Brand name: Mefoxin
Drug class: Cephamycins
CAS number: 33564-30-6

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Antibacterial; β-lactam antibiotic; cephamycin.

Uses for cefOXitin

Bone and Joint Infections

Treatment of bone and joint infections caused by susceptible Staphylococcus aureus (including penicillinase-producing strains).

Gynecologic Infections

Treatment of gynecologic infections (including endometritis, pelvic cellulitis, pelvic inflammatory disease [PID]) caused by susceptible Streptococcus agalactiae (group B streptococci), Escherichia coli, Neisseria gonorrhoeae, Bacteroides (including B. fragilis), Clostridium, Peptococcus niger, or Peptostreptococcus.

Cefoxitin (or cefotetan) in conjunction with doxycycline considered a regimen of choice by CDC and others when a parenteral regimen indicated for treatment of PID.

When an oral regimen is used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or other parenteral third-generation cephalosporin (e.g., cefotaxime) given in conjunction with a 14-day regimen of oral doxycycline.

Because cefoxitin (like cephalosporins) is not active against Chlamydia, concomitant use of a drug active against Chlamydia (e.g., doxycycline) is necessary when these organisms are suspected pathogens.

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis and intra-abdominal abscess) caused by susceptible E. coli, Klebsiella, Bacteroides (including B. fragilis), or Clostridium.

Has been effective in mixed aerobic-anaerobic infections. However, cefoxitin may no longer provide reliable coverage against B. fragilis, and metronidazole is recommended by many clinicians to provide coverage against B. fragilis in combination anti-infective regimens used for empiric treatment of intra-abdominal infections.

For initial empiric treatment of mild to moderate community-acquired, extrabiliary, complicated intra-abdominal infections in adults (e.g., perforated or abscessed appendicitis), IDSA recommends either monotherapy with cefoxitin, ertapenem, moxifloxacin, tigecycline, or the fixed combination of ticarcillin and clavulanic acid, or a combination regimen that includes either a cephalosporin (cefazolin, cefotaxime, ceftriaxone, cefuroxime) or fluoroquinolone (ciprofloxacin, levofloxacin) in conjunction with metronidazole.

Respiratory Tract Infections

Treatment of lower respiratory tract infections (including pneumonia and lung abscess) caused by susceptible S. aureus (including penicillinase-producing strains), S. pneumoniae, or other streptococci (except enterococci), Haemophilus influenzae, E. coli, Klebsiella, or Bacteroides.

Septicemia

Treatment of septicemia caused by susceptible S. aureus (including penicillinase-producing strains), S. pneumoniae, E. coli, Klebsiella, or Bacteroides (including B. fragilis).

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by susceptible S. aureus (including penicillinase-producing strains), S. epidermidis, S. pyogenes (group A β-hemolytic streptococci), or other streptococci (except enterococci), E. coli, Klebsiella, Proteus mirabilis, Bacteroides (including B. fragilis), Clostridium, P. niger, or Peptostreptococcus.

Urinary Tract Infections (UTIs)

Treatment of UTIs caused by susceptible E. coli, Klebsiella, Morganella morganii, P. mirabilis, P. vulgaris, or Providencia (including P. rettgeri).

Gonorrhea and Associated Infections

Alternative for treatment of uncomplicated cervical, urethral, or rectal gonorrhea^{† [off-label]} caused by susceptible Neisseria gonorrhoeae in adults or adolescents.

Regimen of choice is IM ceftriaxone and either azithromycin or doxycycline. Although IM cefoxitin (with probenecid) may be effective for uncomplicated urogenital and anorectal gonorrhea, CDC states it offers no advantage over IM ceftriaxone for urogenital infections and has uncertain efficacy for pharyngeal gonorrhea.

Mycobacterial Infections

Treatment of infections caused by Mycobacterium abscessus^{† [off-label]} or M. fortuitum^{† [off-label]}; used in conjunction with other antimycobacterial anti-infectives.

For serious skin, soft tissue, and bone infections caused by M. abscessus, ATS and IDSA recommend a multiple-drug regimen of oral clarithromycin (or azithromycin) used in conjunction with parenteral anti-infectives (e.g., amikacin, cefoxitin, imipenem). This multiple-drug regimen also used in treatment of M. abscessus lung disease; however, anti-infectives may help control symptoms and disease progression, but long-term sputum conversion is unlikely. In patients with focal infections and limited lung disease, curative therapy may be possible if surgical resection is used in conjunction with a multiple-drug treatment regimen.

