Kanamycin Sulfate

Class: Aminoglycosides
VA Class: AM300
CAS Number: 25389-94-0

• Neurotoxicity and Ototoxicity


• 
  

  Neurotoxicity (manifested as both auditory and vestibular ototoxicity) can occur.¹ Other neurotoxicity manifestations include vertigo, numbness, skin tingling, muscle twitching, and seizures.¹

  
  


• 
  

  Eighth-cranial nerve impairment develops principally in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.¹

  
  


• 
  

  Aminoglycoside-induced ototoxicity is irreversible, usually bilateral, and may be partial or total.¹

  
  


• 
  

  Risk of hearing loss increases with degree of exposure to either high peak or high trough serum concentrations.¹

  
  


• 
  

  Adjust dosage or discontinue kanamycin if evidence of ototoxicity (e.g., dizziness, vertigo, tinnitus, roaring in the ears, hearing loss) occurs.¹

  
  


• 
  

  Patients developing cochlear damage may not have symptoms during aminoglycoside treatment to warn them of eighth-cranial nerve toxicity and total or partial, irreversible, bilateral deafness may occur after drug discontinued.¹

  
  

• Nephrotoxicity


• 
  

  Potentially nephrotoxic.¹

  
  


• 
  

  Oliguria may indicate renal impairment.¹

  
  


• 
  

  Nephrotoxicity develops principally in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.¹

  
  

• Patient Monitoring


• 
  

  Patients should be under close clinical observation because of potential toxicities.¹

  
  


• 
  

  Closely monitor renal and eighth-cranial nerve function, especially in patients with known or suspected renal impairment at start of treatment and also in those whose renal function is initially normal but who develop renal dysfunction during treatment.¹

  
  


• 
  

  Periodically monitor serum kanamycin concentrations to ensure adequate concentrations and avoid potentially toxic and prolonged peak concentrations (>35 mcg/mL).¹

  
  


• 
  

  Rising trough concentrations (>10 mcg/mL) may indicate tissue accumulation.¹ Tissue accumulation, excessive peak concentrations, cumulative dose, advanced age, and dehydration may contribute to ototoxicity and nephrotoxicity.¹

  
  


• 
  

  Evaluate urine for decreased specific gravity and increased excretion of protein, cells, and casts; periodically determine BUN, S_cr, and CL_cr.¹

  
  


• 
  

  When feasible, perform serial audiograms in patients old enough to be tested, particularly high-risk patients.¹

  
  


• 
  

  Discontinue kanamycin or adjust dosage if there is evidence of impaired renal, vestibular, or auditory function.¹

  
  

• Neuromuscular Blockade


• 
  

  Concomitant use of an aminoglycoside with anesthesia and muscle-relaxing drugs may cause neuromuscular blockade with respiratory paralysis.¹ May occur with aminoglycosides given by any route, including intraperitoneal instillation.¹

  
  


• 
  

  Consider possibility of neuromuscular blockade and respiratory paralysis when administering aminoglycosides, especially concurrently with anesthetics or neuromuscular-blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in patients receiving massive transfusions of citrate-anticoagulated blood.¹ (See Interactions.)

  
  


• 
  

  Calcium salts may reduce neuromuscular blockade, but mechanical respiratory assistance may be necessary.¹

  
  

• Interactions


• 
  

  Avoid concurrent and/or sequential use of other neurotoxic or nephrotoxic drugs, particularly other aminoglycosides (including paromomycin), amphotericin B, bacitracin, cisplatin, colistimethate/colistin, polymyxin B, vancomycin, and viomycin.¹ (See Interactions.)

  
  


• 
  

  Avoid concurrent use of potent diuretics (e.g., ethacrynic acid, furosemide, meralluride sodium [not commercially available in the US], sodium mercaptomerin [not commercially available in the US], mannitol) since diuretics themselves may cause ototoxicity and IV diuretics enhance toxicity by altering serum and tissue aminoglycoside concentrations.¹ (See Interactions.)

  
  

Introduction

Antibacterial and antituberculosis agent; aminoglycoside antibiotic obtained from cultures of Streptomyces kanamyceticus.^{1 4 21}

Uses for Kanamycin Sulfate

Serious Bacterial Infections

Has been used for short-term treatment of serious bacterial infections caused by susceptible Acinetobacter, Escherichia coli, Enterobacter aerogenes, Klebsiella pneumoniae, Proteus, or Serratia marcescens.^{1 4} Not a drug of choice; use only when causative agent is susceptible and other anti-infectives are ineffective or contraindicated.²¹ When a parenteral aminoglycoside is indicated, amikacin, gentamicin, or tobramycin usually is preferred.^{4 21}

Has been used in conjunction with a penicillin or cephalosporin for initial therapy of serious infections when the causative agent is unknown.¹ If anaerobic bacteria are suspected, consider using a suitable anti-infective in conjunction with kanamycin.¹ Adjust therapy based on in vitro susceptibility testing.¹

Has been used for treatment of known or suspected staphylococcal infections in certain situations.¹ This includes initial treatment of severe infections when the causative organisms may be either gram-negative bacteria or staphylococci, treatment of infections caused by susceptible staphylococci in patients hypersensitive to other more appropriate anti-infectives, and treatment of mixed infections that may involve both gram-negative bacteria and staphylococci.¹ Not a drug of choice for staphylococcal infections.¹

Mycobacterial Infections

Treatment of active (clinical) tuberculosis† (TB) in conjunction with other antituberculosis agents.^{6 7 21}

Second-line agent used in the treatment of TB in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.⁶

Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.^{6 e}

Kanamycin Sulfate Dosage and Administration

Administration

Administer by IV infusion or IM injection.¹

IV administration generally is recommended in patients with life-threatening infections, septicemia, shock, severe hypotension, CHF, hematologic disorders, severe burns, or reduced muscle mass.^b

Has been administered by inhalation via a nebulizer.¹

Has been administered by intraperitoneal instillation^{1 4} or irrigation (abscess cavities, pleural space, peritoneal and ventricular cavities).¹

Has been administered orally,² but a preparation for oral administration is no longer commercially available in the US.

