Dalacin

Dalacin C Phosphate Sterile Solution

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin.

Excipients with known effect:

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

Warnings

This product contains benzyl alcohol. (9.45mg/ml as preservative). Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates characterized by central nervous system depression, metabolic acidosis, gasping respirations, cardio-vascular failure and haematological anomalies (“gasping syndrome”). Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Use only if it is necessary and if there are no alternatives possible. If given in high volumes, should be used with caution and preferably for short term treatment in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis) due to benzoic acid (a metabolite of benzyl alcohol).

Premature and low-birth weight infants may be more likely to develop toxicity.

Benzyl Alcohol containing products should not be used in pre-term or full-term neonates unless strictly necessary.

Benzyl alcohol can cross the placenta and clindamycin should only be used during pregnancy if clearly needed.

Dalacin C Phosphate should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

Studies indicate a toxin(s) produced by clostridia (especially Clostridium difficile) is the principal direct cause of antibiotic-associated colitis. These studies also indicate that this toxigenic clostridium is usually sensitive in vitro to vancomycin. When 125 mg to 500 mg of vancomycin are administered orally four times a day for 7 - 10 days, there is a rapid observed disappearance of the toxin from faecal samples and a coincident clinical recovery from the diarrhoea. (Where the patient is receiving colestyramine in addition to vancomycin, consideration should be given to separating the times of administration).

Colitis is a disease, which has a clinical spectrum from mild, watery diarrhoea to severe, persistent diarrhoea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucus. If allowed to progress, it may produce peritonitis, shock and toxic megacolon. This may be fatal. The appearance of marked diarrhoea should be regarded as an indication that the product should be discontinued immediately. The disease is likely to follow a more severe course in older patients or patients who are debilitated. Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis. The presence of the disease may be further confirmed by culture of the stool for C. difficile on selective media and assay of the stool specimen for the toxin(s) of C. difficile.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD.Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

Precautions

Caution should be used when prescribing Dalacin C Phosphate to individuals with a history of gastro-intestinal disease, especially colitis.

Periodic liver and kidney function tests should be carried out during prolonged therapy. Such monitoring is also recommended in neonates and infants. Safety and appropriate dosage in infants less than one month old have not been established.

Prolonged administration of Dalacin C Phosphate, as with any anti-infective, may result in super-infection due to organisms resistant to clindamycin.

Care should be observed in the use of Dalacin C Phosphate in atopic individuals.

The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

None stated

Benzyl alcohol

Disodium edetate

Sterilised water for injections

• N76 Other inflammatory diseases of the vagina and vulva

24 months

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

Dalacin C Phosphate 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, cefamandole nafate, cephazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime sodium, ceftizoxime sodium, gentamicin sulphate, netilmicin sulphate, piperacillin and tobramycin.

The compatibility and duration of stability of drug admixtures will vary depending upon concentration and other conditions.

Pfizer Limited

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UK

PL 00057/0959

27^th December 1997 / 22^nd May 2002/7^th August 2009

03/2018

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva

• N76 Other inflammatory diseases of the vagina and vulva