Clindamycin Phosphate and Sapropterin Powder for Oral Solution

• Generic Name: clindamycin
• Dosage Forms: n.a.
• Other Brand Names:

  Cleocin HCl, Cleocin Pediatric, Cleocin Phosphate, Cleocin Phosphate ADD-Vantage, Clindesse, ClindaMax Vaginal, Cleocin

Acute Otitis Media (AOM)

Alternative for treatment of AOM.

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of first choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.

AAP states clindamycin (with or without a third generation cephalosporin) is a possible alternative for treatment of AOM in patients who fail to respond to initial treatment with first-line or preferred alternatives.

May be effective in infections caused by penicillin-resistant Streptococcus pneumoniae; may not be effective against multidrug-resistant S. pneumoniae and usually inactive against Haemophilus influenzae. If used for retreatment of AOM, consider concomitant use of an anti-infective active against H. influenzae and Moraxella catarrhalis (e.g., cefdinir, cefixime, cefuroxime).

Bone and Joint Infections

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

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

Gynecologic Infections

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

Treatment of pelvic inflammatory disease (PID); used in conjunction with other anti-infectives. When a parenteral regimen is indicated for treatment of PID, IV clindamycin in conjunction with IV or IM gentamicin is one of several recommended regimens.

Intra-abdominal Infections

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

No longer routinely recommended for treatment of intra-abdominal infections because of increasing incidence of Bacteroides fragilis resistant to clindamycin.

Pharyngitis and Tonsillitis

Alternative for treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci; GAS) in patients who cannot receive β-lactam anti-infectives.

AAP, IDSA, and AHA recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis; other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.

Respiratory Tract Infections

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

IDSA and ATS consider clindamycin an alternative for treatment of community-acquired pneumonia (CAP) caused by S. pneumoniae or S. aureus (methicillin-susceptible strains) in adults. IDSA also considers clindamycin an alternative for treatment of CAP caused by S. pneumoniae, S. pyogenes, or S. aureus in pediatric patients. For treatment of pneumonia caused by methicillin-resistant S. aureus (MRSA; also known as oxacillin-resistant S. aureus or ORSA), IDSA states clindamycin is one of several options, unless the strain is resistant to clindamycin.

Septicemia

Treatment of serious septicemia caused by S. aureus, streptococci, or anaerobes.

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible staphylococci, S. pneumoniae, other streptococci, or anaerobes. One of several preferred drugs for treatment of staphylococcal and streptococcal skin and skin structure infections, including those known or suspected to be caused by susceptible MRSA.

Treatment of clostridial myonecrosis (gas gangrene) caused by Clostridium perfringens or other Clostridium; used in conjunction with or as alternative to penicillin G.

Alternative for treatment of infected human or animal (e.g., dog, cat, reptile) bite wounds; used in conjunction with either an extended-spectrum cephalosporin or co-trimoxazole. Purulent bite wounds usually are polymicrobial and broad-spectrum anti-infective coverage recommended. Nonpurulent infected bite wounds usually caused by staphylococci and streptococci, but can be polymicrobial.

Actinomycosis

Alternative to penicillin G or ampicillin for treatment of actinomycosis, including infections caused by Actinomyces israelii.

Anthrax

Alternative for treatment of anthrax.

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. 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); if meningitis is established or suspected, use IV ciprofloxacin (rather than doxycycline) and chloramphenicol, rifampin, or penicillin.

Based on in vitro data, possible alternative for postexposure prophylaxis following a suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax) when drugs of choice (ciprofloxacin, doxycycline) not tolerated or cannot be used.

Babesiosis

Treatment of babesiosis caused by Babesia microti or other Babesia.

Regimens of choice for babesiosis are clindamycin in conjunction with quinine or atovaquone in conjunction with azithromycin. Clindamycin and quinine regimen generally preferred for severe babesiosis caused by B. microti and infections caused by M. divergens, B. duncani, B. divergens-like organisms, or B. venatorum.

Also consider exchange transfusions in severely ill patients with high levels of parasitemia (>10%), significant hemolysis, or compromised renal, hepatic, or pulmonary function.

