clindamycin

IM:

REMS

PO: IV: Treatment of:
- Skin and skin structure infections,
- Respiratory tract infections,
- Septicemia,
- Intra-abdominal infections,
- Gynecologic infections,
- Osteomyelitis,
- Endocarditis prophylaxis.
Severe acne.
Bacterial vaginosis.

Unlabeled Use:

PO: IV: Treatment of
Pneumocystis jiroveci
pneumonia, CNS toxoplasmosis, and babesiosis.

Action ⬆ ⬇

Inhibits protein synthesis in susceptible bacteria at the level of the 50S ribosome.

Therapeutic effects:

Bactericidal or bacteriostatic, depending on susceptibility and concentration.

Spectrum:

Active against most gram-positive aerobic cocci, including:
- Staphylococci,
- Streptococcus pneumoniae,
- other streptococci, but not enterococci.
Has good activity against those anaerobic bacteria that cause bacterial vaginosis, including Bacteroides fragilis, Gardnerella vaginalis, Mobiluncus spp., Mycoplasma hominis, and Corynebacterium.
Also active against Pneumocystis jirovecii, Propionibacterium acnes, and Toxoplasma gondii.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following PO/IM administration. Minimal absorption following topical/vaginal use.

Distribution: Widely distributed. Does not significantly cross blood-brain barrier. Crosses the placenta; enters breast milk.

Protein Binding: 94%.

Metabolism/Excretion: Mostly metabolized by the liver by the CYP3A4 isoenzyme.

Half-Life: Neonates: 3.6–8.7 hr; Infants up to 1 yr: 3 hr; Children and adults: 2–3 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	60 min	6–8 hr
IM	rapid	1–3 hr	6–8 hr
IV	rapid	end of infusion	6–8 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Regional enteritis or ulcerative colitis (topical foam);
Previous Clostridioides difficile-associated diarrhea (CDAD);
Severe hepatic impairment;
Diarrhea;
Known alcohol intolerance (topical solution, suspension).

Use Cautiously in:

OB: Safety not established in pregnancy for topical administration; systemic administration during 2nd and 3rd trimesters not associated with risk of congenital abnormalities; approved for vaginal use in 3rd trimester of pregnancy; injection contains benzyl alcohol, which can cross placenta;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Injection contains benzyl alcohol, which can cause gasping syndrome in infants and neonates.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmias, hypotension

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), ERYTHEMA MULTIFORME, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, urticaria

GI: diarrhea, CDAD, bitter or metallic taste, esophagitis, esophageal ulcer, nausea, vomiting

Local: local irritation (topical products), phlebitis at IV site

Neuro: dizziness, headache, vertigo

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

May enhance the neuromuscular blocking action of other neuromuscular blocking agents.
CYP3A4 inhibitors may ↑ levels.
CYP3A4 inducers, including rifampin, may ↓ levels and lead to therapeutic failure.
Concurrent use with irritants, abrasives, or desquamating agents may result in additive irritation.

Route/Dosage ⬆ ⬇

PO (Adults ): Most infections: 150–450 mg every 6 hr. Pneumocystis jiroveci pneumonia: 1200–1800 mg/day in divided doses with 15–30 mg primaquine/day (unlabeled). CNS toxoplasmosis: 1200–2400 mg/day in divided doses with pyrimethamine 50–100 mg/day (unlabeled); Bacterial endocarditis prophylaxis: 600 mg 1 hr before procedure.
PO (Children >1 mo): 10–30 mg/kg/day divided every 6–8 hr; maximum dose 1.8 g/day. Bacterial endocarditis prophylaxis: 20 mg/kg 1 hr before procedure.
IM IV (Adults ): Most infections: 300–600 mg every 6–8 hr or 900 mg every 8 hr (up to 4.8 g/day IV has been used; single IM doses of >600 mg are not recommended). Pneumocystis jiroveci pneumonia: 2400–2700 mg/day in divided doses with primaquine (unlabeled). Toxoplasmosis: 1200–4800 mg/day in divided doses with pyrimethamine. Bacterial endocarditis prophylaxis: 600 mg 30 min before procedure.
IM IV (Children >1 mo): 20–40 mg/kg/day (based on total body weight) divided every 6–8 hr; maximum dose: 4.8 g/day. Bacterial endocarditis prophylaxis: 20 mg/kg 30 min before procedure; maximum dose: 600 mg.
(Adults and Adolescents): Cleocin, Clindamax: 1 applicatorful (5 g) at bedtime for 3 or 7 days (7 days in pregnant patients); Clindesse: one applicatorful (5 g) single dose; or 1 suppository (100 mg) at bedtime for 3 nights. Xaciato: one applicatorful (5 g) single dose.
(Adults and Adolescents): Solution: 1% solution/suspension applied twice daily (range 1–4 times daily). Foam, gel: 1% foam or gel applied once daily.

