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Dosage and Administration

Administration

Administer orally, IM, or by intermittent or continuous IV infusion. Do not administer by rapid IV injection.

In the treatment of serious anaerobic infections, parenteral route usually used initially and oral clindamycin substituted when warranted by patient's condition. In clinically appropriate circumstances, treatment may be initiated with oral clindamycin.

Single IM doses should not exceed 600 mg, and no more than 1.2 g should be administered by IV infusion in a 1-hour period.

Clindamycin phosphate ADD-Vantage® vials and the commercially available clindamycin phosphate injection in 5% dextrose should be used only for IV infusion.

For solution and drug compatibility information, see Compatibility under Stability.

Oral Administration

Clindamycin hydrochloride capsules and clindamycin palmitate hydrochloride oral solution can be administered without regard to food.

To avoid the possibility of esophageal irritation, administer clindamycin hydrochloride capsules with a full glass of water.

Reconstitution

Reconstitute clindamycin palmitate hydrochloride oral solution by adding 75 mL of water to the 100-mL bottle. A large portion of the water should be added initially and the bottle shaken vigorously; the remainder of the water should then be added and the bottle shaken until the solution is uniform. The resulting solution contains 75 mg of clindamycin/5 mL.

IV Infusion

Dilution

Prior to IV infusion, clindamycin phosphate injections (including ADD-Vantage^® vials) must be diluted with a compatible IV solution to a concentration ≤18 mg/mL. (See Rate of Administration under Dosage and Administration.)

The clindamycin phosphate pharmacy bulk package is not intended for direct IV infusion; doses of the drug from the bulk package must be further diluted in a compatible IV infusion solution prior to administration. The bulk package is intended for use only under a laminar flow hood. Entry into the vial should be made using a sterile transfer set or other sterile dispensing device, and the contents dispensed in aliquots using appropriate technique; multiple entries with a syringe and needle are not recommended because of the increased risk of microbial and particulate contamination. After entry into the bulk package vial, the entire contents should be used promptly and any unused portion discarded within 24 hours after initial entry.

The commercially available clindamycin phosphate injections in 5% dextrose should not be used in series connections with other plastic containers, since such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.

Rate of Administration

By intermittent IV infusion over a period of at least 10–60 minutes and at a rate ≤30 mg/minute. No more than 1.2 g should be given by IV infusion in a single 1-hour period.

The manufacturers suggest that 300- or 600-mg doses be diluted in 50 mL of compatible diluent and infused over 10 or 20 minutes, respectively; 900-mg doses be diluted in 50–100 mL of diluent and infused over 30 minutes; or 1.2-g doses be diluted in 100 mL of diluent and infused over 40 minutes.

Alternatively, the initial dose can be given as a single rapid infusion over 30 minutes followed by continuous IV infusion (see Table).

Dosage

Available as clindamycin hydrochloride, clindamycin palmitate hydrochloride, and clindamycin phosphate; dosage expressed in terms of clindamycin.

Pediatric Patients

General Dosage in Neonates

Oral

Oral Solution: Manufacturer recommends 8–12 mg/kg daily for serious infections, 13–16 mg/kg daily for severe infections, and 17–25 mg/kg daily for more severe infections. Daily dosage is given in 3 or 4 equally divided doses. In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.

Neonates <1 week of age: AAP recommends 5 mg/kg every 12 hours in those weighing ≤2 kg or 5 mg/kg every 8 hours in those weighing >2 kg.

Neonates 1–4 weeks of age: AAP recommends 5 mg/kg every 12 hours in those weighing <1.2 kg, 5 mg/kg every 8 hours in those weighing 1.2–2 kg, and 5–7.5 mg/kg every 6 hours in those weighing >2 kg.

IV or IM

Manufacturer recommends 15–20 mg/kg daily given in 3 or 4 equally divided doses. The lower dosage may be adequate for small, premature neonates.

Neonates <1 week of age: AAP recommends 5 mg/kg every 12 hours in those weighing ≤2 kg or 5 mg/kg every 8 hours in those weighing >2 kg.

Neonates 1–4 weeks of age: AAP recommends 5 mg/kg every 12 hours in those weighing <1.2 kg, 5 mg/kg every 8 hours in those weighing 1.2–2 kg, and 5–7.5 mg/kg every 6 hours in those weighing >2 kg.

