PHYSICIAN LEAFLET

Dalacin^@C Phosphate Sterile Solution

clindamycin phosphate

PAA052884

577

PHYSICIAN LEAFLET

For further information consult the Summary of Product Characteristics.

Qualitative and quantitative composition

Each ml of solution contains clindamycin phosphate equivalent to 150 mg clindamycin, benzyl alcohol 9.45 mg/ml, disodium edetate and sterilised water for injections.

Directions for use

Parenteral (I.M. or IV. administration). Dalacin C Phosphate must be diluted prior to IV. administration and should be infused over at least 10-60 minutes.

Parenteral (I.M. or IV. administration)

Adults including the elderly:

Serious infections:    600-1200 mg/day in 2, 3 or 4 equal doses.

More severe infections:    1200-2700 mg/day in 2, 3 or 4 equal doses.

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

Children (over 1 month of age):

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

More severe infections:    25-40 mg/kg/day in three or four equal doses.

In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

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

The usual infusion rates are as follows:

Dose	Diluent	Time
300mg	50mL	10 min
600mg	50mL	20 min
900mg	50-100mL	30 min
1200mg	100mL	40 min

Indications

The management of serious infections due to organisms susceptible to this anti-infective.

Contra-indication etc.

Contra-indications:

Dalacin C Phosphate is contra-indicated in patients previously found to be sensitive to clindamycin, lincomycin or to any components of the formulation particularly benzyl alcohol.

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

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PATIENT INFORMATION LEAFLET_

Dalacin® C Phosphate

Sterile Solution 150 mg/ml

clindamycin phosphate

cause of antibiotic-associated colitis. These studies also indicate that this toxigenic Clostridium is usually sensitive in-vitro to vancomycin. 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.

The appearance of marked diarrhoea should be regarded as an indication that the product should be discontinued immediately. Clostridium difficile associated diarrhoea (CDAD) has been reported to occur over 2 months after the administration of antibacterial agents.

Precautions:

History of gastro-intestinal disease; use in atopic individuals; super-infection with resistant organisms.

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.

The dosage of Dalacin C Phosphate may require reduction in patients with renal or hepatic impairment due to prolongation of the serum half-life.

Interactions:

Use with caution in patients receiving neuromuscular blocking agents. Do not use concurrently with erythromycin.

Vitamin K antagonists

Increased coagulation tests (PT/INR) and/or bleeding, have been reported in patients treated with clindamycin in combination with a vitamin K antagonist (e.g. warfarin, acenocoumarol and fluindione). Coagulation tests, therefore, should be frequently monitored in patients treated with vitamin K antagonists.

Pregnancy and lactation:

Safety of use in pregnancy has not been established. Exercise caution when prescribing to nursing mothers.

Benzyl alcohol can cross the placenta (see Warnings).

Undesirable effects:

Side effects include nausea, vomiting, cramps, abdominal pain, diarrhoea, hypersensitivity reaction such as Stevens Johnson syndrome, liver dysfunction and jaundice, blood dyscrasia, pruritus, vaginitis, dermatitis, cardiopulmonary arrest and hypotension (following too rapid an administration) and local reactions at the site of injection. The appearance of marked diarrhoea should be regarded as an indication that this drug should be discontinued immediately.

Overdose:

In cases of overdosage no specific treatment is indicated. The serum biological half-life of lincomycin 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.

Handling and Storage requirements

Do not store this product above 25°C.

Do not refrigerate or freeze.

This product is for single dose only.

Any unused solution should be discarded.

Dilution and Compatibility:

In-vitro compatibility studies monitored for 24 hours at room temperature using a concentration no greater than 6 mg/ml have demonstrated no inactivation or physical incompatibility with the use of Dalacin C Phosphate in IV solutions containing sodium chloride, glucose or potassium usually used clinically.

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, cefamondole nafate, cephazolin sodium, cefotaxime sodium, cefoxitin sodium, ceftazidime sodium, ceftizoxime sodium, gentamicin sulphate, netilmicin sulphate, piperacillin, tobramycin and ciprofloxacin.

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

Incompatibilities:

Solutions of clindamycin salts have a low pH and incompatibilities may reasonably be expected with alkaline preparations or drugs unstable at low pH. Incompatibility has been reported with: ampicillin sodium, aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium, diphenylhydantoin, idarubicin hydrochloride, magnesium sulphate, phenytoin sodium and ranitidine hydrochloride. Marketing Authorisation Holder Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK.

Manufacturer

Pharmacia NV/SA, Rijksweg 12, B-2870 Puurs, Belgium.

Date of preparation: 07/2014 Ref: DA 14_0 mixed with a sugar or saline (salt) solution before use and given using a drip.

When giving you Dalacin C, your doctor will ensure that the concentration of clindamycin does not exceed 18 mg per ml and the rate it is given to you does not exceed 30 mg per minute. If Dalacin is given too fast it could rarely cause a heart attack.

Adults/Elderly

The recommended dose of Dalacin C Solution is 600 to 2700 mg clindamycin per day in two to four equal doses, depending on the severity of your infection. Higher doses than this (up to 4800 mg daily) may be given by your doctor for very severe infections.

Children

The recommended dosage for children (over 1 month of age) is 15 to 40 mg of clindamycin per kg bodyweight each day in three or four equal doses.

Higher doses of up to 300 mg per day (regardless of body weight) may be given by your doctor for very severe infections until a full response to treatment is observed.

Normally Dalacin C is only given to patients in hospital.

The medical staff will be keeping a close eye on you during your treatment. If you need to have more than one course of treatment with clindamycin, your doctor may want to check that the clindamycin is not having any effect on the way your kidneys and liver are working.

Long term use can also make you more likely to get other infections that do not respond to Dalacin C treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Tell your doctor immediately if you develop:

•    severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur during or after completing treatment with antibiotics and can be a sign of serious bowel inflammation

•    signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)

•    blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips

•    yellowing of the skin and whites of the eyes (jaundice).

Other possible side effects may include:

•    Effects on your nervous system: impaired sense of taste

•    Effects on your skin:

reddening of the skin, skin rash, itching (hives)

•    Effects on your stomach and intestines: throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhoea

PAA052884