|
|
|
Pronunciation |
|
(klin
da MYE
sin) |
|
|
U.S. Brand
Names |
|
Cleocin-3®; Cleocin HCl®; Cleocin
Pediatric®; Cleocin Phosphate®; Cleocin T®;
Clinda-Derm® Topical Solution; Clindets® Pledgets;
C/T/S® Topical
Solution |
|
|
Generic
Available |
|
Yes: Injection |
|
|
Canadian Brand
Names |
|
Dalacin® C
[Hydrochloride] |
|
|
Synonyms |
|
Clindamycin Hydrochloride; Clindamycin Phosphate |
|
|
Pharmacological Index |
|
Antibiotic, Miscellaneous |
|
|
Use |
|
Dental: Alternate antibiotic, when amoxicillin cannot be used, for the
standard regimen for prevention of bacterial endocarditis in patients undergoing
dental procedures; an alternative to penicillin VK and erythromycin for treating
orofacial infections; alternate antibiotic for prophylaxis for dental patients
with total joint replacement
Medical: Treatment against aerobic and anaerobic streptococci (except
enterococci), most staphylococci, Bacteroides sp and
Actinomyces; used topically in treatment of severe acne, vaginally for
Gardnerella vaginalis or bacterial vaginosis; alternate treatment for
toxoplasmosis; prophylaxis in the prevention of bacterial endocarditis in
high-risk patients undergoing surgical or dental procedures in patients allergic
to penicillin; may be useful in PCP |
|
|
Pregnancy Risk
Factor |
|
B |
|
|
Contraindications |
|
Hypersensitivity to clindamycin or any component; previous pseudomembranous
colitis, hepatic impairment |
|
|
Warnings/Precautions |
|
Dosage adjustment may be necessary in patients with severe hepatic
dysfunction; can cause severe and possibly fatal colitis; use with caution in
patients with a history of pseudomembranous colitis; discontinue drug if
significant diarrhea, abdominal cramps, or passage of blood and mucus
occurs |
|
|
Adverse
Reactions |
|
>10%: Gastrointestinal: Diarrhea
1% to 10%:
Dermatologic: Rashes
Gastrointestinal: Pseudomembranous colitis (more common with oral form),
nausea, vomiting
<1%: Hypotension, urticaria, Stevens-Johnson syndrome, eosinophilia,
neutropenia, granulocytopenia, thrombocytopenia, elevated liver enzymes,
thrombophlebitis, sterile abscess at I.M. injection site, polyarthritis, rare
renal dysfunction |
|
|
Overdosage/Toxicology |
|
Symptoms of overdose include diarrhea, nausea, vomiting; following GI
decontamination
Treatment is supportive |
|
|
Drug
Interactions |
|
CYP3A3/4 enzyme substrate |
|
|
Stability |
|
Do not refrigerate reconstituted oral solution because it will
thicken; oral solution is stable for 2 weeks at room temperature following
reconstitution; I.V. infusion solution in NS or D5W solution is
stable for 16 days at room temperature |
|
|
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 |
|
|
Pharmacodynamics/Kinetics |
|
Absorption: ~10% of topically applied drug is absorbed systemically; 90%
absorbed rapidly from GI tract following oral administration
Distribution: No significant levels are seen in CSF, even with inflamed
meninges; crosses the placenta; distributes into breast milk; high
concentrations in bone and urine
Metabolism: Hepatic
Half-life: Neonates: Premature: 8.7 hours; Full-term: 3.6 hours; Adults:
1.6-5.3 hours, average: 2-3 hours
Time to peak serum concentration: Oral: Within 60 minutes; I.M.: Within 1-3
hours
Elimination: Most of drug eliminated by hepatic metabolism
|
|
|
Usual Dosage |
|
Avoid in neonates (contains benzyl alcohol)
Oral: 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
>1 month: 20-40 mg/kg/day in 3-4 divided doses
Children and Adults: Topical: Apply a thin film twice daily
Adults:
Oral: 150-450 mg/dose every 6-8 hours; maximum dose: 1.8 g/day
I.M., I.V.: 1.2-1.8 g/day in 2-4 divided doses; maximum dose: 4.8 g/day
Bacterial endocarditis prophylaxis: 600 mg 1 hour prior to the procedure
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 or oral clindamycin 450 mg 5 times/day for 10-14 days
Pneumocystis carinii pneumonia:
Oral: 300-450 mg 4 times/day with primaquine
I.M., I.V.: 1200-2400 mg/day with pyrimethamine
I.V.: 600 mg 4 times/day with primaquine
Vaginal: One full applicator (100 mg) inserted intravaginally once daily
before bedtime for 3 or 7 consecutive days
Intravaginal suppositories: Insert one ovule (100 mg clindamycin) daily into
vagina at bedtime for 3 days
Dosing adjustment in hepatic impairment: Adjustment recommended in
patients with severe hepatic disease |
|
|
Dietary
Considerations |
|
Peak concentrations may be delayed with food; may be taken with
food |
|
|
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 |
|
|
Mental Health: Effects
on Mental Status |
|
None reported |
|
|
Mental Health:
Effects on Psychiatric
Treatment |
|
May cause neutropenia; use caution with clozapine and
carbamazepine |
|
|
Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
|
|
Dental Health:
Effects on Dental Treatment |
|
No effects or complications reported |
|
|
Patient
Information |
|
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 gastrointestinal 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 or improvement or worsening of condition.
