Download Clindamycin Basics Clinical Pharmacology

Clindamycin
Basics
U.S. Brand Names
Cleocin HCl®; Cleocin Pediatric®; Cleocin Phosphate®; Cleocin T®; Cleocin®; Cleocin® Vaginal Ovule; Clindagel®;
ClindaMax®; ClindaReach®; Clindesse®; Evoclin®
Medication Safety Issues
Sound-alike/look-alike issues:
Cleocin® may be confused with bleomycin, Clinoril®, Cubicin®, Lincocin®
Clindamycin may be confused with clarithromycin, Claritin®, vancomycin
Generic Available
Yes: Excludes foam, vaginal suppositories
Pharmacologic Category
Antibiotic, Lincosamide, Topical Skin Product, Acne
Lincosamide Antibiotic; Acne Product, Topical
Related Terms
Clindamycin Hydrochloride; Clindamycin Palmitate; Clindamycin Phosphate
Clinical Pharmacology
Mechanism of Action
Reversibly binds to 50S ribosomal subunits preventing peptide bond formation thus inhibiting bacterial protein synthesis;
bacteriostatic or bactericidal depending on drug concentration, infection site, and organism
Pharmacokinetics
Absorption: Topical solution, phosphate: Minimal; Oral, hydrochloride: Rapid (90%); Vaginal cream, phosphate: ~5%; Vaginal
suppository, phosphate: ~30%
Distribution: High concentrations in bone and urine; no significant levels in CSF, even with inflamed meninges
Vd: ~2 L/kg
Metabolism: Hepatic; forms metabolites (variable activity); Clindamycin phosphate is converted to clindamycin HCl (active)
Half-life elimination: Neonates: Premature: 8.7 hours; Full-term: 3.6 hours; Children: ~2 hours; Adults: ~2-3 hours; Elderly
4 hours (range: 3.4-5.1 hours); Vaginal cream: 1.5-2.6 hours following repeated dosing; Vaginal suppository: 11 hours
(range: 4-35 hours, limited by absorption rate)
Time to peak, serum: Oral: Within 60 minutes; I.M.: 1-3 hours; Vaginal cream: ~10-14 hours (range: 4-24 hours); Vaginal
suppository: ~5 hours (range: 1-10 hours)
Excretion: Urine (10%) and feces (~4%) as active drug and metabolites
Indications & Usage
Use
Treatment of susceptible bacterial infections, mainly those caused by anaerobes, streptococci, pneumococci, and
staphylococci; bacterial vaginosis (vaginal cream, vaginal suppository); pelvic inflammatory disease (I.V.); topically in
treatment of severe acne; vaginally for Gardnerella vaginalis
Use: Unlabeled/Investigational
May be useful in PCP; alternate treatment for toxoplasmosis; bacterial vaginosis (oral)
Contraindications
Hypersensitivity to clindamycin, lincomycin, or any component of the formulation
Topical and vaginal products: Additional contraindications: Previous pseudomembranous colitis, regional enteritis, ulcerative
colitis
Warnings/Precautions
Boxed warnings:
• Colitis: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Colitis: [U.S. Boxed Warning]: Can cause severe and possibly fatal colitis. Prolonged use may result in fungal or
bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has
been observed >2 months postantibiotic treatment. Use with caution in patients with a history of gastrointestinal
disease. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; monitor hepatic enzymes periodically as
dosage adjustments may be necessary in patients with severe impairment.
Special populations:
• Atopic patients: Use with caution in atopic patients.
Dosage form specific issues:
• Benzyl alcohol: Some products may contain benzyl alcohol which has been associated with "gasping syndrome" in
neonates.
• Tartrazine: Some products may contain tartrazine, which may cause allergic reactions in certain individuals.
• Vaginal products: May weaken condoms, or contraceptive diaphragms; barrier contraceptives are not recommended
concurrently or for 3-5 days (depending on the product) following treatment.
Pregnancy & Lactation
Pregnancy Risk Factor
B
Pregnancy Implications
Because adverse effects were not observed in animals, clindamycin is classified as pregnancy category B. Clindamycin crosses
the placenta throughout pregnancy and at term, but use during pregnancy has not been shown to cause adverse fetal effects.
