Hexagon Pharma


Full Prescribing Info
Clindamycin hydrochloride.
Each capsule contains Clindamycin hydrochloride BP equivalent to Clindamycin 300 mg.
Pharmacology: Mechanism of Action: Clindamycin has an antimicrobial spectrum similar to that of lincomycin but its activity against sensitive organisms is greater.
Pharmacokinetics: Clindamycin is widely distributed in body fluids and tissues including bone but it does not reach the cerebrospinal fluid in significant concentrations.
Clindamycin diffuses across the placenta into the fetal circulation and has been reported to appear in breast milk.
High concentrations occur in bile. About 10% of a dose is excreted in the urine as active clindamycin and about 4% in the faeces; the remainder is inactivated in the liver.
Increased urinary recovery of clindamycin has been reported in patients with liver disease. It is not effectively removed from the blood by dialysis.
Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.
Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, physician should consider the nature of infection and the suitability of less toxic alternatives (eg, erythromycin).
Anaerobes: Serious respiratory tract infections such as emphysema, anerobic pneumonitis ad lung abscess; serious skin and soft tissue infections; septicemia; intraabdominal infections such as peritonitis and intraabdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulites and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections.
Pneumococci: Serious respiratory tract infections.
Dosage/Direction for Use
Adults: Serious Infection: 150 mg every 6 hours or as prescribed by the physician. More Severe Infection: 300 mg every 8 hours.
Children: Serious Infection: 15 mg/kg body weight/day or as prescribed by the physician. Severe Infection: 20 mg/kg body weight in 3-4 divided doses.
In children, regardless of body weight, the maximum recommended dose is 300 mg (base) daily for severe infections.
Clindamycin is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening.
Therefore it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections less toxic antimicrobial agents are inappropriate as described. It should not be used in patients with non-bacterial infections such as most bacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.
Studies indicate that a toxin produced in Clostridium difficile is one primary cause of antibiotic-associated colitis.
After diagnosis of pseudomembranous colitis usually severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.
Diarrhea, colitis and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with clindamycin.
Usage in Meningitis: Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
Special Precautions
General: Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Clindamycin HCl should be prescribed with caution in individuals with history of gastrointestinal disease, particularly colitis.
Clindamycin HCl should be prescribed with caution in atopic individuals.
Indicated surgical procedures should be performed in conjunction with antibiotic therapy.
The use of clindamycin HCl occasionally results in overgrowth of nonsusceptible organisms particularly yeasts.
Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.
Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies rarely occur. Therefore dosage modification in patients with liver enzyme determinations should be made when treating patients with severe liver disease.
Adverse Reactions
The following reactions have been reported with the use of clindamycin.
Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes as well as urticaria have been observed during drug therapy. Rare instances of erythema multiform, some resembling Stevens-Johnson syndrome and a few cases of anaphylactoid reactions have also been reported.
Skin and Mucous Membrane: Pruritus, vaginitis and rare instances of exfoliative dermatitis have been reported.
Liver: Jaundice, hepatic damage and abnormalities in liver function tests have been observed during clindamycin therapy.
Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria and/or proteinuria hs been observed in rare instances.
Hematopoietic: Transient neutropenia (leucopenia) and eosinophilia, agranulocytosis and thrombocytopenia have been reported. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.
Musculoskeletal: Rare instances of polyarthritis have been reported.
Drug Interactions
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 n patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently.
Erythromycin should not be administered concurrently with clindamycin because these 2 drugs showed antagonistic actions in vitro.
Store at temperature not exceeding 30°C. Protect from direct sunlight.
MIMS Class
ATC Classification
J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.
Cap 300 mg x 100's.
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