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Tobramycin (Systemic)

Medically reviewed by Drugs.com. Last updated on Sep 25, 2019.

Pronunciation

(toe bra MYE sin)

Index Terms

  • Tobramycin Sulfate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

Generic: 10 mg/mL (2 mL); 80 mg/2 mL (2 mL); 1.2 g/30 mL (30 mL)

Solution, Injection [preservative free]:

Generic: 80 mg/2 mL (2 mL); 2 g/50 mL (50 mL)

Solution Reconstituted, Injection:

Generic: 1.2 g (1 ea)

Solution Reconstituted, Injection [preservative free]:

Generic: 1.2 g (1 ea)

Pharmacologic Category

  • Antibiotic, Aminoglycoside

Pharmacology

Interferes with bacterial protein synthesis by binding to 30S ribosomal subunit, resulting in a defective bacterial cell membrane

Absorption

Oral: Poorly absorbed

IM: Rapid and complete

Distribution

Distributes to extracellular fluid, including serum, abscesses, ascitic, pericardial, pleural, synovial, lymphatic, and peritoneal fluids; poor penetration into CSF, eye, bone, prostate; Vd: Higher in neonates than older pediatric and adult patients; also increased in patients with edema, ascites, fluid overload; decreased in patients with dehydration; Systemic:

Neonates: 0.45 ± 0.1 L/kg

Infants: 0.4 ± 0.1 L/kg

Children: 0.35 ± 0.15 L/kg

Adolescents: 0.3 ± 0.1 L/kg

Adults: 0.2 to 0.3 L/kg

Excretion

Normal renal function: Urine (~90% to 95%) within 24 hours

Time to Peak

Serum: IM: 30 to 60 minutes; IV: ~30 minutes; Note: Distribution may be prolonged after larger doses. One study reported a 1.7-hour distribution period after a 60-minute, high-dose aminoglycoside infusion (Demczar 1997).

Half-Life Elimination

Neonates: ≤1,200 g: 11 hours; >1,200 g: 2 to 9 hours

Infants: 4 ± 1 hour

Children: 2 ± 1 hour

Adolescents: 1.5 ± 1 hour

Adults: IV: 2 to 3 hours; directly dependent upon glomerular filtration rate

Adults with impaired renal function: 5 to 70 hours

Protein Binding

<30%

Special Populations: Renal Function Impairment

Clearance is decreased in renal impairment.

Use: Labeled Indications

Treatment of documented or suspected infections caused by susceptible gram-negative bacilli, including Pseudomonas aeruginosa.

Contraindications

Hypersensitivity to tobramycin, other aminoglycosides, or any component of the formulation

Dosing: Adult

Note: Individualization is critical because of the narrow therapeutic index.

In underweight and nonobese patients, use of total body weight (TBW) instead of ideal body weight for determining the initial mg/kg/dose is widely accepted (Nicolau 1995). Ideal body weight (IBW) also may be used to determine doses for patients who are neither underweight nor obese (Gilbert 2009).

Initial and periodic plasma drug levels (eg, peak and trough with conventional dosing, post dose level at a prespecified time with extended-interval dosing) should be determined, particularly in critically-ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery).

Severe life-threatening infections: IM, IV:

Conventional: 1 to 2.5 mg/kg/dose every 8 to 12 hours; to ensure adequate peak concentrations early in therapy, higher initial dosage may be considered in selected patients when extracellular water is increased (edema, septic shock, postsurgical, and/or trauma)

Once-daily: 4 to 7 mg/kg/dose once daily; some clinicians recommend this approach for all patients with normal renal function; this dose is at least as efficacious with similar, if not less, toxicity than conventional dosing.

