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Clindamycin Hydrochloride, Clindamycin Palmitate Hydrochloride, Clindamycin Phosphate: Dosage and Administration

Reconstitution and Administration

Clindamycin hydrochloride and clindamycin palmitate hydrochloride are administered orally. Clindamycin phosphate is administered by IM injection or by intermittent or continuous IV infusion.

Clindamycin Phosphate

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, clindamycin hydrochloride capsules should be administered orally with a full glass of water.

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

Parenteral Administration

Prior to IV administration, clindamycin phosphate injection (including that contained in ADD-Vantage® vials) must be diluted with a compatible IV solution to a concentration not exceeding 18 mg/mL. For intermittent IV infusion, the diluted solution should be infused over a period of at least 10-60 minutes and at a rate not exceeding 30 mg/minute; the drug should not be administered IV undiluted as a bolus.

The manufacturers suggest that 300- or 600-mg doses of the drug be diluted in 50 mL of diluent and infused over 10 or 20 minutes, respectively, 900-mg doses of the drug be diluted in 50-100 mL of diluent and infused over 30 minutes, or that 1.2-g doses be diluted in 100 mL of diluent and infused over 40 minutes. No more than 1.2 g of the drug should be given by IV infusion in a single 1-hour period.

As an alternative to intermittent IV infusion, clindamycin may be given by continuous IV infusion after the first dose of the drug has been given by rapid IV infusion. The commercially available injections of clindamycin phosphate in 5% dextrose are administered by IV infusion. The container should be checked for minute leaks by firmly squeezing the bag. Clindamycin phosphate in 5% dextrose injection should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

The injection should be discarded if the container seal is not intact or leaks are found or if the solution is not clear. Additives should not be introduced into the injection container.

The injection 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 the fluid from the secondary container is complete. The clindamycin phosphate pharmacy bulk packages are 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 in 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. The date and time when the pharmacy bulk package was opened initially should be recorded on the pharmacy bulk vial.

After entry into a bulk package vial, the entire contents of the Cleocin Phosphate® pharmacy bulk package vial should be used promptly; any unused portion should be discarded within 24 hours after initial entry into the vial. The manufacturer of another clindamycin phosphate pharmacy bulk package (Gensia) states that the contents should be used as soon as possible after initial entry, but within 4 hours; if not used immediately, the vial should be stored at room temperature under the laminar flow hood during this period.

Dosage

Dosage is expressed in terms of clindamycin and depends on the severity of the infection and the susceptibility of the infecting organism. In the treatment of serious anaerobic infections, parenteral clindamycin is usually used initially and oral clindamycin may be substituted when the condition of the patient warrants; however, in clinically appropriate circumstances, treatment may be initiated or continued with oral clindamycin. The duration of clindamycin therapy depends on the type and severity of infection. If clindamycin is used in infections caused by group A b-hemolytic streptococci, therapy should be continued for at least 10 days. At least 6 weeks of therapy may be required for serious infections such as endocarditis or osteomyelitis.

Oral Dosage

General Adult Dosage

The usual adult oral dosage of clindamycin is 150-450 mg every 6 hours, depending on the type and severity of infection.

General Pediatric Dosage

The usual oral dosage of clindamycin for pediatric patients is 8-25 mg/kg daily given in 3 or 4 equally divided doses. For children weighing 10 kg or less, the minimum oral dosage recommended by one manufacturer is 37.5 mg 3 times daily. Bacterial Vaginosis When oral clindamycin is used as an alternative regimen for the treatment of bacterial vaginosis in nonpregnant women, the US Centers for Disease Control and Prevention (CDC) and other clinicians recommend a dosage of 300 mg twice daily for 7 days. The same dosage is recommended by the CDC and others when oral clindamycin is used for the treatment of bacterial vaginosis in pregnant women.

Prevention of Bacterial Endocarditis

For prophylaxis of bacterial endocarditis in penicillin-allergic patients at high or moderate risk who are undergoing certain dental procedures or upper respiratory tract surgery or instrumentation (see Uses: Prevention of Bacterial Endocarditis), the American Heart Association (AHA), American Dental Association (ADA), and others currently recommend that adults receive a single 600-mg dose of clindamycin and that children receive a single 20-mg/kg dose of the drug 1 hour before the procedure.Pediatric dosage should not exceed adult dosage.

Toxoplasmosis

For long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis in patients with human immunodeficiency virus (HIV) infection when the regimen of first choice (pyrimethamine and sulfadiazine) cannot be used.

