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Tuesday, 10 July 2012

Gentamicin Sulfate

Class: Aminoglycosides
VA Class: AM300
CAS Number: 1405-41-0

Patients should be under close clinical observation because of potential ototoxicity and nephrotoxicity.^a ^b ^c

Neurotoxicity (manifested as both auditory and vestibular ototoxicity) can occur, usually in patients with preexisting renal damage and in those with normal renal function who receive doses higher or treatment longer than recommended.^a ^b ^c Aminoglycoside-induced ototoxicity usually is irreversible.^a ^b ^c Other neurotoxicity manifestations include numbness, skin tingling, muscle twitching, and seizures.^a ^b ^c

Potentially nephrotoxic.^a ^b ^c Risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged treatment.^a ^b ^c

Monitor renal and eighth-cranial nerve function closely, especially in patients with known or suspected renal impairment at start of treatment and also in those whose renal function is initially normal but develop renal dysfunction during treatment.^a ^b ^c Evaluate urine for decreased specific gravity and increased excretion of protein, cells, and casts; periodically determine BUN, S_cr, and Cl_cr.^a ^b ^c

Serial audiograms should be obtained, if feasible, in patients old enough to be tested, particularly in high-risk patients.^a ^b ^c Discontinue or adjust dosage if there is evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss) or nephrotoxicity.^a ^b ^c Rarely, changes in eighth-cranial nerve and renal function may not manifest until after the drug is discontinued.^a ^b ^c

Monitor serum gentamicin concentrations, when feasible, to assure adequate concentrations and avoid potentially toxic and prolonged peak concentrations (>12 mcg/mL) and avoid trough concentrations >2 mcg/mL.^a ^b ^c Excessive peak and/or trough serum concentrations may increase risk of renal and eighth-cranial nerve toxicity.^a ^b ^c In the event of overdose or toxic reactions, hemodialysis may aid in removal of gentamicin, especially if renal function is, or becomes, compromised.^a ^b ^c Lower concentrations are removed by peritoneal dialysis compared with hemodialysis.^a ^b ^c

Avoid concurrent and/or sequential use of other neurotoxic or nephrotoxic drugs (systemic or topical), particularly other aminoglycosides, cephaloridine (no longer available in US), viomycin, polymyxin B, colistin, cisplatin, and vancomycin.^a ^b ^c Other factors that may increase risk of toxicity are advanced age and dehydration.^a ^b ^c

Avoid concurrent use of potent diuretics (e.g., ethacrynic acid, furosemide) since diuretics themselves may cause ototoxicity and may enhance toxicity by altering serum and tissue aminoglycoside concentrations.^a ^b ^c

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

Introduction

Antibacterial; aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea.^a ^b ^c ^h

Uses for Gentamicin Sulfate

Bone and Joint Infections

Treatment of serious bone and joint infections caused by susceptible Staphylococcus aureus, Citrobacter, Enterobacter, Escherichia coli, Klebsiella, Proteus, Serratia, or Pseudomonas aeruginosa.^a ^b ^c Used as an adjunct to other appropriate anti-infectives.^e

Endocarditis

Treatment of staphylococcal endocarditis†; used as an adjunct to recommended anti-infectives (e.g., nafcillin, oxacillin, cefazolin, vancomycin).^k ^l

Treatment of endocarditis† caused by viridans streptococci (e.g., S. milleri, S. mitis, S. mutans) or S. bovis (nonenterococcal group D streptococcus); used as an adjunct to recommended anti-infectives (e.g., penicillin G, ceftriaxone, vancomycin).^k ^l

Treatment of enterococcal endocarditis†;^k ^l used in conjunction with an appropriate anti-infective (e.g., penicillin G, ampicillin, vancomycin).^k ^l

Treatment of endocarditis caused by slow-growing fastidious gram-negative bacilli termed the HACEK group† (i.e., Haemophilus parainfluenzae, H. aphrophilus, Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Kingella kingae); used in conjunction with ampicillin.^l

Prevention of bacterial endocarditis in patients undergoing certain GU and GI (except esophageal) procedures† who have cardiac conditions that put them at high risk.²⁵⁵ Gentamicin used as an adjunct to ampicillin or vancomycin (used in penicillin-allergic patients) in high-risk patients; amoxicillin, ampicillin, or vancomycin is used alone in those at moderate risk.²⁵⁵ Consult most recent AHA recommendations for specific information on which cardiac conditions are associated with high or moderate risk of endocarditis and which procedures require prophylaxis.²⁵⁵

Gynecologic Infections

Treatment of pelvic inflammatory disease† (PID); used in conjunction with clindamycin.²⁰¹ ²¹² When a parenteral regimen is indicated for treatment of PID, IV clindamycin in conjunction with an IV or IM aminoglycoside (e.g., gentamicin) is one possible regimen since it provides good coverage for anaerobes.²⁰¹ ²¹² However, this regimen may not provide optimal coverage for Neisseria gonorrhoeae and Chlamydia trachomatis, and a regimen of cefoxitin (or cefotetan) and doxycycline may be preferred when these organisms are suspected as primary pathogens.²⁰¹

Intra-abdominal Infections

Treatment of serious intra-abdominal infections (including peritonitis) caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Serratia, or Ps. aeruginosa.^a ^b ^c Used as an adjunct to other appropriate anti-infectives.^e

