Clindamycin

Pronunciation: KLIN-da-MYE-sin
Class: Antibiotic, Anti-infective, Lincosamide Clindamycin Hydrochloride

Trade Names

Cleocin
- Capsules 75 mg
- Capsules 150 mg
- Capsules 300 mg

Dalacin C (Canada)
Clindamycin Palmitate Hydrochloride

Cleocin Pediatric
- Granules for oral solution 75 mg per 5 mL

Clindamycin Phosphate

Cleocin
- Vaginal ovules 100 mg
- Vaginal cream 2%

Cleocin Phosphate
- Injection 150 mg/mL

Cleocin Phosphate IV
- Injection 300 mg
- Injection 600 mg
- Injection 900 mg

Cleocin T
- Gel 1%
- Lotion 1%
- Solution, topical 1%

Clindagel
- Gel 1%

ClindaMax
- Gel 1%
- Lotion, topical 1%

ClindaReach
- Solution, topical 1%

Clindesse
- Vaginal cream 2%

Clindets
- Pledget 1%

Evoclin
- Foam 1%

Apo-Clindamycin (Canada)
Clindasol (Canada)
Clinda-T (Canada)
Dalacin C Flavored Granules (Canada)
Dalacin C Phosphate Sterile Solution (Canada)
Dalacin T Topical Solution (Canada)
Dalacin Vaginal Cream (Canada)
Gen-Clindamycin (Canada)
ratio-Clindamycin (Canada)
Taro-Clindamycin (Canada)

Pharmacology

Suppresses bacterial protein synthesis.

Pharmacokinetics

Absorption

Oral

Rapidly absorbed. C max is 2.5 mcg/mL. T max is 45 min. Bioavailability is 90%.

IM

T max is 3 h (adults) and 1 h (children).

IV

C max is 7 to 14 mcg/mL.

Topical

Very low levels present in the serum (0 to 3 ng/mL) after multiple applications.

Vaginal

Approximately 5% is absorbed (cream); 30% absorbed (suppositories).

Distribution

Widely distributed (including bones); no significant levels attained in CSF. Excreted in breast milk.

Metabolism

Rapidly converted to active clindamycin.

Elimination

The average biological half-life is 2.4 to 3.2 h. Approximately 10% of bioactivity is excreted in the urine (0.2% for topical administration) and 3.6% in the feces; the remainder is excreted as inactive metabolites.

Special Populations

Renal Function Impairment

The serum half-life is increased slightly. Dosage adjustment is not usually needed.

Hepatic Function Impairment

The serum half-life is increased slightly. Dosage adjustment is not usually needed.

Indications and Usage

Treatment of serious infections caused by susceptible strains of anaerobic bacteria staphylococci, streptococci, and pneumococci in conditions such as lower respiratory tract infections, skin and skin structure infections, gynecological infections, intra-abdominal infections, septicemia, and bone and joint infections (PO/IV/IM). Treatment of acne vulgaris (topical use). Treatment of bacterial vaginosis (vaginal use) in nonpregnant women and second or third trimester pregnant women ( Cleocin and ClindaMax only).

Unlabeled Uses

Alternative to sulfonamides in combination with pyrimethamine in the acute treatment of CNS toxoplasmosis in AIDS patients; treatment of Chlamydia trachomatis infections in women; alternative to metronidazole in the treatment of bacterial vaginosis caused by Gardnerella vaginalis .

Contraindications

Hypersensitivity to lincosamides or any product component; history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Dosage and Administration

Adults

PO 150 to 450 mg every 6 h.

Children Clindamycin hydrochloride

PO 8 to 20 mg/kg/day divided into 3 to 4 doses.

Clindamycin palmitate hydrochloride

PO 8 to 25 mg/kg/day divided into 3 to 4 doses. In children weighing 10 kg or less, 37.5 mg 3 times daily should be considered the minimum recommended dosage.

Acne
Adults

Topical Apply thin film to affected area once daily ( Clindagel , Evoclin ) or twice daily ( Clindets ). More than 1 pledget may be used if necessary.

Acute Pelvic Inflammatory Disease
Adults

IV 900 mg every 8 h with gentamicin loading dose of 2 mg/kg IV or IM, followed by 1.5 mg/kg every 8 h. Parenteral therapy may be discontinued after 24 h. After discharge from hospital, continue with doxycycline 100 mg twice daily for 10 to 14 days or oral clindamycin 450 mg 4 times daily for 10 to 14 days.