Prevention of Opportunistic Infections

Working Group of the US Public Health Service and the Infectious Diseases Society of America (USPHS/IDSA) recommends that adults and adolescents receive oral clindamycin in a dosage of 300-450 mg given every 6-8 hours with pyrimethamine (25-50 mg once daily) and leucovorin (10-25 mg once daily). For long-term suppressive therapy to prevent relapse of toxoplasmosis in HIV-infected infants and children, the USPHS/IDSA recommends an oral clindamycin dosage of 20-30 mg/kg daily given in 4 divided doses with oral pyrimethamine (1 mg/kg once daily) and oral leucovorin (5 mg once every 3 days).

Long-term suppressive therapy for prophylaxis against relapse of toxoplasmosis in HIV-infected individuals generally is continued for life, unless immune recovery has occurred as the result of potent antiretroviral therapy.

Acne In adults, inflammatory acne vulgaris has been treated with 150 mg of oral clindamycin twice daily.

Malaria

If clindamycin is used in conjunction with quinine sulfate for the treatment of uncomplicated chloroquine-resistant Plasmodium falciparum malaria, some clinicians recommend that adults receive a regimen of 900 mg of clindamycin 3 times daily for 5 days with oral quinine sulfate (650 mg every 8 hours for 3-7 days). Children should receive clindamycin in a dosage of 20-40 mg/kg daily given in 3 divided doses for 5 days with oral quinine sulfate (25 mg/kg daily given in 3 divided doses for 3-7 days). In areas where relative resistance to quinine has been reported (e.g. Southeast Asia), quinine therapy should be continued for 7 days.

Pharyngitis and Tonsillitis

If oral clindamycin is used for the treatment of symptomatic patients who have multiple, recurrent episodes of pharyngitis known to be caused by Streptococcus pyogenes (group A b-hemolytic streptococci), the Infectious Diseases Society of America (IDSA) recommends that children receive a 10-day regimen of oral clindamycin in a dosage of 20-30 mg/kg daily given in 3 divided doses.

 

Adults should receive a 10-day regimen of oral clindamycin in a dosage of 600 mg daily given in 2-4 divided doses; the IDSA states that this dosage has not been specifically studied in adults and was extrapolated from the pediatric dosage.

Parenteral Dosage

General Adult Dosage

The usual adult IM or IV dosage of clindamycin is 600 mg to 2.7 g daily administered in 2-4 equally divided doses, depending on the type and severity of infection. 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. In the treatment of life-threatening infections, the adult IV dosage may be increased to a maximum of 4.8 g daily.

To maintain serum clindamycin concentrations of 4-5 mcg/mL in adults, clindamycin may be infused IV at an initial rate of 10 mg/minute for 30 minutes followed by continuous IV infusion at a rate of 0.75 mg/minute. Alternatively, initial IV infusion of the drug at a rate of 15 mg/minute for 30 minutes followed by continuous IV infusion at 1 mg/minute will maintain serum concentrations of 5-6 mcg/mL, or initial IV infusion at a rate of 20 mg/minute for 30 minutes followed by continuous IV infusion at 1.25 mg/minute will maintain serum concentrations greater than 6 mcg/mL.

General Pediatric Dosage

The usual IM or IV dosage of clindamycin for children older than 1 month of age is 15-40 mg/kg daily administered in 3 or 4 equally divided doses, depending on the type and severity of infection. Alternatively, these children may receive 350-450 mg/m2 daily given in divided doses.

The American Academy of Pediatrics (AAP) recommends that neonates younger than 1 week of age receive IM or IV clindamycin in a dosage of 5 mg/kg every 12 if they weigh 2 kg or less or 5 mg/kg every 8 hours if they weigh more than 2 kg. Neonates 1-4 weeks of age should receive IM or IV clindamycin in a dosage of 5 mg/kg every 8 hours if they weigh 2 kg or less (5 mg/kg every 12 hours for those less than 1.2 kg) and 5-7. mg/kg every 6 hours if they weigh more than 2 kg.

Pelvic Inflammatory Disease

For the treatment of acute pelvic inflammatory disease (PID) when a parenteral regimen is indicated, adolescents and adults may receive 900 mg of clindamycin IV every 8 hours. Gentamicin sulfate should be administered IV or IM concomitantly; an initial IV or IM gentamicin dose of 2 mg/kg followed by 1.5 mg/kg every 8 hours is recommended in adolescents and adults with normal renal function; alternatively, single-daily dosing of gentamicin may be employed.