Meningitis and Other CNS Infections

Treatment of CNS infections (meningitis) caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Serratia, or Ps. aeruginosa.^a ^b ^c ^e

Aminoglycosides should not be used alone for treatment of meningitis;ⁱ usually used as an adjunct to other anti-infectives in initial treatment.^f ⁱ Used in conjunction with ampicillin for initial empiric treatment of neonatal S. agalactiae meningitis or for Listeria monocytogenes meningitis.^f

Respiratory Tract Infections

Treatment of serious respiratory tract infections caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Serratia, or Ps. aeruginosa.^a ^b ^c ^d ^e Used as an adjunct to an appropriate β-lactam (e.g., ceftriaxone, cefotaxime, cefepime, piperacillin and tazobactam, ticarcillin and clavulanate) or carbapenem (e.g., imipenem, meropenem) for empiric treatment of nosocomial pneumonia.^e

Septicemia

Treatment of septicemia caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Serratia, or Ps. aeruginosa.^a ^b ^c ^d ^e

Used as an adjunct to an appropriate β-lactam (e.g., ceftriaxone, cefotaxime, cefepime, piperacillin and tazobactam, ticarcillin and clavulanate) or carbapenem (e.g., imipenem, meropenem) for empiric treatment of life-threatening septicemia.^e

Skin and Skin Structure Infections

Treatment of serious skin and skin structure infections caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Serratia, or Ps. aeruginosa.^a ^b ^c Used as an adjunct to other appropriate anti-infectives.^e

Urinary Tract Infections (UTIs)

Treatment of serious complicated and recurrent UTIs caused by susceptible S. aureus, Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Serratia, or Ps. aeruginosa.^a ^b ^c ^d ^e Used as an adjunct to other appropriate anti-infectives.^e

Not indicated for uncomplicated UTIs unless causative organism is resistant to other less-toxic alternatives.^a ^b ^c

Brucellosis

Treatment of brucellosis†; used in conjunction with a tetracycline or co-trimoxazole.^e

Granuloma Inguinale (Donovanosis)

Adjunct for treatment of granuloma inguinale† (donovanosis) caused by Calymmatobacterium granulomatis.²⁰¹ CDC recommends doxycycline or co-trimoxazole as drugs of choice; ciprofloxacin, erythromycin, and azithromycin are alternatives.²⁰¹ Some clinicians suggest adding an IV aminoglycoside (e.g., gentamicin) if improvement is not evident within the first few days of therapy and in pregnant or HIV-infected patients.²⁰¹

Plague

Treatment of plague† caused by Yersinia pestis, including naturally occurring or endemic bubonic, septicemic, or pneumonic plague or plague that occurs as the result of biologic warfare or bioterrorism.²⁵⁶ ²⁵⁸ ^e ^f Although streptomycin generally has been considered the drug of choice for plague, gentamicin also is a drug of choice since it may be as effective and is more readily available than streptomycin.^f

Tularemia

Treatment of tularemia† caused by Francisella tularensis, including naturally occurring or endemic tularemia or tularemia that occurs as the result of biologic warfare or bioterrorism.²⁵⁷ ²⁵⁸ Although streptomycin generally has been considered the drug of choice for tularemia, gentamicin is more readily available and may be used as an alternative when streptomycin is unavailable.²⁵⁷ ²⁵⁸

Empiric Therapy in Febrile Neutropenic Patients

Empiric anti-infective therapy of presumed bacterial infections in febrile neutropenic patients†.^d ^e ⁱ ^j Used in conjunction with an appropriate antipseudomonal cephalosporin (e.g., ceftazidime, ceftriaxone), extended-spectrum penicillin (e.g., ticarcillin, piperacillin and tazobactam, ticarcillin and clavulanate), or carbapenem (e.g., imipenem, meropenem).^e ^j

Consult published protocols for the treatment of infections in febrile neutropenic patients for specific recommendations regarding selection of the initial empiric regimen, when to change the initial regimen, possible subsequent regimens, and duration of therapy in these patients.^j Consultation with an infectious disease expert knowledgeable about infections in immunocompromised patients also is advised.^j

Gentamicin Sulfate Dosage and Administration

Administration

Administer by IV infusion or IM injection.^a ^b ^c Also has been administered without preservatives intrathecally or intraventricularly to supplement IM or IV administration in the treatment of CNS infections.^h

IV Infusion

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

Reconstitution and Dilution

For adults, prepare IV infusions by diluting the calculated dose of gentamicin with 50–200 mL of 0.9% sodium chloride or 5% dextrose injection.^h

ADD-Vantage vials should be diluted according to the manufacturer’s directions prior to IV infusion.^h

Rate of Administration

IV infusions are given over 30 minutes to 2 hours.^h

IM Injection

For IM injection, the appropriate dose should be withdrawn from multiple-dose vials.^h

Solutions prepared from or commercially available in pharmacy bulk packages, those available in ADD-Vantage vials, or the commercially available injections in 0.9% sodium chloride should not be used for IM administration of the drug.^h

Dosage

Available as gentamicin sulfate; dosage is expressed in terms of gentamicin.^a ^b ^c

