Peldacyn Special Precautions

Capsule: Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrom (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients received clindamycin therapy. If a hypersensitivity or severe skin reaction occurs, clindamycin should be discontinued and appropriate therapy should be initiated (see Contraindications and Adverse Reactions).
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of Clostridium difficile. This has been reported with the use of nearly all antibacterial agents, including clindamycin. Clostridium difficile produced toxins A and B which contribute to the development of Clostridium difficile associated diarrhea (CDAD) and is primary cause of "antibiotic-associated colitis".
It is important to consider the diagnosis of CDAD in patients who present with diarrhoea subsequent to the administration of antibacterial agents. This may progress to colitis, including pseudomembranous colitis (see Adverse Reactions), which may range from mild to fatal colitis. If antibiotic-associated diarrhea or antibiotic-associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including clindamycin, should be discontinued and adequate therapeutic measures should be initiated immediately. Medicinal products inhibiting peristalsis are contraindicated in this situation.
Caution should be used when prescribing clindamycin to individuals with a history of gastro-intestinal disease, especially colitis.
Since clindamycin does not diffuse adequately into cerebrospinal fluid, the medicinal product should not be used in the treatment of meningitis.
If therapy is prolonged, renal and hepatic function tests should be performed.
The use of clindamycin may result in overgrowth of non-susceptible organisms, particularly yeasts.
Treatment with clindamycin is possibly an alternative treatment in case of penicillin allergy (penicillin hypersensitivity). An allergic cross-reaction between clindamycin and penicillin is not known and not expected because of the structural differences of both substances. However, (in isolated cases) anaphylaxis has been observed after clindamycin treatment of patients with existing penicillin allergy. This should be taken into consideration before treating penicillin allergic patients with clindamycin.
Effects on ability to drive and use machines: Clindamycin has no or negligible influence on the ability to drive and use machines.
Solution for Injection: Patients with history of colitis, renal or hepatic disease, hypersensitivity to drugs or allergic antigen; dysphagia and atopic individuals. Elderly, neonate, foetus immaturus.
General Precautions: In order to prevent appearance of resistant strains, susceptibility should be tested prior to treatment and should be used as short as therapeutic period needed.
Mild colitis could be covered by drug discontinuance. Moderate to severe cases should be managed with fluid, electrolyte and protein supplementation as indicated. Antiperistaltic agents eg, opiates and diphenoxylate with atropine may prolonged and/or worsen the condition.
Vancomycin has been found to be effective in the treatment of pseudomembranous colitis associated with antibiotics produced by Clostridium difficile. The usual adult dosage is vancomycin 500 mg to 2 g/day orally in 3-4 divided doses administered for 7-10 days.
The use of clindamycin occasionally results in overgrowth of nonsusceptible organisms, particularly yeast.
Use in Newborn and Infants: When clindamycin is administered to newborns or infants, appropriate monitoring of organ system is advised.