CLINDAHEXAL Capsule Ref.[50558] Active ingredients: Clindamycin

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 1 Company Reg. No.: 1990/001979/07

4.1. Therapeutic indications

Clindamycin is indicated in serious infections caused by organisms susceptible to its action.

In vitro susceptibility studies should be performed. Infections due to susceptible organisms, which respond to an effective dose, include:

  • infections of the upper and lower respiratory tract (pharyngitis, tonsillitis, sinusitis, otitis media, bronchitis, pneumonia), (β haemolytic streptococci, Diplococcus pneumoniae)
  • infections of the skin and soft tissue (abscesses, cellulitis, infected wounds, β haemolytic streptococci, Corynebacterium acnes), and
  • dental infections (periapical abscesses and gingivitis), (Actinomyces israelii)

4.2. Posology and method of administration

Adults

Mild to moderately severe infection: 150 mg every six hours.

Severe infections: 300 mg to 450 mg every six hours.

Clindamycin should be taken with meals. Should clindamycin be taken between meals, it should be taken with a full glass of water, to avoid oesophageal irritation.

Note: For beta haemolytic streptococcal infections, treatment with clindamycin should continue for at least 10 days to diminish the likelihood of subsequent rheumatic fever or glomerulonephritis.

The serum half-life of clindamycin in patients with markedly reduced renal function is approximately twice that of the half-life of the compound in normal patients. The dose of clindamycin should be appropriately adjusted.

Method of administration

Oral.

4.9. Overdose

The incidence of gastrointestinal side effects increase with increased dose. Treatment is supportive and symptomatic.

The serum biological half-life of clindamycin is 2,4 hours. Haemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

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

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store at or below 25°C.

6.5. Nature and contents of container

White opaque PVC/Aluminium blisters containing 10 capsules each. 2 (10) blister strips to be packed into a carton i.e. 20 capsules per carton or 10 (10) blister strips to be packed into a carton i.e. 100 capsules per carton, or

White Polypropylene securitainers containing 20 or 100 capsules.

Not all packs may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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