Drug Notebook

FDA Alerts

    Diarrhea and Colitis
  • Clostridium difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including clindamycin, and may range in severity from mild to life-threatening. Anti-infectives alter normal flora of the colon and may permit overgrowth of clostridia; a toxin produced by C. difficile is one primary cause of antibiotic-associated colitis.
  • It is important to consider a diagnosis of CDAD in patients who develop diarrhea subsequent to clindamycin treatment. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks after cessation of clindamycin therapy.
  • After a diagnosis of CDAD has been established, initiate therapeutic measures.

    Mild cases usually respond to drug discontinuation alone.

    In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an anti-infective clinically effective against CDAD. (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis under Cautions.)

  • Because clindamycin has been associated with severe colitis (potentially fatal), it should be reserved for treatment of serious infections when less toxic anti-infectives are inappropriate.
  • Do not use for nonbacterial infections.

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clindamycin
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(klin da MYE sin)

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  • May be bacteriostatic or bactericidal in action, depending on concentration attained at site of infection and susceptibility of the infecting organism.
  • Inhibits protein synthesis in susceptible organisms by reversibly binding to 50S ribosomal subunits.
  • Clindamycin palmitate hydrochloride and clindamycin phosphate are inactive until hydrolyzed in vivo to free clindamycin.
  • Spectrum of activity includes many gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and many gram-positive and -negative anaerobic bacteria. Inactive against fungi and viruses.
  • Gram-positive aerobes: Active against Staphylococcus aureus (including penicillinase-producing strains), S. epidermidis (including penicillinase-producing strains), Streptococcus pneumoniae, and other streptococci. Also active in vitro against Arcanobacterium haemolyticum and Bacillus anthracis. Enterococci faecalis are resistant.
  • Gram-negative aerobes: Active against some strains of Corynebacterium diphtheriae, Haemophilus influenzae, and Neisseria gonorrhoeae. N. meningitidis and Enterobacteriaceae are resistant.
  • Anaerobes: Active against Actinomyces, Bacteroides, Eubacterium, Fusobacterium, Propionibacterium, Peptococcus, Peptostreptococcus, and Veillonella. Some strains of Clostridium perfringens are susceptible, but C. difficile and other Clostridium usually are resistant.
  • Active against Plasmodium.
  • Complete cross-resistance usually occurs between clindamycin and lincomycin.
  • Staphylococci resistant to erythromycins rapidly develop clindamycin resistance.

Advice to Patients

  • Advise patients that antibacterials (including clindamycin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).
  • Importance of completing full course of therapy, even if feeling better after a few days.
  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with clindamycin or other antibacterials in the future.
  • Clindamycin hydrochloride capsules and clindamycin palmitate hydrochloride oral solution can be taken without regard to meals.
  • Take clindamycin hydrochloride capsules with a full glass of water to avoid the possibility of esophageal irritation.
  • Importance of discontinuing drug and informing clinician if significant diarrhea occurs.
  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, and any concomitant illnesses
  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.
  • Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

Clindamycin Hydrochloride
RoutesDosage FormsStrengthsBrand NamesManufacturer
OralCapsules75 mg (of clindamycin)

Cleocin HCl® (with tartrazine)

Pfizer
150 mg (of clindamycin)*

Cleocin HCl® (with tartrazine)

Pfizer
300 mg (of clindamycin)

Cleocin HCl®

Pfizer
* available generically
Clindamycin Palmitate Hydrochloride
RoutesDosage FormsStrengthsBrand NamesManufacturer
OralFor solution75 mg (of clindamycin) per 5 mL

Cleocin Pediatric® (with ethylparaben)

Pfizer
Clindamycin Phosphate
RoutesDosage FormsStrengthsBrand NamesManufacturer
ParenteralInjection150 mg (of clindamycin) per mL*

Cleocin Phosphate® (with benzyl alcohol 9.45 mg/mL and edetate disodium 0.5 mg/mL)

Pfizer
9 g (150 mg/mL) (of clindamycin) pharmacy bulk package

Cleocin Phosphate® (with benzyl alcohol 9.45 mg/mL and edetate disodium 0.5 mg/mL)

Pfizer

Clindamycin Phosphate Injection (with benzyl alcohol 9.45 mg/mL and edetate disodium 0.5 mg/mL)

AstraZeneca, Hospira, Lederle
Injection, for IV infusion only150 mg (of clindamycin) per mL (300 mg)

Clindamycin Phosphate ADD-Vantage® (with benzyl alcohol 9.45 mg/mL and edetate disodium 0.5 mg/mL)

Hospira
150 mg (of clindamycin) per mL (600 and 900 mg)

Cleocin Phosphate® ADD-Vantage® (with benzyl alcohol 9.45 mg/mL and edetate disodium 0.5 mg/mL)

Pfizer

Clindamycin Phosphate ADD-Vantage® (with benzyl alcohol 9.45 mg/mL and edetate disodium 0.5 mg/mL)

Hospira
* available generically
Clindamycin Phosphate in Dextrose
RoutesDosage FormsStrengthsBrand NamesManufacturer
ParenteralInjection, for IV infusion6 mg (of clindamycin) per mL (300 mg) in 5% Dextrose

Cleocin Phosphate® IV (Galaxy® [Baxter])

Pfizer
12 mg (of clindamycin) per mL (600 mg) in 5% Dextrose

Cleocin Phosphate® IV (Galaxy® [Baxter])

Pfizer
18 mg (of clindamycin) per mL (900 mg) in 5% Dextrose

Cleocin Phosphate® IV (Galaxy® [Baxter])

Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Cleocin 150MG Capsules PFIZER U.S.30/$101.84 or 90/$284.99
Cleocin 300MG Capsules PFIZER U.S.30/$216.68 or 90/$581.6
Clindamycin HCl 150MG Capsules GREENSTONE30/$24.99 or 90/$69.97
Clindamycin HCl 300MG Capsules RANBAXY PHARMACEUTICALS30/$79.99 or 90/$238.98

AHFS Drug Information. © Copyright, 1959-2008, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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