Serious Infections
Adults

PO 150 to 300 mg every 6 hours.

More severe infections

PO 300 to 450 mg every 6 h.

IV/IM 600 to 1,200 mg/day in 2 to 4 equally divided doses. For more serious infections, 1,200 to 2,700 mg/day in 2 to 4 equally divided doses may be administered. For severe or life-threatening infections, the dose may be increased. Doses as high as 4,800 mg daily have been given IV. Single IM injections of more than 600 mg are not recommended. Administration of more than 1,200 mg in a single 1-h infusion is not recommended. Alternative dosing may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusions.

To maintain serum levels above 4 mcg/mL

Rapid infusion rate is 10 mg/min for 30 min followed by a maintenance dose of 0.75 mg/min.

To maintain serum levels above 5 mcg/mL

Rapid infusion rate is 15 mg/min for 30 min followed by a maintenance dose of 1 mg/min.

To maintain serum levels above 6 mcg/mL

Rapid infusion rate is 20 mg/min for 30 min followed by a maintenance dose of 1.25 mg/min.

Children 1 mo to 16 y of age

IV/IM 20 to 40 mg/kg daily in 3 or 4 equally divided doses with the higher doses being given for severe infections. Alternative dosing based on BSA may be considered. 350 mg/m 2 daily for serious infections and 450 mg/m 2 daily for more severe infections.

Newborns younger than 1 mo of age

IV/IM 15 to 20 mg/kg daily in 3 or 4 equally divided doses; the lower dose may be adequate for small premature infants.

Vaginosis
Adults

Intravaginal cream 1 applicatorful, preferably at bedtime, for 3 or 7 consecutive days in nonpregnant patients and 7 consecutive days in pregnant patients. Clindesse : 1 applicatorful any time of the day for 1 day. Intravaginal suppositories Insert 1 suppository/day, preferably at bedtime, for 3 consecutive days.

General Advice

  • Capsules and oral solution
  • Administer without regard to meals, but administer with food if GI upset occurs.
  • Administer capsules with a full glass of water to reduce esophageal irritation.
  • Administer prescribed dose of oral solution using dosing spoon or dosing syringe.
  • Injection
  • For IV infusion or IM administration only. Not for intradermal, subcutaneous, or intra-arterial administration.
  • To minimize injection-site reactions, administer by deep IM injection and avoid prolonged use of indwelling IV catheters.
  • Do not administer undiluted solution by IV bolus. Infuse over at least 10 to 60 min. Follow manufacturer's guidelines for recommended dilutions and infusion rates.
  • Follow manufacturer's recommendations for reconstituting clindamycin when using the ADD-Vantage system.
  • Do not add other drugs to the clindamycin infusion bag.
  • Do not use plastic IV containers in series connections because of risk of air embolism.
  • Topical gel, solution, and lotion
  • For topical use only. Not for ophthalmic, vaginal, or oral administration.
  • Cleanse areas to be treated before applying medication.
  • Shake lotion well just before use.
  • If using topical solution pledget, remove pledget from foil just before use. Do not use if seal is broken. Discard pledget after single use.
  • Topical solution contains an alcohol base and will cause burning and irritation if applied to sensitive surfaces. Avoid contact with the eyes, mucous membranes, and abraded skin. If accidental contact occurs, rinse with large amounts of cool tap water.
  • Do not use any other topical acne medication unless directed by health care provider.
  • Do not dispense foam directly onto hands or face; foam will melt on contact with warm skin. Dispense amount directly onto cap or on a cool surface. If the can seems warm or the foam seems runny, run the can under cold water.
  • Vaginal cream and ovules
  • For intravaginal use only. Not for ophthalmic, dermal, or oral administration.
  • Administer Cleocin and ClindaMax vaginal cream using the disposable applicator provided with medication.
  • Administer Clindesse vaginal cream using the prefilled disposable applicator.
  • Administer suppository using reusable applicator.
  • If accidental contact of vaginal cream with the eye(s) occurs, rinse the eye(s) with large amounts of cool tap water.

Storage/Stability

Capsules, oral solution, and injection

Store between 68° and 77°F. Do not refrigerate oral solution (causes thickening). Discard any unused oral solution after 14 days.