Availability ⬆ ⬇

(Generic available)

Capsules: 75 mg; 150 mg; 300 mg
Oral solution: 75 mg/5 mL
Solution for injection: 150 mg/mL
Premixed infusion: 300 mg/50 mL 0.9% NaCl; 600 mg/50 mL 0.9% NaCl; 900 mg/50 mL 0.9% NaCl
Topical: 1% lotion, gel, foam, solution, suspension, single-use applicators
Vaginal cream: 2%
Vaginal gel: 2%
Vaginal suppositories (ovules): 100 mg
In combination with: benzoyl peroxide (Acanya, Onexton), tretinoin (Veltin, Ziana) (see Appendix [not included in this PDA edition]).

Assessment ⬆ ⬇

Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
Obtain specimens for culture and sensitivity prior to initiating therapy. First dose may be given before receiving results.
Monitor bowel elimination. Report diarrhea, abdominal cramping, fever, and bloody stools to health care professional promptly as a sign of CDAD. May begin up to several wk following the cessation of therapy.
Assess patient for hypersensitivity (skin rash, urticaria).

Lab Test Considerations:

Monitor CBC; may cause transient ↓ in leukocytes, eosinophils, and platelets.
- May cause ↑ alkaline phosphatase, bilirubin, CK, AST, and ALT concentrations.

Implementation ⬆ ⬇

PO: Administer with a full glass of water. May cause esophageal irritation; patient should be in an upright (60–90°) position during and for 30–60 min after administration. May be given with or without meals. Shake liquid preparations well. Do not refrigerate. Stable for 14 days at room temperature. Avoid administering before bed.
IM: Inject undiluted. Do not administer >600 mg in a single IM injection.
Applicators are supplied for vaginal administration. When treating bacterial vaginosis, concurrent treatment of male partner is not usually necessary.
Contact with eyes, mucous membranes, and open cuts should be avoided during topical application. If accidental contact occurs, rinse with copious amounts of cool water.
- Wash affected areas with warm water and soap; rinse and pat dry prior to application. Apply to entire affected area.

IV Administration:

Intermittent Infusion: Diluent: Vials must be diluted before use. Dilute a dose of 300 mg or 600 mg in 50 mL and a dose of 900 mg or 1200 mg in 100 mL. Compatible diluents include D5W, 0.9% NaCl, D5/0.9% NaCl, D5/0.45% NaCl, or LR. Admixed solution stable for 16 days at room temperature. Premixed infusion is already diluted and ready to use.Concentration: Not to exceed 18 mg/mL.
Rate: Infuse over 10–60 min. Not to exceed 30 mg/min. Hypotension and cardiopulmonary arrest have been reported following rapid IV administration.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient to take as directed and complete total regimen, even if feeling better. Take missed doses as soon as possible unless almost time for next dose. Do not double doses. Advise patient that sharing of this medication may be dangerous.
- Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professional.
- Advise patient to report signs of superinfection (furry overgrowth on the tongue, vaginal or anal itching or discharge).
- Notify health care professional if no improvement within a few days.
- Patients with a history of rheumatic heart disease or valve replacement need to be taught the importance of antimicrobial prophylaxis before invasive medical or dental procedures.
- Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Use with caution during 1st trimester. If breastfeeding, alternate drugs are preferred. If breastfeeding continued, monitor infant for diarrhea, thrush, and diaper rash.
IV: Inform patient that bitter or metallic taste occurring with IV administration is not clinically significant.
Instruct patient on proper use of vaginal applicator. Insert high into vagina at bedtime. Instruct patient to remain recumbent for ≥30 min following insertion. Advise patient to use sanitary napkin to prevent staining of clothing or bedding. Continue therapy during menstrual period.
- Advise patient to refrain from vaginal sexual intercourse during treatment.
- Caution patient that mineral oil in clindamycin cream may weaken latex or rubber contraceptive devices. Such products should not be used within 72 hr of vaginal cream.
Caution patient applying topical clindamycin that solution is flammable (vehicle is isopropyl alcohol). Avoid application while smoking or near heat or flame.
- Advise patient to notify health care professional if excessive drying of skin occurs.
- Advise patient to wait 30 min after washing or shaving area before applying.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