DALACIN C Capsule Ref.[50846] Active ingredients: Clindamycin

Dose

If significant diarrhoea occurs during therapy, this antibiotic should be discontinued (see section 4.4).

To avoid the possibility of oesophageal irritation, DALACIN C capsules should be taken with a full glass of water.

Adults

• Serious Infections: 150 mg – 300 mg every six hours.
• More severe infections: 300 mg – 450 mg every six hours.

Children

Clindamycin should be dosed based on total body weight regardless of obesity. The maximum daily dose in obese children should not exceed the adult dose.

• Serious Infections: 8-16 mg/kg/day divided into three or four equal doses.
• More severe infections: 16-25 mg/kg/day divided into three or four equal doses.

DALACIN C capsules should only be used for children who are able to swallow capsules.

The use of capsules may not be suitable to provide the exact mg/kg doses required for the treatment of children.

For the treatment of anaerobic infections

DALACIN C Phosphate Solution for Injection should be used initially. This may be followed by oral therapy with DALACIN C capsules at the discretion of the physician.

For the treatment of Pelvic Inflammatory Disease – Inpatient treatment

Clindamycin phosphate 900 mg (IV) q8h daily plus an antibiotic with an appropriate Gramnegative aerobic spectrum administered IV; e.g. gentamicin in patients with normal renal function. Continue (IV) drugs for at least 4 days and at least 48 hours after the patient improves. Then continue oral clindamycin hydrochloride 450 mg q6h daily to complete 10-14 days total therapy.

For the treatment of Cervicitis due to Chlamydia trachomatis

Clindamycin hydrochloride by mouth 450 mg 4 times daily for 10-14 days.

For the treatment of β-haemolytic streptococcal infections

In cases of β-haemolytic streptococcal infections, treatment should continue for at least ten days.

For the treatment of multi-drug resistant Plasmodium falciparum infection

Limited data from uncontrolled studies using a variety of doses suggest that clindamycin, orally at a dose of 5-10 mg/kg twice daily for minimum of 5 days, is useful alternative therapy when used in combination with quinine, for the treatment of multi-drug resistant Plasmodium falciparum infection.

Overdosage with orally administered clindamycin has been rare. Adverse reactions similar to those seen with normal doses can be expected, however, unexpected reactions could occur (see section 4.8).

The minimal toxic or lethal dose is not well established. At therapeutic doses, the primary toxic effects may involve the gastrointestinal tract and may include severe diarrhoea and pseudomembranous colitis that may result in death. Rapid administration of large doses intravenously has resulted in ventricular dysrhythmias, hypotension and cardiac arrest. Dermatitis, nephrotoxicity, hepatotoxicity, and various haematological abnormalities are toxic effects that occur less frequently.

No specific antidote is known. Support respiratory and cardiac function. In cases of overdose, drug levels of clindamycin are not clinically useful. However, monitoring serum concentrations in patients with markedly reduced renal and hepatic function, may be indicated during high-dose therapy. Monitor full blood count in patients with significant exposure as clindamycin may produce abnormalities of the haematopoietic system. Because clindamycin may cause hepatotoxicity, monitor liver function tests in patients with significant exposure.

Neither haemodialysis nor peritoneal dialysis appear to be effective in reducing clindamycin levels significantly.

Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen and intravenous corticosteroids should also be administered as indicated.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

60 months.

Store below 25°C.

Blister packs of 16, 24 or 100 capsules*.

^* Not all pack sizes available.

None stated.