Patient should be well hydrated prior to and during therapy to minimize chemical irritation of renal tubules from high urine kanamycin concentrations.¹

Assess renal function prior to and daily or more frequently during therapy.¹ Keep patients under close clinical observation because of the risk of ototoxicity and nephrotoxicity.¹ (See Neurotoxicity and Ototoxicity under Cautions.)

IV Administration

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

Administer concomitant anti-infectives (e.g., cephalosporins, penicillins) separately; do not admix.¹

Dilution

Prepare IV infusions by adding 500 mg of kanamycin to 100–200 mL or 1 g to 200–400 mL of compatible diluent (e.g., 0.9% sodium chloride, 5% dextrose).¹

Rate of Administration

Administer slowly over 30–60 minutes.¹

IM Administration

Inject deeply into the upper outer quadrant of the gluteal muscle.¹

Intraperitoneal Instillation

Instill into the peritoneal cavity through a polyethylene catheter sutured into the wound at closure (e.g., following exploration for established peritonitis or after peritoneal contamination due to fecal spill during surgery).¹

Consider risk of toxicity with this route; closely monitor serum concentrations.¹ If possible, postpone until patient has fully recovered from the effects of anesthesia and skeletal muscle relaxants.¹ (See Interactions.)

Dilution

Prepare intraperitoneal solution by diluting 500 mg kanamycin in 20 mL sterile water for injection.¹

Irrigation

If used as an irrigating solution in abscess cavities, pleural space, or peritoneal and ventricular cavities, consider risk of toxicity with this route; closely monitor serum concentrations.¹

Dilution

Prepare a solution for irrigation containing 2.5 mg kanamycin per mL.¹

Nebulization

Monitor serum concentrations carefully during nebulization therapy.¹

Dilution

Prepare a solution for nebulization by diluting 1 mL of kanamycin injection (250 mg/mL) in 3 mL of 0.9% sodium chloride injection.¹

Dosage

Available as kanamycin sulfate; dosage expressed in terms of kanamycin.¹

Dosage is identical for either IV or IM administration.¹

Base dosage on patient's pretreatment body weight and renal status.¹ For obese patients, base dosage on lean body mass.¹

Many clinicians recommend that dosage be determined using appropriate pharmacokinetic methods for calculating dosage requirements and patient-specific pharmacokinetic parameters (e.g., elimination rate constant, volume of distribution) derived from serum concentration-time data; susceptibility of the causative organism; severity of the infection; and the patient's immune and clinical status.^b Because of potential toxicity, fixed-dosage recommendations not based on patient weight or serum drug concentrations are not advised.^b

Determine peak and trough serum kanamycin concentrations periodically during therapy.^{1 b} Adjust dosage to maintain desired serum concentrations whenever possible, especially in patients with life-threatening infections, suspected toxicity or nonresponse to treatment, decreased or varying renal function, and/or when increased aminoglycoside clearance (e.g., patients with cystic fibrosis, burns) or prolonged therapy is likely.^{4 200 201 202 203}

In general, desirable peak kanamycin concentrations (30–60 minutes following IM injection or 15–30 minutes after completion of an IV infusion)^b during parenteral therapy are 15–30 mcg/mL^{1 4 8 b} and trough concentrations (just prior to the next dose) should not exceed 5–10 mcg/mL.^{1 4 8 b} Some evidence suggests that an increased risk of toxicity may be associated with prolonged peak kanamycin concentrations >30–35 mcg/mL.^{4 8} Manufacturer recommends avoiding peak serum concentrations (30–90 minutes after injection) >35 mcg/mL and trough concentrations (just prior to the next dose) >10 mcg/mL.¹

Once daily† administration of kanamycin is recommended for the treatment of tuberculosis†;⁶ once-daily regimens are rarely used for other indications.⁴

Usual duration of parenteral treatment for serious bacterial infections is 7–10 days.¹ In difficult and complicated infections, reevaluate use of kanamycin if treatment duration >14 days is being considered.^{1 4} Long-term use is not recommended.^{1 4}

If the drug is continued, closely monitor serum kanamycin concentrations and renal, auditory, and vestibular functions if the drug is continued.¹

Well-hydrated patients with normal kidney function who receive a total kanamycin dose of ≤15 g have a low risk of toxic reactions.¹

Pediatric Patients

General Pediatric Dosage

Use with caution in premature infants and neonates because renal immaturity may prolong serum half-life.¹

AAP states kanamycin is inappropriate for treatment of mild to moderate infections.⁷

Serious Bacterial Infections

Uncomplicated infections usually respond within 24–48 hours; if definite clinical response does not occur within 3–5 days, discontinue kanamycin and reevaluate susceptibility of the causative organism.¹ Failure to respond may be caused by resistance or the presence of septic foci requiring surgical drainage.¹

IV

15 mg/kg daily given in 2 or 3 equally divided doses every 8 or 12 hours.¹

Infants and children >4 weeks of age: AAP recommends 15–22.5 mg/kg daily given in 3 divided doses;⁷ some clinicians recommend 30 mg/kg daily given in 3 divided doses.⁷

IM

15 mg/kg daily given in 2 equally divided doses every 12 hours; alternatively, use 3 or 4 equally divided doses every 6 or 8 hours if continuously high blood concentrations desired.¹

Infants and children >4 weeks of age: AAP recommends 15–22.5 mg/kg daily given in 3 divided doses;⁷ some clinicians recommend 30 mg/kg daily given in 3 divided doses.⁷

Tuberculosis†

Treatment of Active (Clinical) Tuberculosis†

Should not be used alone for treatment of TB; must be given in conjunction with other antituberculosis agents.⁶

IV or IM

Children <15 years of age weighing ≤40 kg: 15–30 mg/kg daily (up to 1 g) given once daily or twice weekly recommended by ATS, CDC, and IDSA.⁶

Children ≥15 years of age or weighing >40 kg: ATS, CDC, and IDSA recommend 15 mg/kg daily (up to 1 g) given as a single daily dose 5–7 times weekly for the first 2–4 months or until culture conversion;⁶ dosage can then be reduced to 15 mg/kg daily (up to 1 g) given as a single daily dose 2–3 times weekly.⁶

