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Clindamycin (Systemic)


VA CLASSIFICATION
Primary: AM300
Secondary: AP101

Commonly used brand name(s): Cleocin; Cleocin Pediatric; Dalacin C; Dalacin C Flavored Granules; Dalacin C Phosphate.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (systemic)—

antiprotozoal—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Bone and joint infections (treatment)—Parenteral clindamycin is indicated in the adjunctive surgical treatment of chronic bone and joint infections, and acute hematogenous osteomyelitis caused by staphylococci. {13}

Pelvic infections, female (treatment)—Clindamycin is indicated in the treatment of female pelvic infections, including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infections caused by anaerobes. {01} {13}

Intra-abdominal infections (treatment)—Clindamycin is indicated in the treatment of intra-abdominal infections (such as peritonitis and abscesses) caused by anaerobes. {13}

Pneumonia, anaerobic (treatment)
Pneumonia, pneumococcal (treatment)
Pneumonia, staphylococcal (treatment) or
Pneumonia, streptococcal (treatment)—Clindamycin is indicated as a primary agent in the treatment of pneumonia, including serious respiratory tract infections (such as empyema, pneumonitis, and lung abscess) caused by anaerobes. Clindamycin is indicated as a secondary agent in the treatment of pneumonia caused by susceptible strains of pneumococci, staphylococci, and streptococci. {01} {07} {13}

Septicemia, bacterial (treatment)—Oral and parenteral clindamycin are indicated in the treatment of septicemia caused by anaerobes. In addition, parenteral clindamycin is indicated in the treatment of septicemia caused by streptococci and staphylococci. {13}

Skin and soft tissue infections (treatment)—Clindamycin is indicated in the treatment of serious skin and soft tissue infections caused by anaerobes, streptococci, and staphylococci. {13}

[Actinomycosis (treatment)]1—Clindamycin is used in the treatment of actinomycosis. {01} {45}

[Babesiosis (treatment)]1—Clindamycin is used concurrently with quinine in the treatment of severe babesiosis caused by Babesia microti . {48} {49} {50}

[Erysipelas (treatment)]1—Clindamycin is used in the treatment of erysipelas. {01}

[Malaria (treatment)]1—Clindamycin is used in combination with quinine in the treatment of chloroquine-resistant malaria caused by Plasmodium falciparum in patients for whom standard therapy is contraindicated (e.g., children, pregnant women, sulfa allergy). {41} {42} {43} {44}

[Otitis media, chronic suppurative (treatment)]1—Clindamycin is used in the treatment of chronic suppurative otitis media. {01}

[Pneumonia, Pneumocystis carinii (treatment)]1—Clindamycin is used in combination with primaquine in the treatment of Pneumocystis carinii pneumonia (PCP) in patients unresponsive or intolerant to standard therapy. {35} {36} {53}

[Sinusitis (treatment)]1—Clindamycin is used in the treatment of sinusitis. {01} {45}

[Toxoplasmosis, central nervous system (CNS) (treatment)]1—Clindamycin is used in combination with pyrimethamine in the treatment of CNS toxoplasmosis in patients who are unresponsive or intolerant to standard therapy. {31} {32} {33} {34} {52}

—Not all species or strains of a particular organism may be susceptible to clindamycin.

Unaccepted
Clindamycin is not indicated in the treatment of meningitis since it penetrates poorly into cerebrospinal fluid (CSF), even in the presence of inflamed meninges.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Clindamycin hydrochloride: 461.44
    Clindamycin palmitate hydrochloride: 699.86
    Clindamycin phosphate: 504.96

Mechanism of action/Effect:

Antibacterial (systemic)—The lincomycins inhibit protein synthesis in susceptible bacteria by binding to the 50 S subunits of bacterial ribosomes and preventing peptide bond formation. {24} They are usually considered bacteriostatic, but may be bactericidal in high concentrations or when used against highly susceptible organisms.

Absorption:

Rapidly absorbed from the gastrointestinal tract following oral administration; not inactivated by gastric acid. {14} Approximately 90% absorbed orally in fasting state; absorption unaffected by food. {09}

Distribution:

Widely and rapidly distributed to most fluids and tissues, except cerebrospinal fluid (CSF); high concentrations in bone, bile, and urine {09}. Readily crosses the placenta. Also excreted in breast milk.


