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Logo CLINDAC INJECTION 600 mg/4 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLINDAC INJECTION 600 mg/4 mL

COMPOSITION:
Each 4 mL Clindac contains
clindamycin phosphate equivalent to 600 mg Clindamycin and 0,9% v/v benzyl alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Clindamycin exhibits its action by binding to the 50S subunit of the bacterial ribosome and thereby suppressing protein synthesis. On parenteral administration, the phosphate ester is rapidly hydrolyzed to the active parent compound. Following intramuscular injection, peak plasma concentrations are only attained after 3 hours in adults and 1 hour in children. The peak plasma concentrations obtained following intramuscular administration are: 6 µg/mL with a 300 mg dose and 9 µg/mL with a 600 mg dose in adults. Immediately after a 20 - 45 minute intravenous infusion of 600 mg, the plasma concentrations is approximately 10 µg/mL. The half-life of clindamycin is about 2,7 hours and modest accumulation is thus expected to occur if it is given every 6 hours. The half-life may be lengthened in patients with impaired renal function, and dosage in these patients should be adjusted according to plasma concentrations. Accumulation may also occur in patients with hepatic failure.
Clindamycin is 90% plasma protein bound. It is widely distributed in many fluids and tissues including bone, but not in sufficient concentrations in the cerebrospinal fluid. It does however cross the placental barrier. It accumulates in polymorphonuclear leukocytes and alveolar macrophages and is also concentrated in abscesses in experimental animals.
About 10% of clindamycin is excreted unaltered in the urine and small quantities are to be found in the faeces.
Clindamycin has been shown to have in vitro activity against isolates of the following organisms (in vitro sensitivity does not necessarily imply in vivo efficacy):–
Gram positive cocci: Staphylococcus aureus; Streptococcus (anaerobic species); Streptococcus pneumoniae.
Gram negative cocci: Clostridium perfringens.
Gram negative bacilli: Campylobacter jejuni, Bacteroides species;
Fusobacterium nucleatum.
Susceptibility tests should be performed.

INDICATIONS:
Bacteriological studies to determine the causative organism should be performed and its susceptibility to Clindac (clindamycin) tested. It is indicated in the treatment of infections caused by susceptible strains of:
Staph. aureus: abscesses, bacteremia, endocarditis, pneumonia and osteomyelitis, but not in meningitis or in methicillin resistant organisms.
Streptococcus (anaerobic species): bacteremia, endocarditis, abscesses and upper respiratory infections (sinusitis).
Strep. pneumoniae: pneumonia, endocarditis, arthritis and upper respiratory infections.
Clostridium perfringens: gas gangrene.
Campylobacter jejuni: enteritis.
Bacteroides species: oral disease, upper respiratory tract infections and lung abscess.
Fusobacterium nucleatum: ulcerative pharyngitis, lung abscess, empyema, genital infections, gingivitis.

CONTRA-INDICATIONS:
Hypersensitivity to clindamycin or lincomycin.
Do not administer to patients with diarrhoeal states.
The safety for use of Clindac (clindamycin) in pregnancy and lactation has not been established.
Treatment of meningitis. No significant levels of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.

WARNINGS:
Use with caution in patients with impaired liver and renal function. Use with caution with other medicines having a neuromuscular blocking activity. When used in infants of less than 1 month of age, appropriate monitoring of organ system functions is desirable.
Clindamycin therapy has been associated with severe colitis which may end fatally. Therefore it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. The colitis is usually characterized by severe persistent diarrhoea and severe abdominal cramps and may be associated with the passage of blood and mucus. When significant diarrhoea occurs the medication should be discontinued. Diarrhoea, colitis and pseudomembranous colitis have been observed commencing up to several weeks following cessation of therapy with clindamycin.

DOSAGE AND DIRECTIONS FOR USE:
Clindac (clindamycin) ampoules are not for multiple dosing and any unused portion must be discarded.
Intramuscular injections:
ADULTS:
Moderate to severe infections: 600 to 1200 mg/day in 2, 3 or 4 equal divided doses.
Severe infections: 1200 to 2700 mg/day in 2, 3 or 4 equal doses.
CHILDREN: over the age of 1 month
15 to 40 mg/kg body mass daily in divided doses.
In severe infections: Not less than 300 mg daily (irrespective of body mass)
NEONATES:
Safety and appropriate dosages in infants less than one month old have not been established.

Intravenous Infusion:
Clindac (clindamycin) may be administered in the form of a single rapid infusion of the initial dose followed by continuous IV infusion. This will maintain the serum levels of Clindac (clindamycin) at the following levels:
       
Serum clindamycin level Rapid infusion rate Maintenance infusion rate
above 4 µg/mL 10 mg/min for 30 min 0,75 mg/min
5 µg/mL 15 mg/min for 30 min 1,00 mg/min
6 µg/mL 20 mg/min for 30 min 1,25 mg/min

Single intramuscular injections of greater than 600 mg are not recommended.
Clindac (clindamycin) must be diluted prior to intravenous administration to a dilution of 300 mg in 50 mL of diluent (6 mg/mL) of more. Infusion rates are as follows:

Dose Diluent Time
300 mg 50 mL 10 min
600 mg 100 mL 20 min
900 mg 150 mL 30 min
1200 mg 200 mL 45 min

Administration of more than 1200 mg in a single 1 hour infusion is not recommended.
Clindac (clindamycin), should not be injected intravenously as an undiluted bolus, but should rather be infused over at least 20 to 60 minutes.
Suitable diluents may contain: sodium chloride, dextrose. These solutions should not be used if cloudiness occurs. Solutions containing Vit. B complex are incompatible. Clindac (clindamycin) is also incompatible with aminophylline, ampicillin sodium, barbiturates, calcium gluconate, magnesium sulphate, and phenytoin sodium.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Diarrhoea, which can be severe and persistent, nausea, vomiting, abdominal cramps and abnormality of taste.
Hypersensitivity reactions including skin rashes and urticaria, leucopenia and eosinophilia, abnormalities of liver function tests and jaundice have been reported. Agranulocytosis, thrombocytopenia, erythema multiform. Anaphylactic reactions may occur. Immediate emergency treatment should be applied. Thrombophlebitis may occur after intravenous administration.
Patients with renal and/or hepatic disease should be treated with caution, and serum clindamycin levels monitored during therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions.
Treatment should be symptomatic and supportive.

IDENTIFICATION:
A clear colourless to faint yellow solution in clear 5 mL ampoules.

PRESENTATION:
Ten ampoules per container.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/20.1.1/254

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
Port Elizabeth, 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
November 1991
  12-254/2-94
  Tradepak P.E.

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