AAP recommends 15–30 mg/kg daily (up to 1 g) in infants, children, or adolescents.⁷

Adults

Serious Bacterial Infections

Uncomplicated infections usually respond within 24–48 hours; if definite clinical response does not occur within 3–5 days, discontinue kanamycin and reevaluate susceptibility of the causative organism.¹ Failure to respond may be caused by resistance or the presence of septic foci requiring surgical drainage.¹

IV

15 mg/kg daily in 2 or 3 equally divided doses given every 8 or 12 hours for 7–10 days.¹

IM

15 mg/kg (up to 1.5 g) daily given in 2 equally divided doses every 12 hours for 7–10 days; alternatively, 3 or 4 equally divided doses every 6 or 8 hours if continuously high blood concentrations desired.¹

Intraperitoneal

Instill 500 mg into the peritoneal cavity for established peritonitis or after peritoneal contamination due to fecal spill during surgery.¹

Irrigation

Instill 2.5 mg/mL solution into abscess cavities, pleural space, or peritoneal or ventricular cavities.¹

Inhalation

250 mg 2–4 times daily.¹ Administer diluted in 3 mL of 0.9% sodium chloride using a nebulizer.¹

Tuberculosis†

Treatment of Active (Clinical) Tuberculosis†

Should not be used alone for treatment of TB; must be given in conjunction with other antituberculosis agents.⁶

IV or IM

ATS, CDC, and IDSA recommend 15 mg/kg (up to 1 g) given once daily 5–7 times weekly for 2–4 months or until culture conversion;⁶ dosage can then be reduced to 15 mg/kg once daily (up to 1 g) 2–3 times weekly.⁶

Prescribing Limits

Pediatric Patients

Serious Bacterial Infections

All Routes

Maximum: 1.5 g daily.¹ Total dose ≤15 g.¹

Treatment of Active (Clinical) Tuberculosis†

IV or IM

Maximum 1 g.⁶

Adults

Serious Bacterial Infections

All Routes

Maximum: 1.5 g daily.¹ Total dose ≤15 g.¹

Treatment of Active (Clinical) Tuberculosis†

IV or IM

Maximum 1 g.⁶

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

Serious Bacterial Infections

Dosage adjustments necessary in patients with renal impairment.^{1 4 8 15} Whenever possible, monitor serum kanamycin concentrations, especially in patients with changing renal function.¹

Various methods have been used to determine aminoglycoside dosage for patients with renal impairment, and there is wide variation in dosage recommendations for these patients.^{1 8 15}

Manufacturer recommends an initial dosage of 7.5 mg/kg given at intervals (in hours) calculated by multiplying the patient’s steady-state serum creatinine (in mg/dL) by 9.¹

The dosing method of Sarubbi and Hull (based on corrected Cl_cr) also has been recommended.^b Consult specialized references for specific information on dosage for patients with renal impairment.

Dosage calculation methods should not be used in patients undergoing hemodialysis or peritoneal dialysis.^a

In adults with renal failure undergoing hemodialysis, some clinicians recommend supplemental doses of 50–75% of the initial loading dose at the end of each dialysis period.⁸

Dialysis patients: monitor serum kanamycin concentrations and adjust dosage to maintain desired concentrations.^a

Treatment of Active (Clinical) Tuberculosis†

Adults

IV or IM

ATS, CDC, and IDSA recommend that usual doses be given at less frequent intervals; lower doses may reduce efficacy.⁶ These experts recommend 12–15 mg/kg daily given 2 or 3 times weekly.⁶

Hemodialysis patients: Give dose after hemodialysis is finished.⁶ Monitor serum kanamycin concentrations and adjust dosage to maintain desired concentrations.⁶

Geriatric Patients

Treatment of Active (Clinical) Tuberculosis†

IV or IM

>59 years of age: 10 mg/kg daily (up to 750 mg).⁶

Select dosage with caution and closely monitor renal function because of age-related decreases in renal function.^a

Cautions for Kanamycin Sulfate

Contraindications

• 
  

  History of hypersensitivity or serious toxic reactions to kanamycin or other aminoglycosides.¹

  
  


• 
  

  Long-term therapy (e.g., tuberculosis) because of toxic hazards associated with extended administration.¹

  
  

Warnings/Precautions

Warnings

Neurotoxicity and Ototoxicity

Patients receiving aminoglycosides should be under close clinical observation because of possible ototoxicity.¹

Vestibular and permanent bilateral auditory ototoxicity occurs most frequently in those with past or present history of renal impairment, those receiving other ototoxic drugs, and those who receive high dosages or prolonged treatment.¹

Serial audiograms should be obtained, if feasible, in patients old enough to be tested, particularly in high-risk patients.¹

Discontinue kanamycin or adjust dosage if there is evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss).¹

Some aminoglycosides have caused fetal ototoxicity when administered to pregnant women.¹ (See Pregnancy under Cautions.)

Nephrotoxicity

Patients receiving aminoglycosides should be under close clinical observation because of possible nephrotoxicity.¹ Renal function should be assessed prior to therapy and daily, or more frequently, during therapy.¹

Nephrotoxicity occurs most frequently in those with past or present history of renal impairment, those receiving other nephrotoxic drugs, and those who receive high dosage or prolonged treatment.¹

Monitor urine for increased protein excretion and the presence of cells and casts.¹ Obtain Cl_cr, S_cr, and/or BUN at the onset of therapy, frequently during therapy, and at or shortly after the end of therapy.¹ If renal function is changing, test more frequently.¹

Dosage reduction and increased hydration may be desirable if other evidence of renal dysfunction occurs (e.g., decreased Cl_cr, decreased urine specific gravity, increased BUN or serum creatinine, oliguria).¹

If azotemia increases or if a progressive decrease in urinary output occurs, discontinue kanamycin.¹

Aminoglycoside-induced nephrotoxicity usually is reversible.¹

Neuromuscular Blockade

Neuromuscular blockade and respiratory paralysis reported with high kanamycin dosage.¹