Although optimum regimens not identified for treatment of M. fortuitum infections, ATS and IDSA recommend that pulmonary infections be treated with a regimen consisting of at least 2 anti-infectives selected based on results of in vitro susceptibility testing and tolerability (e.g., amikacin, clarithromycin, cefoxitin, ciprofloxacin or ofloxacin, a sulfonamide, imipenem, doxycycline). In serious skin, bone, and soft tissue infections, ≥4 months of treatment with ≥2 anti-infectives active against the clinical isolate is necessary to provide a high likelihood of cure; 6 months of treatment recommended for bone infections. Surgery usually indicated for extensive disease, abscess formation, or when drug therapy is difficult.

Perioperative Prophylaxis

Perioperative prophylaxis in women undergoing hysterectomy or cesarean section. Cefazolin, cefotetan, cefoxitin, or ampicillin and sulbactam usually recommended for women undergoing vaginal, abdominal, or laparoscopic hysterectomy; cefazolin usually recommended for women undergoing cesarean section.

Perioperative prophylaxis in patients undergoing colorectal or other GI surgery. Cefoxitin, cefotetan, cefazolin (in conjunction with metronidazole), ampicillin and sulbactam, or ertapenem usually recommended. Many clinicians recommend using both a parenteral and oral regimen (i.e., neomycin in conjunction with erythromycin or metronidazole and mechanical bowel preparation) for perioperative prophylaxis in patients undergoing colorectal surgery,

Perioperative prophylaxis in patients undergoing uncomplicated (nonperforated) appendectomy. Cefoxitin, cefotetan, or cefazolin (in conjunction with metronidazole) usually recommended for patients undergoing appendectomy.

Perioperative prophylaxis in patients undergoing biliary tract surgery. Cefazolin usually recommended for high-risk patients undergoing open biliary tract surgery; alternatives include cefotetan, cefoxitin, or ampicillin and sulbactam. Prophylaxis not considered necessary for low-risk patients undergoing elective laparoscopic cholecystectomy.

cefOXitin Dosage and Administration

Administration

Administer by IV injection or infusion. Also has been given by IM injection^{† [off-label]}.

IV route preferred in patients with bacteremia, septicemia, or other severe or life-threatening infections, or in patients with lowered resistance resulting from debilitating conditions (e.g., malnutrition, trauma, surgery, diabetes, heart failure, malignancy), particularly with shock.

For solution and drug compatibility information, see Compatibility under Stability.

IV Injection

Reconstitution

Vials containing 1 or 2 g of cefoxitin: Reconstitute with 10 mL of sterile water for injection to provide solutions containing approximately 95 or 180 mg/mL, respectively. Shake to dissolve; let stand until clear.

Rate of Administration

Inject appropriate dose of reconstituted solution directly into a vein over a 3- to 5-minute period or slowly into the tubing of a compatible IV solution.

IV Infusion

Other IV solutions flowing through a common administration tubing or site should be discontinued while cefoxitin is infused.

Reconstitution

Vials containing 1 or 2 g of cefoxitin: Reconstitute with 10 mL or 10–20 mL, respectively, of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection to provide solutions containing approximately 95 or 95–180 mg/mL, respectively. Shake to dissolve; let stand until clear. Then, further dilute reconstituted solution in 50 mL to 1 L of a compatible IV solution.

Pharmacy bulk package containing 10 g of cefoxitin: Reconstitute with 43 or 93 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or 5% dextrose injection to provide solutions containing approximately 200 or 100 mg/mL, respectively. Shake to dissolve; let stand until clear. Not intended for direct IV infusion; prior to administration, doses from reconstituted pharmacy bulk package vial must be further diluted in 50 mL to 1 L of a compatible IV solution within 4 hours. Transfer individual doses to a compatible IV solution using suitable sterile transfer device or dispensing set; do not use syringe with needle since leakage could occur. Consult manufacturer’s directions for additional information.

Duplex drug delivery system containing 1 or 2 g of cefoxitin powder and 50 mL of 4 or 2.2% dextrose injection, respectively, in separate chambers: Reconstitute (activate) according to the manufacturer’s directions. If refrigerated after reconstitution (see Storage under Stability), allow solution to reach room temperature prior to administration.

