clindamycin (Cleocin, Cleocin Pediatric, Clindesse, ClindaMax Vaginal)

Dosing and uses of Cleocin, Clindesse (clindamycin)

• Adult
• Pediatric

 

Adult dosage forms and strengths

capsule

• 75mg
• 150mg
• 300mg

injectable solution

• 150mg/mL

oral solution

• 75mg/5mL

intravenous solution

• 300 mg/50mL (5% dextrose)
• 600 mg/50mL (5% dextrose)
• 900 mg/50mL (5% dextrose)

 

Serious Infections Caused by Anaerobic Bacteria

150-450 mg PO q6-8hr; not to exceed 1.8 g/day, Or

1.2-2.7 g/day IV/IM divided q6-12hr; not to exceed 4.8 g/day

 

Amnionitis

450-900 mg IV q8hr

 

Inhalational & Gastrointestinal Anthrax (Off-label)

900 mg IV q8hr with ciprofloxacin 400 mg PO q12hr or doxycycline 150-300 mg PO q12hr

 

Bacterial Vaginosis

300 mg PO q12hr for 7 days

 

Surgical Prophylaxis

900 mg PO/IV 1 hr prior to procedure; may redose q6hr if necessary

 

Bite Wounds (Human or Animal)

300 mg PO q6hr

 

Gangrenous Pyomyositis

900 mg IV q8hr with penicillin g

 

Group B Streptococcus

Neonatal prophylaxis

900 mg IV q8hr until delivery

 

Orofacial/Parapharyngeal Space Infections

150-450 mg PO q6hr for at least 7 days; not to exceed 1.8 g/day, Or

600-900 mg IV q8hr

 

Pelvic Inflammatory Disease

900 mg IV q8hr with gentamicin 2 mg/kg; THEN 1.5 mg/kg q8hr; continue after discharge with doxycycline 100 mg PO q12hr to complete 14 days of therapy

 

Toxic Shock Syndrome

900 mg IV q8hr plus oxacillin or nafcillin (2 g IV q4hr) or vancomycin (30 mg/kg/day IV divided q12hr

 

Endocarditis Prophylaxis (Off-label)

600 mg PO/IV/IM 30-60 min before procedure

Avoid IM injections in patients receiving anticoagulant therapy; administer PO in these circumstances; in general, administer IV only if patient does not tolerate or is unable to absorp oral medications

Dosing considerations

• Recent AHA guidelines recommend only for high-risk patients undergoing invasive procedures

 

CNS Toxoplasmosis, With Pyrimethamine or Leucovorin (Off-label)

600 mg IV or PO q6hr for at least 6 weeks

 

Gardnerella Vaginalis (Off-label)

PO: 300 mg PO q12hr for 7 days

 

Pneumocystis (Carinii) Jiroveci (Off-label)

30 mg/kg/day divided q6-8hr

300-450 mg PO q6-8hr with primaquine for 21 days

600-900 mg IV q6-8hr with primaquine for 21 days

 

Sarcoidosis (Orphan)

Orphan indication sponsor

• Autoimmunity Research Foundation; 3423 Hill Canyon Avenue; Thousand Oaks, CA 91360

 

Administration

PO: May take with food

 

Pediatric dosage forms and strengths

capsule

• 75mg
• 150mg
• 300mg

injectable solution

• 150mg/mL

oral solution

• 75mg/5mL

intravenous solution

• 300 mg/50mL (5% dextrose)
• 600 mg/50mL (5% dextrose)
• 900 mg/50mL (5% dextrose)

 

Serious Infections Caused by Anaerobic Bacteria

<7 days

• <2 kg (or >7 days, <1.2 kg): 10 mg/kg/day IV/IM divided q12hr
• >2 kg (or >7 days, 1.2-2 kg): 15 mg/kg/day IV/IM divided q8hr

>7 days

• >2 kg: 20 mg/kg/day IV/IM divided q6hr

<1 month

• 15-20 mg/kg/day divided q6-8hr

>1 month

• Hydrochloride: 8-20 mg/kg/day PO
• Palmitate: 8-25 mg/kg/day divided q6-8hr; 37.5 mg q8hr minimum palmitate dose

 

Anthrax

15-40 mg/kg/day IV divided q6-8hr

8-25 mg/kg/day PO divided 6-8hr

 

Endocarditis

Prophylaxis

20 mg/kg PO 30-60 min before procedure, Or

20 mg/kg IV/IM within 30-60 minutes before procedure

 

Streptococcal Pharyngitis

May consider use in patients allergic to penicillin (IDSA guidelines)

Chronic carrier treatment: 20-30 mg/kg/day PO divided q8hr; not to exceed 300 mg/dose

Acute treatment in penicillin-allergic patients: 7 mg/kg/dose TID for 10 days; not to exceed 300 mg/dose

 

Orofacial Infections

10-20 mg/kg/day PO divided q6-8hr, Or

15-25 mg/kg/day IV divided q6-8hr

May adjust dose as necessary not to exceed 40 mg/kg/day

 

Dosing Considerations

IM: No more than 600 mg per injection

Endocarditis: Recent AHA guidelines recommend only for invasive procedures in high-risk patients

 

Administration

May take with food

 

Cleocin, Clindesse (clindamycin) adverse (side) effects

Frequency not defined

Abdominal pain

Agranulocytosis

Eosinophilia (transient)

Diarrhea

Fungal overgrowth

Pseudomembranous colitis

Hypersensitivity

Stevens-Johnson syndrome

Rashes

Urticaria

Hypotension

Nausea

Vomiting

Sterile abscess at IM site

Thrombophlebitis

Granulocytopenia

Neutropenia

Thrombocytopenia

Polyarthritis

Renal dysfunction

 