Topical: Wash hands before applying or wear gloves. Apply thin film of gel,
lotion, or solution to affected area. May apply porous dressing. Report
persistent burning, swelling, itching, or worsening of condition.
Vaginal: Wash hands before using. At bedtime, gently insert full applicator
into vagina and expel cream. Wash applicator with soap and water following use.
Remain lying down for 30 minutes following administration. Avoid intercourse
during 7 days of therapy. Report adverse reactions (dizziness, nausea, vomiting,
stomach cramps, or headache) or lack of improvement or worsening of condition.
|
|
|
Nursing
Implications |
|
Administer by I.V. intermittent infusion over at least 10-60 minutes, at a
rate not to exceed 30 mg/minute; final concentration for administration
should not exceed 12 mg/mL
Observe for changes in bowel frequency; during prolonged therapy monitor CBC,
liver and renal function tests periodically |
|
|
Dosage Forms |
|
Capsule, as hydrochloride: 75 mg, 150 mg, 300 mg
Cream, vaginal: 2% (40 g)
Gel, topical, as phosphate: 1% [10 mg/g] (7.5 g, 30 g)
Granules for oral solution, as palmitate: 75 mg/5 mL (100 mL)
Infusion, as phosphate, in D5W: 300 mg (50 mL); 600 mg (50 mL)
Injection, as phosphate: 150 mg/mL (2 mL, 4 mL, 6 mL, 50 mL, 60 mL)
Lotion: 1% [10 mg/mL] (60 mL)
Pledgets: 1%
Solution, topical, as phosphate: 1% [10 mg/mL] (30 mL, 60 mL, 480 mL)
Suppository, vaginal: 2.5 g (clindamycin 100 mg) |
|
|
References |
|
"Advisory Statement. Antibiotic Prophylaxis for Dental Patients With Total Joint Replacements. American Dental Association; American Academy of Orthopedic Surgeons,"
J Am Dent Assoc, 1997, 128(7):1004-8.
Dajani AS, Taubert KA, Wilson W, et al,
"Prevention of Bacterial Endocarditis. Recommendations by the American Heart Association,"
JAMA, 1997, 277(22):1794-801.
Falagas ME and Gorbach SL, "Clindamycin and Metronidazole," Med Clin North
Am, 1995, 79(4):845-67.
Katlama C, De Wit S, O'Doherty E, et al,
"Pyrimethamine-Clindamycin vs Pyrimethamine-Sulfadiazine as Acute and Long-Term Therapy for Toxoplasmic Encephalitis in Patients With AIDS,"
Clin Infect Dis, 1996, 22(2):268-75.
Smilack JD, Wilson WR, and Cockerill FR 3d,
"Tetracyclines, Chloramphenicol, Erythromycin, Clindamycin, and Metronidazole,"
Mayo Clin Proc, 1991, 66(12):1270-80.
Toma E, Thorne A, Singer J, et al,
"Clindamycin With Primaquine vs Trimethoprim-Sulfamethoxazole Therapy for Mild and Moderately Severe Pneumocystis carinii Pneumonia in Patients With AIDS: A Multicenter, Double-Blind, Randomized Trial (CTN 004). CTN-PCP Study Group,"
Clin Infect Dis, 1998, 27(3):524-30.
Wynn RL and Bergman SA,
"Antibiotics and Their Use in the Treatment of Orofacial Infections, Part I and Part II,"
Gen Dent, 1994, 42(5):398-402, 498-502.
Wynn RL, "Clindamycin: An Often Forgotten but Important Antibiotic," AGD
Impact, 1994, 22:10.
Yoshikawa TT, "Antimicrobial Therapy for the Elderly Patient," J Am
Geriatr Soc, 1990, 38(12):1353-72.
|
|
Copyright © 1978-2000 Lexi-Comp Inc. All Rights Reserved
| |