Clindamycin

Clindamycin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN HCl and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficle. Because CLEOCIN HCl therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• 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, as described in the WARNING box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

• Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, 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.

• Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN HCl and other antibacterial drugs, CLEOCIN HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosage

• If significant diarrhea occurs during therapy, this antibiotic should be discontinued.

• Adults: Serious infections – 150 to 300 mg every 6 hours. More severe infections – 300 to 450 mg every 6 hours. Pediatric Patients: Serious infections – 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections – 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses.

• To avoid the possibility of esophageal irritation, CLEOCIN HCl Capsules should be taken with a full glass of water.

• Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN HCl Capsules.

• In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Indications and Dosing

• Due to risk of severe colitis, reserve use of clindamycin for serious infections when other options are inappropriate.
• Babesiosis: 600 mg ORALLY every 8 hours plus quinine 650 mg ORALLY every 6 to 8 hours for 7 to 10 days.
• Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 600 mg ORALLY 30 to 60 minutes prior to procedure.
• Bacterial infectious disease (Severe), Susceptible infections due to anaerobic organisms, staphylococci, streptococci, pneumococci: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing); (MRSA-associated) 300 to 450 mg ORALLY 3 times daily for cellulitis and 600 mg ORALLY 3 times daily for complicated skin and soft tissue infections (cSSTIs), pneumonia, and bone and joint infections; duration is 5 to 10 days for cellulitis, 7 to 14 days for hospital-associated cSSTIs, 7 to 21 days for pneumonia, 8 weeks for osteomyelitis, and 3 to 4 weeks for septic arthritis (guideline dosing).
• Bacterial vaginosis: 300 mg ORALLY twice daily for 7 days.
• HIV infection - Pneumocystis pneumonia: 300 to 450 mg ORALLY every 6 to 8 hours, in combination with primaquine 15 to 30 mg (base) ORALLY once daily for 21 days.
• HIV infection - Toxoplasmosis: (encephalitis) alternative therapy, 600 mg ORALLY every 6 hours, in combination with pyrimethamine 200 mg ORALLY for 1 dose, then 50 mg (less than 60 kg) or 75 mg (60 kg or greater) ORALLY daily plus leucovorin 10 to 25 mg (can increase to 50 mg) ORALLY daily for at least 6 weeks.
• HIV infection - Toxoplasmosis; Prophylaxis: secondary prophylaxis (alternative regimen), 600 mg ORALLY every 8 hours, in combination with pyrimethamine 25 to 50 mg ORALLY daily plus leucovorin 10 to 25 mg ORALLY daily.
• Impetigo: (Staphylococcus and Streptococcus species) 300 to 400 mg ORALLY 4 times daily for 7 days, depending on clinical response (guideline dosing).
• Infection of skin AND/OR subcutaneous tissue (Severe): 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dose) [4]; MRSA-associated, 300 mg to 450 mg ORALLY 3 times daily for 5 to 10 days (purulent and nonpurulent cellulitis) or 600 mg ORALLY 3 times daily (complicated skin and soft tissue infections [cSSTIs]), generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response.
• Infection of skin AND/OR subcutaneous tissue (Severe): Methicillin-susceptible Staphylococcus aureus or MRSA, 300 to 450 mg ORALLY 3 or [5] 4 times daily [8]; for purulent or nonpurulent cellulitis continue treatment for 5 to 10 days.
• Infection of skin AND/OR subcutaneous tissue (Severe): MRSA, complicated skin and soft tissue infections (cSSTIs), 600 mg ORALLY 3 times daily, generally for 7 to 14 days for hospital-associated cSSTIs; individualize to patient response (guideline dose).
• Infectious disease of abdomen: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
• Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
• Pelvic inflammatory disease: 900 mg IV every 8 hours plus gentamicin (IV or IM) loading dose of 2 mg/kg, followed by 1.5 mg/kg every 8 hours (single daily dosing of gentamicin 3 to 5 mg/kg may be substituted); discontinue IV/IM therapy 24 hours after clinical improvement and continue on clindamycin 450 mg ORALLY 4 times daily or doxycycline 100 mg ORALLY twice daily to complete a total of 14 days of therapy (guideline dosing).
• Pelvic inflammatory disease: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections (manufacturer dosing) .
• Septicemia: 150 to 300 mg ORALLY every 6 hours; use 300 to 450 mg ORALLY every 6 hours for more severe infections.
• Streptococcal pharyngitis: (penicillin-allergic patients) 20 mg/kg/day ORALLY in 3 divided doses (MAX 1.8 g/day).