Dosage is identical for either IV or IM administration.^a ^b ^c

Dosage should be based on patient’s pretreatment body weight.^a ^b ^c

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; in determining dosage, the susceptibility of the causative organism, the severity of infection, and the patient’s immune and clinical status also must be considered.²¹⁴ ²¹⁵ ²¹⁶ ²¹⁷ ²¹⁸ ²⁴² ²⁴³ ²⁴⁴ ²⁴⁵ ²⁴⁶ ²⁴⁷ ²⁴⁸ ²⁴⁹

Peak and trough serum gentamicin concentrations should be determined periodically and dosage adjusted 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.²³⁵ ²³⁶ ²³⁷ ²³⁸ ²³⁹ ²⁴⁰ ²⁴¹ ²⁴² ²⁵⁰

In general, desirable peak serum concentrations of gentamicin are 4–12 mcg/mL and trough concentrations of the drug should not exceed 1–2 mcg/mL.^h Some evidence suggests that an increased risk of toxicity may be associated with prolonged peak serum gentamicin concentrations >10–12 mcg/mL and/or trough concentrations >2 mcg/mL.^h

Once-daily administration† of aminoglycosides is at least as effective as, and may be less toxic than, conventional dosage regimens employing multiple daily doses.²¹⁸ ²¹⁹ ²²⁰ ²²¹ ²²² ²²³ ²²⁴ ²²⁵ ²²⁶ ²²⁷ ²²⁸ ²²⁹ ²³⁰ ²³¹ ²⁵¹ ²⁵² ²⁵³ ²⁵⁴

Pediatric Patients

General Dosage for Neonates

IV or IM

Manufacturer recommends 2.5 mg/kg every 12 hours in premature or full-term neonates ≤1 week of age and 2.5 mg/kg every 8 hours for older neonates.^a ^b ^c

Neonates <1 week of age: AAP recommends 2.5 mg/kg every 18–24 hours for those weighing <1.2 kg and 2.5 mg/kg every 12 hours for those weighing ≥1.2 kg.^f

Neonates 1–4 weeks of age: AAP recommends 2.5 mg/kg every 18–24 hours for those weighing <1.2 kg, 2.5 mg/kg every 8 or 12 hours for those weighing 1.2–2 kg, and 2.5 mg/kg every 8 hours for those weighing >2 kg.^f

General Dosage for Infants and Children

IV or IM

Older infants and children: manufacturer recommends 2.5 mg/kg every 8 hours for older neonates.^a ^b ^c

Children ≥1 month of age: AAP recommends 3–7.5 mg/kg given in 3 divided doses for treatment of severe infections.^f Inappropriate for mild to moderate infections according to AAP.^f

Endocarditis†

Treatment of Staphylococcal Endocarditis†

IV or IM

3 mg/kg daily in 3 divided doses; dosage adjusted to achieve peak serum gentamicin concentrations approximately 3 mcg/mL and trough concentrations <1 mcg/mL.^k

Used in conjunction with nafcillin, oxacillin, cefazolin, or vancomycin; gentamicin used only during the first 3–5 days for native valve infections or during the first 2 weeks for prosthetic valve infections.^k

Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis†

IV or IM

3 mg/kg daily in 3 divided doses; dosage adjusted to achieve peak serum gentamicin concentrations approximately 3 mcg/mL and trough concentrations <1 mcg/mL.^k

Used in conjunction with penicillin G or ceftriaxone; usual duration is 2 weeks for penicillin-susceptible strains (MIC ≤0.1 mcg/mL), 2 weeks for relatively resistant strains (MIC >0.1–0.5 mcg/mL), or 4–6 weeks for strains with high level penicillin resistance (MIC >0.5 mcg/mL).^k If used with vancomycin in patients unable to receive a β-lactam, a 6-week regimen is recommended.^k

Treatment of Enterococcal Endocarditis†

IV or IM

3 mg/kg daily in 3 divided doses; dosage adjusted to achieve peak serum gentamicin concentrations approximately 3 mcg/mL and trough concentrations <1 mcg/mL.^k

Prevention of Endocarditis in Patients Undergoing Certain Genitourinary or GI (except Esophageal) Procedures†

IV or IM

For high-risk patients: 1.5 mg/kg (up to 120 mg) given within 30 minutes prior to the procedure; used in conjunction with recommended regimens of ampicillin or vancomycin.²⁵⁵

Plague†

Treatment of Plague†

IV or IM

Premature neonates and neonates ≤1 week of age: 2.5 mg/kg twice daily.²⁵⁶

Infants and older children: 2.5 mg/kg 3 times daily.²⁵⁶

Usual duration is 10 days;²⁵⁶ some experts recommend 10–14 days.²⁵⁸

Tularemia†

Treatment of Tularemia†

IV or IM

2.5 mg/kg 3 times daily for 10 days.²⁵⁷

Adults

General Adult Dosage

Treatment of Serious Infections

IV or IM

3 mg/kg daily given in 3 equally divided doses every 8 hours.^a ^b ^c

Treatment of Life-threatening Infections

IV or IM

≤5 mg/kg daily given in 3 or 4 equally divided doses.^a ^b ^c Dosage should be reduced to 3 mg/kg daily when clinically indicated.^a ^b ^c

