Product Dossier
LPV
Product Dossier for LPV (phenoxymethylpenicillin 500 mg, iNova Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: iNova Pharmaceuticals
- Active ingredient: phenoxymethylpenicillin 500 mg
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
LPV is phenoxymethylpenicillin. LPV capsules contain either 250 mg or 500 mg of the active phenoxymethylpenicillin (as potassium). LPV 250 mg capsules contain 28 mg potassium per capsule and LPV 500 mg capsules contain 55 mg potassium per capsule.
Approved indications
— Streptococcal infections (without bacteraemia), including mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. — Pneumococcal infections of the respiratory tract (mild to moderately severe). — Fusospirochetosis (Vincent's gingivitis and pharyngitis), including mild to moderately severe infections of the oropharynx. — Prevention of recurrence following rheumatic fever and/or chorea. — Prevention of bacterial endocarditis in patients with congenital and/or rheumatic heart lesions who are to undergo dental procedures or minor upper respiratory tract surgery or instrumentation.
Dosing overview
The dosage of penicillin V should be determined according to the sensitivity of the causative micro-organisms and the severity of infection and adjusted to the clinical response of the patient.
Key safety warnings
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens. There have been well documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including LPV, with a toxin produced by Clostridium difficile appearing to be the primary cause, and the severity of the colitis may range from mild to life threatening. This diagnosis should be considered in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma, and the oral route of administration should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility.
Contraindications
A previous hypersensitivity reaction to any penicillin.
Regulatory history
LPV phenoxymethylpenicillin 250 mg and 500 mg capsules were first listed on the ARTG on 16 October 1998.