Clindamycin Phosphate

Clindagel® is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS).

Clindagel® containing clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following size:

75 mL bottle - NDC 16781-462-75

Store under controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Do not store in direct sunlight.

Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA. by: DPT Laboratories, Ltd., San Antonio, Texas 78215 USA. Revised: Nov 2015

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Clindesse (clindamycin phosphate) in 368 patients. Clindesse (clindamycin phosphate) was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20). The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. Patient demographics in the trials were 51% Caucasian, 36% Black, 10% Hispanic, and 3% Asian, other or unknown. All patients received 100 mg clindamycin phosphate cream intravaginally in a single dose.

Of the 368 women treated with a single dose of Clindesse (clindamycin phosphate) , 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clindesse (clindamycin phosphate) and in 32 of 85 patients (38%) treated with placebo.

Adverse reactions occurring in ≥ 1% of patients receiving Clindesse (clindamycin phosphate) in the three clinical studies are shown in Table 1.

Table 1: Adverse Reactions Occurring in ≥ 1% of Clindesse (clindamycin phosphate) -Treated Patients and at a Higher Rate than Placebo-Treated Patients

Adverse Event	Clindesse (clindamycin phosphate) N=368 n (%)	Placebo N=85 n (%)
Vaginosis fungal NOS*	52 (14)	7 (8)
Headache NOS	10 (3)	2 (2)
Back pain	6 (2)	1 (1)
Constipation	4 (1)	0 (0)
Urinary tract infection NOS	4 (1)	0 (0)
N = number of patients in intent-to-treat population n (%) = number and percentage of patients with reported adverse reaction NOS = not otherwise specified * The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment

Other reactions reported by < 1% of those women treated with Clindesse (clindamycin phosphate) include:

Dermatologic: Pruritic rash

Gastrointestinal: Diarrhea, vomiting

General: Fatigue

Immune System: Hypersensitivity

Nervous System: Dizziness

Reproductive System: Dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema

• Bacterial Vaginosis

Antibacterial; broad-spectrum antibiotic derived from lincomycin.121 126 139

Acute Otitis Media (AOM)

Alternative for treatment of AOM† known or presumed to be caused by penicillin-resistant Streptococcus pneumoniae.253

Not a first-line agent, but AAP and AAFP state clindamycin may be considered in individuals with penicillin hypersensitivity who may have AOM caused by penicillin-resistant S. pneumoniae.253

Use of clindamycin also may be considered if AOM persists after treatment with amoxicillin and clavulanate or ceftriaxone and tympanocentesis is not available to make a bacteriologic diagnosis.253

Bone and Joint Infections

Treatment of serious bone and joint infections (including acute hematogenous osteomyelitis) caused by susceptible Staphylococcus aureus.139

Adjunct in the surgical treatment of chronic bone and joint infections caused by susceptible bacteria.139

Gynecologic Infections

Treatment of serious gynecologic infections (e.g., endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, postsurgical vaginal cuff infection) caused by susceptible anaerobes.121 126 139

Treatment of pelvic inflammatory disease (PID); used in conjunction with other anti-infectives.124 128 257 When a parenteral regimen is indicated for treatment of PID, IV clindamycin in conjunction with an IV or IM aminoglycoside (e.g., gentamicin) is one of the recommended regimens.124 128 257

Intra-abdominal Infections

Treatment of serious intra-abdominal infections (e.g., peritonitis, intra-abdominal abscess) caused by susceptible anaerobes.121 126 139

Pharyngitis and Tonsillitis

Alternative for treatment of pharyngitis and tonsillitis† caused by susceptible Streptococcus pyogenes (group A β-hemolytic streptococci)120 122 135 144 149 in patients who cannot receive β-lactam anti-infectives and have infections caused by macrolide-resistant S. pyogenes.122