Possibility of neuromuscular blockade should be considered, especially in patients receiving anesthetics or neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in those receiving massive transfusions of citrate-anticoagulated blood.¹

Calcium salts may reverse neuromuscular blockade, but mechanical respiratory assistance may be necessary.¹

Sensitivity Reactions

Hypersensitivity

Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with aminoglycosides.¹

Cross-sensitivity

Cross-sensitivity occurs among the aminoglycosides.^{1 b}

Sulfite Sensitivity

Kanamycin injection contains sodium metabisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.¹

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of kanamycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹

Usually used in conjunction with other anti-infectives (e.g., penicillins, cephalosporins) for empiric treatment of serious infections pending results of in vitro susceptibility tests.¹ If anaerobic bacteria are suspected, concomitant use of an anti-infective active against anaerobes is necessary.¹

Topical Instillation

Aminoglycosides may be absorbed in substantial quantities from body surfaces after topical instillation or local irrigation and may cause neurotoxicity, nephrotoxicity, neuromuscular blockade, or respiratory paralysis.^{1 b} Carefully monitor serum levels during treatment.¹

Hydration

Patient should be well hydrated before treatment to prevent irritation of the renal tubules by the high concentrations of kanamycin in the urinary excretory system.¹

Risk of toxic reactions is low in well-hydrated patients with normal kidney function who receive a total kanamycin dose ≤15 g.¹

Neuromuscular Disorders

Use with caution in patients with neuromuscular disorders such as myasthenia gravis, parkinsonism, or infant botulism; may aggravate muscle weakness because of potential curare-like effect on the neuromuscular junction.¹

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.¹ Discontinue drug and institute appropriate therapy if superinfection occurs.¹

Specific Populations

Pregnancy

Category D.¹

Possibility of fetal harm if administered to a pregnant woman.¹ Complete, irreversible, bilateral congenital deafness reported when another aminoglycoside (i.e., streptomycin) was used during pregnancy.¹

If used during pregnancy or if patient becomes pregnant while receiving kanamycin, patient should be apprised of the potential hazard to the fetus.¹

Lactation

Distributed into milk.¹ Use with caution.¹

Pediatric Use

Use with caution in neonates and premature infants because renal immaturity in these patients may result in prolonged serum half-life.¹

Geriatric Use

Increased risk of toxicity; select dosage with caution and closely monitor renal function because of age-related decreases in renal function.¹

When assessing renal function in geriatric patients, Cl_cr may be more useful than BUN or S_cr.¹

Renal Impairment

Risk of neurotoxicity (manifested as vestibular and permanent bilateral auditory ototoxicity) is greater in patients with renal damage than in other patients.¹

Renal function should be assessed prior to and during therapy.¹

Eighth-cranial nerve function should be monitored closely, especially in patients who have known or suspected renal impairment at the start of treatment and also in those whose renal function is initially normal but who develop signs of renal dysfunction during treatment.¹

Common Adverse Effects

Ototoxicity, neurotoxicity.¹

Interactions for Kanamycin Sulfate

Neurotoxic, Ototoxic, or Nephrotoxic Drugs

Concomitant or sequential use with other drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, if possible.^{1 b}

Because of the possibility of an increased risk of ototoxicity due to additive effects or altered serum and tissue aminoglycoside concentrations, do not give concurrently with potent diuretics.^{1 b}

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Amphotericin B	Possible increased incidence of nephrotoxicity and/or neurotoxicity1	Avoid concurrent or sequential use, if possible1
Anti-emetics (e.g., dimenhydrinate, meclizine)	Anti-emetics that suppress nausea and vomiting of vestibular origin and vertigo may mask symptoms of vestibular ototoxicity8
Bacitracin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1	Avoid concurrent or sequential use, if possible1
β-Lactam antibiotics (cephalosporins, penicillins)	In vitro evidence of additive or synergistic antibacterial effects between penicillins and aminoglycosides against some enterococci, Enterobacteriaceae, or Ps. aeruginosa; used to therapeutic advantage (e.g., treatment of endocarditis)b Possible increased incidence of nephrotoxicity reported with some cephalosporins; cephalosporins may spuriously elevate creatinine concentrations1 b Potential in vitro and in vivo inactivation of aminoglycosides1	Do not admix; administer IV solutions of the drugs separately1 Monitor serum aminoglycoside concentrations, especially when high penicillin doses are used or patient has renal impairment1 Promptly assay, freeze, or treat specimens with beta-lactamase1
Carbapenems (imipenem)	In vitro evidence of additive or synergistic antibacterial effects with aminoglycosides against some gram-positive bacteria (Enterococcus faecalis, S. aureus, Listeria monocytogenes)b
Chloramphenicol	Some in vitro evidence of antagonism with aminoglycosides; in vivo antagonism has not been demonstrated and the drugs have been administered concomitantly with no apparent decrease in activityb
Cisplatin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1	Avoid concurrent or sequential use, if possible1
Clindamycin	Some in vitro evidence of antagonism with aminoglycosides; in vivo antagonism has not been demonstrated and the drugs have been administered concomitantly with no apparent decrease in activityb
Colistimethate/Colistin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1	Avoid concurrent or sequential use, if possible1
Diuretics (ethacrynic acid, furosemide, meralluride sodium, sodium mercaptomerin, mannitol)	Possible increased risk of ototoxicity (diuretics themselves may cause ototoxicity) or increased risk of other aminoglycoside-related adverse effects (diuretics may alter aminoglycoside serum or tissue concentrations)1 b
Neuromuscular blocking agents and general anesthetics (succinylcholine, tubocurarine, decamethonium)	Possible potentiation of neuromuscular blockade and respiratory paralysis1	Use concomitantly with caution; closely observe for signs of respiratory depression1
NSAIAs	Possible increased serum aminoglycoside concentrations reported with indomethacin in premature neonates; may be related to indomethacin-induced decreases in urine output	Closely monitor aminoglycoside concentrations and adjust dosage accordingly
Polymyxin B	Possible increased incidence of nephrotoxicity and/or neurotoxicity1	Avoid concurrent or sequential use, if possible1
Tetracyclines	Some in vitro evidence of antagonism with aminoglycosides; in vivo antagonism has not been demonstrated and the drugs have been administered concomitantly with no apparent decrease in activityb
Vancomycin	Possible increased incidence of nephrotoxicity and/or neurotoxicity1	Avoid concurrent or sequential use, if possible1