Postmarketing reports

Metallic taste

 

Warnings

Black box warnings

Clostridium difficile-associated diarrhea (CDAD) has been reported and may range in severity from mild diarrhea to fatal colitis

C difficile produces toxins A and B, which contribute to CDAD; hypertoxin-producing C difficile strains increase morbidity and mortality (more likely to be refractory to antimicrobial therapy and may require colectomy)

If CDAD suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued

 

Contraindications

Hypersensitivity to clindamycin, lincomycin, or formulation components

 

Cautions

Endocarditis prophylaxis: Use only for high-risk patients, per recent AHA guidelines

Risk of potentially fatal pseudomembranous colitis, fungal or bacterial superinfection on prolonged use; discontinue therapy if significant abdominal cramps, diarrhea, or passage of blood and mucus occurs

May increase risk of drug-resistant bacteria if prescribed in the absence of proven or strongly suspected bacterial infection

Use caution in hepatic impairment, monitor for hepatic abnormalities; periodic liver enzyme determinations should be made when treating patients with severe liver disease

Not for use in meningitis due to inadequate penetration into CSF

Severe skin reactions including toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens-Johnson syndrome (SJS), some with fatal outcome, reported; permanently discontinue if reactions occur

Parenteral product contains benzyl alcohol, which has been associated with gasping syndrome and death in newborns

Use with caution in patients with history of gastrointestinal disease, especially colitis

Not for administration as a bolus; infuse over 10-60 min

Consider possibility of clostridium difficile in all patients who present with diarrhea following antibiotic use

Serious anaphylactic reactions require immediate emergency treatment with epinephrine; oxygen and intravenous corticosteroids should also be administered as indicated

Prescribe with caution in atopic individuals

Indicated surgical procedures should be performed in conjunction with antibiotic therapy

Clindamycin dosage modification may not be necessary in patients with renal disease

 

Pregnancy and lactation

Pregnancy category: B

In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities

Lactation: Excreted in breast milk; manufacturer suggests discontinue drug or do not nurse (AAP Committee states compatible with nursing)

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Cleocin, Clindesse (clindamycin)

Mechanism of action

Suppresses protein synthesis by binding to 50S ribosomal subunits; bacteriostatic or bactericidal depending on drug concentration, organism and infection site

 

Absorption

Bioavailability: Oral (rapid; 90%)

Peak serum time: Within 60 min (PO); 1-3 hr (IM)

 

Distribution

High concentrations in bone and urine

No significant levels in CSF, even with inflamed meninges

Crosses placenta; enters breast milk

Vd: ~2 L/kg

 

Metabolism

Hepatic

 

Elimination

Half-life: 2-3 hr (adults); 8.7 hr (premature neonates); 3.6 hr (full-term neonates); 2 hr (children); 4 hr (elderly)

Excretion: Urine (10%) as active drug; feces (~4%) as active drug

 

Administration

IV Incompatibilities

Additive: Aminophylline, ceftriaxone, ciprofloxacin, gentamicin/cefazolin, ranitidine(?)

Syringe: Tobramycin

Y-site: Allopurinol, azithromycin, doxapram, filgrastim, fluconazole, idarubicin

Reported to be physically incompatible with aminophylline, ampicillin, barbiturates, Ca-gluconate, magnesium sulfate, and phenytoin; other reports say ampicillin is additive compatible and magnesium sulfate is Y-site compatible

 

IV Compatibilities

Solution: Compatible with most common diluents

Additive: Amikacin, aztreonam, cefazolin, cefepime, cefoperazone, cefotaxime, cefoxitin, ceftazidime, cefuroxime, cimetidine, fluconazole, gentamicin, heparin, hydrocortisone, kanamycin, methylprednisolone, metoclopramide, metronidazole, netilmicin, ofloxacin, KCl, penicillin G, piperacillin, Na-bicarbonate, tobramycin, verapamil, vitamin B/C

Syringe: Amikacin, aztreonam, caffeine, gentamicin, heparin

Y-site: Amifostine, amiodarone, amphotericin B CholSO4, amsacrine, aztreonam, bivalirudin, cefpirome, cisatracurium, cyclophosphamide, dexmedetomidine, diltiazem, docetaxel, doxorubicin liposomal, enalaprilat, esmolol, etoposide PO4, fenoldopam, fludarabine, foscarnet, gatifloxacin, gemcitabine, granisetron, hetastarch, hydromorphone, heparin, labetalol, levofloxacin, linezolid, meperidine, morphine, midazolam, milrinone, nicardipine, ondansetron, perphenazine, piperacillin/tazobactam, propofol, remifentanil, sargramostim, tacrolimus, teniposide, theophylline, thiotepa, vinorelbine, vitamin B/C, zidovudine

 

IV Preparation

Dilute 300 and 600 mg in 50 mL of D5W

Dilute 900 mg in 50-100 mL of D5W

Dilute 1200 mg in 100 mL of D5W

 

IV Administration

Intermittent IV infusion

• Infuse over 10-60 min at a rate not exceeding 30 mg/min
• See manufacturer's PI for rapid and maintenance rates for specific desired serum levels
• 300 mg doses infuse over 10 min
• 600 mg doses infuse over 20 min
• 900 mg doses infuse over 30 min
• 1200 mg doses infuse over 60 min; no more than 1200 mg of drug should be given by IV infusion in 1 hr

Continuous IV infusion

• May give continuous IV infusion instead of intermittent after first dose has been given by rapid IV infusion