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Clindamycin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Indications and Dosage

• Due to risk of severe colitis, reserve use of clindamycin for serious infections when other options are inappropriate.
• Acute otitis media: 30 to 40 mg/kg/day ORALLY in 3 divided doses for 5 to 7 days (6 years or older with mild to moderate illness), 7 days (2 to 5 years with mild to moderate illness), or 10 days (younger than 2 years or with severe illness).
• Babesiosis: 7 to 10 mg/kg ORALLY every 6 to 8 hours (MAX 600 mg/dose) plus quinine 8 mg/kg ORALLY every 8 hours (MAX 650 mg/dose) for 7 to 10 days.
• Bacterial endocarditis; Prophylaxis: (high-risk patients; dental, respiratory, or infected skin/skin structure or musculoskeletal tissue procedures) 20 mg/kg ORALLY 30 to 60 minutes prior to procedure.
• Bacterial infectious disease (Severe), Susceptible infections due to anaerobic organisms, staphylococci, streptococci, pneumococci: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections; (MRSA-associated infections) 40 mg/kg/day orally divided every 6 to 8 hours (guideline dosing).
• HIV infection - Toxoplasmosis: (congenital toxoplasmosis) 5 to 7.5 mg/kg/dose (MAX 600 mg/dose) ORALLY 4 times daily plus pyrimethamine 2 mg/kg ORALLY once daily for 2 days, then 1 mg/kg ORALLY once daily for 2 to 6 months, then 1 mg/kg ORALLY 3 times weekly plus leucovorin 10 mg ORALLY or IM with each dose of pyrimethamine; total treatment duration is 12 months.
• HIV infection - Toxoplasmosis: (acquired toxoplasmosis) 5 to 7.5 mg/kg/dose (MAX 600 mg/dose) ORALLY 4 times daily plus pyrimethamine 2 mg/kg (MAX 50 mg) ORALLY once daily for 3 days, then 1 mg/kg (MAX 25 mg) ORALLY once daily plus leucovorin 10 to 25 mg ORALLY daily; continue for at least 6 weeks, followed by secondary prophylaxis.
• HIV infection - Toxoplasmosis; Prophylaxis: secondary prophylaxis (alternative regimen), 20 to 30 mg/kg/day ORALLY divided into 3 to 4 doses plus pyrimethamine 1 mg/kg or 15 mg/m(2) (MAX 25 mg) ORALLY daily plus leucovorin 5 mg ORALLY every 3 days.
• Impetigo: (Staphylococcus and Streptococcus species) 20 mg/kg/day ORALLY in 3 divided doses for 7 days, depending on clinical response (guideline dosing).
• Infection of skin AND/OR subcutaneous tissue (Severe): 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections (manufacturer dose).
• Infection of skin AND/OR subcutaneous tissue (Severe): Methicillin-susceptible Staphylococcus aureus, 25 to 30 mg/kg/day ORALLY in 3 divided doses (guideline dose).
• Infection of skin AND/OR subcutaneous tissue (Severe): MRSA, 30 to [8] 40 mg/kg/day [8][5] ORALLY in 3 or 4 divided doses (guideline dose).
• Infectious disease of abdomen: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections .
• Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections.
• Lower respiratory tract infection (Severe), Empyema, abscess, pneumonitis: community-acquired pneumonia (older than 3 months) 30 to 40 mg/kg/day ORALLY in 3 to 4 divided doses (guideline dosing).
• Pelvic inflammatory disease: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; use 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections.
• Septicemia: 8 to 16 mg/kg/day ORALLY divided every 6 to 8 hours; 16 to 20 mg/kg/day ORALLY divided every 6 to 8 hours for more severe infections.

Streptococcal pharyngitis: (penicillin-allergic patients) 20 mg/kg/day ORALLY in 3 divided doses (MAX 1.8 g/day)

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clindamycin in pediatric patients.

Contraindications

CLEOCIN HCl is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Warnings

WARNING See full prescribing information for complete Boxed Warning. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN HCl and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficle. Because CLEOCIN HCl therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

There is limited information regarding Clindamycin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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 . Esophageal ulcer has been reported.

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. Severe skin reactions such as toxic epidermal necrolysis, some with fatal outcome, have been reported . Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, and anaphylactoid reactions have also been reported.

Skin and Mucous Membranes: Pruritus, vaginitis, and rare instances of exfoliative dermatitis have been reported. (See HYPERSENSITIVITY REACTIONS.)

Liver: Jaundice 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 has been observed.

Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Musculoskeletal: Cases of polyarthritis have been reported.

Postmarketing Experience

There is limited information regarding Clindamycin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Clindamycin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Clindamycin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clindamycin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Clindamycin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Clindamycin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Clindamycin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Clindamycin in geriatric settings.

Gender

There is no FDA guidance on the use of Clindamycin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Clindamycin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Clindamycin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Clindamycin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Clindamycin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Clindamycin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Clindamycin Administration in the drug label.

Monitoring

There is limited information regarding Clindamycin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Clindamycin and IV administrations.

Overdosage

• Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed.

• Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

Pharmacology

There is limited information regarding Clindamycin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Clindamycin Mechanism of Action in the drug label.

Structure

There is limited information regarding Clindamycin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Clindamycin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Clindamycin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Clindamycin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Clindamycin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Clindamycin How Supplied in the drug label.

Storage

There is limited information regarding Clindamycin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Clindamycin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Clindamycin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Clindamycin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Clindamycin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.