Benzylpenicillin Sodium for Injection

Active Pharmaceutical Ingredient	CAS NO.	Molecular Formula	Definition	Structural Formula
Benzylpenicillin Sodium	69-57-8	C16H17N2NaO4S	[2S-(2a,5a,6b)]-3,3-Dimethyl-7-oxo-6-[(phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Monosodium Salt

Composition:

Each vial contains 1 MIU (600 mg) or 5 MIU (3.0 g) benzylpenicillin sodium for injection.

API mixing

Filling

Vial sterilization

Uses:

Benzylpenicillin Sodium For Injection is used for treatment of penicillin-sensitive infections: throat infections, otitis media, streptococcal endocarditis, meningococcal disease, pneumonia, tetanus, gas gangrene, diphteria, anthrax, leptospirosis.

Benzylpenicillin is an antibiotic which is effective in streptococcal, pneumococcal, gonococcal and meningococcal infections. Pneumococci, gonococci and meningococci often have decreased sensitivity to penicillin, and benzylpenicillin is not the first choice for pneumococcal meningitis.

Administer preferably by intramuscular injection. In severe cases by slow intravenous injection or intravenous infusion. Doses over 1.2 g should be given slowly by intravenous route only. The intravenous route is preferred for neonates and infants.

Adults and children over 12 years: 2 – 8 MIU daily in 4 divided doses

Neonate and premature infant: 40,000 IU/kg (25 mg/kg) 2 times daily

Infant 1 - 4 weeks: 40,000 IU/kg (25 mg/kg) 3 times daily

Child 1 month - 12 years: 40,000 IU/kg (25 mg/kg) 4 times daily

In severe cases (meningitis, endocarditis) 3 - 4 MIU (1.8 - 2.4 g) up to 6 times daily, given by intravenous route.

Do not use in patients with known penicillin allergy. Cross allergy to other beta-lactams such as cephalosporins should be taken into account. Avoid contact with the skin because of the risk of sensitization. Use only with care in patients with renal impairment. Benzylpenicillin Sodium For Injection should not be given by intrathecal injection because they can cause encephalopathy which may be fatal.

Prolonged use of benzylpenicillin may occasionally result in an overgrowth of non-susceptible organisms or yeast and patients should be observed carefully for superinfections. High dosage of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia unless the sodium content is taken into account.

Administration of benzylpenicillin reduces excretion of methotrexate (increased risk of toxicity). Probenecid inhibits tubular secretion of benzylpenicillin and may be given to increase the plasma concentrations.

Preparation of solutions

Use only freshly prepared solutions.

Hypersensitivity includes skin reactions, edema in the throat, seldom anaphylactic shock. High doses of benzylpenicillin may cause reductions in blood cell count, hypernatraemia and hypokalaemia. Inflammation, phlebitis or thrombophlebitis at injection sites. Patients who have syphilis have occasionally suffered from a type of reaction (Jarisch-Herxheimer reaction) after the injection, with fever, chills, headache and heart problems.

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