General Dosage in Children 1 Month to 16 Years of Age

Oral

Capsules: Manufacturer recommends 8–16 mg/kg daily given in 3 or 4 equally divided doses for serious infections or 16–20 mg/kg daily given in 3 or 4 equally divided doses for more severe infections.

Oral Solution: Manufacturer recommends 8–12 mg/kg daily for serious infections, 13–16 mg/kg daily for severe infections, and 17–25 mg/kg daily for more severe infections. Daily dosage is given in 3 or 4 equally divided doses. In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.

AAP recommends 10–20 mg/kg daily given in 3 or 4 equally divided doses for mild to moderate infections. AAP states oral route inappropriate for severe infections.

IV or IM

Manufacturer recommends 20–40 mg/kg daily given in 3 or 4 equally divided doses. Alternatively, manufacturer recommends 350 mg/m² daily for serious infections or 450 mg/m² daily for more severe infections.

AAP recommends 15–25 mg/kg daily for mild to moderate infections and 25–40 mg/kg daily for severe infections. Daily dosage is given in 3 or 4 equally divided doses.

Acute Otitis Media (AOM)

Oral

30–40 mg/kg daily in 3 divided doses recommended by AAP and AAFP.†

Pharyngitis and Tonsillitis

Treatment of Symptomatic Patients with Multiple, Recurrent Episodes Known to Caused by Streptococcus pyogenes

Oral

20–30 mg/kg daily in 3 divided doses given for 10 days.†

Babesiosis

Oral

IDSA recommends 7–10 mg/kg (up to 600 mg) every 6–8 hours for 7–10 days; used in conjunction with oral quinine (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days). Others recommend 20–40 mg/kg daily in 3 divided doses given for 7–10 days; used in conjunction with oral quinine sulfate (25 mg/kg daily in 3 divided doses for 7–10 days).†

IV

IDSA recommends 7–10 mg/kg (up to 600 mg) every 6–8 hours for 7–10 days; used in conjunction with oral quinine (8 mg/kg [up to 650 mg] every 8 hours for 7–10 days).†

Malaria

Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria

Oral

20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with oral quinine sulfate (10 mg/kg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).†

Treatment of Severe P. falciparum Malaria

Oral

20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†

IV, then Oral

10-mg/kg IV loading dose followed by 5 mg/kg IV every 8 hours; when oral therapy is tolerated, switch to oral clindamycin 20 mg/kg daily in 3 divided doses and continue for a total duration of 7 days.†

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment of Mild to Moderate Infections

Oral

Adolescents: 300–450 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†

IV

Adolescents: 600–900 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†

Toxoplasmosis

Treatment in Infants and Children

Oral or IV

5–7.5 mg/kg (up to 600 mg) 4 times daily; used in conjunction with oral pyrimethamine (2 mg/kg once daily for 3 days then 1 mg/kg once daily) and oral leucovorin (10–25 mg once daily).†

Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.†

Treatment in Adolescents

Oral or IV

600 mg every 6 hours; used in conjunction with oral pyrimethamine (200-mg loading dose then 50–75 mg once daily) and oral leucovorin (10–20 mg once daily; higher dosage may be needed).†

Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.†

Prevention of Recurrence (Secondary Prophylaxis) in Infants and Children

Oral

20–30 mg/kg daily in 4 divided doses; used in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m² once daily) and oral leucovorin (5 mg once every 3 days).†

Secondary prophylaxis against toxoplasmosis generally is continued for life. The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy has not been extensively studied.†

Prevention of Recurrence (Secondary Prophylaxis) in Adolescents

Oral

Dosage for secondary prophylaxis against toxoplasmosis in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults. (See Adult Dosage under Dosage and Administration.)†

Prevention of Bacterial Endocarditis

Patients Undergoing Certain Dental or Respiratory Tract Procedures

Oral

20 mg/kg as a single dose given 30–60 minutes prior to the procedure.†

IM or IV

20 mg/kg as a single dose given 30–60 minutes prior to the procedure.†

Perioperative Prophylaxis

Head or Neck Surgery

IV

15 mg/kg given at induction of anesthesia (within 0.5–1 hour prior to incision); used with or without IV gentamicin. Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.†

Adults

General Adult Dosage

Serious Infections

Oral

150–300 mg every 6 hours.

IV or IM

600 mg to 1.2 g daily in 2–4 equally divided doses.

More Severe Infections

Oral

300–450 mg every 6 hours.

