Betapen 125mg & 250mg Granules

Infections caused by penicillin sensitive microorganisms including sore throat due to Group A beta haemolytic streptococci. Rheumatic fever prophylaxis.

(1) Streptococcal infections:
Adults: 125 to 250 mg every 4 hours
Children: up to 1 year 60 mg every 6 hours.
1 to 5 years: 125 mg every 6 hours.
6 to 12 years: 250 mg every 6 hours.
(2) Rheumatic fever prophylaxis: 125 mg every 12 hours.
FOR BETAPEN 125 mg GRANULES:
DIRECTIONS FOR RECONSTITUTING 100 ml GRANULES FOR SUSPENSION
Add 69 ml of water in divided amounts shaking after each addition.
DIRECTIONS FOR RECONSTITUTING 60 ml GRANULES FOR SUSPENSION
Add 41,5 ml of water in divided amounts shaking after each addition.
FOR BETAPEN 250 mg GRANULES:
DIRECTIONS FOR RECONSTITUTING 100 ml GRANULES FOR SUSPENSION
Add 68 ml of water in divided amounts shaking after each addition.
Method of Administration
For instructions on reconstitution of the medicinal product before administration, see section 6.6

Dysentry and typhus, and other infections caused by penicillin resistant microbes such as Brucella and E. coli. Hypersensitivity to penicillin.

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 is begun.
If any 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 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 promote the over growth of non-susceptible organisms, including fungi. If super infection occurs, appropriate measures should be taken.
BETAPEN GRANULES contains sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose mal-absorption or sucrase-isomaltase insufficiency should not take BETAPEN GRANULES.

Aminoglycosides: Neomycin is reported to reduce the absorption of phenoxymethylpenicillin.
Anticoagulants: Penicillins may interfere with anticoagulant control.
Bacteriostatic antibiotics: Certain bacteriostatic antibiotics such as Chloramphenicol, Erythromycin and Tetracyclines have been reported to antagonise the bactericidal activity of penicillins and concomitant use is not recommended.
Guar gum: Reduced absorption of phenoxymethylpenicillin
Methotrexate: Use of Phenoxymethylpenicillin while taking methotrexate can cause reduced excretion of methotrexate thereby increasing the risk of toxicity.
Probenecid: Reduced excretion of phenoxymethylpenicillin by competing with it for renal tubular secretion.
Sulfinpyrazone: Excretion of penicillins reduced by sulfinpyrazone.
Typhoid vaccine (oral): Penicillins may inactivate oral typhoid vaccine if ingested concomitantly.

Pregnancy: There are no or a limited amount of data from the use of Phenoxymethylpenicillin in pregnant women. As a precautionary measure, it is preferable to avoid the use of Phenoxymethylpenicillin during pregnancy.
Lactation: Phenoxymethylpenicillin metabolites are excreted in human milk to such an extent that effects on breastfed newborns are likely.

This medicine should not affect your ability to drive or to use machinery.

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.
System Class Frequent Less Frequent Frequency Unknown
Infections and infestations Pseudomembranous colitis
Blood and lymphatic Disorders Changes in blood counts, including, thrombocytopenia, neutropenia, leucopenia, eosinophilia and haemolytic anaemia. Coagulation disorders (including prolongation of bleeding time and defective platelet function)
Gastrointestinal disorders Nausea, vomiting, abdominal pain, diarrhoea Sore mouth and black hairy tongue (discolouration of tongue)
Hepatobiliary disorders Hepatitis and cholestatic jaundice
Immune disorders Allergic Severe allergic reactions causing Serum sickness-like
Reactions (typically manifest as skin reactions (See Skin and subcutaneous disorders). angioedema, laryngeal oedema and anaphylaxis reactions characterised by fever, chills and oedema and anaphylaxis
Nervous system disorders Central nervous system toxicity including convulsions (especially with high doses or insevere renal impairment); paraesthesia mayoccur with prolonged use, Neuropathy (usually Associated with high doses of parenteral penicillin)
Renal and urinary disorders Interstitial nephritis
Nephropathy (usually associated with high doses of parenteral penicillin)
Skin and subcutaneous Disorders Urticarial, erythematous or mobilliform rashand pruritus Exfoliative dermatitis
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d , found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Any form of actual toxicity of phenoxymethylpencillin is rare and doses of 8 g have been well tolerated.
Symptoms: 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. Hyperkalaemia may result from overdosage, particularly for patients with renal insufficiency.
Management: 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.