Topical gel, lotion, foam, and solution

Store between 68° and 77°F. Store ClindaReach , Clindets pledgets, and ClindaMax gel and lotion between 59° and 86°F. Protect from freezing.

Vaginal cream

Store between 68° and 77°F. Store Clindesse vaginal cream between 59° and 86°F. Protect from freezing.

Vaginal suppositories

Store between 59° and 86°F. Avoid high humidity and temperatures higher than 86°F. Store Clindagel at 59° to 86°F. Do not store in direct sunlight.

Consult manufacturer's information for storage of diluted parenteral solutions.

Drug Interactions

Aluminum salts, kaolin-pectin antidiarrheals

May delay absorption of clindamycin.

Erythromycin

May cause antagonism.

Nondepolarizing neuromuscular blockers

May enhance actions of neuromuscular-blocking agents.

Incompatibility

Aminophylline, ampicillin, barbiturates, calcium gluconate, magnesium sulfate, phenytoin sodium.

Adverse Reactions

Cardiovascular

Hypotension; cardiopulmonary arrest after too-rapid IV use (rare).

CNS

Intravaginal

Headache (3%).

Dermatologic

Exfoliative dermatitis, hypersensitivity (eg, erythema multiforme; maculopapular rash; skin rash; urticaria; vesiculobullous rash, some cases resembling Stevens-Johnson syndrome [rare]), pruritus.

EENT

Intravaginal

Nasopharyngitis (1%).

GI

Abdominal pain; colitis, including pseudomembranous colitis (0.01% to 10% [more frequent with oral administration]); constipation, diarrhea, esophagitis, nausea, unpleasant or metallic taste (following higher doses of IV infusion); vomiting.

Intravaginal

Constipation (1%).

Genitourinary

Azotemia, oliguria, proteinuria, UTI, vaginitis.

Intravaginal

Fungal vaginosis (14%); vaginal moniliasis (13%); vulvovaginal disorder (7%); vulvovaginitis (6%); vulvovaginal pruritic vaginal pain (2%); trichomonas vaginitis, UTI (1%).

Hematologic

Agranulocytosis, eosinophilia, leukopenia, neutropenia, thrombocytopenia.

Hepatic

Jaundice, LFT abnormalities.

Local

Induration, pain, sterile abscess, thrombophlebitis.

Topical

Dryness (23%); oily skin (18%); erythema (16%); burning, itching, peeling (11%).

Metabolic-Nutritional

Intravaginal

Back pain (2%).

Musculoskeletal

Polyarthritis.

Miscellaneous

Abnormal labor (vaginal); anaphylaxis; fungal infection.

Intravaginal

Fungal infection (2%); abnormal labor, moniliasis (1%). Topical or vaginal use may theoretically produce adverse reactions seen with systemic use as a result of absorption.

Precautions

Warnings

Clostridium difficile

Clostridium difficile –associated diarrhea (CDAD) can occur with clindamycin administration and may range in severity from mild diarrhea to fatal colitis. Because life-threatening colitis can occur, reserve clindamycin therapy for serious infections where less toxic antimicrobial agents are inappropriate. Clindamycin should not be used to treat nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins that can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in patients with diarrhea following antibiotic use. CDAD has been reported to occur more than 2 months after therapy has been stopped. If CDAD is suspected or confirmed, discontinue the causative antibiotic and institute treatment (including fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation).


Monitor

Blood cell count/renal function/liver enzymes

Ensure that blood cell counts, liver enzymes, and renal function are determined periodically during prolonged therapy.

Response to therapy

Monitor patient's response to therapy.

Adverse reactions

Monitor patient for GI, skin, general body adverse reactions, and signs of superinfection.


Pregnancy

Category B . Clindamycin does cross the placenta.

Lactation

Excreted in breast milk.

Children

Monitor organ system functions in newborns and children (16 y of age and younger); parenteral form may contain benzyl alcohol, which can cause gasping syndrome in premature infants.

Intravaginal

Safety and efficacy not established.

Topical

Safety and efficacy not established in children younger than 12 y of age.

Elderly

May not tolerate diarrhea well (dehydration).

Hypersensitivity

Use drug with caution in patients with asthma or significant allergies or who are atopic; anaphylactic/anaphylactoid reactions may occur. Use with caution in atopic patients.

