should be performed to confirm the eradication of the organisms.

Prolonged use of antibiotics may result in the development of superinfection due to organisms resistant to that anti-infective including Pseudomonas and Candida. If superinfection occurs, appropriate measures should be taken. In patients undergoing long-term penicillin V treatment the complete and differential blood count, as well as the liver and kidney function, should be monitored.

Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of penicillins. These are serious and potentially life threatening cutaneous conditions. , progressive skin rash often with blisters or mucosal lesions) and instructed to discontinue use immediately and seek urgent medical attention.

61g sucrose; this should be taken into account in patients with diabetes mellitus. May be harmful to teeth. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.

Ponceau 4R (E124):

May cause allergic reactions.

1 and should be used with caution in patients with known histories of allergy.