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis).

CDC and others recommend treatment of bacterial vaginosis in all symptomatic women (including pregnant women).

Regimens of choice are 7-day regimen of oral metronidazole; 5-day regimen of intravaginal metronidazole gel; or 7-day regimen of intravaginal clindamycin cream. Alternative regimens are 2- or 5-day regimen of oral tinidazole; 7-day regimen of oral clindamycin; or 3-day regimen of intravaginal clindamycin suppositories. Preferred regimens for pregnant women are the oral or intravaginal metronidazole or clindamycin regimens.

Regardless of treatment regimen used, relapse or recurrence is common; retreatment with the same or an alternative regimen (e.g., oral therapy when topical was used initially) may be used in such situations.

Malaria

Treatment of uncomplicated malaria caused by chloroquine-resistant Plasmodium falciparum or when plasmodial species not identified. Used in conjunction with oral quinine; not effective alone.

CDC and others state treatments of choice for uncomplicated chloroquine-resistant P. falciparum malaria or when plasmodial species not identified are the fixed combination of atovaquone and proguanil hydrochloride (atovaquone/proguanil); the fixed combination of artemether and lumefantrine (artemether/lumefantrine); or a regimen of oral quinine in conjunction with doxycycline, tetracycline, or clindamycin. When a quinine regimen used, concomitant doxycycline or tetracycline generally preferred over concomitant clindamycin (more efficacy data available regarding regimens that include a tetracycline); clindamycin preferred in young children or pregnant women who should not receive tetracyclines.

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 tolerated. Severe malaria requires aggressive antimalarial treatment initiated as soon as possible after diagnosis.

Assistance with diagnosis or treatment of malaria is available from CDC Malaria Hotline at 770-488-7788 or 855-856-4713 from 9:00 a.m. to 5:00 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours and on weekends and holidays.

Pneumocystis jirovecii Pneumonia

Treatment of Pneumocystis jirovecii (formerly Pneumocystis carinii) pneumonia (PCP); used in conjunction with primaquine. Designated an orphan drug by FDA for treatment of PCP associated with acquired immunodeficiency syndrome (AIDS).

Co-trimoxazole is drug of choice for treatment of mild, moderate, or severe PCP, including PCP in HIV-infected adults, adolescents, and children. Regimen of primaquine and clindamycin is an alternative for treatment of mild, moderate, or severe PCP in HIV-infected adults and adolescents who have had an inadequate response to co-trimoxazole or when co-trimoxazole is contraindicated or not tolerated. Although data not available regarding use in children, regimen of primaquine and clindamycin also can be considered an alternative to co-trimoxazole in HIV-infected children based on data in adults.

Regimen of primaquine and clindamycin not recommended for prevention of initial episodes (primary prophylaxis) or long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP. Co-trimoxazole is drug of choice for primary and secondary prophylaxis of PCP in HIV-infected adults, adolescents, and children.

Toxoplasmosis

Alternative for treatment of toxoplasmosis caused by Toxoplasma gondii in immunocompromised adults, adolescents, and children (including HIV-infected patients); used in conjunction with pyrimethamine (and leucovorin). CDC, NIH, IDSA, and AAP recommend pyrimethamine (and leucovorin) used in conjunction with sulfadiazine as regimen of choice for initial treatment of toxoplasmosis in HIV-infected adults and adolescents, treatment of congenital toxoplasmosis, and treatment of acquired CNS, ocular, or systemic toxoplasmosis in HIV-infected children. Pyrimethamine (and leucovorin) used in conjunction with clindamycin is the preferred alternative in those unable to tolerate sulfadiazine or who fail to respond to initial regimen.

Alternative for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of toxoplasmosis in HIV-infected adults, adolescents, and children who have completed treatment for the disease; used in conjunction with pyrimethamine and leucovorin. Pyrimethamine (and leucovorin) used in conjunction with sulfadiazine is regimen of choice for secondary prophylaxis. Pyrimethamine (and leucovorin) used in conjunction with clindamycin is one of several alternatives in those who cannot tolerate sulfonamides.

