BENZYLPENICILLIN SODIUM Powder for injection Ref.[6457] Active ingredients: Benzylpenicillin

Route of administration: Intramuscular, intravenous.

Preparation of solutions

Pharmaceutical preparation

Only freshly prepared solutions should be used. Reconstituted solutions of benzylpenicillin sodium are intended for immediate administration.

600 mg vial

Intramuscular injection: 600 mg (1 mega unit) is usually dissolved in 1.6 to 2.0 ml of Water for Injections BP.

600 mg

Intravenous Injection: A suitable concentration is 600 mg (1 mega unit) dissolved in 4 to 10 ml of Water for Injections BP or Sodium Chloride

Injection BP

Intravenous Infusion: It is recommended that 600 mg (1 mega unit) should be dissolved in at least 10 ml of Sodium Chloride Injection BP or Water for Injections BP

Sodium overload and/or heart failure may occur if benzylpenicillin sodium is administered in sodium-containing solvents to patients who suffer from renal failure and/or heart failure. Therefore, for such patients, benzylpenicillin sodium should not be reconstituted in sodium-containing liquids such as Sodium Chloride Injection BP or Ringer’s solution.

Dosage and administration

The following dosages apply to both intramuscular and intravenous injection.

Alternate sites should be used for repeated injections.

Adults

600 to 3,600 mg (1 to 6 mega units) daily, divided into 4 to 6 doses, depending on the indication. Higher doses (up to 14.4 g/day (24 mega units) in divided doses) may be given in serious infections such as adult meningitis by the intravenous route.

In bacterial endocarditis, 7.2 to 12 g (12 to 20 mega units) or more may be given daily in divided doses by the intravenous route, often by infusion.

Doses up to 43.2 g (72 mega units) per day may be necessary for patients with rapidly spreading gas gangrene.

High doses should be administered by intravenous injection or infusion, with intravenous doses in excess of 1.2g (2 mega units) being given slowly, taking at least one minute for each 300 mg (0.5 mega unit) to avoid high levels causing irritation of the central nervous system and/or electrolyte imbalance.

High dosage of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia unless the sodium content is taken into account.

For the prevention of Group B Streptococcal disease of the newborn, a 3 g (5 mega units) loading dose should be given to the mother initially, followed by 1.5 g (2.5 mega units) every 4 hours until delivery.

Children aged 1 month to 12 years

100 mg/kg/day in 4 divided doses; not exceeding 4 g/day.

Infants 1-4 weeks

75 mg/kg/day in 3 divided doses.

Newborn Infants

50 mg/kg/day in 2 divided doses.

Meningococcal disease

Children 1 month to 12 years: 180-300 mg/kg/day in 4-6 divided doses, not exceeding 12 g/day.

Infants 1-4 weeks: 150 mg/kg/day in 3 divided doses.

Newborn infants: 100 mg/kg/day in 2 divided doses.

Adults and children over 12 years: 2.4 g every 4 hours

Suspected meningococcal disease

If meningococcal disease is suspected general practitioners should give a single dose of benzylpenicillin sodium, before transferring the patient to hospital, as follows:

Adults and children over 10 years: 1,200 mg IV (or IM)

Children 1-9 years: 600 mg IV (or IM)

Children under 1 year: 300 mg IV (or IM)

Premature babies and neonates

Dosing should not be more frequent than every 8 or 12 hours in this age group, since renal clearance is reduced at this age and the mean half-life of benzylpenicillin may be as long as 3 hours.

Since infants have been found to develop severe local reactions to intramuscular injections, intravenous treatment should preferably be used.

Patients with renal insufficiency

For doses of 0.6-1.2 g (1-2 mega units) the dosing interval should be no more frequent than every 8-10 hours.

For high doses e.g. 14.4 g (24 mega units) required for the treatment of serious infections such as meningitis, the dosage and dose interval of benzylpenicillin sodium should be adjusted in accordance with the following schedule:

The dose in the above table should be further reduced to 300 mg (0.5 mega units) 8 hourly if advanced liver disease is associated with severe renal failure.

If haemodialysis is required, an additional dose of 300 mg (0.5 mega units) should be given 6 hourly during the procedure.

Elderly Patients

Elimination may be delayed in elderly patients and dose reduction may be necessary.

Excessive blood levels of benzylpenicillin sodium can be corrected by haemodialysis.

Unopened 36 months.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Store below 25°C.

For storage conditions after dilution of the medicinal product, see section 6.3.

Tubular type III glass vials sealed with bromobutyl rubber plugs with aluminium overseals or plastic ‘flip-top’ caps. This product is supplied in vials containing 600 mg of powder in boxes containing 10, 25, 50, and 100 vials.

Not all pack sizes may be marketed.

After contact with skin, wash immediately with water. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice if discomfort persists.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.