Endocarditis†

Treatment of Staphylococcal Endocarditis†

IVor IM

1 mg/kg every 8 hours.^l Used in conjunction with nafcillin, oxacillin, cefazolin, or vancomycin; gentamicin used only during the first 3–5 days of therapy for native valve infections or during the first 2 weeks for prosthetic valve infections.^l

Treatment of Endocarditis Caused by Viridans Streptococci or S. bovis†

IV or IM

1 mg/kg every 8 hours.^l Used in conjunction with penicillin G, ceftriaxone, or vancomycin; gentamicin used only during the first 2 weeks of therapy.^l

Treatment of Enterococcal Endocarditis†

IV or IM

1 mg/kg every 8 hours.^l Used in conjunction with penicillin G, ampicillin, or vancomycin; usual duration is 4–6 weeks.^l

Treatment of Endocarditis Caused by HACEK group†

1 mg/kg every 8 hours.^l Used in conjunction with ampicillin; usual duration is 4 weeks.^l (HACEK: H. parainfluenzae, H. aphrophilus, A. actinomycetemcomitans, C. hominis, E. corrodens, K. kingae)

Prevention of Endocarditis in Patients Undergoing Certain Genitourinary or GI (except Esophageal) Procedures†

IV or IM

For high-risk patients: 1.5 mg/kg (up to 120 mg) given within 30 minutes prior to the procedure; used in conjunction with recommended regimens of ampicillin or vancomycin.²⁵⁵

Gynecologic Infections†

Pelvic Inflammatory Disease† (PID)

IV or IM

Initially, 2 mg/kg followed by 1.5 mg/kg every 8 hours;²⁰¹ ²¹² used in conjunction with IV clindamycin (900 mg every 8 hours).²⁰¹ ²¹² After clinical improvement occurs, discontinue IV clindamycin and gentamicin and switch to oral clindamycin (450 mg 4 times daily) or oral doxycycline (100 mg twice daily) to complete 14 days of therapy.²⁰¹

Granuloma Inguinale (Donovanosis)†

IV

1 mg/kg every 8 hours; added as an adjunct to the recommended or alternative drugs (doxycycline, co-trimoxazole, ciprofloxacin, erythromycin, azithromycin) if improvement is not evident within the first few days of therapy or in pregnant or HIV-infected patients.²⁰¹

Plague†

Treatment of Plague†

IV or IM

5 mg/kg once daily or, alternatively, a 2-mg/kg loading dose following by 1.7 mg/kg 3 times daily.²⁵⁶ ²⁵⁸ Usual duration is 10 days;²⁵⁶ some experts recommend 10–14 days.²⁵⁸

Tularemia†

Treatment of Tularemia†

IV or IM

5 mg/kg once daily for 10 days;²⁵⁷ some experts recommend 3–5 mg/kg daily for 10–14 days.²⁵⁸

Special Populations

Renal Impairment

Dosage adjustments necessary in patients with renal impairment.^a ^b ^c Whenever possible monitor serum gentamicin concentrations, especially in patients with changing renal function.^a ^b ^c

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.^h The manufacturers recommend an initial dose of 1–1.7 mg/kg, followed by 1-mg/kg doses given at intervals (in hours) calculated by multiplying the patient’s steady-state serum creatinine (in mg/dL) by 8.^h The dosing method of Sarubbi and Hull, which is based on corrected Cl_cr also has been recommended.^h Specialized references should be consulted for specific information on dosage for patients with renal impairment.

Dosage calculation methods should not be used in patients undergoing hemodialysis or peritoneal dialysis.^h In patients with renal failure undergoing hemodialysis, the manufacturers recommend supplemental doses of 1–1.7 mg/kg at the end of each dialysis period in adults and supplemental doses of 2–2.5 mg/kg at the end of each dialysis period in children.^h

Geriatric Patients

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

No dosage adjustments except those related to renal impairment.^a ^b ^c (See Renal Impairment under Dosage and Administration.)

Cautions for Gentamicin Sulfate

Contraindications

History of hypersensitivity or serious toxic reactions to gentamicin or other aminoglycosides.^a ^b ^c

Warnings/Precautions

Warnings

Ototoxicity

Patients receiving aminoglycosides should be under close clinical observation because of possible ototoxicity.^a ^b ^c

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 dosage or prolonged treatment.^a ^b ^c

Serial audiograms should be obtained, if feasible, in patients old enough to be tested, particularly in high-risk patients.^a ^b ^c

Discontinue gentamicin or adjust dosage if there is evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, hearing loss).^a ^b ^c

Some aminoglycosides have caused fetal ototoxicity when administered to pregnant women.^a ^b ^c (See Pregnancy under Cautions.)