Brucellosis: IM, IV: 240 mg (IM) daily or 5 mg/kg (IV) daily for 7 days; either regimen recommended in combination with doxycycline

Cerebrospinal fluid (CSF) shunt infection (adjunct to systemic therapy): Intraventricular (use a preservative-free preparation) (off-label route): 5 to 20 mg/day; some experts recommend adjusting dosage and administration interval based on CSF tobramycin concentrations (goal: 10 to 20 times MIC of causative organism) (IDSA [Tunkel 2017]; data are limited (Smetana 2018). When intraventricular tobramycin is administered via a ventricular drain, clamp drain for 15 to 60 minutes after administration (allows solution to equilibrate in CSF) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]). Note: Intraventricular administration is generally reserved for use in patients who fail parenteral therapy despite removal of CSF shunt or when CSF shunt cannot be removed (Baddour 2018).

Cholangitis: IM, IV: 4 to 6 mg/kg once daily with ampicillin

Diverticulitis, complicated: IM, IV: 1.5 to 2 mg/kg every 8 hours (with ampicillin and metronidazole)

Meningitis, bacterial due to Pseudomonas aeruginosa: IV: 5 mg/kg/day in divided doses every 8 hours (administered with other antimicrobials) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017])

Pelvic inflammatory disease: IM, IV: Loading dose: 2 mg/kg, then 1.5 mg/kg every 8 hours or 4.5 mg/kg once daily

Plague (Yersinia pestis): IM, IV: Treatment: 5 mg/kg/day, followed by postexposure prophylaxis with doxycycline

Pneumonia, hospital-acquired or ventilator-associated: IV: 5 to 7 mg/kg/day once daily for 7 days; may consider shorter or longer duration depending on rate of clinical improvement. When used as empiric therapy, use in combination with an agent active against S. aureus and an additional antipseudomonal agent. Note: Aminoglycosides are not recommended as monotherapy in patients with hospital-acquired or ventilator-associated pneumonia due to P. aeruginosa (Kalil 2016).

Prophylaxis against endocarditis (dental, oral, upper respiratory procedures, GI/GU procedures): IM, IV: 1.5 mg/kg with ampicillin (50 mg/kg) 30 minutes prior to procedure. Note: AHA guidelines now recommend prophylaxis only in patients undergoing invasive procedures and in whom underlying cardiac conditions may predispose to a higher risk of adverse outcomes should infection occur. As of April 2007, routine prophylaxis no longer recommended by the AHA.

Tularemia: IM, IV: 5 mg/kg/day divided every 8 hours for 1 to 2 weeks

Urinary tract infection, complicated (including pyelonephritis) (alternative agent): Outpatients: IM, IV: 5 mg/kg once, followed by 5 to 14 days of appropriate oral therapy. Note: Alternative parenteral agent when fluoroquinolones or beta-lactams cannot be used due to allergy, intolerance, unmodifiable drug interactions, or resistance (Hooton 2018).

Dosing: Geriatric

Dosage should be based on an estimate of ideal body weight.

IM, IV: 1.5 to 5 mg/kg/day in 1 to 2 divided doses

IV: Once daily or extended interval: 5 to 7 mg/kg/dose given every 24, 36, or 48 hours based on creatinine clearance

Dosing: Pediatric

Note: Dosage should be based on an estimate of ideal body weight. In morbidly obese children, adolescents, and adults, dosage requirement may best be estimated using a dosing weight of IBW + 0.4 (TBW - IBW). Dosage should be individualized based upon serum concentration monitoring. Initial and periodic plasma drug concentrations (eg, peak and trough with conventional dosing, post dose level at a prespecified time with extended-interval dosing) should be determined, particularly in critically ill patients with serious infections or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major surgery). Some dosing based on gentamicin studies:

General dosing, susceptible infection:

Conventional dosing: Infants, Children, and Adolescents: IM, IV: 6 to 7.5 mg/kg/day divided every 6 to 8 hours; individualize dosing based on patient-specific clinical parameters (Red Book [AAP 2015])

Extended-interval dosing: Limited data available:

Weight-directed: Infants, Children, and Adolescents: IV: 4.5 to 7.5 mg/kg/dose every 24 hours (Contopoulos-Ioannidis 2004; Red Book [AAP 2015])

Age-directed: Based on data from 114 patients, the following has been suggested (McDade 2010):

Infants ≥3 months and Children <2 years: IV: 9.5 mg/kg/dose every 24 hours

Children 2 to <8 years: IV: 8.5 mg/kg/dose every 24 hours

Children ≥8 years and Adolescents: IV: 7 mg/kg/dose every 24 hours

Cystic fibrosis, pulmonary infection: Infants, Children, and Adolescents:

Conventional dosing: IM, IV: 3.3 mg/kg/dose every 8 hours (Flume 2009)

Extended-interval dosing: IV: Initial: 10 to 12 mg/kg/dose every 24 hours (Flume 2009; Smyth 2005; Van Meter 2009); Note: The CF Foundation recommends extended-interval dosing as preferred over conventional dosing.

Endocarditis, treatment: Children and Adolescents: IV: 3 to 6 mg/kg/day divided every 8 hours; use in combination with other antibiotics dependent upon organism and source of infection (ie, valve-type) (AHA [Baltimore 2015])

Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 3 to 7.5 mg/kg/day divided every 8 to 24 hours (Solomkin 2010)

CNS infection:

Meningitis (Tunkel 2004):

Infants and Children: IV: 7.5 mg/kg/day divided every 8 hours

Adolescents: IV: 5 mg/kg/day divided every 8 hours

VP-shunt infection, ventriculitis: Limited data available: Infants, Children, and Adolescents: Intraventricular/intrathecal (use a preservative-free preparation): 5 to 20 mg/day

Peritonitis (CAPD) (Warady 2012): Limited data available: Infants, Children, and Adolescents: Intraperitoneal: Continuous: Loading dose: 8 mg per liter of dialysate; maintenance dose: 4 mg per liter

Urinary tract infection:

Traditional dosing: Infants and Children 2 to 24 months: IV: 5 mg/kg/day divided every 8 hours (AAP 2011)

Extended-interval dosing: Limited data available: Based on data from 179 patients, the following age-directed dosing has been suggested (Carapetis 2001):

Infants and Children <5 years: IV: 7.5 mg/kg/dose every 24 hours

Children 5 to 10 years: IV: 6 mg/kg/dose every 24 hours

Children >10 years and Adolescents: IV: 4.5 mg/kg/dose every 24 hours

Dosing: Obesity

In moderate obesity (TBW/IBW ≥1.25) or greater, (eg, morbid obesity [TBW/IBW >2]), initial dosage requirement may be estimated using a dosing weight of IBW + 0.4 (TBW - IBW) (Traynor 1995).

Reconstitution

Solution for injection: Dilute in 50-100 mL NS or D5W for IV infusion.

Administration

IM: May be administered IM by withdrawing the appropriate dose directly from a vial or by using a prefilled syringe. The pharmacy bulk package and tobramycin in sodium chloride 0.9% is not intended for IM administration.

IV: Administer by intermittent infusion over 20 to 60 minutes; higher doses are generally administered over 60 minutes (Aminimanizani 2002; Demczar 1997). Flush line with saline before and after administration.

Intraventricular (off-label route): Use preservative-free preparations only. When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow tobramycin solution to equilibrate in the CSF (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).

Dietary Considerations

May require supplementation of calcium, magnesium, potassium.

Storage

Stable at room temperature both as the clear, colorless solution and as the dry powder. Reconstituted solutions remain stable for 24 hours at room temperature and 96 hours when refrigerated.