Dosage of gentamicin (dose and/or dosing interval) should be adjusted according to serum gentamicin concentrations. Both parenteral drugs can be discontinued after there is clinical improvement and therapy then continued with oral clindamycin in a dosage of 450 mg 4 times (every 6 hours) daily to complete 14 days of therapy. Alternatively, oral doxycycline (100 mg twice daily) can be given to complete 14 days of therapy.

Patients with PID who do not demonstrate substantial clinical improvement (e.g., defervescence; reduction in direct or rebound abdominal tenderness; reduction in uterine, adnexal, and cervical motion tenderness) within 72 hours of initiating oral or parenteral therapy usually require additional diagnostic tests and/or surgical intervention.

Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia

If a regimen of clindamycin and primaquine is used for the treatment of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia, some clinicians recommend that adults receive clindamycin in a dosage of 600 mg IV every 6 hours (or 300-450 mg orally every 6 hours) for 21 days in conjunction with oral primaquine (30 mg once daily for 21 days).

Prevention of Perinatal Group B Streptococcal Disease

If clindamycin is used for intrapartum anti-infective prophylaxis to prevent perinatal group B streptococcal (GBS) disease in women with penicillin hypersensitivity who should not receive a b-lactam anti-infective, the CDC recommends that 900 mg of clindamycin be given IV every 8 hours until delivery. When indicated, such prophylaxis is initiated at the time of labor or rupture of membranes.

Streptococcus agalactiae (group B streptococci) with resistance to clindamycin have been reported with increasing frequency. Therefore, clinical isolates obtained during GBS prenatal screening should be tested for in vitro susceptibility to clindamycin whenever use of the drug is being considered for prevention of perinatal GBS disease in women hypersensitive to penicillin. (See Uses: Prevention of Perinatal Group B Streptococcal Disease.)

Prevention of Bacterial Endocarditis

When a parenteral regimen is used for prophylaxis of bacterial endocarditis in penicillin-allergic patients at high or moderate risk who are undergoing certain dental procedures or upper respiratory tract surgery or instrumentation (see Uses: Bacterial Endocarditis), the AHA, ADA, and others currently recommend that adults receive a single 600-mg dose of clindamycin and that children receive a single 20-mg/kg dose administered IV within 30 minutes before the procedure. Pediatric dosage should not exceed adult dosage.

Perioperative Prophylaxis

If clindamycin is used for perioperative prophylaxis in patients undergoing head and neck surgery, some clinicians recommend a dose of 600-900 mg of clindamycin IV in conjunction with IV gentamicin 1.5 mg/kg immediately prior to surgery; this may be repeated if surgery is prolonged or major blood loss occurs. Postoperative doses of prophylactic drugs generally are unnecessary. Other clinicians recommend a dose of 600 mg (15 mg/kg for children) IV in conjunction with IV gentamicin 1.7 mg/kg at the time of induction of anesthesia and repeated twice at 8-hour intervals for a total of 3 doses. For prophylaxis following contaminated or dirty surgery such as surgery involving a perforated abdominal viscus, some clinicians suggest that 600 mg of clindamycin be given IV every 6 hours in conjunction with 1.5 mg/kg of gentamicin IV every 8 hours. The regimen should be continued postoperatively for about 5 days and is considered treatment rather than prophylaxis.

Anthrax

Although the optimum regimen for the treatment of inhalational anthrax remains to be established, several patients who developed inhalational anthrax in the context of an intentional release of anthrax spores (biologic warfare, bioterrorism) were treated successfully with a multiple-drug regimen that included IV clindamycin (900 mg every 8 hours), IV ciprofloxacin (400 mg every 8 hours), and IV rifampin (300 mg every 12 hours).

Babesiosis

For the treatment of babesiosis caused by Babesia microti, some clinicians recommend that adults receive a regimen of clindamycin given in a dosage of 1.2 g IV twice daily or 600 mg orally 3 times daily for 7-10 days in conjunction with oral quinine in a dosage of 650 mg 3 times daily for 7 days. For pediatric patients with babesiosis, some clinicians recommend a clindamycin dosage of 20-40 mg/kg daily given in 3 divided doses for 7 days in conjunction with oral quinine in a dosage of 25 mg/kg daily given in 3 divided doses for 7 days.

Dosage in Renal and Hepatic Impairment

Although reduced clindamycin dosage may be required in patients with severe renal or hepatic impairment, modification of dosage is not necessary in those with mild or moderate renal or hepatic disease.

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