LONGERPEN 1200000
-
Chemical Name:
Benzyl Penicillin (Benzathine) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Penicillin -
Pharmaceutical Form:
Vial -
Composition:
Benzyl Penicillin 1200000i.u
LONGERPEN
for Injection (Vial)
Benzyl Penicillin (Benzathine)
1-PHARMACOLOGY:
LONGERPEN is an antibiotic with bactericidal action against penicillin-susceptible microorganisms. It acts through the inhibition of biosynthesis of cell-wall mucopeptide and belongs to the B-lactams, of the group penicillin G with a depot effect of long duration.
A single injection of LONGERPEN injection provides adequate amount of penicillin in blood with long lasting action against infections susceptible to the following strains: Streptococcus A, Treponema pallidum and Treponema pertenue.
2-PHARMACOKINETICS:
LONGERPEN maximum concentration in serum occurs within 12 to 24 hours after injection. The long half-life provides stable and long-lasting penicillin concentrations in blood: 14 days after intramuscular injection of 2.400.000 IU, The concentration in serum is 0.12 µg/ml.
On the 21st day after injection of 1.200.000 IU, 88% to 97.4% of individuals have 0.06 µg/ml of penicillin in blood.
LONGERPEN diffusion in the body fluid is good, but very poor in the tissues. Binding to plasma-proteins is 40% to 60%. Biotransformation is weak and it is mainly eliminated in urine.
3-INDICATIONS:
LONGERPEN is prescribed in the following indications:
-Prophylaxis of relapses in acute rheumatic fever.
-Infections of the upper respiratory tract due to susceptible streptococci.
-Treatment of syphilis, yaws, bejel and pinta.
4-CONTRA – INDICATIONS:
Allergy to penicillins.
5-PRECAUTIONS:
-History of allergy to penicillins or cephalosporins before administration of treatment.
-LONGERPEN must be administered in deep intramuscular injections, never intravenously.
-In case of hypersensitivity (anaphylaxis), they are treated with good success by epinephrin, steroids,calcium and/or antihistaminics. Previous questioning is therefore required before administration.
6-PREGNANCY AND LACTATION:
LONGERPEN crosses the placental barrier and goes into maternal milk. It should be used carefuly in nursing mothers.
7-ADVERSE REACTIONS:
Allergic manifestations: Fever, urticaria, eosinophilia, quinke’s edema and anaphylactic shock in exceptional cases.
Reversible hematologic reactions: Anaemia, thrombocytopenia, leukopenia, disorders of coagulation.
8-DRUG INTERACTIONS:
Tetracycline may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided.
Concurrent administration of penicillins and probenecid increase and prolongs serum penicillin levels.
9-DOSAGE & ADMINISTRATION:
Benzathine Benzyl Penicillin is administered by deep intramuscular injection.
Shake thoroughly before using the aqueous suspensions.
-For streptococcal pharyngitis and the primary prevention of rheumatic fever the adult dose is a single intramuscular injection of 1.200.000 IU.
-Children under 30 kg body-weight may be given 600.000 IU to 900.000 IU.
-To prevent recurrence of acute rheumatic fever 1.200.000 IU is given intramuscularly every 3 or 4 weeks, a dose of 600.000 has been recommended for children under 30kg body-weight.
-Treatment of treponemiasis: 1 intramuscular injection of 2 * 1.200.000 IU every 8 days.
-For the treatment of treponemal infections, such as yaws, pinta, and endemic syphilis (bejel), a single intramuscular dose of benzathine penicillin 1.200.000 IU is given, or 600.000 IU in children.
-For early syphilis, two doses of benzathine penicillin 1.200.000 by deep intramuscular injection is given usually as 2 injections at separate sites. In late syphilis, 2 intramuscular injection of 1.200.000 IU is given at weekly intervals for 3 consecutive weeks.
-Benzathine Penicillin is not usually recommended for the treatment of neurosyphilis because of reports of inadequate penetration into the CSF. Infants up to 2 years of age may be given a single intramuscular dose of 50.000 IU per kg body-weight for the treatment of congenital syphilis provided there is no evidence of infection in the CSF.
Preparation of suspension for I.M. Injection:
Dissolve the content of the vial LONGERPEN – 600.000 in 2 mL of water for Injection.
Dissolve the content of the vial LONGERPEN – 1.200.000 in 3 mL of water for Injection.
10-PACKAGING & COMPOSITION:
-LONGERPEN 600000 – for Injection: A pack of 1 vial. Each vial contains sterile Benzathine Benzylpenicillin equivalent to 600000 IU Benzylpenicillin.
-LONGERPEN 1200000 – for Injection: A pack of 1 vial. Each vial contains sterile Benzathine Benzylpenicillin equivalent to 1200000 IU Benzylpenicillin.
11-STORAGE CONDITIONS:
Store LONGERPEN– for Injection at temperature below 25°C.
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