Kanamycin Sulfate Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract.^{4 16 17 21}

Rapidly absorbed following IM injection;^{1 13 21} peak serum concentrations attained within 1 hour.¹

Aminoglycosides are quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation or intraoperative topical application in association with medical procedures.^{1 b} Also rapidly absorbed from the bronchial tree, wounds, or denuded skin after local instillation, or when used to irrigate joints; use of large doses at these sites may result in substantial plasma concentrations of the drugs.^b

Plasma Concentrations

Following a single IM dose of 7.5 mg/kg in adults with normal renal function, peak plasma concentrations average 22 mcg/mL within 1 hour;¹ 8 hours after the dose, plasma concentrations average 3.2 mcg/mL.¹ Plasma concentrations are similar following IV infusion over 1 hour.¹

Premature infants: Single IM dose of 6.3–8.5 mg/kg resulted in peak plasma concentrations averaging 17.5 mcg/mL within 1 hour and 5.8 mcg/mL at 12 hours.¹⁸

Neonates 1–7 days of age: Single IM dose of 7.5 mg/kg or 10 mg/kg resulted in peak serum concentrations of 21.8 or 26.8 mcg/mL, respectively, 30 minutes after dose.¹⁹ When given by IV infusion over 20 minutes, plasma concentrations were 21.4 or 29.3 mcg/mL, respectively.¹⁹

Intraperitoneal instillation of 500 mg in 20 mL of 0.9% sodium chloride: Peak plasma concentration of 19 mcg/mL within 15 minutes.¹⁴

Special Populations

Plasma concentrations may be lower in pregnant women.⁴

Plasma concentrations are higher in patients with renal impairment.^{1 4 15}

Plasma concentrations may be decreased in patients with severe burns.¹

Distribution

Extent

Distributed into most body tissues and fluids including pleural fluid, synovial fluid, ascitic fluid, gallbladder, and bile.^{1 4} Low concentrations in saliva and bronchial secretions.⁴

Low concentrations in CSF in adults with uninflamed meninges.^{1 4}

Infants: CSF concentration is 10–20% of serum concentrations if normal meninges; may be 50% if meninges are inflamed.¹

Crosses the placenta and is distributed into cord blood and amniotic fluid.^{1 4}

Distributed into milk.¹

Elimination

Elimination Route

Excreted principally in urine by glomerular filtration; not reabsorbed by renal tubules.¹

Removed by hemodialysis^{4 10 15} and peritoneal dialysis.^{4 15}

Half-life

Adults: 2–4 hours.^{1 4 8 9 11 13 15}

Special Populations

Geriatric patients: Half-life may be prolonged.⁴

Premature neonates: 9 hours.¹⁸

Neonates 1–7 days of age: 4.3–5.1 hours.¹⁹

Severe burn patients: Possible decreased half-life.¹

Renal impairment: Prolonged half-life.^{1 4 15}

Severe renal impairment: 27–80 hours.^{4 8 15}

Stability

Storage

Parenteral

Injection

20–25°C.¹

Stable for 24 hours at room temperature in most IV fluids (e.g., 0.9% sodium chloride, 5% dextrose).⁵

Solution may darken during storage; does not indicate a loss of potency.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible

Amino acids 4.25%, dextrose 25%

Dextrose 5% in sodium chloride 0.9%

Dextrose 5 or 10% in water

Isolyte M or P with dextrose 5%

Ringer’s injection, lactated

Sodium chloride 0.9%

Drug Compatibility

Manufacturer states that kanamycin should not be admixed with β-lactam antibiotics because of possible mutual inactivation.¹

Admixture CompatibilityHID

Compatible

Ascorbic acid injection

Cefoxitin sodium

Chloramphenicol sodium succinate

Clindamycin phosphate

Dopamine HCl

Furosemide

Penicillin G potassium

Penicillin G sodium

Polymyxin B sulfate

Sodium bicarbonate

Vitamin B complex with C

Incompatible

Amphotericin B

Chlorpheniramine maleate

Colistimethate sodium

Heparin sodium

Methohexital sodium

Variable

Hydrocortisone sodium succinate

Y-Site CompatibilityHID

Compatible

Cyclophosphamide

Furosemide

Heparin sodium with hydrocortisone sodium succinate

Hydromorphone HCl

Magnesium sulfate

Meperidine HCl

Morphine sulfate

Perphenazine

Potassium chloride

Vitamin B complex with C

Actions and SpectrumActions

• 
  

  Usually bactericidal.¹

  
  


• 
  

  Inhibits protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.^{1 b}

  
  


• 
  

  In vitro spectrum of activity includes many gram-negative aerobic bacteria (including most Enterobacteriaceae and Pseudomonas aeruginosa), some mycobacteria, and some aerobic gram-positive bacteria.^{1 b} Inactive against fungi, viruses, and most anaerobic bacteria.^b

  
  


• 
  

  Gram-positive aerobes: Active in vitro against penicillinase-producing and nonpenicillinase-producing Staphylococcus aureus,¹ S. epidermidis,¹ Streptococcus pyogenes (group A β-hemolytic streptococci),¹ S. pneumoniae,¹ and group D streptococci.¹

  
  


• 
  

  Gram-negative aerobes: Active in vitro and in clinical infections against Acinetobacter,¹ Citrobacter,¹ Enterobacter aerogenes,¹ Escherichia coli,¹ Haemophilus influenzae,¹ Klebsiella pneumoniae,¹ Neisseria gonorrhoeae,¹ Proteus,¹ Providencia,¹ Salmonella,¹ Shigella,¹ and Serratia marcescens.¹

  
  


• 
  

  Mycobacteria: Active against Mycobacterium tuberculosis^{4 6} and may be active against multidrug-resistant strains.⁶ Active in vitro against some strains of M. abscessus.