Commercially available premixed injection (frozen): Thaw at room temperature (25°C) or under refrigeration (5°C); do not thaw by immersion in a water bath or by exposure to microwave radiation. A precipitate may have formed in the frozen injection, but should dissolve with little or no agitation after reaching room temperature. Discard thawed injection if an insoluble precipitate is present or if container seals or outlet ports are not intact or leaks are found. Do not use in series connections with other plastic containers; such use could result in air embolism from residual air being drawn from the primary container before administration of fluid from the secondary container is complete.

Rate of Administration

Administer by intermittent or continuous IV infusion.

IM Injection† [off-label]

Administer IM injections deeply into a large muscle, such as upper outer quadrant of gluteus maximus. Use aspiration to ensure needle is not in a blood vessel.

Reconstitution

IM injections are prepared by adding 2 mL of sterile water for injection or 0.5 or 1% lidocaine hydrochloride injection (without epinephrine) to each g of cefoxitin.

Dosage

Available as cefoxitin sodium; dosage expressed in terms of cefoxitin.

Pediatric Patients

General Pediatric Dosage

IV

Children ≥3 months of age: Manufacturers recommend 80–160 mg/kg daily given in 4–6 equally divided doses.

Children beyond neonatal period: AAP recommends 80 mg/kg daily given in 3–4 divided doses for mild to moderate infections or 160 mg/kg daily given in 4 divided doses for severe infections.

Perioperative Prophylaxis

Colorectal Surgery, Appendectomy (Nonperforated), or Other GI Surgery

IV

Children ≥3 months of age: Manufacturers recommend 30–40 mg/kg given within 0.5–1 hour prior to incision. Although manufacturers state 30–40 mg/kg can be given every 6 hours after the procedure for up to 24 hours, postoperative doses usually unnecessary.

Children ≥1 year of age: Some clinicians recommend 40 mg/kg given within 1 hour prior to incision.

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given.

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.

Adults

General Adult Dosage

Uncomplicated Infections (Bacteremia Absent or Unlikely)

IV

1 g every 6–8 hours.

Moderately Severe or Severe Infections

IV

1 g every 4 hours or 2 g every 6–8 hours.

Infections Requiring Higher Dosage (e.g., Gangrene)

IV

2 g every 4 hours or 3 g every 6 hours.

Gonorrhea and Associated Infections†

Uncomplicated Urethral, Cervical, or Rectal Gonorrhea†

IM^†

2 g as a single dose given with oral probenecid (1 g).

Pelvic Inflammatory Disease

IV

2 g every 6 hours; used in conjunction with IV or oral doxycycline (100 mg every 12 hours). Cefoxitin may be discontinued 24–48 hours after clinical improvement occurs and oral doxycycline (100 mg every 12 hours) continued to complete 14 days of treatment.

IM†

2 g as a single dose given with oral probenecid (1 g); followed by a 14-day regimen of oral doxycycline (100 mg twice daily) with or without oral metronidazole (500 mg twice daily).

Mycobacterium abscessus Infections†

IV

If used in initial combination regimens for treatment of serious skin, soft tissue, and bone infections (see Mycobacterial Infections under Uses), ATS and IDSA recommend up to 12 g daily given in divided doses for at least 2 weeks until clinical improvement. At least 4 months of antimycobacterial treatment is necessary for treatment of serious skin and soft tissue infections; 6 months of antimycobacterial treatment recommended for bone infections.

Perioperative Prophylaxis

Gynecologic and Obstetric Surgery

IV

Hysterectomy (abdominal, vaginal, laparoscopic): 1 or 2 g given within 0.5–1 hour prior to incision. Although manufacturers also recommend additional 2-g doses every 6 hours (for up to 24 hours), postoperative doses usually unnecessary.

Cesarean section: 1 or 2 g given 0.5–1 hour prior to incision. Manufacturers recommend giving the dose as soon as umbilical cord is clamped, but there is some evidence that giving the dose prior to incision is more effective than after clamping. Although manufacturers state additional 2-g doses can be given at 4 and 8 hours after initial dose, postoperative doses usually unnecessary.

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given (e.g., every 2 hours, measured from time of initiation of preoperative dose).

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.

Colorectal Surgery, Appendectomy (Nonperforated), or Other GI Surgery

IV

1 or 2 g given within 0.5–1 hour prior to incision. Although manufacturers state 2 g can be given every 6 hours after the procedure for up to 24 hours, postoperative doses usually unnecessary.