Vol D {29}:

Adults: Approximately 0.66 liter per kg.

Children: Approximately 0.86 liter per kg.


Protein binding:

Very high (92–94%). {29}

Biotransformation:

Hepatic; some metabolites may possess antibacterial activity. Clindamycin palmitate and clindamycin phosphate are inactive; they are rapidly hydrolyzed in vivo to active clindamycin. {11}

Half-life:


Normal renal function:

Adults: 2.4 to 3.0 hours. {09}

Infants and children: 2.5 to 3.4 hours. {13} {38}

Premature infants: 6.3 to 8.6 hours. {29} {38}



End-stage renal failure or severe hepatic impairment:

Slightly increased (3 to 5 hours in adults). {13} {21}


Time to peak serum concentration

Oral—0.75 to 1 hour. {09}

Intramuscular—1 hour (children); 3 hours (adults). {13}

Intravenous—End of infusion. {13}

Peak serum concentration:


Adults (steady-state) {54}:

300 mg intravenously over 10 minutes every 8 hours: Approximately 7 mcg/mL.

600 mg intravenously over 20 minutes every 8 hours: Approximately 10 mcg/mL.

900 mg intravenously over 30 minutes every 12 hours: Approximately 11 mcg/mL.

1200 mg intravenously over 45 minutes every 12 hours: Approximately 14 mcg/mL.

300 mg intramuscularly every 8 hours: Approximately 6 mcg/mL.

600 mg intramuscularly every 12 hours: Approximately 9 mcg/mL.



Children (first dose) {54}:

5 to 7 mg per kg of body weight (mg/kg) intravenously over 1 hour: Approximately 10 mcg/mL.

3 to 5 mg/kg intramuscularly: Approximately 4 mcg/mL.

5 to 7 mg/kg intramuscularly: Approximately 8 mcg/mL.


Elimination:
    Approximately 10% of a total dose is eliminated in the urine and 3.6% in the feces as active drug. The remainder is excreted as inactive metabolites. {09}
    Dialysis—Not removed from the blood by hemodialysis or peritoneal dialysis. {13} {14}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients hypersensitive to lincomycin may be hypersensitive to clindamycin also. There is also a report of a possible cross-sensitivity between clindamycin and doxorubicin. {37}

Pregnancy/Reproduction

Pregnancy—
Clindamycin crosses the placenta {11} and may be concentrated in the fetal liver. However, problems in humans have not been documented. {46}

Breast-feeding

Clindamycin is excreted in breast milk. {09} {14} However, problems in humans have not been documented.

Pediatrics

Clindamycin should be used with caution in infants up to 1 month of age. {13}

Clindamycin phosphate injection contains benzyl alcohol, which has been associated with a fatal gasping syndrome in infants. {05} {06} {25}


Geriatrics


No information is available on the relationship of age to the effects of clindamycin in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Anesthetics, hydrocarbon inhalation or
» Neuromuscular blocking agents    (concurrent use of these medications with clindamycin, if necessary, should be carefully monitored since neuromuscular blockade may be enhanced, resulting in skeletal muscle weakness and respiratory depression or paralysis [apnea]; caution is also recommended when these medications are used concurrently with clindamycin during surgery or in the postoperative period; treatment with anticholinesterase agents or calcium salts may help reverse the blockade {14} {28} {39})


» Antidiarrheals, adsorbent    (concurrent use of kaolin- or attapulgite-containing antidiarrheals with oral clindamycin may significantly delay the absorption of oral clindamycin; concurrent use should be avoided or patients should be advised to take adsorbent antidiarrheals not less than 2 hours before or 3 to 4 hours after oral lincomycins {47})


Antimyasthenics    (concurrent use of medications with neuromuscular blocking action may antagonize the effect of antimyasthenics on skeletal muscle; temporary dosage adjustments of antimyasthenics may be necessary to control symptoms of myasthenia gravis during and following concurrent use)


» Chloramphenicol or
» Erythromycins    (may displace clindamycin from or prevent its binding to 50 S subunits of bacterial ribosomes, thus antagonizing clindamycin's effects; concurrent use is not recommended {13})