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice for pharyngitis and tonsillitis;120 122 123 127 144 oral cephalosporins and oral macrolides are considered alternatives.120 122 123 127 144 Amoxicillin sometimes used instead of penicillin V, especially for young children.122 144

Alternative for treatment of symptomatic patients who have multiple, recurrent episodes of pharyngitis known to be caused by S. pyogenes.122 144

Consider that multiple, recurrent episodes of symptomatic pharyngitis within several months to years may indicate that the patient is a streptococcal carrier experiencing repeated episodes of nonstreptococcal pharyngitis (e.g., viral) pharyngitis; treatment not usually recommended for streptococcal pharyngeal carriers.122 144

Respiratory Tract Infections

Treatment of serious respiratory tract infections (e.g., pneumonia, empyema, lung abscess) caused by susceptible anaerobes, S. pneumoniae, other streptococci, or S. aureus.121 126 139 151

A drug of choice for treatment of community-acquired pneumonia (including aspiration pneumonia) when anaerobes are identified or suspected.151

Septicemia

Treatment of serious septicemia caused by susceptible anaerobes, streptococci, or S. aureus.121 126 139

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible anaerobes, S. pyogenes, other streptococci, or staphylococci.120 121 126 139

Actinomycosis

Treatment of actinomycosis† caused by Actinomyces israelii;120 144 follow-up treatment (6–12 months) after initial parenteral treatment (4–6 weeks) with penicillin G or ampicillin.144

Anthrax

Alternative for treatment of anthrax†.103 116 117

Component of multiple-drug parenteral regimens recommended for treatment of inhalational anthrax that occurs as the result of exposure to B. anthracis spores in the context of biologic warfare or bioterrorism.103 117 119 Initiate treatment with IV ciprofloxacin or doxycycline and 1 or 2 other anti-infective agents predicted to be effective (e.g., chloramphenicol, clindamycin, rifampin, vancomycin, clarithromycin, imipenem, penicillin, ampicillin);103 117 if meningitis is established or suspected, use IV ciprofloxacin (rather than doxycycline) and chloramphenicol, rifampin, or penicillin.117

Babesiosis

Treatment of babesiosis† caused by Babesia microti.101 104 105 144

Regimens of choice for babesiosis are clindamycin in conjunction with quinine or atovaquone in conjunction with azithromycin;104 111 144 256 the clindamycin and quinine regimen may be preferred for severe babesiosis.256 Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), significant hemolysis, or compromised renal, hepatic, or pulmonary function.104 144 256

Bacillus cereus Infections

Treatment of invasive disease caused by Bacillus cereus†.120 144 Anti-infectives not usually indicated for gastroenteritis caused by B. cereus.144

Bacterial Vaginosis

Treatment of bacterial vaginosis† (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in pregnant or nonpregnant women.124 128 180 181 182 183 194 196 203

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).128 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.128

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.128

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole; a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream;124 128 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.124 128 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.128

Regardless of regimen used, relapse or recurrence is common;128 189 192 193 194 195 197 an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.128 183

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.128

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga canimorsus†.120

Clostridium Infections

Alternative to penicillin G for treatment of clostridial myonecrosis (gas gangrene) caused by Clostridium perfringens or other Clostridium.120 144 Anti-infectives not usually indicated for gastroenteritis caused by C. perfringens.144

Malaria

Treatment of uncomplicated malaria† caused by chloroquine-resistant Plasmodium falciparum or when the plasmodial species has not been identified.104 113 114 115 252 Used in conjunction with oral quinine; not effective alone.114 252

CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria are a regimen of oral quinine in conjunction with doxycycline, tetracycline, or clindamycin or a regimen of atovaquone and proguanil.114 252 A regimen of quinine and doxycycline (or tetracycline) generally preferred over quinine and clindamycin,252 except for young children or pregnant women who should not receive tetracyclines.104 113 115 252

Treatment of severe malaria caused by P. falciparum†; used in conjunction with IV quinidine gluconate initially and then with oral quinine when an oral regimen is tolerated.252