Clindamycin pharmacokinetics are not affected by pregnancy. Clindamycin therapy is recommended in certain pregnant
patients for prophylaxis of group B streptococcal disease in newborns, prophylaxis and treatment of Toxoplasma gondii
encephalitis, or for the treatment of Pneumocystis pneumonia (PCP), bacterial vaginosis, or malaria.
Lactation
Enters breast milk/not recommended
Adverse Reactions
Systemic: Frequency not defined:
Cardiovascular: Cardiac arrest (rare; I.V. administration), hypotension (rare; I.V. administration)
Dermatologic: Erythema multiforme (rare), exfoliative dermatitis (rare), pruritus, rash, Stevens-Johnson syndrome (rare),
urticaria
Gastrointestinal: Abdominal pain, diarrhea, esophagitis, nausea, pseudomembranous colitis, vomiting
Genitourinary: Vaginitis
Hematologic: Agranulocytosis, eosinophilia (transient), neutropenia (transient), thrombocytopenia
Hepatic: Jaundice, liver function test abnormal
Local: Induration/pain/sterile abscess (I.M.), thrombophlebitis (I.V.)
Neuromuscular & skeletal: Polyarthritis (rare)
Renal: Renal dysfunction (rare)
Miscellaneous: Anaphylactoid reactions (rare)
Topical:
>10%: Dermatologic: Dryness, burning, itching, scaliness, erythema, or peeling of skin (lotion, solution); oiliness (gel, lotion)
<1% (Limited to important or life-threatening): Pseudomembranous colitis, nausea, vomiting, diarrhea (severe), abdominal
pain, folliculitis, hypersensitivity reactions
Vaginal:
>10%: Genitourinary: Vaginal candidiasis (≤13%), vulvovaginal pruritus (from Candida albicans)
1% to 10%:
Dermatologic: Pruritus (≤1%)
Genitourinary: Vulvovaginal disorder (3% to 7%), vulvovaginitis (4% to 6%), vaginal pain (≤2%), trichomonal vaginitis
(1%)
Miscellaneous: Fungal infection (1% to 2%)
<1% (Limited to important or life-threatening): Abdominal cramps, allergic reaction, atrophic vaginitis, bacterial infection,
diarrhea, dizziness, dysuria, endometriosis, epistaxis, erythema, fever, hypersensitivity, hyperthyroidism, local edema,
menstrual disorder, metrorrhagia, nausea, pain, pruritus, pyelonephritis, rash, urinary tract infection, urticaria, vaginal
burning, vertigo, vomiting
Interactions
Drug Interactions
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Erythromycin: May diminish the therapeutic effect of Lincosamide Antibiotics. Risk X: Avoid combination
Erythromycin (Systemic): Lincosamide Antibiotics may diminish the therapeutic effect of Erythromycin (Systemic). Risk X:
Avoid combination
Kaolin: May decrease the absorption of Lincosamide Antibiotics. Risk D: Consider therapy modification
Neuromuscular-Blocking Agents: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of NeuromuscularBlocking Agents. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is
affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being
treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 24 hours after cessation
of antibacterial agents. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Peak concentrations may be delayed with food.
Herb/Nutraceutical: St John's wort may decrease clindamycin levels.