Opioid (narcotic) analgesics    (respiratory depressant effects of drugs with neuromuscular blocking activity may be additive to central respiratory depressant effects of opioid analgesics, possibly leading to increased or prolonged respiratory depression or paralysis [apnea]; caution and careful monitoring of the patient are recommended)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Alanine aminotransferase (ALT [SGPT]), serum and
Alkaline phosphatase, serum and
Aspartate aminotransferase (ALT [SGOT]), serum    (concentrations may be increased)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Gastrointestinal disease, history of, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis{09}{14}    (clindamycin may cause pseudomembranous colitis)


» Hepatic function impairment, severe{31}    (the half-life of clindamycin is prolonged in patients with severe hepatic function impairment; this may require an adjustment in dosage)


Hypersensitivity to lincomycins or doxorubicin
Renal function impairment, severe    (patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe; however, patients receiving clindamycin with very severe renal impairment and/or very severe hepatic impairment accompanied by severe metabolic abnormalities may require a reduction in dosage)



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):


For antibiotic-associated pseudomembranous colitis (AAPMC)
Colonoscopy and/or
Proctosigmoidoscopy    (proctosigmoidoscopy and/or colonoscopy may be required in selected, severely ill patients with persistent symptoms of AAPMC to document the presence of pseudomembranes; it is no longer recommended as a routine monitoring parameter {13} {14} {40})


Stool examinations    (cytotoxin assays of stool samples for the presence of Clostridium difficile and its cytotoxin, neutralizable by C. sordellii antitoxin, may be required prior to treatment in patients with AAPMC to document the presence of C. difficile and/or its cytotoxin; however, C. difficile and its cytotoxin may persist following treatment with oral vancomycin despite clinical improvement; follow-up cytotoxin assays are generally not recommended with complete clinical improvement {13} {14})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent {13} {14}
    
Pseudomembranous colitis (severe abdominal or stomach cramps and pain; abdominal tenderness; diarrhea, watery and severe, which may also be bloody; fever)

Incidence less frequent {13} {14}
    
Hypersensitivity (skin rash, redness, and itching)
    
neutropenia (sore throat and fever)
    
thrombocytopenia (unusual bleeding or bruising)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent {13} {14}
    
Gastrointestinal disturbances (abdominal pain; diarrhea; nausea and vomiting)

Incidence less frequent {13} {14}
    
Fungal overgrowth (itching of rectal or genital areas)



Those indicating possible pseudomembranous colitis and the need for medical attention if they occur after medication is discontinued
    
Severe abdominal or stomach cramps and pain
    
abdominal tenderness
    
watery and severe diarrhea, which may also be bloody
    
fever




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Clindamycin (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Hypersensitivity to clindamycin, lincomycin, or doxorubicin

Pregnancy—Clindamycin crosses the placenta





Breast-feeding—Clindamycin is excreted in breast milk





Use in children—Clindamycin should be used cautiously in infants up to 1 month of age; clindamycin injection contains benzyl alcohol, which has been associated with a fatal gasping syndrome in infants

Other medications, especially hydrocarbon inhalation anesthetics, neuromuscular blocking agents, adsorbent antidiarrheals, chloramphenicol, or erythromycins
Other medical problems, especially a history of gastrointestinal disease, particularly ulcerative colitis, or severe hepatic function impairment

Proper use of this medication
» Taking clindamycin capsules with a full glass of water or with meals to avoid esophageal ulceration

Proper administration technique for clindamycin oral solution; not using after expiration date

» Compliance with full course of therapy, especially in streptococcal infections

» Importance of not missing doses and taking at evenly spaced times

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
Regular visits to physician to check progress

Checking with physician if no improvement within a few days

» For severe diarrhea, checking with physician before taking any antidiarrheals; for mild diarrhea, taking attapulgite-containing antidiarrheals at least 2 hours before or 3 to 4 hours after taking oral clindamycin; other antidiarrheals may worsen or prolong the diarrhea; checking with physician or pharmacist if mild diarrhea continues or worsens

Caution if surgery with general anesthesia is required


Side/adverse effects
Signs of potential side effects, especially pseudomembranous colitis, hypersensitivity, neutropenia, and thrombocytopenia


General Dosing Information
Therapy should be continued for at least 10 days in group A beta-hemolytic streptococcal infections to help prevent the occurrence of acute rheumatic fever. {09}

For oral dosage forms only:

o The capsule dosage form should be taken with food or a full glass (240 mL) of water to avoid esophageal irritation. {09}