If procedure is prolonged >3–4 hours, major blood loss occurs, or other factors are present that shorten drug half-life, additional intraoperative doses may be given (e.g., every 2 hours, measured from time of initiation of preoperative dose).

Duration of prophylaxis should be <24 hours for most procedures; no evidence to support continuing prophylaxis after wound closure or until all indwelling drains and intravascular catheters are removed.

Prescribing Limits

Pediatric Patients

Maximum 12 g daily.

Adults

Maximum 12 g daily.

Special Populations

Renal Impairment

Dosage adjustments necessary in those with Cl_cr ≤50 mL/minute.

Adults with Cl_cr ≤50 mL/minute: Give an initial loading dose of 1–2 g followed by maintenance dosage based on Cl_cr (see Table 1).

Adults undergoing hemodialysis: Give a loading dose of 1–2 g after each dialysis period followed by maintenance dosage based on Cl_cr (see Table 1).

Pediatric patients with renal impairment: Make dosage adjustments similar to those recommended for adults.

Geriatric Patients

Cautious dosage selection because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)

Cautions for cefOXitin

Contraindications

• Known hypersensitivity to cefoxitin or cephalosporins.

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible organisms with prolonged therapy. Careful observation of the patient is essential. Institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including cefoxitin, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.

If CDAD suspected or confirmed, discontinue anti-infective therapy not directed against C. difficile whenever possible. Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions, including rash (maculopapular or erythematous), pruritus, fever, eosinophilia, urticaria, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

If an allergic reaction occurs, discontinue cefoxitin and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).

Cross-hypersensitivity

Partial cross-allergenicity among β-lactam antibiotics, including penicillins, cephalosporins, and cephamycins.

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to cefoxitin, cephalosporins, penicillins, or other drugs. Cautious use recommended in individuals hypersensitive to penicillins. Avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction and administer with caution in those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.

General Precautions

History of GI Disease

Use with caution in patients with history of GI disease, particularly colitis. (See Superinfection/Clostridium difficile-associated Diarrhea and Colitis [CDAD] under Cautions.)

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.

Patients with Diabetes

Like other dextrose-containing solutions, use commercially available Duplex drug delivery system containing 1 or 2 g of cefoxitin powder and 50 mL of 4 or 2.2% dextrose injection, respectively, with caution in patients with overt or known subclinical diabetes mellitus or in patients with carbohydrate intolerance for any reason.

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of cefoxitin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

Sodium Content

Contains approximately 53.8 mg (2.3 mEq) of sodium per g of cefoxitin.

Specific Populations

Pregnancy

Category B.

Lactation

Distributed into milk in low concentrations; use with caution.

Pediatric Use

Safety and efficacy in infants <3 months of age not established.

Use of high doses in children ≥3 months of age have been associated with an increased incidence of eosinophilia and elevated serum AST concentration.

Cefoxitin reconstituted with bacteriostatic water for injection containing benzyl alcohol should not be used in infants. Benzyl alcohol as a preservative has been associated with toxicity in neonates; although these effects have not been demonstrated in infants >3 months of age, small infants in this age range may also be at risk for benzyl alcohol toxicity.

Geriatric Use

No overall differences in safety and efficacy in those ≥65 years of age compared with younger adults, but the possibility of increased sensitivity in some geriatric individuals cannot be ruled out.

Substantially eliminated by kidneys; risk of toxicity may be greater in those with impaired renal function. Select dosage with caution and consider monitoring renal function because of age-related decreases in renal function. (See Renal Impairment under Dosage and Administration.)

Renal Impairment

High and prolonged serum concentrations may occur.

Reduce dosage in those with Cl_cr ≤50 mL/minute. See Renal Impairment under Dosage and Administration.

Common Adverse Effects

Local reactions at the IV administration site (including thrombophlebitis), hypersensitivity reactions, diarrhea.

Drug Interactions

Specific Drugs and Laboratory Tests

cefOXitin Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from the GI tract; must be administered parenterally.

Following IM administration in healthy adults, peak serum concentrations attained within 20–30 minutes.

Distribution

Extent

Widely distributed into body tissues and fluids, including ascitic, pleural, and synovial fluid.

Therapeutic concentrations may be obtained in bile if biliary obstruction is not present.

Diffuses poorly into CSF following IM or IV administration, even when meninges are inflamed.

Readily crosses the placenta and is distributed into milk in low concentrations.