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

Treatment of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia† (PCP); used in conjunction with primaquine.104 145 146 148 150 152 153 155 157 158 159 169 170 204 205 206 254 Designated an orphan drug by FDA for use in this condition.212

Co-trimoxazole is initial drug of choice for treatment in most adults, adolescents, and children, including HIV-infected patients; a regimen of clindamycin and primaquine is an alternative for adults and adolescents with mild to moderately severe PCP who have had an inadequate response to co-trimoxazole or when co-trimoxazole is contraindicated or not tolerated.104 145 146 148 150 152 153 155 157 158 159 169 170 204 254

Clindamycin in conjunction with primaquine has been used as an alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP†,150 159 but USPHS/IDSA states the regimen should only be considered for primary or secondary prophylaxis of PCP in unusual situations when the usually recommended agents (co-trimoxazole, dapsone, dapsone with pyrimethamine and leucovorin, aerosolized pentamidine, atovaquone) cannot be used.210

Toxoplasmosis

Alternative for treatment of toxoplasmosis† in immunocompromised adults, adolescents, or children (including HIV-infected patients) who relapse or fail to respond to or are unable to tolerate the regimen of choice (pyrimethamine in conjunction with sulfadiazine and leucovorin).129 130 131 132 138 164 166 167 168 172 204 205 254 255 Clindamycin is used in conjunction with pyrimethamine and leucovorin and is the preferred alternative.163 164 166 172 204 205 254 255

Alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis† in HIV-infected individuals who cannot receive the regimen of choice (sulfadiazine in conjunction with pyrimethamine and leucovorin).210 254 Clindamycin is used in conjunction with pyrimethamine and leucovorin.210 254 Consider that the clindamycin regimen may be less effective than the sulfadiazine regimen in preventing toxoplasmosis recurrence210 213 and that only the sulfadiazine regimen appears to provide protection against both toxoplasmosis and P. jiroveci.210

Prevention of Bacterial Endocarditis

Alternative for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis† in penicillin-allergic patients with certain cardiac conditions who are undergoing certain dental procedures (i.e., procedures that involve manipulation of gingival tissue, the periapical region of teeth, or perforation of oral mucosa) or certain invasive respiratory tract procedures (i.e., procedures involving incision or biopsy of respiratory mucosa).141

Consult most recent AHA recommendations for information on which cardiac conditions are associated with the highest risk of adverse outcome from endocarditis and specific recommendations regarding use of prophylaxis to prevent endocarditis in these patients.141

Prevention of Perinatal Group B Streptococcal Disease

Alternative to penicillin G or ampicillin for prevention of perinatal group B streptococcal (GBS) disease† in penicillin-allergic pregnant women at risk for anaphylaxis with a β-lactam anti-infective.214 245

Intrapartum anti-infective prophylaxis to prevent early-onset neonatal GBS disease is administered to women identified as GBS carriers during routine prenatal GBS screening performed at 35–37 weeks during the current pregnancy and to women who have GBS bacteriuria during the current pregnancy, a previous infant with invasive GBS disease, unknown GBS status with delivery at <37 weeks gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.214 245

Penicillin G is the regimen of choice and ampicillin is the preferred alternative.214 245 Cefazolin can be used in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity, but clindamycin or erythromycin should be used in penicillin-allergic women at high risk for anaphylaxis.214

Consider that S. agalactiae (group B streptococci) with in vitro resistance to clindamycin and erythromycin has been reported with increasing frequency;214 perform in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening.214 GBS resistant to erythromycin often are resistant to clindamycin, although this may not be evident in results of in vitro testing.214 If in vitro susceptibility testing is not possible, results are unknown, or isolates are found to be resistant to erythromycin or clindamycin, vancomycin is recommended for intrapartum prophylaxis in penicillin-allergic women at high risk for anaphylaxis with β-lactams.214

