INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CLINDAHEXA® 150 capsules

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CLINDAHEXA® 150 capsules

COMPOSITION
Each capsule contains
clindamycin hydrochloride hydrate equivalent to 150 mg clindamycin base.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.1. Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION
Clindamycin binds exclusively to the 50S subunit of the bacterial ribosomes and suppresses protein synthesis.
Depending on the sensitivity of the organism and the concentration of the antibiotic, it may be either bactericidal or bacteriostatic.
Clindamycin is rapidly absorbed after oral administration.
Bone and other body fluid levels are obtained rapidly.
Absorption is almost complete (90%).
Blood levels exceed the minimum inhibitory concentration (MIC) for most Gram-positive organisms for at least six hours following the administration of the usually recommended doses.
The biological half life is 2,4 hours.
Clindamycin has antibacterial activity against Gram-positive organisms and to a lesser degree against Gram-negative organisms.
Spectrum of activity includes:
- Staphylococci (including penicillinase producing and methicillin resistant strains.
- Beta haemolytic streptococci.
- Diplococcus pneumoniae
- Clostridium perfringes
- Corynebacterium acnes
- Actinomyces israelii
In vitro activity does not necessarily imply in vivo efficacy.
Clindamycin is not active against most strains of Streptococcus faecalis, Escherichia coli, Shigella spp, Salmonella spp, Proteus spp and Pseudomonas spp.

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 (pharangitis, tonsillitis, sinusitis, otitis media, bronchitis, pneumonia), infections of the skin and soft tissue (abscesses, cellulitis, infected wounds) and dental infections (periapical abscesses and gingivitis)
Serious infections such as acute and chronic osteomyelitis and bacteraemia, have responded to the usually recommended dose.

CONTRA-INDICATIONS
Hypersensitivity to Clindamycin.
Patients with a hypersensitivity to lincomycin.
Safety for use in pregnancy and lactation has not been established. Clindamycin is not indicated for use in infants below 30 days of age.

WARNINGS
Cross resistance has been demonstrated between lincomycin hydrochloride and clindamycin.
Antagonism has been demonstrated with erythromycin.
Staphylococci may also develop resistance to clindamycin.
Severe and persistent diarrhoea has been reported during or after treatment with clindamycin. This diarrhoea has been associated with blood and mucous in the stools and has sometimes resulted in acute colitis which may end fatally.
This may be due to pseudomembrane formation. Should diarrhoea occur during therapy, clindamycin should be discontinued. Any significant diarrhoea occurring several weeks post therapy should be managed as if antibiotic associated.
If colitis is suspected endoscopy is recommended and clindamycin should be discontinued. It has been indicated that a toxin(s) produced by Clostridia (especially Clostridium difficile) is the main direct cause of antibiotic associated colitis. Elderly and female patients may be more likely to experience severe diarrhoea or pseudomembranous colitis.

DOSAGE AND DIRECTIONS FOR USE
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 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.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
These include abdominal discomfort, occasional loose stools or diarrhoea, nausea and vomiting. (See warnings). If persistent diarrhoea occurs during therapy, the medication should be discontinued.
Hypersensitivity reactions such as skin rash and urticaria have been reported. Neutropenia (leukopenia) has been observed. Less frequently anaphylaxis has occurred. Agranulocytosis, eosinophilia, thrombocytopaenia, erythema multiforme, polyarthritis.
Clindamycin should be prescribed with caution in atopic individuals or in patients with a history of gastro-intestinal disease, particularly colitis. Caution is also advised in patients wih hepatic or severe renal impairment who may require dosage adjustment.
Periodic liver function tests and blood counts should be performed during prolonged therapy. Abnormalities of liver function tests, jaundice and hepatic damage have been reported.
Periodic serum levels of Clindamycin should be determined in patients with renal insufficiency.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See side effects and special precautions.
The incidence of gastro-intestinal side effects increases with increased dose.
Induction of emesis and gastric lavage. Treatment is supportive and symptomatic. Haemodialysis and peritoneal dialysis are ineffective means of removing the compound from the blood.

IDENTIFICATION
ClindaHexal 150 Brown/red-brown hard gelatin capsules, size 1, filled with white homogenous powder.

PRESENTATION
White Polypropylene securitainers of 20 or 100 capsules.

STORAGE INSTRUCTION
Store at room temperature, below 25°C in airtight container.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
32/20.1.1/0038

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Hexal Pharma (SA) (PTY) Ltd.
10 Fangio Road
Mahogany Ridge
Westmead
Pinetown

DATE OF PUBLICATION OF THIS PACKAGE INSERT
February 1999

CLAP6

Updated on this site: April 2005
Source: Hospital Pharmacy

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