Plasma Protein Binding

50–80%.

Elimination

Metabolism

≤2% of a dose is metabolized to descarbamylcefoxitin, which is microbiologically inactive.

Elimination Route

Rapidly eliminated in urine by glomerular filtration and renal tubular excretion. About 85% of a dose excreted unchanged in urine within 6 hours

Half-life

Adults with normal renal function: 0.7–1.1 hours.

Special Populations

Patients with renal impairment: Serum concentrations higher and serum half-life prolonged. Serum half-life averages 6.3 hours or 21.5 hours in adults with Cl_cr about 18 mL/min or 2 mL/min, respectively.

Geriatric adults 64–88 years of age with renal function normal for their age: 0.9–1.5 hours.

Stability

Storage

Parenteral

Powder for Injection or IV Infusion

Vials containing 1 or 2 g of cefoxitin: 2–25° C; avoid exposure to temperatures >50° C.

Reconstituted solutions for IV administration prepared using sterile or bacteriostatic water, 0.9% sodium chloride, or 5% dextrose are stable for 6 hours at room temperature or 1 week when refrigerated at <5°C. After further dilution in 50 mL to 1 L of a compatible IV infusion solution, stable for an additional 18 hours at room temperature or an additional 48 hours if refrigerated.

Powder and reconstituted solutions may darken; does not indicate loss of potency.

Powder for IV infusion

Pharmacy bulk package vial containing 10 g of cefoxitin: 2–25°C; avoid temperatures >50°C. Transfer and dilute reconstituted solution in a compatible IV infusion solution within 4 hours after vial originally entered; discard any portion of reconstituted solution not used within 4 hours. After further dilution in 50 mL to 1 L of a compatible IV infusion solution, stable for an additional 18 hours at room temperature or an additional 48 hours if refrigerated.

Store commercially available Duplex drug delivery system containing 1 or 2 g of cefoxitin powder and 50 mL of dextrose injection at 20–25°C (may be exposed to 15–30°C). Following reconstitution (activation), use within 12 hours if stored at room temperature or within 7 days if stored in a refrigerator; do not freeze.

Injection (Frozen) for IV Infusion

-20°C or lower. After thawing, stable for 24 hours at room temperature (25°C) or 21 days under refrigeration (2–8°C).

Do not refreeze after thawing.

Compatibility

Parenteral

Solution CompatibilityHID

Drug Compatibility

Actions and Spectrum

• Cephamycin; sometimes classified with second generation cephalosporin based on spectrum of activity.

• Usually bactericidal.

• Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.

• Spectrum of activity includes some gram-positive and -negative aerobic bacteria and some anaerobic bacteria; inactive against Chlamydia, fungi, and viruses.

• Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (including penicillinase-producing strains), S. epidermidis, S. pneumoniae, S. pyogenes (group A β-hemolytic streptococci), and S. agalactiae (group B streptococci). Oxacillin-resistant staphylococci (methicillin-resistant staphylococci) and most enterococci (e.g., Enterococcus faecalis) are resistant.

• Gram-negative aerobes: Active in vitro and in clinical infections against E. coli, H. influenzae, Klebsiella (including K. pneumoniae), M. morganii, N. gonorrhoeae, P. mirabilis, P. vulgaris, and Providencia (including P. rettgeri). Also active in vitro against Eikenella corrodens (non-β-lactamase-producing strains), K. oxytoca, Salmonella, and Shigella. Many strains of Enterobacter cloacae and most strains of Pseudomonas aeruginosa are resistant.

• Anaerobes: Active in vitro and in clinical infections against Bacteroides distasonis, B. fragilis, B. ovatus, B. thetaiotaomicron, Clostridium (including C. perfringens but not C. difficile), Peptococcus niger, and Peptostreptococcus. Also active in vitro against Fusobacterium, Prevotella bivia, and Propionibacterium.

• Active in vitro against some mycobacteria, including Mycobacterium abscessus, M. fortuitum, and M. mucogenicum. Has variable activity against M. smegmatis; however, M. chelonae and M. immunogenum are resistant.

Advice to Patients

• Advise patients that antibacterials (including cefoxitin) should only be used to treat bacterial infections; they do not treat viral infections (e.g., the common cold).

• Importance of completing full course of therapy, even if feeling better after a few days.

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefoxitin or other antibacterials in the future.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

• Importance of informing clinicians if an allergic reaction occurs.

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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