DIOPEN®
NAME AND DOSAGE FORM OF PRODUCTS
PHENOXY-METHYL PENICIlLLIN
TABLET 250 mg BP
DESCRIPTION
White and round with breakline one side and engraved with “Diopen” on another side. Size: 10mm
PHARMACOLOGY
Phenoxymethyl penicillin inhibits mucopeptide synthesis of the bacterial cell wall.
PHARMACOKINETICS
Absorption
Phenoxymethyl Penicillin is 60% to 73% Orally absorbed, reaching its peak plasma concentration of 2 to 3 mcg/ml within 30 minutes to one hour.
Distribution
Phenoxymethyl Penicillin is widely distributed to most tissues and body fluids. Distribution cerebrapinal fluid is low with noninflamed maninges. Protein bind in, is 80% with 0.5 l/kg as the volume of distribution.
Metabolism
Hepatic biotransformation is 55%
Elimination
Mainly renal (20% to 40% as unc~ged) ~half life is within 30 minutes to one hour
INDICATION AND USAGE
Treatment of upper respiratory tract infections, treatment of pneumococcal, streptococci, and staphylococcal infections and fusospirochetosis of oropharynx caused by susceptible microorganisms.
DOSAGE AND ADMINISTRATION
Adults: 500mg every four to six hours depending on severity of the condition
Elderly As for adults reduce dosage if renal function is markedly impaired
Children over 5 years: The adult dose.
Children 5 years or less: 125mg every six hours.
infants (Up to 1 year) 62.5mg every six hours.
In all but the most serious cases, the last dose of the day may be doubled to avoid disturbing sleep. Ideally, each dose should be given half an hour (or at least three hours after)
CONTRAINDICATIONS
Hypersensitivity to penicillins. Do not treat servere pneumonia, empyema, bacteremia, pericarditis, meningitis and purulent or septic arthritis with oral penicillin V during acute age stage.
In pregnancy: Although laboratory and clinical studies have shown no evidence of teratogenicity, caution should be exercised when prescribing for the pregnant patient.
DRUG INTERACTlONS
Betablockers may potentiate anaphylatic reactions of penicillin, pen-V may reduce efficacy to oral contraceptives while the bactericidal effects of Pen-V can impaired by tetracyclines.
PRECAUTIONS
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Orally therapy should not be relied upon in patients with severe illiness, or with nausea, vomiting, gastric dilation, cardiospasm or intestinal hyper motility. Occasionally patients do not absorb therapeutic amount of orally administered penicillin. Administer with caution in the presence of markedly impaired renal function as safe dosage may be lower than that usually recommended. Prolonger use of antibiotics may promote the overgrowth of on-susceptible organism, including fungi, If super infection occurs. appropriate measures should be taken.
SIDE EFFECTS
The most common reaction to orally peniclllin are nausea, vomiting, epigastric distress, diarrhoea and black, hairy tongue.The hypersensitivity reactions noted are skin eruption (Ranging from maculopapular to exfoliative dermatitis) urticaria: reaction resembling serum sickness, including chills fever oedema, arthralgia and prostration, laryngeal oedema and anaphylaxis. Fever and eosinophilia may frequentty be only reaction observed.
Hemolytic anaemie,leucopenia, neuropathy and doses of parenteral penicillin.
OVERDOSAGE
Neuromuscular Hyperexcitability, agitation, confusion, asterixis, hallucinations. stupor, coma, multifocal myoclonus, enocephalopathy, hyperkelemia.
STORAGE
Tablets and dry powder for oral suspension should be stored In a dry place at a temperature not exceeding 25°C.
PACKING AND PACK SIZE
In blister packs of 10 x 10’s
In bulk tins of 500’s and 1000’s tablets
SHELF LIFE: Two years from the manufacturing date.