For treatment of adverse effects


For antibiotic-associated pseudomembranous colitis (AAPMC):
   • Some patients may develop antibiotic-associated pseudomembranous colitis (AAPMC), caused by Clostridium difficile toxin, during or following administration of lincomycins. Mild cases may respond to discontinuation of the drug alone. Moderate to severe cases may require fluid, electrolyte, and protein replacement.
   • In cases not responding to the above measures or in more severe cases, oral doses of metronidazole, bacitracin, cholestyramine, or vancomycin may be used. Oral vancomycin is effective in doses of 125 to 500 mg every 6 hours for 5 to 10 days. The dose of metronidazole is 250 to 500 mg every 8 hours; cholestyramine, 4 grams four times a day; and bacitracin, 25,000 units, orally, four times a day. Recurrences may be treated with a second course of these medications. {30}
   • Cholestyramine and colestipol resins have been shown to bind C. difficile toxin in vitro . If cholestyramine or colestipol resin is administered in conjunction with oral vancomycin, the medications should be administered several hours apart since the resins have been shown to bind oral vancomycin also.
   • In addition, antibiotic-associated pseudomembranous colitis may result in severe watery diarrhea, which may occur during therapy or up to several weeks after therapy is discontinued. If diarrhea occurs, administration of antiperistaltic antidiarrheals (e.g., opiates, diphenoxylate and atropine combination, loperamide) is not recommended since they may delay the removal of toxins from the colon, thereby prolonging and/or worsening the condition.



Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CLINDAMYCIN HYDROCHLORIDE CAPSULES USP

Usual adult and adolescent dose
Antibacterial
Oral, 150 to 300 mg (base) every six hours. {09}

[Malaria (treatment)]1
Oral, 900 mg (base) three times a day for three days. {43}

[Pneumonia, Pneumocystis carinii (treatment)]1
Oral, 1200 to 1800 mg (base) per day in divided doses in combination with 15 to 30 mg of primaquine daily. {35} {36} {53}

[Toxoplasmosis, central nervous system (CNS) (treatment)]1
Oral, 1200 to 2400 mg (base) per day in divided doses in combination with 50 to 100 mg of pyrimethamine daily. {31} {32} {33} {34} {52} {55} {56}


Usual pediatric dose
Antibacterial
Infants up to 1 month of age: Dosage must be individualized by physician. Use with caution.

Infants 1 month of age and over: Oral, 2 to 5 mg (base) per kg of body weight every six hours; or 2.7 to 6.7 mg per kg of body weight every eight hours.

Note: In children weighing 10 kg or less, the minimum recommended dose is 37.5 mg every eight hours.


[Malaria (treatment)]1
Oral, 6.7 to 13.3 mg per kg of body weight three times a day for three days. {43}


Strength(s) usually available
U.S.—


75 mg (base) (Rx) [Cleocin (tartrazine)][Generic]


150 mg (base) (Rx) [Cleocin (tartrazine)][Generic]


300 mg (base) (Rx) [Cleocin (tartrazine)]

Canada—


150 mg (base) (Rx) [Dalacin C]


300 mg (base) (Rx) [Dalacin C{58}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Take with food or water.
   • Continue medicine for full time of treatment.


CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION USP

Usual adult and adolescent dose
See Clindamycin Hydrochloride Capsules USP .

Usual pediatric dose
See Clindamycin Hydrochloride Capsules USP . {12}

Strength(s) usually available
U.S.—


75 mg per 5 mL (base) (when reconstituted according to manufacturer's instructions) (Rx) [Cleocin Pediatric (sucrose)]

Canada—


75 mg per 5 mL (base) (when reconstituted according to manufacturer's instructions) (Rx) [Dalacin C Flavored Granules{59}]

Packaging and storage:
Prior to reconstitution, store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Do not refrigerate the reconstituted solution since it may thicken and be difficult to pour when chilled.

Stability:
After reconstitution, solutions retain their potency for 14 days at room temperature. {12}

Auxiliary labeling:
   • Do not refrigerate.
   • Shake well.
   • Continue medicine for full time of treatment.
   • Beyond-use date.

Note: When dispensing, include a calibrated liquid-measuring device.




Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

CLINDAMYCIN PHOSPHATE INJECTION USP

Usual adult and adolescent dose
Antibacterial
Intramuscular or intravenous, 300 to 600 mg (base) every six to eight hours; or 900 mg every eight hours. {13}

[Babesiosis (treatment)]1
Intravenous, 300 to 600 mg clindamycin (base) four times a day with concurrent oral administration of 650 mg of quinine, three or four times a day for seven to ten days. {49} {50}

[Pneumonia, Pneumocystis carinii (treatment)]1
Intravenous, 2400 to 2700 mg (base) per day in divided doses in combination with 15 to 30 mg of primaquine daily. {35} {36} {53}

[Toxoplasmosis, central nervous system (CNS) (treatment)]1
Intravenous, 1200 to 4800 mg (base) per day in divided doses in combination with 50 to 100 mg of pyrimethamine daily. {31} {32} {33} {34} {52} {55} {56}


Usual adult prescribing limits
Up to 2.7 grams (base) daily.

Note: Doses up to 4.8 grams daily have been used. However, some medical experts recommend a maximum dose of 2.7 grams daily.


Usual pediatric dose
Antibacterial
Infants up to 1 month of age: Intramuscular or intravenous, 3.75 to 5 mg (base) per kg of body weight every six hours; or 5 to 6.7 mg per kg of body weight every eight hours. {05} {13}

Infants 1 month of age and over: Intramuscular or intravenous, 3.75 to 10 mg (base) per kg of body weight or 87.5 to 112.5 mg per square meter of body surface every six hours; or 5 to 13.3 mg per kg of body weight or 116.7 to 150 mg per square meter of body surface every eight hours. {13}


Note: In children, regardless of body weight, the minimum recommended dose is 300 mg (base) daily for severe infections.
Bone infection—Intramuscular or intravenous, 7.5 mg per kg of body weight every six hours.

[Babesiosis (treatment)]1
Dosage has not been established; however, based on one case report in an infant, the suggested dose is: Intravenous or intramuscular, 20 mg per kg of body weight per day of clindamycin with concurrent oral administration of 25 mg per kg of body weight per day of quinine for seven to ten days. {48}


Strength(s) usually available
U.S.—


300 mg (base) in 2 mL (Rx) [Cleocin (benzyl alcohol 9.45 mg)][Generic]


600 mg (base) in 4 mL (Rx) [Cleocin (benzyl alcohol 9.45 mg)][Generic]


900 mg (base) in 6 mL (Rx) [Cleocin (benzyl alcohol 9.45 mg)][Generic]


9000 mg (base) in 60 mL (Rx)[Generic]

Canada—


300 mg (base) in 2 mL (Rx) [Dalacin C Phosphate (benzyl alcohol)]


600 mg (base) in 4 mL (Rx) [Dalacin C Phosphate (benzyl alcohol)]


900 mg (base) in 6 mL (Rx) [Dalacin C Phosphate (benzyl alcohol)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Preparation of dosage form:
To prepare initial dilution for intravenous use, each dose must be diluted as follows (it must not be administered undiluted as a bolus):

Dose
(mg)
Diluent
(mL)
Duration of
administration
(min)
300
50
10
600
100
20
900
100
30


Caution: Products containing benzyl alcohol are not recommended for use in neonates. A fatal toxic syndrome consisting of metabolic acidosis, CNS depression, respiratory problems, renal failure, hypotension, and possibly seizures and intracranial hemorrhages has been associated with this use.

Stability:
Clindamycin phosphate retains its potency for 24 hours at room temperature in intravenous infusions containing sodium chloride, dextrose, potassium, vitamin B complex, cephalothin, kanamycin, gentamicin, penicillin, or carbenicillin. {13}

Incompatibilities:
Clindamycin phosphate is physically incompatible with ampicillin, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate. {13}

Additional information:
Clindamycin phosphate may also be administered as a single rapid infusion (initial dose) followed by continuous intravenous infusion as follows {13}:

Clindamycin
serum concentrations
(desired mainte-
nance—mcg/mL)
Infusion rate and
duration
(initial)
Infusion rate
(continuous—
mg/min)
Rate
(mg/min)
Duration
(min)
> 4
10
30
0.75
> 5
15
30
1
> 6
20
30
1.25
1 Not included in Canadian product labeling.




Revised: 08/14/98



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