Perioperative Prophylaxis

Alternative for perioperative prophylaxis to reduce the incidence of infections in patients undergoing certain clean, contaminated surgeries when drugs of choice (e.g., cefazolin, cefuroxime, cefoxitin, cefotetan) cannot be used because of hypersensitivity to β-lactam anti-infectives.

Experts state clindamycin or vancomycin is a reasonable alternative for perioperative prophylaxis in patients allergic to β-lactam anti-infectives who are undergoing cardiac surgery (e.g., CABG, valve repairs, cardiac device implantation), neurosurgery (e.g., craniotomy, spinal and CSF-shunting procedures, intrathecal pump placement), orthopedic surgery (e.g., spinal procedures, hip fracture, internal fixation, total joint replacement), non-cardiac thoracic surgery (e.g., lobectomy, pneumonectomy, lung resection, thoracotomy), vascular surgery (e.g., arterial procedures involving a prosthesis, the abdominal aorta, or a groin incision), lower extremity amputation for ischemia, or certain transplant procedures (e.g., heart and/or lung). Clindamycin also a reasonable alternative for perioperative prophylaxis in such patients undergoing head and neck surgery (e.g., incisions through oral or pharyngeal mucosa).

For procedures that might involve exposure to enteric gram-negative bacteria, experts state that clindamycin or vancomycin used in conjunction with an aminoglycoside (e.g., amikacin, gentamicin, tobramycin), aztreonam, or a fluoroquinolone is a reasonable alternative in patients allergic to β-lactam anti-infectives. These procedures include certain GI and biliary tract procedures (e.g., esophageal or gastroduodenal procedures, appendectomy for uncomplicated appendicitis, surgery involving unobstructed small intestine, colorectal procedures), gynecologic and obstetric surgery (e.g., cesarean section, hysterectomy), urologic procedures involving an implanted prosthesis, and certain transplant procedures (e.g., liver, pancreas and/or kidney).

Prevention of Bacterial Endocarditis

Alternative to amoxicillin or ampicillin for prevention of α-hemolytic (viridans group) streptococcal bacterial endocarditis in penicillin-allergic patients 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) who have certain cardiac conditions that put them at highest risk of adverse outcomes from endocarditis.

Anti-infective prophylaxis solely for prevention of bacterial endocarditis no longer recommended by AHA for patients undergoing GU or GI procedures.

Cardiac conditions identified by AHA as associated with highest risk of adverse outcomes from endocarditis: Prosthetic cardiac valves or prosthetic material used for cardiac valve repair, previous infective endocarditis, certain forms of congenital heart disease, and cardiac valvulopathy after cardiac transplantation.

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

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 high risk for anaphylaxis if they receive a β-lactam anti-infective.

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 of gestation 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 of gestation, amniotic membrane rupture for ≥18 hours, or intrapartum temperature of ≥38°C.

Penicillin G is drug of choice and ampicillin is the preferred alternative for anti-infective prophylaxis of GBS. Cefazolin is recommended for GBS prophylaxis in penicillin-allergic women who do not have immediate-type penicillin hypersensitivity; clindamycin or, alternatively, vancomycin is recommended for such prophylaxis in penicillin-allergic women at high risk for anaphylaxis (e.g., history of anaphylaxis, angioedema, respiratory distress, or urticaria after receiving a penicillin or cephalosporin).

Consider that S. agalactiae (group B streptococci; GBS) with in vitro resistance to clindamycin has been reported with increasing frequency; perform in vitro susceptibility tests of clinical isolates obtained during GBS prenatal screening. GBS isolates susceptible to clindamycin but resistant to erythromycin in vitro should be evaluated for inducible clindamycin resistance. If GBS isolate is intrinsically resistant to clindamycin, demonstrates inducible resistance to clindamycin, or if susceptibility to clindamycin and erythromycin are unknown, use vancomycin instead of clindamycin for GBS prophylaxis.

Consult most recent CDC and AAP guidelines for additional information on prevention of perinatal GBS disease.

• Generic Name: sapropterin
• Dosage Forms: n.a.
• Other Brand Names: Kuvan

• It is used to treat phenylketonuria (PKU).