Perioperative Prophylaxis

Perioperative prophylaxis† to reduce the incidence of infections in patients undergoing clean, contaminated head and neck surgery.125 140 Regimens of choice are IV clindamycin (with or without gentamicin) or IV cefazolin.125 140

Has been used for perioperative prophylaxis in patients undergoing nonperforated appendectomy†.140 Cephalosporins (cefazolin, cefoxitin) usually recommended for perioperative prophylaxis in patients undergoing GI procedures (e.g., esophageal and gastroduodenal surgery, biliary tract surgery, colorectal surgery, nonperforated appendectomy); 125 140 clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended in patients hypersensitive to cephalosporins.125

Clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended as an alternative to cephalosporins (cefazolin, cefoxitin) for perioperative prophylaxis in gynecologic and obstetric surgery (vaginal, abdominal, or laparoscopic hysterectomy)† in patients hypersensitive to cephalosporins (the preferred agents).125

Clindamycin in conjunction with gentamicin, ciprofloxacin, levofloxacin, or aztreonam recommended for perioperative prophylaxis and postoperative treatment in contaminated or dirty surgery involving a perforated abdominal viscus† in patients hypersensitive to cephalosporins when cefoxitin (the preferred agent) cannot be used.125

Administration

Administer orally,121 126 IM,139 or by intermittent or continuous IV infusion.139 Do not administer by rapid IV injection.139

In the treatment of serious anaerobic infections, parenteral route usually used initially and oral clindamycin substituted when warranted by patient’s condition.121 126 In clinically appropriate circumstances, treatment may be initiated with oral clindamycin.121 126

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.139

Clindamycin phosphate ADD-Vantage vials and the commercially available clindamycin phosphate injection in 5% dextrose should be used only for IV infusion.139

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

Oral Administration

Clindamycin hydrochloride capsules126 and clindamycin palmitate hydrochloride oral solution121 can be administered without regard to food.

To avoid the possibility of esophageal irritation, administer clindamycin hydrochloride capsules with a full glass of water.126

Reconstitution

Reconstitute clindamycin palmitate hydrochloride oral solution by adding 75 mL of water to the 100-mL bottle.121 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.121 The resulting solution contains 75 mg of clindamycin/5 mL.121

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.139 (See Rate of Administration under Dosage and Administration.)

The clindamycin phosphate pharmacy bulk package is not intended for direct IV infusion;139 doses of the drug from the bulk package must be further diluted in a compatible IV infusion solution prior to administration.139 The bulk package is intended for use only under a laminar flow hood.139 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.139 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.139

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.139

Rate of Administration

By intermittent IV infusion over a period of at least 10–60 minutes139 and at a rate ≤30 mg/minute.139 No more than 1.2 g should be given by IV infusion in a single 1-hour period.139

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.139

Alternatively, the initial dose can be given as a single rapid infusion over 30 minutes followed by continuous IV infusion (see Table).139

Infusion Rates for Continuous IV Infusion139

Target Serum Clindamycin Concentrations	Infusion Rate for Initial Dose	Maintenance Infusion Rate
>4 mcg/mL	10 mg/minute for 30 minutes	0.75 mg/minute
>5 mcg/mL	15 mg/minute for 30 minutes	1 mg/minute
>6 mcg/mL	20 mg/minute for 30 minutes	1.25 mg/minute

Dosage

Available as clindamycin hydrochloride,126 clindamycin palmitate hydrochloride,121 and clindamycin phosphate;139 dosage expressed in terms of clindamycin.121 126 139

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.121 Daily dosage is given in 3 or 4 equally divided doses.121 In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.121

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.144

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.144

IV or IM

Manufacturer recommends 15–20 mg/kg daily given in 3 or 4 equally divided doses.139 The lower dosage may be adequate for small, premature neonates.139