Dosing
Dosing: Adults
Usual dose:
Oral: 150-450 mg/dose every 6-8 hours; maximum dose: 1.8 g/day
I.M., I.V.: 1.2-2.7 g/day in 2-4 divided doses; maximum dose: 4.8 g/day
Acne: Topical:
Gel, pledget, lotion, solution: Apply a thin film twice daily
Foam (Evoclin®): Apply once daily
Amnionitis:I.V.: 450-900 mg every 8 hours
Anthrax:I.V.: 900 mg every 8 hours with ciprofloxacin or doxycycline
Babesiosis (unlabeled use):
Oral: 600 mg 3 times/day for 7 days with quinine
I.V.: 1.2 g twice daily for 7 days with quinine
Bacterial vaginosis:Intravaginal:
Suppositories: Insert one ovule (100 mg clindamycin) daily into vagina at bedtime for 3 days
Cream:
Cleocin®: One full applicator inserted intravaginally once daily before bedtime for 3 or 7 consecutive days in nonpregnant
patients or for 7 consecutive days in pregnant patients
Clindesse®: One full applicator inserted intravaginally as a single dose at anytime during the day in nonpregnant patients
Bite wounds (canine):Oral: 300 mg 4 times/day with a fluoroquinolone
Gangrenous pyomyositis:I.V.: 900 mg every 8 hours with penicillin G
Group B streptococcus (neonatal prophylaxis):I.V.: 900 mg every 8 hours until delivery
Orofacial/parapharyngeal space infections:
Oral: 150-450 mg every 6 hours for at least 7 days; maximum dose: 1.8 g/day
I.V.: 600-900 mg every 8 hours
Pelvic inflammatory disease: I.V.: 900 mg every 8 hours with gentamicin 2 mg/kg, then 1.5 mg/kg every 8 hours;
continue after discharge with doxycycline 100 mg twice daily to complete 14 days of total therapy
Pneumonia due toPneumocystis jiroveci(unlabeled use): I.V.: 600 mg every 8 hours with primaquineor pentamidine for
21 days
Prophylaxis against infective endocarditis (unlabeled use):
Oral: 600 mg 1 hour before procedure with no follow-up dose needed
I.M., I.V.: 600 mg within 30 minutes before procedure. Intramuscular injections should be avoided in patients who are
receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever
possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral
medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive
procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should
infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Toxic shock syndrome:I.V.: 900 mg every 8 hours with penicillin G or ceftriaxone
Toxoplasmosis (unlabeled use):Oral, I.V.: 600 mg every 6 hours with pyrimethamine and leucovorin calcium
Dosing: Elderly
Refer to adult dosing.
Dosing: Pediatric
Usual dose:
Oral: Infants and Children: 8-20 mg/kg/day as hydrochloride; 8-25 mg/kg/day as palmitate in 3-4 divided doses;
minimum dose of palmitate: 37.5 mg 3 times/day
I.M., I.V.:
<1 month: 15-20 mg/kg/day in 3-4 divided doses
>1 month: 20-40 mg/kg/day in 3-4 divided doses
Anthrax:I.V.: 7.5 mg/kg every 6 hours
Prophylaxis against infective endocarditis (unlabeled use):
Oral: 20 mg/kg 1 hour before procedure with no follow-up dose needed
I.M., I.V.: 20 mg/kg within 30 minutes before procedure. Intramuscular injections should be avoided in patients who are
receiving anticoagulant therapy. In these circumstances, orally administered regimens should be given whenever
possible. Intravenously administered antibiotics should be used for patients who are unable to tolerate or absorb oral
medications.
Note: American Heart Association (AHA) guidelines now recommend prophylaxis only in patients undergoing invasive
procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should
infection occur. As of April 2007, routine prophylaxis for GI/GU procedures is no longer recommended by the AHA.
Orofacial infections:
Oral: 10-20 mg/kg/day in 3-4 equally divided doses
I.V.: 15-25 mg/kg/day in 3-4 equally divided doses
Acne: Topical: Children ≥12 years: Refer to adult dosing.
Babesiosis (unlabeled use): Oral: 20-40 mg/kg divided every 8 hours for 7 days plus quinine
Toxoplasmosis (HIV-exposed/-positive; secondary prevention [unlabeled use]): Oral: 20-30 mg/kg/day divided
every 6-8 hours plus pyrimethamine and leucovorin (CDC, 2009)
Dosing: Renal Impairment
No adjustment required.
Dosing: Hepatic Impairment
Systemic use: Adjustment is recommended in patients with severe hepatic disease.