  
  


• 
  

  Partial cross-resistance occurs between kanamycin and other aminoglycosides.^b

  
  


• 
  

  Some M. tuberculosis resistant to streptomycin may be susceptible to kanamycin,⁶ but M. tuberculosis demonstrates complete cross-resistance between kanamycin and amikacin.^{4 6} Cross-resistance also can occur between kanamycin and capreomycin.^f

  
  


• 
  

  There have been recent reports of extensively drug-resistant (XDR) TB.^{c d e} XDR TB is caused by M. tuberculosis resistant to both rifampin and isoniazid that also are resistant to

Triveen-PRx RNF

Dosage Form: capsule
Triveen™-PRx RNF

Capsules

Rx Only

Triveen-PRx RNF Description

Triveen™-PRx RNF is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Triveen™-PRx RNF is supplied as an oblong, maroon softgel capsule with "T558" imprinted on one side.

Each capsule has the following active ingredient:
Folic Acid	1.2 mg

* from approximately 350 mg of Omega-3s derived from approximately 380 mg of purified fish oil.
Each capsule also contains the following ingredients for nutritional supplementation:
Vitamin C (ascorbic acid)	28 mg
Calcium (tribasic calcium phosphate)	160 mg
Iron (ferrous fumarate)	26 mg
Vitamin D3 (cholecalciferol)	400 IU
Vitamin E (d-alpha tocopherol)	30 IU
Vitamin B6 (pyridoxine hydrochloride)	25 mg
DHA (Docosahexaenoic Acid)	300 mg*
Docusate Sodium	55 mg

Inactive Ingredients

Gelatin, Glycerin, Soybean Oil, Purified water, Lecithin, Yellow Beeswax, Natural Creamy Orange Flavor, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, FD&C Blue #1.

INDICATIONS

Triveen™-PRx RNF is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

Contraindications

Triveen™-PRx RNF capsules is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Warnings

Daily ingestion of more than 3 g per day of omega-3 fatty acids (ALA, EPA, and DHA) from fish oils may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids – including DHA, should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

This product contains soybean oil and fish oil.

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Precautions

General

Folic acid, when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

PATIENT INFORMATION

Triveen™-PRx RNF is a prescription vitamin for use only under the direction and supervision of a licensed physician.

INTERACTIONS

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Drugs which may interact with folate include:

• Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of this AED in the blood and allowing breakthrough seizures to occur.


• Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine.


• Cholestyramine: Reduces folic acid absorption and reduces serum folate levels.


• Colestipol: Reduces folic acid absorption and reduces serum folate levels.


• Cycloserine: Reduces folic acid absorption and reduces serum folate levels.


• Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim.


• Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine.


• Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin.


• Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac.


• Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy.


• Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone.


• Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts.


• Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine.


• Smoking and Alcohol: Reduced serum folate levels have been noted.


• Sulfasalazine: Inhibits the absorption and metabolism of folic acid.


• Metformin treatment in patients with type 2 diabetes decreases serum folate.


• Warfarin can produce significant impairment in folate status after a 6-month therapy.

Adverse Reactions

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride.

Triveen-PRx RNF Dosage and Administration

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

How is Triveen-PRx RNF Supplied

Bottles of 30 softgel capsules.

NDC 13811-558-30

Bottles of 60 softgel capsules.

NDC 13811-558-60

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].

Call your doctor about side effects. You may report by calling 888 9 TRIGEN (888-987-4436).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:

TRIGEN Laboratories, Inc.

Sayreville, NJ 08872

www.trigenlab.com

Rev. 08/11

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-558-30

Rx Only

Triveen™-PRx

RNF

Capsules

30 CAPSULES

TRIGEN

LABORATORIES

TRIVEEN-PRX  RNF folic acid, ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, doconexent, and docusate sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-558 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Folic Acid (Folic Acid) Folic Acid 1.2 mg Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 28 mg Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 160 mg Iron (Iron) Iron 26 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Doconexent (Doconexent) Doconexent 300 mg Docusate Sodium (Docusate) Docusate Sodium 55 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Glycerin   Soybean Oil   Water   Yellow Wax   FD&C Red No. 40   Titanium Dioxide   Ethyl Vanillin   FD&C Yellow No. 6   FD&C Blue No. 1

Product Characteristics Color RED (maroon) Score no score Shape CAPSULE (oblong) Size 25mm Flavor ORANGE (Creamy Orange) Imprint Code T558 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-558-30 30 CAPSULE In 1 BOTTLE None 2 13811-558-60 60 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		05/15/2010

Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 09/2011TRIGEN Laboratories, Inc.

St. John&apos;s Wort

Pronunciation: Not applicable.
Generic Name: St. John's Wort
Brand Name: Generics only. No brands available.

St. John's Wort is used for:

Treating mild to moderate depression, nervousness, insomnia (difficulty sleeping), and infections. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.

St. John's Wort is an herbal product. It is thought to work by balancing certain chemicals in the brain, which improves mood.

Do NOT use St. John's Wort if:

• you are allergic to any ingredient in St. John's Wort


• you are pregnant


• you are taking an antidepressant, amphetamines, blood thinners (eg, warfarin), bromocriptine, narcotic analgesics, pramipexole, or ropinirole


• you are taking or have taken a serotonin reuptake blocker (eg, fluoxetine) within the past 14 days


• you have a history of severe depression or feel like harming yourself or others

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using St. John's Wort:

Some medical conditions may interact with St. John's Wort. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of bipolar disorder (manic-depressive illness) or infertility

Some MEDICINES MAY INTERACT with St. John's Wort. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aldosterone blockers (eg, eplerenone), blood thinners (eg, warfarin), benzodiazepines (eg, alprazolam), cancer chemotherapy medicines, digoxin, HIV medicines (eg, delavirdine, efavirenz, indinavir), HMG-CoA reductase inhibitors (eg, simvastatin), immunosuppressants (eg, cyclosporine, tacrolimus), selective serotonin reuptake inhibitors (SSRIs; eg, fluoxetine), or verapamil because the effectiveness may be decreased by St. John's Wort

This may not be a complete list of all interactions that may occur. Ask your health care provider if St. John's Wort may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use St. John's Wort:

Use St. John's Wort as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take this product with food.


• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• It may take several weeks of St. John's wort use before relief of depression is noticed.


• If you miss taking a dose of St. John's Wort for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use St. John's Wort.

Important safety information:

• This product may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this product. Using this product alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drink alcohol while taking this product.


• St. John's wort interacts with some medicines, which may be dangerous. St. John's wort may affect the way your liver metabolizes other medicines. Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter. This includes medicine that contains pseudoephedrine, phenylpropanolamine, l-tryptophan, herbal phen-fen products, or yohimbine.


• Do not exceed the recommended dose for this herbal product.


• If you are taking St. John's wort for depression and your symptoms do not improve after 4 to 6 weeks of regular use, contact your doctor. Contact your doctor as soon as possible if your symptoms become worse of if your depression is severe. St. John's wort is Hypericum perforatum and should not be confused with other Hypericum species. Other Hypericum products do not have the same effects. Read the label carefully or ask your doctor or pharmacist.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are taking this product.


• This product may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this product. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• St. John's wort may decrease the effectiveness of your birth control pill. Use an additional form of contraception (eg, condoms) while using St. John's wort.


• St. John's Wort is not recommended for use in CHILDREN.


• PREGNANCY and BREAST-FEEDING: Do not take this product if you are pregnant. Do not breast-feed while taking this product.

Possible side effects of St. John's Wort:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; dry mouth; feeling of stomach fullness; increased sensitivity to sunlight; restlessness; tiredness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; changes in sexual function; confusion; diarrhea; fever; muscle spasms; nausea; profuse sweating; shivering; tremors or twitching; unusual mental or mood changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: St. John's Wort side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of St. John's Wort:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep St. John's Wort out of the reach of children and away from pets.

General information:

• If you have any questions about St. John's Wort, please talk with your doctor, pharmacist, or other health care provider.


• St. John's Wort is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about St. John's Wort. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More St. John's Wort resources

• St. John's Wort Side Effects (in more detail)
• St. John's Wort Use in Pregnancy & Breastfeeding
• St. John's Wort Drug Interactions
• St. John's Wort Support Group
• 4 Reviews for St. John's Wort - Add your own review/rating

• St. John's Wort Natural MedFacts for Professionals (Wolters Kluwer)


• St. John's Wort Natural MedFacts for Consumers (Wolters Kluwer)


• St. John's wort Concise Consumer Information (Cerner Multum)

Compare St. John's Wort with other medications

• Depression
• Night Terrors

SSD AF

Generic Name: silver sulfadiazine topical (SIL ver SUL fa DYE a zeen TOP ik al)

Brand Names: Silvadene, SSD, SSD AF, Thermazene

What is SSD AF (silver sulfadiazine topical)?

Silver sulfadiazine is an antibiotic. It fights bacteria and fungus on the skin.

Silver sulfadiazine topical (for the skin) is used to treat or prevent infections on areas of burned skin.

Silver sulfadiazine topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about SSD AF (silver sulfadiazine topical)?

You should not use this medication if you are allergic to silver sulfadiazine or another sulfa medication.

Before using this medication, tell your doctor if you have liver disease, kidney disease, or an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

The person applying this medication to burn wounds should wear sterile disposable gloves. Take care to keep the treatment area as clean as possible to prevent further infection.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Avoid exposing treated skin areas to sunlight, sunlamps, or tanning beds. Silver sulfadiazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing when you are outdoors. Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, easy bruising or bleeding, unusual weakness, pale or yellowed skin, dark colored urine, ulcers on treated skin areas, swelling or weight gain, urinating less than usual, or a severe blistering or peeling red skin rash.

What should I discuss with my healthcare provider before using SSD AF (silver sulfadiazine topical)?

You should not use this medication if you are allergic to silver sulfadiazine or another sulfa medication.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• liver disease;


• kidney disease; or


• 
  

  an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

  
  

FDA pregnancy category B. Silver sulfadiazine is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether silver sulfadiazine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use SSD AF (silver sulfadiazine topical)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after applying silver sulfadiazine cream. The person applying this medication to burn wounds should wear sterile disposable gloves. Take care to keep the treatment area as clean as possible to prevent further infection.

Clean the area to be treated as directed by your doctor. Apply enough of the medication to cover the affected area evenly. Silver sulfadiazine cream should be applied in a layer about one 16th of an inch thick (1.5 millimeter).

Silver sulfadiazine cream is usually applied 1 or 2 times daily. Burn wounds must be kept covered with this medication at all times. Treated skin areas can be left uncovered, or you may use a gauze bandage if directed by your doctor.

If needed, apply more cream to replace any medication that has come off on bandages, clothing, or bed linens. Reapply the cream after bathing or water therapy.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any follow-up visits to your doctor.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store silver sulfadiazine topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. Your burn wounds should be kept covered with silver sulfadiazine cream at all times.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of silver sulfadiazine is not likely to cause life-threatening symptoms.

What should I avoid while using SSD AF (silver sulfadiazine topical)?

Avoid exposing treated skin areas to sunlight, sunlamps, or tanning beds. Silver sulfadiazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing when you are outdoors. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use silver sulfadiazine topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

SSD AF (silver sulfadiazine topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  pale or yellowed skin, dark colored urine;

  
  


• 
  

  ulcers on treated skin areas;

  
  


• 
  

  blood in your urine;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, nausea and vomiting;

  
  


• 
  

  swelling, weight gain; or

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

  
  

Less serious side effects may include:

• 
  

  brown or gray discoloration of treated skin;

  
  


• 
  

  mild itching or burning; or

  
  


• 
  

  upset stomach.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect SSD AF (silver sulfadiazine topical)?

Tell your doctor about all other medications you use, especially cimetidine (Tagamet).

This list is not complete and there may be other drugs that can interact with silver sulfadiazine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More SSD AF resources

• SSD AF Side Effects (in more detail)
• SSD AF Use in Pregnancy & Breastfeeding
• SSD AF Drug Interactions
• SSD AF Support Group
• 0 Reviews for SSD AF - Add your own review/rating

• SSD AF Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Silvadene MedFacts Consumer Leaflet (Wolters Kluwer)


• Silvadene Prescribing Information (FDA)


• Thermazene Prescribing Information (FDA)

Compare SSD AF with other medications

• Burns, External

Where can I get more information?