Drug Interactions

Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Arbekacin: May enhance the nephrotoxic effect of Aminoglycosides. Arbekacin may enhance the ototoxic effect of Aminoglycosides. Monitor therapy

Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Avoid combination

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Monitor therapy

Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Monitor therapy

CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Monitor therapy

Cefazedone: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (2nd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (3rd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (4th Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalothin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephradine: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Consider therapy modification

CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Monitor therapy

Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Monitor therapy

Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Monitor therapy

Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination

Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination

Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination

Neuromuscular-Blocking Agents: Aminoglycosides may enhance the respiratory depressant effect of Neuromuscular-Blocking Agents. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Monitor therapy

Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Monitor therapy

Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Bacampicillin; Cloxacillin; Dicloxacillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Benzathine; Penicillin V Potassium. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Test Interactions

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro, leading to a potential underestimation of aminoglycoside serum concentration.

Adverse Reactions

Frequency not defined.

Central nervous system: Confusion, disorientation, dizziness, headache, lethargy, vertigo

Dermatologic: Exfoliative dermatitis, pruritus, skin rash, urticaria

Endocrine & metabolic: Decreased serum calcium, decreased serum magnesium, decreased serum potassium, decreased serum sodium, increased lactate dehydrogenase, increased nonprotein nitrogen

Gastrointestinal: Diarrhea, nausea, vomiting

Genitourinary: Casts in urine, oliguria, proteinuria

Hematologic & oncologic: Anemia, eosinophilia, granulocytopenia, leukocytosis, leukopenia, thrombocytopenia

Hepatic: Increased serum ALT, increased serum AST, increased serum bilirubin

Local: Pain at injection site

Otic: Auditory ototoxicity, hearing loss, tinnitus, vestibular ototoxicity

Renal: Increased blood urea nitrogen, increased serum creatinine

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Anaphylaxis, Clostridioides (formerly Clostridium) difficile-associated diarrhea, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

ALERT: U.S. Boxed Warning

Ototoxicity:

Neurotoxicity, manifested as both auditory and vestibular ototoxicity, can occur. The auditory changes are irreversible, are usually bilateral, and may be partial or total. Eighth nerve impairment and nephrotoxicity may develop, primarily in patients having preexisting renal damage and in those with healthy renal function to whom aminoglycosides are administered for longer periods or in higher doses than those recommended. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of aminoglycoside-induced hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations. Patients who develop cochlear damage may not have symptoms during therapy to warn them of eighth-nerve toxicity, and partial or total irreversible bilateral deafness may continue to develop after the drug has been discontinued. Keep patients treated with tobramycin injection and other aminoglycosides under close clinical observation because these drugs have an inherent potential for causing ototoxicity.

Nephrotoxicity:

Rarely, nephrotoxicity may not become apparent until the first few days after cessation of therapy. Aminoglycoside-induced nephrotoxicity usually is reversible. Keep patients treated with tobramycin injection and other aminoglycosides under close clinical observation because these drugs have an inherent potential for causing nephrotoxicity.

Monitoring:

Closely monitor renal and eighth nerve function in patients with known or suspected renal impairment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Periodically monitor peak and trough serum concentrations of aminoglycosides during therapy to assure adequate levels and to avoid potentially toxic levels. Prolonged serum concentrations above 12 mcg/mL should be avoided. Rising trough levels (above 2 mcg/mL) may indicate tissue accumulation. Such accumulation, excessive peak concentrations, advanced age, and cumulative dose may contribute to ototoxicity and nephrotoxicity. Examine urine for decreased specific gravity and increased excretion of protein, cells, and casts. Periodically measure serum urea nitrogen (BUN), serum creatinine, and creatinine clearance. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of impairment of renal, vestibular, or auditory function requires discontinuation of the drug or dosage adjustment.

Use tobramycin injection with caution in premature and neonatal infants because of their renal immaturity and the resulting prolongation of serum half-life of the drug.

Concurrent therapy:

Avoid concurrent and sequential use of other neurotoxic or nephrotoxic antibiotics, particularly other aminoglycosides (eg, amikacin, streptomycin, neomycin, kanamycin, gentamicin, paromomycin), cephaloridine, viomycin, polymyxin B, colistin, cisplatin, and vancomycin. Other factors that may increase patient risk are advanced age and dehydration.

