CLINDAMYCIN Solution for Injection or Infusion

Active ingredients: Clindamycin

Therapeutic indications

Clindamycin is indicated for the treatment of severe infections (see section 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.

Posology and method of administration

Posology

Parenteral (IM or IV administration). Clindamycin 150mg/ml Solution for Injection and Infusion must be diluted prior to I.V. administration and should be infused over at least 10-60 minutes.

Adults

Serious infections: 600mg-1.2g/day in two, three or four equal doses.

More severe infections: 1.2-2.7g/day in two, three or four equal doses.

Single I.M. injections of greater than 600mg are not recommended nor is administration of more than 1.2g in a single one-hour infusion.

For more serious infections, these doses may have to be increased. In life-threatening situations, doses as high as 4.8g daily have been given intravenously to adults.

Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion.

Children (over 1 month of age)

Serious infections: 15-25mg/kg/day in three or four equal doses.

More severe infections: 25-40mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300mg/day regardless of body weight.

Elderly patients

The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone.

Dosage in renal/hepatic impairment

Clindamycin dosage modification is not necessary in patients with renal or hepatic insufficiency

Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.

Method of administration

The concentration of clindamycin in diluent for infusion should not exceed 18mg per ml and INFUSION RATES SHOULD NOT EXCEED 30MG PER MINUTE.

The usual infusion rates are as follows:

DoseDiluentTime
300mg50ml10 min
600mg50ml20 min
900mg50-100ml30 min
1200mg100ml40 min

Overdose

Management

In cases of overdosage no specific treatment is indicated.

The serum biological half-life of Clindamycin is 2.4 hours. Clindamycin cannot readily be removed from the blood by dialysis or peritoneal dialysis.

If an allergic adverse reaction occurs, therapy should be with the usual emergency treatments, including corticosteroids, adrenaline and antihistamines.

Shelf life

Shelf life

Unopened: 2 years.

After dilution: 24 hours.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. 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 be no longer than 24 hours at 2 to 8°C, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.

Special precautions for storage

Do not store above 25°C. Keep ampoules in the outer carton. Do not refrigerate or freeze.

Please refer to Sections 6.3 and 6.6 for storage after dilution.

Nature and contents of container

Type 1 flint glass ampoule containing 2ml or 4ml sterile, aqueous solution, packed in cardboard carton, together with a leaflet. 1 or 5 ampoules in each pack.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

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

Solution for injection is for single use only. Any unused product should be discarded.

Infusion

Clindamycin 150mg/ml Solution for Injection and Infusion has been shown to be physically and chemically compatible for at least 24 hours in dextrose 5% water and sodium chloride injection solutions containing the following antibiotics in usually administered concentrations: Amikacin sulphate, aztreonam, cefotaxime sodium, ceftazidime sodium, gentamicin sulphate, piperacillin and tobramycin. The compatibility and duration of stability of drug admixtures will vary depending upon concentration and other conditions. The compatibility and duration of stability of drug admixtures will vary depending upon concentration and other conditions. The reconstitution/dilution should be made under aseptic conditions. The solution should be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.