Renal Function

Use drug with caution in patients with severe renal disease with severe metabolic aberrations.

Hepatic Function

Use drug with caution in patients with severe hepatic disease with severe metabolic aberrations.

Special Risk Patients

Use with caution in patients with a history of GI disease or atopic patients.

Superinfection

May result in bacterial or fungal overgrowth of nonsusceptible organisms.

Tartrazine Sensitivity

Some products contain tartrazine, which may cause allergic-type reactions in susceptible individuals.

Debilitated patients

May not tolerate diarrhea well (dehydration).

Meningitis

Drug does not diffuse into CSF. Do not use to treat meningitis.

Mineral oil

Vaginal cream contains mineral oil, which may weaken latex rubber condoms or diaphragms.

Overdosage

Symptoms

No available information.

Patient Information

  • Reinforce to patient or caregiver the need to take exactly as prescribed and complete the entire course of therapy, even if symptoms of infection have disappeared. Caution patient or caregiver that skipping doses or not completing the full course of therapy may allow the infection to worsen and increase the possibility that the bacteria will become resistant to the antibiotic, which may cause infections that will not be treatable in the future.
  • Instruct patient to notify health care provider if infection does not appear to be improving or appears to be getting worse.
  • Advise patient to report the following signs of superinfection to health care provider: black, furry tongue; white patches in mouth; foul-smelling stools; vaginal itching or discharge.
  • Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder, and to seek medical care if noted and to not treat at home. Caution patient that this may occur even weeks after completing therapy.
  • Advise patient to report any other bothersome adverse reaction to health care provider.
  • Capsules and oral solution
  • Advise patient or caregiver that capsules and oral solution can be taken without regard to meals, but to take with food if stomach upset occurs.
  • Advise patient to take capsules with a full glass of water.
  • Advise patient or caregiver that oral solution should be administered using a dosing spoon or syringe.
  • Injection
  • Advise patient, family, or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
  • Advise patient to report injection-site pain or redness to health care provider.
  • Topical gel, solution, and lotion
  • Advise patient to cleanse areas to be treated before applying medication, then apply a thin film of medication once daily ( Clindagel or Evoclin ) or twice daily to entire affected areas.
  • Advise patient using lotion to shake well just before use.
  • Advise patient using topical solution pledget to remove pledget from foil just before use and then discard pledget after using. Caution patient not to use pledget if seal is broken.
  • Advise patient using topical solution that it contains an alcohol base and will cause burning and irritation if applied to sensitive surfaces. Caution patient to avoid contact with the eyes, mucous membranes, and abraded skin. Advise patient that if accidental contact occurs, to rinse with large amounts of cool tap water.
  • Advise patient that if local irritation occurs, to apply the medication less frequently. If irritation persists, advise patient to discontinue use and notify health care provider.
  • Caution patient not to use any other topical acne medication unless ordered by health care provider.
  • Advise patient to notify health care provider if acne does not improve or worsens.
  • Vaginal cream and suppositories
  • Remind patient using suppositories that they are for intravaginal use only and not to take by mouth.
  • For patient using Cleocin or ClindaMax vaginal cream, review instructions for filling applicator and administering medication. Advise patient that applicator is disposable and not to reuse.
  • For patient using Clindesse vaginal cream, review instructions for preparing the prefilled applicator and administering medication. Advise patient that applicator is disposable and not to reuse.
  • For patient using vaginal suppositories, review instructions for loading and administering applicator and cleaning applicator for reuse. Advise patient that suppository can also be inserted directly using fingers.
  • Advise patient using vaginal cream that if accidental contact with the eye(s) occurs, to rinse with large amounts of cool tap water. Advise patient to notify health care provider if eye irritation persists after rinsing.
  • Advise patient to avoid vaginal intercourse or use of other vaginal products (eg, tampons, douches) during treatment with clindamycin vaginal products.
  • Caution patient that vaginal cream contains mineral oil and vaginal suppository contains an oil-type base that can weaken latex or rubber products such as condoms and vaginal contraceptive diaphragms. Caution patient not to use such products within 72 h following treatment with Cleocin or ClindaMax vaginal cream or vaginal suppositories, or within 5 days of treatment with Clindesse vaginal cream.
  • Advise patient to discontinue use and notify health care provider if vaginal irritation develops while using the medication.

Copyright © 2009 Wolters Kluwer Health.

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