Do not give aminoglycosides concurrently with potent diuretics, such as ethacrynic acid and furosemide. Some diuretics themselves cause ototoxicity, and intravenously (IV) administered diuretics enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.

Pregnancy:

Aminoglycosides can cause fetal harm when administered to a pregnant woman.

Warnings/Precautions

Concerns related to adverse effects:

• Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include pre-existing renal impairment, concomitant nephrotoxic medications, advanced age, and dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible.

• Neuromuscular blockade and respiratory paralysis: May cause neuromuscular blockade, respiratory failure, and prolonged respiratory paralysis, especially when given soon after anesthesia or muscle relaxants.

• Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity; usual risk factors include pre-existing renal impairment, concomitant neuro-/nephrotoxic medications, advanced age, and dehydration. Ototoxicity is proportional to the amount of drug given and the duration of treatment. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible damage. Tinnitus and/or hearing loss have also been reported. Discontinue treatment if signs of ototoxicity occur.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hearing impairment: Use with caution in patients with pre-existing vertigo, tinnitus, or hearing loss.

• Hypocalcemia: Use with caution in patients with hypocalcemia.

• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis and Parkinson disease.

• Renal impairment: Use with caution in patients with pre-existing renal insufficiency; dosage modification required during systemic therapy.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pregnancy: [US Boxed Warnings]: Aminoglycosides may cause fetal harm if administered to a pregnant woman.

Dosage form specific issues:

• Sulfite: Solution for injection may contain sodium metabisulfate; use caution in patients with sulfite allergy.

Other warnings/precautions:

• Long-term use: Systemic therapy is not intended for long-term therapy due to toxic hazards associated with extended administration.

Monitoring Parameters

Urinalysis, urine output, BUN, serum creatinine, peak and trough plasma tobramycin levels. Levels are typically obtained after the third dose in conventional dosing. Be alert to ototoxicity; hearing should be tested before and during treatment

Some penicillin derivatives may accelerate the degradation of aminoglycosides in vitro. This may be clinically-significant for certain penicillin (ticarcillin, piperacillin, carbenicillin) and aminoglycoside (gentamicin, tobramycin) combination therapy in patients with significant renal impairment. Close monitoring of aminoglycoside levels is warranted.

Pregnancy Considerations

Tobramycin crosses the placenta.

[US Boxed Warning]: Aminoglycosides may cause fetal harm if administered to a pregnant woman. There are several reports of total irreversible bilateral congenital deafness in children whose mothers received another aminoglycoside (streptomycin) during pregnancy. Although serious side effects to the fetus/infant have not been reported following maternal use of all aminoglycosides, a potential for harm exists.

Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of tobramycin may be altered (Bourget 1991). Tobramycin injection may be used for the management of cystic fibrosis in pregnant patients with Pseudomonas aeruginosa (inhalation is preferred unless risk of infection is great) (Edenborough 2008) and as an alternative antibiotic for prophylactic use prior to cesarean delivery (Bratzler 2013).

Patient Education

What is this drug used for?

• It is used to treat bacterial infections.

Frequently reported side effects of this drug

• Headache

• Diarrhea

• Nausea

• Vomiting

• Injection site pain

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Kidney problems like urinary retention, hematuria, change in amount of urine passed, or weight gain.

• Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting.

• Dizziness

• Passing out

• Chills

• Pharyngitis

• Muscle weakness

• Burning or numbness feeling

• Twitching

• Tinnitus

• Hearing impairment

• Hearing loss

• Seizures

• Bruising

• Bleeding

• Severe loss of strength and energy

• Confusion

Clostridioides (formerly Clostridium) (C. diff)-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.

• Stevens-Johnson syndrome/toxic epidermal necrolysis like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in mouth, throat, nose, or eyes.

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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