Available Products
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] =
Discontinued product
Note: Strength is expressed as base
Aerosol, topical, as phosphate [foam]:
Evoclin®: 1% (50 g, 100 g) [contains ethanol 58%]
Capsule, as hydrochloride: 75 mg, 150 mg, 300 mg
Cleocin HCl®: 75 mg [contains tartrazine], 150 mg [contains tartrazine], 300 mg
Cream, vaginal, as phosphate: 2% (40 g)
Cleocin®: 2% (40 g) [contains benzyl alcohol and mineral oil; packaged with 7 disposable applicators]
ClindaMax®: 2% (40 g) [contains benzyl alcohol and mineral oil; packaged with 7 disposable applicators] [DSC]
Clindesse®: 2% (5 g) [contains mineral oil; prefilled single disposable applicator]
Gel, topical, as phosphate: 1% (30 g, 60 g)
Cleocin T®: 1% (30 g, 60 g)
Clindagel®: 1% (40 mL, 75 mL)
ClindaMax®: 1% (30 g, 60 g)
Granules for oral solution, as palmitate hydrochloride: 75 mg/5 mL (100 mL)
Cleocin Pediatric®: 75 mg/5 mL (100 mL) [cherry flavor]
Infusion, as phosphate [premixed in D5W]:
Cleocin Phosphate®: 300 mg (50 mL); 600 mg (50 mL); 900 mg (50 mL) [contains edetate disodium]
Injection, solution, as phosphate: 150 mg/mL (2 mL, 4 mL, 6 mL, 60 mL)
Cleocin Phosphate®: 150 mg/mL (2 mL, 4 mL, 6 mL, 60 mL) [contains benzyl alcohol and edetate disodium]
Lotion, as phosphate: 1% (60 mL)
Cleocin T®, ClindaMax®: 1% (60 mL)
Pledgets, topical: 1% (60s, 69s)
Cleocin T®: 1% (60s) [contains isopropyl alcohol 50%]
ClindaReach®: 1% (120s) [contains isopropyl alcohol 50%; packaged as a kit containing 1 collapsible applicator, 64
appliques, and 64 unmedicated pads]
Solution, topical, as phosphate: 1% (30 mL, 60 mL)
Cleocin T®: 1% (30 mL, 60 mL) [contains isopropyl alcohol 50%]
Suppository, vaginal, as phosphate:
Cleocin® Vaginal Ovule: 100 mg (3s) [contains oleaginous base; single reusable applicator]
Administration
Administration, Oral
May administer with meals to decrease GI upset. Administer with at least 8 ounces of water and have patient sit up for at
least 30 minutes after taking to reduce the risk of esophageal irritation and ulceration. Give around-the-clock to promote less
variation in peak and trough serum levels.
Administration, I.M.
Deep I.M. sites, rotate sites. Do not exceed 600 mg in a single injection.
Administration, I.V.
Never administer as bolus; administer by I.V. intermittent infusion over at least 10-60 minutes, at a rate not to exceed 30
mg/minute (do not exceed 1200 mg/hour). Final concentration for administration should not exceed 18 mg/mL.
Administration, I.V. Detail
pH: 6.0-6.3 (usual); 5.5-7.0 (range)
Administration, Topical
Foam: Dispense directly into cap or onto a cool surface. Do not dispense directly into hands.
Administration, Other
Intravaginal:
Cream: Insertion should be as far as possible into the vagina without causing discomfort.
Ovule: The foil should be removed; if the applicator is used for insertion, it should be washed for additional use.
Storage & Compatibility
Storage
Capsule: Store at room temperature of 20°C to 25°C (68°F to 77°F).
Cream: Store at room temperature.
Foam: Store at room temperature of 20°C to 25°C (68°F to 77°F). Avoid fire, flame, or smoking during or following
application.
Gel: Store at room temperature.
Clindagel®: Do not store in direct sunlight.
I.V.: Infusion solution in NS or D5W solution is stable for 16 days at room temperature, 32 days refrigerated, or 8 weeks
frozen. Prior to use, store vials and premixed bags at controlled room temperature 20°C to 25°C (68°F to 77°F). After
initial use, discard any unused portion of vial after 24 hours.
Lotion: Store at room temperature of 20°C to 25°C (68°F to 77°F).
Oral solution: Do not refrigerate reconstituted oral solution (it will thicken). Following reconstitution, oral solution is stable for
2 weeks at room temperature of 20°C to 25°C (68°F to 77°F).
Ovule: Store at room temperature of 15°C to 30°C (68°F to 77°F).
Pledget: Store at room temperature.
Topical solution: Store at room temperature of 20°C to 25°C (68°F to 77°F).
I.V. Compatibility
Stable in D5R, D51/2NS, D5NS, D5W, D10W, LR, NS; variable stability (consult detailed reference) in peritoneal dialysis
solutions.