• Your pharmacist can provide more information about silver sulfadiazine topical.

See also: SSD AF side effects (in more detail)

Novantrone

Generic Name: mitoxantrone (Intravenous route)

mye-toe-ZAN-trone

Intravenous route(Solution)

Mitoxantrone should be given slowly into a freely flowing IV infusion and must never be given subQ, IM, or intra-arterially. Not for intrathecal use; severe injury with permanent sequelae can result from intrathecal administration. Except for the treatment of acute nonlymphocytic leukemia, therapy generally should not be given to patients with baseline neutrophil counts of less than 1500 cells/mm(3). Cardiotoxicity, potentially fatal, has been associated with treatment. Presence or history of cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Monitor cardiac function (cardiac signs/symptoms and left ventricular ejection fraction (LVEF)) in all patients during therapy. Patients with multiple sclerosis (MS) who have a baseline LVEF below the lower limit of normal should not receive mitoxantrone. Monitor MS patients for cardiac function prior to each dose. Do not give additional doses if clinically significant drop in LVEF during treatment and do not administer a cumulative dose greater than 140 mg/m(2) in MS patients. When mitoxantrone therapy is withdrawn, late-occurring cardiotoxicity should be evaluated on an annual basis in MS patients. Mitoxantrone therapy in MS patients and in cancer patients increases the risk of developing secondary acute myeloid leukemia .

Commonly used brand name(s)

In the U.S.

• Novantrone


• OTN Mitoxantrone

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Uses For Novantrone

Mitoxantrone injection is used alone or together with other medicines to treat advanced prostate cancer and acute nonlymphocytic leukemia (ANLL). It belongs to the group of medicines known as antineoplastics or cancer medicines. Mitoxantrone is also used to treat some forms of multiple sclerosis (MS). This medicine will not cure MS, but it may extend the time between relapses.

Mitoxantrone interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by mitoxantrone, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some unwanted effects may not occur for months or years after the medicine is used.

Before you begin treatment with mitoxantrone, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Novantrone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mitoxantrone injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mitoxantrone injection in the elderly. However, elderly patients are more likely to have age-related medical problems, which may require caution in patients receiving mitoxantrone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Valspodar


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots or bleeding problems or


• Blood disease (e.g., anemia, low white blood cell counts) or


• Bone marrow depression or


• Congestive heart failure or


• Heart or blood vessel disease—May cause side effects to become worse.

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles) or


• Infections—There is an increased risk of severe infections affecting other parts of the body.

• Gout, history of or


• Kidney stones—May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of mitoxantrone

This section provides information on the proper use of a number of products that contain mitoxantrone. It may not be specific to Novantrone. Please read with care.

Mitoxantrone is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to take them at the right times.

A nurse or other trained health professional will give you this medicine in a hospital or cancer clinic. This medicine is given through a needle placed in one of your veins.

If you have pain, burning, redness, or swelling of your skin area where the needle is placed, tell your doctor or nurse right away.

If this medicine gets on your skin, rinse the area well with warm water and tell your doctor. If the medicine gets in your eyes, rinse your eyes with large amounts of water, and tell your doctor.

While you are receiving mitoxantrone, your doctor may want you to drink extra fluids so you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Mitoxantrone often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if your stomach is upset. Ask your doctor for ways to lessen these effects.

This medicine comes with a patient package insert. Read and follow the information carefully. Ask your doctor if you have any questions.

Precautions While Using Novantrone

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests and tests for your heart function may be needed to check for unwanted effects.

You should not receive this medicine if you are pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Also, your doctor may require you to have a pregnancy test before you receive each dose of this medicine, to make sure you are not pregnant.

Check with your doctor right away if you are having chest pain or discomfort; fast or irregular heartbeats; shortness of breath; swelling of the feet and lower legs; or troubled breathing. These could be symptoms of a serious heart problem.

This medicine may change the color of your urine to a bluish-green color. The whites of your eyes may also appear slightly bluish-green. This is normal, especially within the first 24 hours after you receive the medicine.

While you are being treated with mitoxantrone, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Mitoxantrone may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not receive live virus vaccines (eg, nasal flu vaccine, measles, mumps, or rubella) since there is a chance they could pass the virus to you. Also, avoid persons who have received live virus vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Mitoxantrone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Novantrone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bladder pain


• bloody or cloudy urine


• cough or shortness of breath


• difficult, burning, or painful urination


• dizziness


• fainting


• fast, slow, or irregular heartbeat


• frequent urge to urinate


• lower back or side pain


• pale skin


• stomach pain


• swelling or inflammation of the mouth


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Blood in the urine or stools


• decrease in urination


• fever or chills


• pinpoint red spots on the skin


• seizures


• sore, red eyes


• swelling of the feet and lower legs


• yellow eyes or skin

Rare

• Blue skin at the place of injection


• pain or redness at the place of injection


• skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Absent, missed, or irregular menstrual periods


• back pain


• body aches or pains


• congestion


• constipation


• diarrhea


• dryness or soreness of the throat


• hair loss


• headache


• longer or heavier menstrual periods


• nausea or vomiting


• oral bleeding


• pain or tenderness around the eyes and cheekbones


• runny nose


• sneezing


• stopping of menstrual bleeding


• stuffy nose


• tender, swollen glands in the neck


• thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Novantrone side effects (in more detail)

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More Novantrone resources

• Novantrone Side Effects (in more detail)
• Novantrone Use in Pregnancy & Breastfeeding
• Novantrone Drug Interactions
• Novantrone Support Group
• 1 Review for Novantrone - Add your own review/rating

• Novantrone Prescribing Information (FDA)


• Novantrone MedFacts Consumer Leaflet (Wolters Kluwer)


• Novantrone Concise Consumer Information (Cerner Multum)


• Novantrone Monograph (AHFS DI)


• Mitoxantrone Prescribing Information (FDA)


• Mitoxantrone Professional Patient Advice (Wolters Kluwer)

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