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Cleocin (clindamycin hydrochloride, clindamycin palmitate hydrochloride, clindamycin phosphate)

BOXED WARNING

Clostridium difficile-associated diarrhea (CDAD) reported and may range in severity from mild diarrhea to fatal colitis. Due to association w/ severe colitis, reserve use for serious infections where less toxic agents are inappropriate. Not for use w/ nonbacterial infections such as most URIs. CDAD must be considered in all patients w/ diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile and surgical evaluation may be instituted as clinically indicated.

OTHER BRAND NAMES

Cleocin Pediatric

THERAPEUTIC CLASS

Lincomycin derivative

DEA CLASS

RX

INDICATIONS

Treatment of the following serious infections caused by susceptible strains of microorganisms: respiratory tract infections, skin and skin structure infections, septicemia, intra-abdominal infections, gynecological infections. (IV) Treatment of bone and joint infections and as adjunctive therapy in the surgical treatment of chronic bone and joint infections.

ADULT DOSAGE

Serious Infections

Respiratory tract/skin and skin structure/intra-abdominal/gynecological infections and septicemia; (IV) bone and joint infections and adjunctive therapy in the surgical treatment of chronic bone and joint infections

Cap:
150-300mg PO q6h
More Severe: 300-450mg PO q6h

Inj:

Aerobic Gram-Positive Cocci and More Susceptible Anaerobes:
600-1200mg/day IV/IM given in 2, 3, or 4 equal doses
More Severe (Particularly Due to Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens):
1200-2700mg/day IV/IM given in 2, 3, or 4 equal doses
More Serious/Life-Threatening:
May have to increase dose; as much as 4800mg/day IV have been given

Single IM inj >600mg are not recommended

Alternative Administration:
Administer 1st dose as a single rapid infusion, followed by continuous IV infusion
To Maintain Serum Clindamycin Levels >4mcg/mL:
Rapid Infusion Rate: 10mg/min for 30 min
Maint Infusion Rate: 0.75mg/min
To Maintain Serum Clindamycin Levels >5mcg/mL:
Rapid Infusion Rate: 15mg/min for 30 min
Maint Infusion Rate: 1mg/min
To Maintain Serum Clindamycin Levels >6mcg/mL:
Rapid Infusion Rate: 20mg/min for 30 min
Maint Infusion Rate: 1.25mg/min

β-hemolytic Streptococcal Infection:
Treat for at least 10 days

PEDIATRIC DOSAGE

Serious Infections

Cap:
8-16mg/kg/day (4-8mg/lb/day) PO divided into 3 or 4 equal doses
More Severe: 16-20mg/kg/day (8-10mg/lb/day) PO divided into 3 or 4 equal doses

Sol:

8-12mg/kg/day (4-6mg/lb/day) PO divided into 3 or 4 equal doses
Severe: 13-16mg/kg/day (6.5-8mg/lb/day) PO divided into 3 or 4 equal doses
More Severe: 17-25mg/kg/day (8.5-12.5mg/lb/day) PO divided into 3 or 4 equal doses

≤10kg:

Minimum Dose: 1/2 tsp (37.5mg) tid

Inj:
Neonates (<1 Month):
15-20mg/kg/day given in 3-4 equal doses; lower dosage may be adequate for small prematures
1 Month-16 Years:
20-40mg/kg/day IV/IM given in 3 or 4 equal doses; use higher dose for more severe infections

Alternative Dosing:
350mg/m2/day
More Severe: 450mg/m2/day

β-hemolytic Streptococcal Infection:
Treat for at least 10 days

ADMINISTRATION

Oral/IM/IV route

Cap
Take w/ full glass of water to avoid esophageal irritation

Sol
Reconstitute 100mL bottles w/ 75mL of water
Reconstitution Instructions:
1. Add a large portion of water and shake vigorously
2. Add remainder of the water and shake until sol is uniform

IM
Administer undiluted

IV
Administer diluted

IV Dilution and Infusion Rates:
Concentration of clindamycin in diluent should not exceed 18mg/mL
Infusion rates should not exceed 30mg/min
300mg Dose: Dilute w/ 50mL; infuse over 10 min
600mg Dose: Dilute w/ 50mL; infuse over 20 min
900mg Dose: Dilute w/ 50-100mL; infuse over 30 min
1200mg Dose: Dilute w/ 100mL; infuse over 40 min
Administration of >1200mg in a single 1-hr infusion is not recommended