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.144

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.144

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.126

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.121 Daily dosage is given in 3 or 4 equally divided doses.121 In children weighing ≤10 kg, manufacturer recommends a minimum dosage of 37.5 mg 3 times daily.121

AAP recommends 10–20 mg/kg daily given in 3 or 4 equally divided doses for mild to moderate infections.144 AAP states oral route inappropriate for severe infections.144

IV or IM

Manufacturer recommends 20–40 mg/kg daily given in 3 or 4 equally divided doses.139 Alternatively, manufacturer recommends 350 mg/m2 daily for serious infections or 450 mg/m2 daily for more severe infections.139

AAP recommends 15–25 mg/kg daily for mild to moderate infections and 25–40 mg/kg daily for severe infections.144 Daily dosage is given in 3 or 4 equally divided doses.144

Acute Otitis Media† (AOM) Oral

30–40 mg/kg daily in 3 divided doses recommended by AAP and AAFP.253

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.122

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).256 Others recommend 20–40 mg/kg daily in 3 divided doses given for 7–10 days;104 used in conjunction with oral quinine sulfate (25 mg/kg daily in 3 divided doses for 7–10 days).104 111 144

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).256

Malaria† Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria† Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;104 252 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).104 252

Treatment of Severe P. falciparum Malaria† Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;252 used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.252

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.252

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.252

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia† Treatment of Mild to Moderate Infections† Oral

Adolescents: 300–450 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

IV

Adolescents: 600–900 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

Toxoplasmosis† Treatment in Infants and Children† Oral or IV

5–7.5 mg/kg (up to 600 mg) 4 times daily;255 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).255

Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.255

Treatment in Adolescents† Oral or IV

600 mg every 6 hours;254 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).254

Continue acute treatment for ≥6 weeks; longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.254

Prevention of Recurrence (Secondary Prophylaxis) in Infants and Children† Oral

20–30 mg/kg daily in 4 divided doses;210 used in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m2 once daily) and oral leucovorin (5 mg once every 3 days).210

Secondary prophylaxis against toxoplasmosis generally is continued for life.210 The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy has not been extensively studied.210

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.210 (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.141

IM or IV

20 mg/kg as a single dose given 30–60 minutes prior to the procedure.141

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.140 Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.125

Adults

General Adult Dosage Serious Infections Oral

150–300 mg every 6 hours.126

IV or IM

600 mg to 1.2 g daily in 2–4 equally divided doses.139

More Severe Infections Oral

300–450 mg every 6 hours.126

IV or IM

1.2–2.7 g daily in 2–4 equally divided doses.139

For life-threatening infections, dosage may be increased up 4.8 g daily.139

Gynecologic Infections Pelvic Inflammatory Disease IV, then Oral

Initially, 900 mg IV every 8 hours;124 128 257 used in conjunction with IV or IM gentamicin.124 128 257 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.128 Alternatively, oral doxycycline can be used to complete 14 days of therapy.124 128

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.122 IDSA states this dosage was not specifically studied in adults and was extrapolated from pediatric dosage recommendation.122

Anthrax† Treatment of Inhalational Anthrax† IV

900 mg every 8 hours.119

Used in multiple-drug regimens that initially include IV ciprofloxacin or IV doxycycline and 1 or 2 other anti-infectives predicted to be effective.103 116 117 119

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.103 117

Babesiosis† Oral

600 mg 3 times daily given for 7–10 days recommended by IDSA and others;104 256 used in conjunction with oral quinine (650 mg every 6–8 hours for 7–10 days).104 111 256

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).256 Others recommend 1.2 g twice daily given for 7–10 days;104 used in conjunction with oral quinine (650 mg 3 times daily for 7–10 days).104 111

Bacterial Vaginosis† Treatment in Pregnant or Nonpregnant Women† Oral

300 mg twice daily given for 7 days.124 128 180 183 193 196 197

Malaria† Treatment of Uncomplicated Chloroquine-resistant P. falciparum Malaria† Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;104 252 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).104 252