Nephrotoxicity

Patients receiving aminoglycosides should be under close clinical observation because of possible nephrotoxicity.^a ^b ^c Renal function should be assessed prior to and periodically during therapy.^a ^b ^c

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.^a ^b ^c

Dosage reduction may be desirable if other evidence of renal dysfunction occurs (e.g., decreased Cl_cr, decreased urine specific gravity, increased BUN or S_cr, oliguria).^a ^b ^c

If azotemia increases or if a progressive decrease in urinary output occurs, discontinue gentamicin.^a ^b ^c

Neuromuscular Blockade

Neuromuscular blockade and respiratory paralysis reported with high gentamicin dosage (40 mg/kg) in animal studies.^a ^b ^c

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.^a ^b ^c

Calcium salts may reverse neuromuscular blockade.^a ^b ^c

Sensitivity Reactions

Cross-Hypersensitivity

Cross-allergenicity occurs among the aminoglycosides.^a ^b ^c

Sulfite Sensitivity

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

General Precautions

Selection and Use of Anti-infectives

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

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

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.^a ^b ^c If anaerobic bacteria are suspected, concomitant use of an anti-infective active against anaerobes is necessary.^a ^b ^c

Superinfection

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.^a ^b ^c Discontinue drug and institute appropriate therapy if superinfection occurs.^a ^b ^c

Interactions

Because of possible additive toxicity, avoid concurrent and/or sequential use of other neurotoxic or nephrotoxic drugs (systemic, oral, or topical), particularly bacitracin, cisplatin, amphotericin B, cephaloridine (no longer available in US), paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides.^a ^b ^c Do not administer concurrently with potent diuretics.^b ^c (See Specific Drugs under Interactions.)

Consider possibility of neuromuscular blockade and respiratory paralysis in patients receiving anesthetics or neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, decamethonium).^a ^b ^c (See Specific Drugs under Interactions.)

Use with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since drugs used in these patients may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.^a ^b ^c

Topical Instillation

Aminoglycoside may be absorbed in significant quantities from body surfaces after topical instillation† and may cause neurotoxicity and nephrotoxicity.^a ^b ^c

Specific Populations

Pregnancy

Category D.^a ^c

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

If used during pregnancy or if patient becomes pregnant while receiving gentamicin, the patient should be apprised of the potential hazard to the fetus.^a ^b ^c

Lactation

Low concentrations of aminoglycosides may be distributed into milk.ⁱ Use with caution.ⁱ

Pediatric Use

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

Geriatric Use

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

Monitoring renal function during aminoglycoside therapy is particularly important in geriatric patients.^a ^b ^c ^d Cl_cr may be more useful than determining BUN or S_cr.^a ^b ^c ^d

Renal Impairment

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

Renal function should be assessed prior to and during therapy.^a ^b ^c

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.^a ^b ^c

Common Adverse Effects

Ototoxicity or nephrotoxicity.^a ^b ^c ⁱ

Interactions for Gentamicin Sulfate

Neurotoxic, Ototoxic, or Nephrotoxic Drugs

Concomitant or sequential use with other drugs that have neurotoxic, ototoxic, or nephrotoxic effects (e.g., aminoglycosides, acyclovir, amphotericin B, bacitracin, capreomycin, cephalosporins, colistin, cephaloridine, viomycin, polymyxin B, colistin, cisplatin, vancomycin) may result in additive toxicity and should be avoided, if possible.^a ^b ^c ⁱ In addition, because of the possibility of an increased risk of ototoxicity due to additive effects or altered serum and tissue aminoglycoside concentrations, aminoglycosides should not be given concurrently with potent diuretics such as ethacrynic acid or furosemide.^b ^c ⁱ

Specific Drugs

Drug	Interaction	Comments
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;ⁱ used to therapeutic advantage (e.g., treatment of endocarditis)ⁱ Possible increased incidence of nephrotoxicity reported with some cephalosporins; cephalosporins may spuriously elevate creatinine concentrations^a ^b ^c Potential in vitro and in vivo inactivation of aminoglycosides^a ^b ^c ^HID ⁱ	Do not admix; administer IV solutions of the drugs separately^HID ⁱ Monitor serum aminoglycoside concentrations, especially when high penicillin doses are used or patient has renal impairmentⁱ
Carbapenems (imipenem)	In vitro evidence of additive or synergistic antibacterial effects with aminoglycosides against some gram-positive bacteria (E. faecalis, S. aureus, L. monocytogenes)ⁱ
Chloramphenicol	Some in vitro evidence of antagonism with aminoglycosides;ⁱ in vivo antagonism has not been demonstrated and the drugs have been administered concomitantly with no apparent decrease in activityⁱ
Clindamycin	Some in vitro evidence of antagonism with aminoglycosides;ⁱ in vivo antagonism has not been demonstrated and the drugs have been administered concomitantly with no apparent decrease in activityⁱ
Diuretics (ethacrynic acid, furosemide)	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)^a ^b ^c
Neuromuscular blocking agents and general anesthetics (succinylcholine, tubocurarine)	Possible potentiation of neuromuscular blockade and respiratory paralysis^a ^b ^c ⁱ	Use concomitantly with caution; observe closely for signs of respiratory depressionⁱ
NSAIAs	Possible increased serum aminoglycoside concentrations reported with indomethacin in premature neonates; may be related to indomethacin-induced decreases in urine outputⁱ	Closely monitor aminoglycoside concentrations and adjust dosage accordinglyⁱ
Probenecid	Does not affect renal tubular transport of tobramycin^a ^b ^c
Tetracyclines	Some in vitro evidence of antagonism with aminoglycosides;ⁱ in vivo antagonism has not been demonstrated and the drugs have been administered concomitantly with no apparent decrease in activityⁱ

Gentamicin Sulfate Pharmacokinetics

Absorption

Bioavailability

Not absorbed orally; must be given parenterally.^d ⁱ

Rapidly absorbed following IM injection; peak plasma concentrations attained within 30–90 minutes.^a ^b ^c ⁱ