Physical Incompatibilities:
Ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate

Do not add supplementary medication to Galaxy Container

HOW SUPPLIED

Cap: (HCl) 75mg, 150mg, 300mg; Inj: (Phosphate) 150mg/mL [2mL, 4mL, 6mL vial]; 150mg/mL [4mL, 6mL ADD-Vantage vial]; 300mg/50mL, 600mg/50mL, 900mg/50mL [Galaxy plastic container]; (Pediatric) Sol: (Palmitate) 75mg/5mL [100mL]

WARNINGS/PRECAUTIONS

D/C use if significant diarrhea occurs during therapy. Reserve use for penicillin (PCN)-allergic patients or other patients for whom a PCN is inappropriate. May increase bacterial resistance if used in the absence of a proven/strongly suspected bacterial infection or a prophylactic indication; take appropriate measures if superinfection develops. Not for treatment of meningitis. Caution w/ severe liver disease, history of GI disease (eg, colitis), and in atopic or elderly patients. (75mg/150mg Caps) Contains tartrazine, which may cause allergic-type reactions (eg, bronchial asthma); caution w/ aspirin hypersensitivity. (Inj) Do not inject IV undiluted as bolus. Contains benzyl alcohol; has been associated w/ serious adverse events, including "gasping syndrome" and death in pediatric patients. Premature infants and low birth weight infants may be more likely to develop benzyl alcohol toxicity. (Cap/Inj) Severe skin reactions (eg, toxic epidermal necrolysis) reported; permanently d/c treatment in case of such an event.

ADVERSE REACTIONS

CDAD, abdominal pain, pseudomembranous colitis, N/V, maculopapular skin rash, pruritus, vaginitis, jaundice, abnormal LFTs, transient neutropenia, eosinophilia, drug reaction w/ eosinophilia and systemic symptoms, azotemia, oliguria, polyarthritis.

DRUG INTERACTIONS

May enhance the action of neuromuscular blockers; use w/ caution. Antagonism reported between clindamycin and erythromycin; avoid use concurrently.

PREGNANCY AND LACTATION

Category B, not for use in nursing.

MECHANISM OF ACTION

Lincomycin-derivative antibiotic; inhibits bacterial protein synthesis by binding to the 50S subunit of the ribosome.

PHARMACOKINETICS

Absorption: Cap (150mg): Rapid. Cmax=2.5mcg/mL, Tmax=45 min. Inj: Tmax=3 hrs (Adults, IM), 1 hr (Pediatric Patients, IM). Inj/Sol: Administration of variable doses resulted in different parameters. Distribution: Wide; distributed in body fluids, tissues, and bones; found in breast milk. Elimination: Cap: Urine (10%), feces (3.6%); T1/2=2.4 hrs. Inj: T1/2=3 hrs (Adults), 2.5 hrs (Pediatric Patients). Sol: T1/2=2 hrs.

ASSESSMENT

Assess for history of hypersensitivity to drug or lincomycin, history of GI disease, presence of meningitis, atopy, and possible drug interactions. Assess hepatic function and pregnancy/nursing status. Obtain baseline culture and susceptibility tests.

MONITORING

Monitor for CDAD, superinfection, allergic reactions, severe skin reactions, and other adverse reactions. Monitor for changes in bowel frequency in older patients. If available, consider culture and susceptibility information when modifying antibacterial therapy. If on prolonged therapy, perform periodic LFTs, renal function tests, and blood counts. Perform periodic liver enzyme determinations in patients w/ severe liver disease.

PATIENT COUNSELING

Inform about potential benefits/risks of therapy. Inform that therapy only treats bacterial, not viral, infections. Instruct to take exactly ud and inform that skipping doses or not completing full course may decrease effectiveness and increase antibiotic resistance. Instruct to contact physician if an allergic reaction develops. Advise that watery and bloody stools (w/ or w/o stomach cramps and fever) may occur as late as ≥2 months after therapy; instruct to notify physician if this occurs. Advise to notify physician if pregnant/nursing.

STORAGE

20-25°C (68-77°F). (Inj) Galaxy Container: 25°C (77°F); avoid temperatures >30°C (86°F). Refer to PI for stability information regarding diluted solutions. (Sol) Do not refrigerate the reconstituted sol; stable at room temperature for 2 weeks.

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