Treatment of Severe P. falciparum Malaria† Oral

20 mg/kg daily in 3 equally divided doses given for 7 days;104 252 used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.104 252

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.252

Used in conjunction with IV quinidine gluconate (followed by oral quinine sulfate) given for a total duration of 3–7 days.252

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia† Treatment of Mild to Moderate Infections† Oral

300–450 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

IV

600–900 mg every 6–8 hours given for 21 days;104 254 used in conjunction with oral primaquine (15–30 mg once daily for 21 days).104 254

Toxoplasmosis† Treatment† Oral or IV

600 mg every 6 hours;254 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).254

Continue acute treatment for ≥6 weeks.254

Prevention of Recurrence (Secondary Prophylaxis)† Oral

300–450 mg every 6–8 hours;210 254 used in conjunction with oral pyrimethamine (25–50 mg once daily) and oral leucovorin (10–25 mg once daily).210 254

Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients who have completed initial treatment of toxoplasmosis encephalitis (TE).210

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/mm3.210 254

Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3.210 254

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.141

IM or IV

600 mg as a single dose given 30–60 minutes prior to the procedure.141

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.214

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.125 140 Additional intraoperative doses suggested every 3–6 hours for prolonged procedures (>4 hours) or if major blood loss occurs.125

Special Populations

Hepatic Impairment

Dosage adjustments not necessary in those with mild or moderate hepatic impairment.126 139

Renal Impairment

Dosage adjustments not necessary in those with mild or moderate renal impairment.126 139

Absorption

Bioavailability

Approximately 90% of an oral dose of clindamycin hydrochloride rapidly absorbed from GI tract;126 peak serum concentration attained within 45–60 minutes.126 d

Prior to absorption, clindamycin palmitate hydrochloride is hydrolyzed in the GI tract to active clindamycin.d

Clindamycin palmitate oral solution and clindamycin hydrochloride capsules are bioequivalent.d

Following IM administration of clindamycin phosphate, peak serum concentrations occur within 3 hours in adults and 1 hour in children.d

Food

Although peak plasma concentrations may be delayed, food does not have an appreciable effect on the extent of absorption of clindamycin hydrochloride capsules126 or clindamycin palmitate hydrochloride oral solution.121

Distribution

Extent

Distributed into many body tissues and fluids.d

Only small amounts of the drug diffuse into CSF.d

Readily crosses the placentad and is distributed into milk.100

Plasma Protein Binding

93%.d

Elimination

Metabolism

Partially metabolized to bioactive and inactive metabolites.d

Elimination Route

Excreted in urine, bile, and feces.d

Half-life

2–3 hours in adults and children with normal renal function.d

Serum half-life in neonates depends on gestational and chronologic age and body weight.102

Special Populations

Serum half-life increased slightly in patients with markedly reduced renal or hepatic function.d

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clindamycin Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	75 mg (of clindamycin)	Cleocin HCl	Pfizer
		150 mg (of clindamycin)*	Cleocin HCl	Pfizer
		300 mg (of clindamycin)	Cleocin HCl	Pfizer

Clindamycin Palmitate Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution	75 mg (of clindamycin) per 5 mL	Cleocin Pediatric	Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Clindamycin Phosphate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	150 mg (of clindamycin) per mL*	Cleocin Phosphate	Pfizer
		9 g (150 mg/mL) (of clindamycin) pharmacy bulk package	Cleocin Phosphate	Pfizer
			Clindamycin Phosphate Injection
	Injection, for IV infusion only	150 mg (of clindamycin) per mL (300 mg)	Clindamycin Phosphate ADD-Vantage
		150 mg (of clindamycin) per mL (600 and 900 mg)	Cleocin Phosphate ADD-Vantage	Pfizer
			Clindamycin Phosphate ADD-Vantage

Clindamycin Phosphate in Dextrose

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion	6 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