Benzabiotic 1.200.000 I.U.
(Vial)

Warning:
to prepare the solution powder deep muscular injection just
Benzabiotic vial not for intravenous injection.
Do not inject intravenously or other combines with INTRAVENOUS.

Composition:
  • Benzabiotic 1.200.000 IU
  • Each Vial contains:
    Benzathine Benzyl penicillin..... 1,200,000 I.U.
    Solvent:
    water injection............ 5 ml.

What is Benzabitic and what are the reasons for its use?
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Benzabiotic and other antibacterial drugs, Benzabiotic should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response.

Clinical Pharmacology:
Penicillin G benzathine has an extremely low solubility and, thus, the drug is slowly released from intramuscular injection sites. The drug is hydrolyzed to penicillin G.
This combination of hydrolysis and slow absorption results in blood serum levels much lower but much more prolonged than other parenteral penicillins.
Intramuscular administration of 300,000 units of penicillin G benzathine in adults results in blood levels of 0.03 to 0.05 units per ml, which are maintained for 4 to 5 days. Similar blood levels may persist for 10 days following administration of 600,000 units and for 14 days following administration of 1,200,000 units. Blood concentrations of 0.003 units per ml may still be detectable 4 weeks following administration of 1,200,000 units.
Approximately 60% of penicillin G is bound to serum protein. The drug is distributed throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys with lesser amounts in the liver, skin, and intestines.
Penicillin G penetrates into all other tissues and the spinal fluid to a lesser degree. With normal kidney function, the drug is excreted rapidly by tubular excretion. In neonates and young infants and in individuals with impaired kidney function, excretion is considerably delayed.

Microbiology:
Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci.

Indications & usage:
The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine:
  • Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci.
  • Venereal infections Syphilis, yaws, bejel, and pinta.
  • Medical Conditions in which Penicillin G Benzathine Therapy is Indicated as Prophylaxis:
    • Rheumatic fever
    • and/or chorea Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions.
    • It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.

Contraindications:
A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

Drug interaction:
Concurrent use of these drugs with Benzabiotic should be avoided:
  • Tetracycline: As a bacteriostatic antibiotic, it may antagonize the bactericidal effect of penicillin.
  • Probenecid: Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin.
Pregnancy & lactation:
  • Pregnancy Category B:
    Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been conducted with this drug.
  • Nursing Mothers:
    Soluble penicillin G is excreted in breast milk. Caution should be exercised when penicillin G benzathine is administered to a nursing woman.

Adverse reactions:
As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria.
Skin eruptions (maculopapular to exfoliative dermatitis), urticaria, laryngeal edema, fever, eosinophilia; other serum sickness-like reactions (including chills, fever, edema, arthralgia, and prostration); and anaphylaxis including shock and death.

Dosage & administration:
  • Streptococcal (Group A) Upper Respiratory Infections (for example, pharyngitis) :
    • Adults: a single injection of 1,200,000 units;
    • Older pediatric patients: a single injection of 900,000 units;
    • Infants and pediatric patients under 60 lbs.: 300,000 to 600,000 units.
  • Syphilis:
    • Primary, secondary, and latent 2,400,000 units (1 dose).
    • Late (tertiary and neurosyphilis) 2,400,000 units at 7-day intervals for three doses.
  • Congenital:
    • Under 2 years of age: 50,000 units/kg/body weight;
    • Ages 2 to 12 years: adjust dosage based on adult dosage schedule.
  • Yaws, Bejel, and Pinta: 1,200,000 units (1 injection).
  • Prophylaxis: For Rheumatic Fever and glomerulonephritis.
  • Following an acute attack: penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks.

Method of administration:
Penicillin G benzathine should only be prescribed for the indications listed in this insert.
Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock.

Storage:
Before reconstitution:
Keep at temperature not exceeding 30°C Administered directly just after reconstitution.

How supplied?
Carton box containing flint colourless (type 1) glass vial containing 900 mg powder giving 5 ml suspension after reconstitution closed by bromobutyl rubber stopper &sealed with aluminum flip off seal cap and insert leaflet.