Distribution

Extent

Distributed into bone, heart, gallbladder, lung tissue, bile, sputum, bronchial secretions, and interstitial, pleural, and synovial fluids.^a ^b ^c ^d ^h

Only low concentrations distributed into CSF following IM or IV administration.ⁱ

Crosses the placenta.^d Aminoglycosides may be distributed into milk in low concentrations.ⁱ

Plasma Protein Binding

Only minimally bound to plasma proteins.^a ^b ^c

Elimination

Metabolism

Not metabolized.ⁱ

Elimination Route

50–93% of a single IM dose excreted unchanged by glomerular filtration within 24 hours.^h

May be removed by hemodialysis^a ^b ^c ⁱ or peritoneal dialysis.ⁱ

Half-life

2–3 hours in adults

Monday, 9 July 2012

Neomycin,Polymyxin B,Bacitracin,Hydrocortisone

Dosage Form: ophthalmic ointment
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP

(Sterile)

DESCRIPTION:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use.

Each Gram Contains: ACTIVES: Neomycin sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, Bacitracin Zinc equivalent to 400 bacitracin units, Hydrocortisone 10 mg (1%); INACTIVES: White Petrolatum, Mineral Oil.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis.

The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis.

The structural formulae are:

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg.

The structural formula is:

Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone.

Its structural formula is:

CLINICAL PHARMACOLOGY:

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.

The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.

Microbiology:

The anti-infective components in neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against Serratia marcescens (see INDICATIONS AND USAGE).

INDICATIONS AND USAGE:

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

CONTRAINDICATIONS:

Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

This product is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

PRECAUTIONS:

General:

The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of the reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg /mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C. Corticosteroids have been found to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 to 18 of gestation and in mice when applied topically at a concentration of 15% on days 10 to 13 of gestation. There are no adequate and well-controlled studies in pregnant women. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection:

The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used.

Local irritation on instillation has also been reported.

DOSAGE AND ADMINISTRATION:

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS: above.

HOW SUPPLIED:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic tip applicator in the following size:

3.5 g - Prod. No. 03934.

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY

Storage:

Store between 15° - 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Rx only

Revised November 2007

Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

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9113900 (Flat)

Principal Display Panel

RXV

RXV Products

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment USP

STERILE

Rx only

Net wt. 3.5 g

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
neomycin sulfate and polymyxin b sulfate, bacitracin zinc and hydrocortisone ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	14049-467
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (NEOMYCIN)	NEOMYCIN SULFATE	3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B)	POLYMYXIN B SULFATE	10000 [USP'U] in 1 g
BACITRACIN ZINC (BACITRACIN)	BACITRACIN ZINC	400 [USP'U] in 1 g
HYDROCORTISONE (HYDROCORTISONE)	HYDROCORTISONE	10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL
PETROLATUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	14049-467-34	1 TUBE In 1 CARTON	contains a TUBE
1		3.5 g In 1 TUBE	This package is contained within the CARTON (14049-467-34)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064068	10/30/1995

Labeler - RXV (059580480)

Registrant - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE

Revised: 11/2010RXV

More Neomycin,Polymyxin B,Bacitracin,Hydrocortisone resources

Neomycin,Polymyxin B,Bacitracin,Hydrocortisone Dosage
Neomycin,Polymyxin B,Bacitracin,Hydrocortisone Use in Pregnancy & Breastfeeding
Neomycin,Polymyxin B,Bacitracin,Hydrocortisone Drug Interactions
Neomycin,Polymyxin B,Bacitracin,Hydrocortisone Support Group
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Conjunctivitis, Bacterial
Uveitis

Sunday, 8 July 2012

Acamprosate

Pronunciation: a-kam-PROE-sate
Generic Name: Acamprosate
Brand Name: Campral

Acamprosate is used for:

Treating alcohol addiction by helping certain patients to avoid alcohol. Acamprosate is used in combination with a treatment program that includes social support.

Acamprosate is an anti-alcohol agent. It is thought to work by restoring the balance of certain chemicals in the brain of patients who have used large amounts of alcohol.

Do NOT use Acamprosate if:

you are allergic to any ingredient in Acamprosate

you have severe kidney problems

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

Before using Acamprosate:

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

if you are pregnant, planning to become pregnant, or are 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 kidney problems or a history of depression or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with Acamprosate. However, no specific interactions with Acamprosate are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acamprosate 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 Acamprosate:

Use Acamprosate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Acamprosate may be taken with or without food.

Swallow whole. Do not break, crush, or chew before swallowing.

Continue to take Acamprosate even if you feel well. Do not miss any doses.

If you miss a dose of Acamprosate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acamprosate.

Important safety information:

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

Do not drink alcohol while you are using Acamprosate. Continue taking Acamprosate even if you begin drinking alcohol again. Discuss any drinking with your doctor.

Alcohol-dependent patients should be monitored for the development of depression or suicidal thinking. Patients and their families or caregivers should pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.

Acamprosate will not reduce or eliminate alcohol withdrawal symptoms. Discuss any questions or concerns with your doctor.

Acamprosate has been shown to help you avoid alcohol only in combination with a treatment program that includes counseling and support. Discuss treatment program options with your doctor.