IV or IM

1.2–2.7 g daily in 2–4 equally divided doses.

For life-threatening infections, dosage may be increased up 4.8 g daily.

Gynecologic Infections

Pelvic Inflammatory Disease

IV, then Oral

Initially, 900 mg IV every 8 hours; used in conjunction with IV or IM gentamicin. After clinical improvement occurs, discontinue IV clindamycin and gentamicin and switch to oral clindamycin in a dosage of 450 mg 4 times daily to complete 14 days of therapy. Alternatively, oral doxycycline can be used to complete 14 days of therapy.

Pharyngitis and Tonsillitis

Treatment of Symptomatic Patients with Multiple, Recurrent Episodes Known to Caused by Streptococcus pyogenes

Oral

600 mg daily in 2–4 divided doses given for 10 days. IDSA states this dosage was not specifically studied in adults and was extrapolated from pediatric dosage recommendation.†

Anthrax

Treatment of Inhalational Anthrax

IV

900 mg every 8 hours.†

Used in multiple-drug regimens that initially include IV ciprofloxacin or IV doxycycline and 1 or 2 other anti-infectives predicted to be effective.†

Duration of treatment is 60 days if anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.†

Babesiosis

Oral

600 mg 3 times daily given for 7–10 days recommended by IDSA and others; used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days).†

IV

IDSA recommends 300–600 mg every 6 hours for 7–10 days; used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days). Others recommend 1.2 g twice daily given for 7–10 days; used in conjunction with oral quinine (650 mg 3 times daily for 7–10 days).†

Bacterial Vaginosis

Treatment in Pregnant or Nonpregnant Women

Oral

300 mg twice daily given for 7 days.†

Malaria

Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria

Oral

20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with oral quinine sulfate (650 mg 3 times daily given for 3 days if infection was acquired in Africa or South America or for 7 days if acquired in Southeast Asia).†

Treatment of Severe P. falciparum Malaria

Oral

20 mg/kg daily in 3 equally divided doses given for 7 days; used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†

IV, then Oral

10-mg/kg IV loading dose followed by 5 mg/kg IV every 8 hours; when oral therapy is tolerated, switch to oral clindamycin 20 mg/kg daily in 3 divided doses and continue for a total duration of 7 days.†

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.†

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment of Mild to Moderate Infections

Oral

300–450 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†

IV

600–900 mg every 6–8 hours given for 21 days; used in conjunction with oral primaquine (15–30 mg once daily for 21 days).†

Toxoplasmosis

Treatment

Oral or IV

600 mg every 6 hours; used in conjunction with oral pyrimethamine (200-mg loading dose then 50–75 mg once daily) and oral leucovorin (10–20 mg once daily; higher dosage may be needed).†

Continue acute treatment for ≥6 weeks.†

Prevention of Recurrence (Secondary Prophylaxis)

Oral

300–450 mg every 6–8 hours; used in conjunction with oral pyrimethamine (25–50 mg once daily) and oral leucovorin (10–25 mg once daily).†

Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients who have completed initial treatment of toxoplasmosis encephalitis (TE).†

Consideration can be given to discontinuing secondary prophylaxis in adults or adolescents who successfully completed initial treatment for TE, are asymptomatic with respect to TE, and have a sustained (≥6 months) increase in CD4⁺ T-cell counts to >200/mm³.†

Reinitiate secondary prophylaxis if CD4⁺ T-cell count decreases to <200/mm³.†

Prevention of Bacterial Endocarditis

Patients Undergoing Certain Dental or Respiratory Tract Procedures

Oral

600 mg as a single dose given 30–60 minutes prior to the procedure.†

IM or IV

600 mg as a single dose given 30–60 minutes prior to the procedure.†

Prevention of Perinatal Group B Streptococcal Disease

Women at Risk Who Should Not Receive β-lactam Anti-infectives

IV

900 mg every 8 hours; initiate at time of labor or rupture of membranes and continue until delivery.†

Perioperative Prophylaxis

Head or Neck Surgery

IV

600–900 mg given at induction of anesthesia (within 0.5–1 hour prior to incision); used with or without IV gentamicin. Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.†

Special Populations

Dosage in Hepatic Impairment

Dosage adjustments not necessary in those with mild or moderate hepatic impairment.

Dosage in Renal Impairment

Dosage adjustments not necessary in those with mild or moderate renal impairment.