Clindal/Clindal Injection

Clindal: Each capsule contains clindamycin 150 mg and 300 mg as clindamycin HCl, respectively.
Clindal Injection: Each mL contains: Clindamycin (as phosphate) 150 mg.

Pharmacotherapeutic Group: Antibacterial.
Pharmacology: Pharmacokinetics: Clindamycin is widely distributed in body fluids and tissues including bone but it does not reach the CSF 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 feces; 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.
Microbiology: Clindamycin has an antimicrobial spectrum similar to that of lincomycin but its activity against sensitive organisms is greater.

Clindal: Treatment of serious anaerobic infections especially those caused by Bacteroides fragilis. As an alternative to penicillin in some severe staphylococcal and streptococcal infections including staphylococcal osteomyelitis. Because of its potential toxicity, clindamycin should only be used when there is no suitable alternative.
Clindal Injection: Antibacterial, Serious infections caused by susceptible Gram-positive organisms, staphylococci (both penicillinase and non-penicillinase producing), streptococci (except Streptococcus faecalis) and pneumococci. It is also indicated in serious infections caused by susceptible anaerobic pathogens.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective quantities.

Clindal cap: Adults: Serious Infections: 300 mg every 6 hrs.
Administration: Precaution During Application: Because esophageal ulcer may occur if this drug stays and disintegrates in esophagus, administer with water or milk and be careful to administer clindamycin right before sleep.
Clindal Injection: Adults: Serious infections: 600 mg - 1.2 g/day in two, three or four equal doses.
More severe infections: 1.2 - 2.7 g/day in two, three or four equal doses.
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. (See Table 1.)

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Single I.M. injections of greater than 600 mg are not recommended.
Children (over 1 month of age): Serious infections: 15 - 25 mg/kg/day in three or four equal doses.
More severe infections: 25 - 40 mg/kg/day in three or four equal doses in severe infections.
Or as prescribed by the physician.
Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.
Dilution and Infusion rates: Clindamycin must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minutes. The usual infusion dilutions and rates are as follows: See Table 2.

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Administration of more than 1200 mg in a single 1 hour infusion is not recommended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dilution and compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of Clindamycin in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, Kanamycin, gentamicin, penicillin or carbenicillin.
The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.
The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions.

Patient with a history of hypersensitivity to lincomycin or clindamycin. Patients with diarrheal states.

Clindal should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of diarrhea which may develop, since cases of colitis have been reported during or even 2-3 weeks following the administration of clindamycin.
Studies indicate a toxin(s) produced by clostridia (especially Clostridium difficile) is the principal direct cause of antibiotic-associated colitis. These also indicate that this toxigenic clostridium is usually sensitive in vitro to vancomycin. When vancomycin 125-500 mg are administered orally 4 times a day for 7-10 days, there is a rapid observed disappearance of the toxin from fecal samples and a coincident clinical recovery from diarrhea. When the patient is receiving cholestyramine in addition to vancomycin, consideration should be given to separating the times of administration.
Colitis is a disease which has a clinical spectrum from mild, watery diarrhea to severe, persistent diarrhea, leucocytosis, fever, severe abdominal cramps, which may be associated with the passage of blood and mucous. If allowed to progress, it may produce peritonitis, shock and toxic megacolon. This may be fatal.
The appearance of marked diarrhea should be regarded as an indication that the product should be discontinued immediately. The disease is likely to follow a more severe course in older patients who are debilitated. Diagnosis is usually made by the recognition of the clinical symptoms, but can be substantiated by endoscopic demonstration of pseudomembranous colitis. The presence of the disease may be further confirmed by culture of the stool for Clostridium difficile on selective media and assay of the stool specimen for the toxin(s) of C. difficile.

Patients with impaired hepatic and renal function.
Since clindamycin is reported to possess neuromuscular-blocking activity, it should be used with care with other drugs having similar activity.
Caution should be used when prescribing Clindamycin to individuals with a history of gastrointestinal disease, especially colitis.
Periodic liver and kidney function tests should be carried out during prolonged therapy. Such monitoring is also recommended in neonates and infants.
The dosage of Clindamycin may require reduction in patients with renal or hepatic impairment due to prolongation of the serum half-life.
Prolonged administration of Clindamycin, as with any anti-infective, may result in super-infection due to organisms resistant to clindamycin.
Care should be observed in the use of Clindamycin in atopic individuals.
Precautions During Application: Because esophagus ulcer may occur if this drug stays and disintegrates in esophagus, administer with water or milk and be careful to administer this drug right before sleep.

Pregnancy: Safety for use in pregnancy has not yet been established.
Lactation: Clindamycin is excreted in human milk. Caution should be exercised when Clindamycin is administered to a nursing mother. It is unlikely that a nursing infant can absorb a significant amount of clindamycin from its gastro-intestinal tract.

Clindamycin HCl may cause diarrhea which can be severe and persistent, nausea, vomiting, abdominal cramps and taste abnormality. Severe pseudomembranous colitis has occurred in some patients and has occasionally been fatal. Colitis and diarrhea have been reported during treatment and after its completion. Some reports suggest that the intestinal effects may be due to superinfection. Hypersensitivity reactions including skin rashes and urticaria may occur and transient leukopenia and eosinophilia, elevations of alkaline phosphatase and serum aminotransferases and jaundice have been reported.
Agranulocytosis, thrombocytopenia and erythema multiforme have been observed.

Gastro-intestinal tract: Nausea, vomiting, abdominal pain and diarrhea.
Haematopoietic: Transient neutropenia (leucopenia), eosinophilia, agranulocytosis and thrombocytopenia have been reported.
No direct aetiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.
Skin and mucous membranes: Pruritus, vaginitis and rare instances of exfoliative and vesiculobullous dermatitis have been reported.
Hypersensitivity reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequent reported reactions.
Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.
Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. It should be used with caution, therefore, in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance the two drugs should not be administered concurrently.
The following drugs are physically incompatible with clindamycin phosphate: Ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate and magnesium sulfate.

Clindal: Store at temperatures not exceeding 30°C.
Shelf-Life: 150-mg Capsule: 24 months. 300-mg Capsule: 36 months.
Clindal Injection: Preserve in hermetic containers.
Store at temperatures not exceeding 30°C.

Other Antibiotics

J01FF01 - clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.

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