Phenoxymethylpenicillin

Brands of Phenoxymethylpenicillin in Kenya

As-V, Astra Lifecare
Elypen, Elys Chemical Industries Ltd
Penmed-V, Medivet Products Ltd
Speniv, Kentons Limited


Phenoxymethylpenicillin in Kenya : INDICATIONS

Phenoxymethylpenicillin and phenoxymethylpenicillin potassium 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 the dosage form.

Phenoxymethylpenicillin is indicated for the treatment of the following infections

Streptococcal infections:

Pharyngitis

Scarlet fever

Skin and soft tissue infections (e.g erysipelas)

Pneumococcal infections:

Pneumonia

Otitis media

Vincent’s gingivitis and pharyngitis

Phenoxymethylpenicillin is also indicated for

Prophylaxis of rheumatic fever and/or chorea

Prophylaxis of pneumococcal infection (e.g. in asplenia and inpatients with sickle cell disease

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

DOSAGE AND ADMINISTRATION

The usual dosage recommendations are as follows:

Adults and children over 12 years: 250mg – 500mg every six hours

Children: Infants (up to 1 year): 62.5mg every 6 hours

1-5 years: 125mg every six hours

6-12 years: 250mg every six hours

Prophylactic Use

Prophylaxis of rheumatic fever/chorea: 250mg twice daily on a continuing basis

Prophylaxis of pneumococcal infection (e.g. in asplenia and in sickle cell disease):

Adults and children over 12 years: 500mg every 12 hours

Children 6-12 years: 250mg every 12 hours

Children below 5 years: 125mg every 12 hours.

Elderly

The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired.

Renal impairment

The dosage should be reduced if renal function is markedly impaired.

Hepatic impairment

Dosage adjustment may be necessary in patients with impaired liver function when they also have renal failure. In this situation the liver may be a major excretion route.

CONTRAINDICATIONS

Phenoxymethylpenicillin is contraindicated in patients known to be hypersensitive to Penicillin and should be used with caution in patients with known histories of allergy.

DRUG INTERACTIONS

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.

ADVERSE EFFECTS

Hypersensitivity

Potential allergic reactions include urticaria, angioneurotic oedema, erythema multiforme, exfoliative dermatitis, fever, joint pain, serum sickness-like reactions, haemolytic anaemia, interstitial nephritis or anaphylactic shock (which could be fatal) with collapse and anaphylactoid reactions (asthma, purpura, gastrointestinal symptoms). Although these are less common, and take a milder course, in oral treatment than during parenteral penicillin treatment, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin.

Gastro-intestinal tract

Phenoxymethylpenicillin potassium is generally well tolerated. Occasionally soft stools occur and they do not require the interruption of the treatment.

Nausea, diarrhoea, vomiting, stomatitis and glossitis are sometimes seen.

Sustained severe diarrhoea should prompt suspicion of pseudomembranous colitis. As this condition may be life-threatening phenoxymethylpenicillin should be withdrawn immediately and treatment guided by bacteriologic studies with appropriate antibiotherapy (i.e. vancomycin)..

Blood

Eosinophilia, haemolytic anaemia, leukopenia, thrombocytopenia and agranulocytosis are extremely rare. Other possible effects on the blood composition include: neutropenia, haemolytic anaemia and coagulation disorders.

Central nervous system

Central nervous system toxicity, including convulsions, has been reported, especially following high doses or in severe renal impairment. Paraesthesia has been reported with prolonged use.

As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis.

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:


Phenoxymethylpenicillin in Kenya
Phenoxymethylpenicillin in Kenya
Phenoxymethylpenicillin in Kenya
Phenoxymethylpenicillin in Kenya
Phenoxymethylpenicillin in Kenya
Phenoxymethylpenicillin in Kenya

Clinical | Pharmacokinetic data


Pregnancy Category: B (No risk in non-human studies)
Routes of Administration: Oral
Bioavailability: 60%
Protein Binding: 80%
Metabolosim: liver
Onset of Action: N/A
Elimination Half life: 30–60 min
Excretion: kidney

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:


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References/ Citation:

  1. PPB Drugs Retention Register
  2. Heimdahl, Anders, and Carl Erik Nord. “Effect of phenoxymethylpenicillin and clindamycin on the oral, throat and faecal microflora of man.Scandinavian journal of infectious diseases 11.3 (1979): 233-242.



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