Y-site administration: Compatible: Acyclovir, amifostine, amiodarone, amphotericin B cholesteryl sulfate complex,
amsacrine, anakinra, aztreonam, bivalirudin, cefpirome sulfate, cisatracurium, cyclophosphamide, dexmedetomidine,
diltiazem, docetaxel, doxorubicin liposome, enalaprilat, esmolol, etoposide, fenoldopam, fludarabine, foscarnet,
gatifloxacin, gemcitabine, granisetron, heparin, hydromorphone, labetalol, levofloxacin, linezolid, magnesium sulfate,
melphalan, meperidine, midazolam, milrinone, morphine, multivitamins, nicardipine, ondansetron, pemetrexed,
perphenazine, piperacillin/tazobactam, propofol, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa,
vinorelbine, vitamin B complex with C, zidovudine. Incompatible: Allopurinol, azithromycin, doxapram, filgrastim,
fluconazole, idarubicin. Variable (consult detailed reference): Drotrecogin alfa.
Compatibility in syringe: Compatible: Amikacin, aztreonam, caffeine citrate, dimenhydrinate, gentamicin, heparin.
Incompatible: Pantoprazole, tobramycin.
Compatibility when admixed: Compatible: Amikacin, ampicillin, aztreonam, cefamandole, cefazolin, cefepime, cefotaxime,
cefoxitin, ceftazidime, ceftizoxime, cefuroxime, cimetidine, fluconazole, gentamicin, heparin, hydrocortisone sodium
succinate, kanamycin, methylprednisolone sodium succinate, metoclopramide, metronidazole, metronidazole with sodium
bicarbonate, ofloxacin, penicillin G, piperacillin, potassium chloride, sodium bicarbonate, tobramycin, verapamil, vitamin B
complex with C. Incompatible: Aminophylline, ampicillin, barbiturates, calcium gluconate, ceftriaxone, ciprofloxacin,
gentamicin with cefazolin, magnesium sulfate, phenytoin. Variable (consult detailed reference): Ranitidine.
Monitoring
Monitoring Parameters
Observe for changes in bowel frequency. Monitor for colitis and resolution of symptoms. During prolonged therapy monitor
CBC, liver and renal function tests periodically.
Breast-Feeding Considerations
Small amounts of clindamycin transfer to human milk. Although the manufacturer does not recommend the use of clindamycin
during breast-feeding, the American Academy of Pediatrics considers clindamycin to be "usually compatible with breastfeeding." Nondose-related effects could include modification of bowel flora. There has been one published case of bloody
stools in a nursing infant, but a causal relationship was not proven.
Patient Education
I.M., I.V.: Report any burning, pain, swelling, or redness at infusion or injection site.
Oral: Take each dose with a full glass of water. Complete full prescription, even if feeling better. You may experience nausea
or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report dizziness;
persistent GI effects (pain, diarrhea, vomiting); skin redness, rash, or burning; fever; chills; unusual bruising or bleeding;
signs of infection; excessive fatigue; yellowing of eyes or skin; change in color of urine or blackened stool; swelling, warmth,
or pain in extremities; difficult respirations; bloody or fatty stool (do not take antidiarrheal without consulting prescriber); or
lack of improvement or worsening of condition.
Topical, foam: Wash hands thoroughly or wear gloves. Do not dispense directly onto hands or face (foam will begin to melt on
contact with warm skin). Dispense an amount the will cover the affected area directly into the cap or onto a cool surface. If
can seems warm or foam seems runny, run can under cold water. Pick up small amounts of foam with fingertips and gently
massage into affected areas until foam disappears. Wash hands thoroughly. Wait 30 minutes before shaving or applying
make-up.
Topical gel, lotion, or solution: Wash hands thoroughly before applying or wear gloves. Apply thin film of gel, lotion, or
solution to affected area. May apply porous dressing. Wash hands thoroughly. Wait 30 minutes before shaving or applying
make-up. Report persistent burning, swelling, itching, excessive dryness, or worsening of condition.
Vaginal: Wash hands before using. At bedtime: If using applicator, gently insert full applicator into vagina and expel cream.
Wash applicator with soap and water following use. If using suppository, insert high into vagina. Remain lying down for 30
minutes following administration. Avoid intercourse during therapy. Report adverse reactions (dizziness, nausea, vomiting,
stomach cramps, or headache) or lack of improvement or worsening of condition.
Dietary Implications
May be taken with food.
View the Patient Handout: English | Spanish
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