Use Acamprosate with caution in the ELDERLY because they may be more sensitive to its effects.

Use Acamprosate with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Acamprosate during pregnancy. It is unknown if Acamprosate is excreted in breast milk. If you are or will be breast-feeding while you are using Acamprosate, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Acamprosate:

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:

Diarrhea; dizziness; gas; loss of appetite; nausea; trouble sleeping; weakness.

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); anxiety; behavior changes; depression; mental or mood changes; nervousness; panic attacks; restlessness; suicidal thoughts or behaviors.

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: Acamprosate 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. Symptoms may include diarrhea.

Proper storage of Acamprosate:

Store Acamprosate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acamprosate out of the reach of children and away from pets.

General information:

If you have any questions about Acamprosate, please talk with your doctor, pharmacist, or other health care provider.

Acamprosate 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 Acamprosate. 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

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Drugs associated with Functional Gastric Disorder

The following drugs and medications are in some way related to, or used in the treatment of Functional Gastric Disorder. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Functional Gastric Disorder

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Drug List:

Alka-Seltzer-Anti-Gas

Anti-Gas-Ultra-Strength

Baby-Gasz

Digex

Equalize-Gas-Relief-Drops

Gas-Aide

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Gastrinex

Genasyme-Suspension

Infantaire-Gas-Relief

Little-Tummys

Maalox-Anti-Gas-Chewable-Tablets

Maalox-Anti-Gas-Extra-Strength

Mi-Acid-Gas-Relief

Mylanta-Gas

Mylanta-Gas-Maximum-Strength

Mylanta-Gas-Relief-Maximum-Strength

Phazyme-Maximum-Strength

Phazyme-Ultra

Phazyme-125

Phazyme-95

Saturday, 7 July 2012

Halcion

Generic Name: triazolam (trye AY zoe lam)

Brand Names: Halcion

What is Halcion (triazolam)?

Triazolam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Triazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia).

Triazolam is used to treat insomnia symptoms, such as trouble falling or staying asleep.

Triazolam may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Halcion (triazolam)?

Triazolam may cause a severe allergic reaction. Stop taking triazolam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Take triazolam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking triazolam and talk with your doctor about another treatment for your sleep disorder.

Do not use this medication if you are allergic to triazolam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or lorazepam (Ativan). This medication can cause birth defects in an unborn baby, or withdrawal symptoms in a newborn. Do not use triazolam if you are pregnant.

Before taking triazolam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, myasthenia gravis, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking triazolam. It can increase some of the side effects, and could possibly cause a fatal overdose.

Avoid using other medicines that make you sleepy. They can add to sleepiness caused by triazolam.

Triazolam may be habit-forming and should be used only by the person it was prescribed for. Triazolam should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Halcion (triazolam)?

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

asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;

glaucoma;

kidney or liver disease;

myasthenia gravis;

a history of depression or suicidal thoughts or behavior; or

a history of drug or alcohol addiction.

Triazolam can cause birth defects in an unborn baby. It may also cause addiction or withdrawal symptoms in a newborn if the mother takes triazolam late in pregnancy. Do not use triazolam if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Triazolam may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of triazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking triazolam.

Do not give this medication to anyone under 18 years old.

How should I take Halcion (triazolam)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take triazolam only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine. Contact your doctor if this medicine seems to stop working as well in helping you fall asleep and stay asleep. Triazolam should be used for only a short time to treat insomnia. After 7 to 10 nights of use, talk with your doctor about whether or not you should keep taking triazolam. Do not take this medication for longer than 4 weeks without your doctor's advice.

Your insomnia symptoms may return when you stop using triazolam after using it over a long period of time. You may need to use less and less before you stop the medication completely.

Keep track of how many tablets have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Halcion dosage (in more detail)

What happens if I miss a dose?

Since triazolam is taken as needed, you are not likely to be on a dosing schedule. Take triazolam only when you have time for several hours of sleep.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of triazolam can be fatal, especially if taken with alcohol.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, slurred speech, tremors, a slow heartbeat, shallow breathing, feeling light-headed, fainting, seizure (black-out or convulsions), or coma.

What should I avoid while taking Halcion (triazolam)?

Do not drink alcohol while you are taking triazolam. It can increase some of the side effects, and could possibly cause a fatal overdose. Triazolam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Halcion (triazolam) side effects

Triazolam may cause a severe allergic reaction. Stop taking triazolam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using triazolam and call your doctor at once if you have any of these serious side effects:

weak or shallow breathing;

fast or pounding heartbeats;

confusion, slurred speech, unusual thoughts or behavior;

hallucinations, agitation, aggression;

thoughts of suicide or hurting yourself;

restless muscle movements in your eyes, tongue, jaw, or neck;

pale skin, easy bruising or bleeding, unusual weakness;

fever, chills, body aches, flu symptoms;

problems with urination; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

daytime drowsiness (or during hours when you are not normally sleeping);

amnesia or forgetfulness;

muscle weakness, lack of balance or coordination;

numbness, burning, pain, or tingly feeling;

headache, blurred vision, depressed mood;

feeling nervous, excited, or irritable;

nausea, vomiting, stomach discomfort; or

dry mouth, increased thirst.

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 Halcion (triazolam)?

