Austell-Pen Vk 125/250 Powder for oral solution

AUSTELL - PEN VK is used prophylactically to prevent recurrence of rheumatic fever. It is also indicated in the treatment of:

• Mild to moderate infections caused by sensitive organisms.
• Pneumococcal infections of the middle ear.
• Streptococcal otitis media and sinusitis.
• Streptococcal pharyngitis caused by Streptococcus pyogenes.

Posology

(1) Streptococcal infection:

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.

Method of administration

AUSTELL - PEN VK is for oral administration. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

• Hypersensitivity to the Phenoxymethylpenicillins or Cephalosporins or to any of the excipients listed in section 6.1.
• Use in Dysentry, and typhus, and other infections caused by penicillin resistant microbes such as Brucella and E.coli.
• For treatment of trivial disorders.

• Penicillins 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 medicine should be discontinued and the patient treated with the usual medicines (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 overgrowth of non-susceptible organisms including fungi. If super infection occurs, appropriate measures should be taken.
• This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

• Aminoglycosides: Neomycin is reported to reduce the absorption of phenoxymethylpenicillin.
• Anticoagulants: Penicillins may interfere with anticoagulants 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.

Safety in pregnancy and lactation has not been established.

None known

a) Summary of the safety profile

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.

b) Tabulated list of adverse reactions

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with phenoxymethylpenicillin

System Organ Class Frequency Frequent Less Frequent Not known Blood and lymphatic system disorders Neutropenia, haemolytic anaemia, leucopenia, prolongation of bleeding time and defective platelet function.

Cardiac disorders Kounis syndrome

Immune system disorders Allergic skin reactions such as exfoliative dermatitis, anaphylaxis, angio-oedema, urticaria and some maculopapular rashes.

Nervous system disorders Convulsions and other signs of toxicity to the central nervous system (CNS).

Gastrointestinal disorders Transient nausea, diarrhoea, pseudomembraneous colitis.

Hepatobiliary disorders Hepatitis and cholestatic jaundice

Skin and subcutaneous tissue disorders Urticarial, erythematous or exfoliative dermatitis, linear IgA mobilliform rash and pruritus

Renal and urinary disorders Nephropathy and interstitial nephritis. Care should be exercised when high doses are given to patients with renal impairment because of the risk of neurotoxicity.

General disorders and administration site conditions Sore mouth/tongue, black hairy tongue.

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 requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Suspected adverse reactions can also be reported directly to the HCR via [email protected].

Any form of actual toxicity of phenoxymethylpenicillin is rare and doses of 8 g have been well tolerated.

Signs and 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.

Treatment

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.