Brand name: Dalacin

Active ingredient (generic name): Clindamycin

Manufacturer: Pfizer

Importer: Behestan Darou

Pharmacotherapeutic group: Antibiotic

Pharmaceutical form: Solution for injection 300mg/2ml

Pharmacodynamic:

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome similarly to macrolides such as erythromycin and inhibit the early stages of protein synthesis. The action of clindamycin is predominantly bacteriostatic although high concentrations may be slowly bactericidal against sensitive strains.

Pharmacokinetic:

Dalacin is absorbed completely and food has no effect on its absorption. Over 90% of clindamycin in the circulation is bound to plasma proteins. The half-life is 1.5 to 3.5 hours

Clindamycin undergoes metabolism, to the active N-demethyl and sulphoxide metabolites and also some inactive metabolites. About 10% of the drug is excreted in the urine as active drug or metabolites and about 4% in the faeces; the remainder is excreted as inactive metabolites.

Therapeutic indication:

Serious infections caused by susceptible Grampositive organisms, staphylococci (both penicillinase- and nonpenicillinase-producing), streptococci (except Streptococcus faecalis) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens such as Bacteroides spp, Fusobacterium spp, Propionibacterium spp, Peptostreptococcus spp. and microaerophilic streptococci.

Dosage and administration:

Adults: Serious infections: 600 mg 1.2 g/day in two, three or four equal doses.

More severe infections: l.22.7 g/day in two, three or four equal doses.

Single IM injections of greater than 600 mg are not recommended nor are administration of more than 1.2 g in a single onehour infusion.

For more serious infections, these doses may have to be increased. In life threatening situations, doses as high as 4.8 g daily have been given intravenously to adults.

Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion.

Children (over 1 month of age): Serious infections: 1525 mg/kg/day in three or four equal doses.

More severe infections: 2540 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.

Adverse reaction:

Undesirable effects are dizziness, headache, vertigo, nausea, vomiting, diarrhea, constipation and abdominal pain.

Contraindication:

Dalacin is contraindicated in patients with a history of hypersensitivity to clindamycin, lincomycin or the hard fat.

Pharmacokinetic interactions:

Cross resistance has been demonstrated between clindamycin and lincomycin, and erythromycin and clindamycin. Antagonism has been demonstrated between clindamycin and erythromycin in vitro.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.

Special warnings:

Virtually all antibiotics have been associated with diarrhea and in some cases pseudomembranous colitis. Therefore, even though only a minimal amount of drug is absorbed, if significant diarrhea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.

Pregnancy and lactation:

Pregnancy category is C. It can be administered after physician careful assessment of the benefits against possible risks. Dalacin can be administered during lactation.

Storage temperature:

Room temperature (15-25 C)

 

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