Before using triazolam, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, other sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by triazolam.

Before taking triazolam, tell your doctor if you are using any of the following:

birth control pills;

cyclosporine (Gengraf, Neoral, Sandimmune);

grapefruit juice;

ranitidine (Zantac);

antibiotics such as isoniazid, itraconazole (Sporanox) or ketoconazole (Nizoral);

antidepressants such as fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), or sertraline (Zoloft);

ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine); or

heart medications such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera).

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

More Halcion resources

Halcion Side Effects (in more detail)
Halcion Dosage
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Halcion Drug Interactions
Halcion Support Group
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Halcion Prescribing Information (FDA)

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Compare Halcion with other medications

Insomnia

Where can I get more information?

Your pharmacist can provide more information about triazolam.

See also: Halcion side effects (in more detail)

Tuesday, 3 July 2012

Thorazine Suppositories

Pronunciation: klor-PROE-ma-zeen
Generic Name: Chlorpromazine
Brand Name: Thorazine

Thorazine Suppositories are an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Thorazine Suppositories are not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.

Thorazine Suppositories are used for:

Treating certain mental or mood disorders (eg, schizophrenia), the manic phase of manic-depressive disorder, anxiety and restlessness before surgery, the blood disease porphyria, severe behavioral and conduct disorders in children, nausea and vomiting, and severe hiccups. It is also used with other medicines to treat symptoms associated with tetanus. It may be used for other conditions as determined by your doctor.

Thorazine Suppositories are a phenothiazine. Exactly how it works is not known.

Do NOT use Thorazine Suppositories if:

you are allergic to any ingredient in Thorazine Suppositories or to other phenothiazines (eg, thioridazine)

you have severe drowsiness

you have recently taken large amounts of alcohol or medicines that may cause drowsiness, such as barbiturates (eg, phenobarbital) or narcotic pain medicines (eg, codeine)

you are taking certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone

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

Before using Thorazine Suppositories:

Some medical conditions may interact with Thorazine Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are 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 alcohol abuse or you consume more than 3 alcoholic drinks per day

if you have asthma, lung infection, or other lung problems (eg, emphysema); increased pressure in the eyes; glaucoma; or if you are at risk for glaucoma

if you have a history of blood problems, enlargement of the prostate gland, epilepsy or seizures, heart problems, low blood pressure, liver problems (eg, cirrhosis), bone marrow problems, low white blood cell count, diabetes, kidney problems, neuroleptic malignant syndrome (NMS), or an adrenal gland tumor (pheochromocytoma)

if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome

if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer

if you are regularly exposed to extreme heat or organophosphate insecticides

Some MEDICINES MAY INTERACT with Thorazine Suppositories. Tell your health care provider if you are taking any other medicines, especially any of the following:

Lithium because the risk of a severe and sometimes permanent nervous system problem (encephalopathic syndrome) characterized by weakness, lethargy, fever, tremor, confusion, or uncontrolled muscle movements may be increased

Certain antiarrhythmic medicines (eg, amiodarone, dofetilide, dronedarone, quinidine, sotalol), cisapride, pergolide, pimozide, quetiapine, or ziprasidone because the risk of side effects, such as racing heartbeat, dizziness, fainting, and life-threatening irregular heartbeat leading to unconsciousness, may be increased by Thorazine Suppositories

Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Thorazine Suppositories, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Thorazine Suppositories 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 Thorazine Suppositories:

Use Thorazine Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wash your hands before and after using Thorazine Suppositories. If the suppository is too soft to use, put it in the refrigerator for about 15 minutes. You may also run cold water over it. Remove the wrapper. Moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum. Use your finger to push it in completely.

Wash your hands immediately after using Thorazine Suppositories.

If you miss a dose of Thorazine Suppositories, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Thorazine Suppositories.

Important safety information:

Thorazine Suppositories may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Thorazine Suppositories with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol while you are using Thorazine Suppositories.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Thorazine Suppositories; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Thorazine Suppositories may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Do not become overheated in hot weather or while you are being active; heatstroke may occur.

Thorazine Suppositories may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Thorazine Suppositories. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Thorazine Suppositories may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

Tell your doctor or dentist that you take Thorazine Suppositories before you receive any medical or dental care, emergency care, or surgery.

Some patients who take Thorazine Suppositories may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Thorazine Suppositories in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Thorazine Suppositories.

Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Thorazine Suppositories. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.

Thorazine Suppositories may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.

Thorazine Suppositories may raise or lower your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. If these symptoms occur, tell your doctor right away.

Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Thorazine Suppositories may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.

Thorazine Suppositories may interfere with certain lab tests, including phenylketonuria (PKU) tests. Be sure your doctor and lab personnel know you are taking Thorazine Suppositories.

Lab tests, including liver function, complete blood cell counts, and eye exams, may be performed while you use Thorazine Suppositories. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Thorazine Suppositories with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness, light-headedness (especially upon standing), rapid heartbeat, breathing problems, urinary retention, and constipation.

Thorazine Suppositories should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Thorazine Suppositories while you are pregnant. Using Thorazine Suppositories during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Thorazine Suppositories are found in breast milk. Do not breast-feed while taking Thorazine Suppositories.

If you stop taking Thorazine Suppositories suddenly, you may have WITHDRAWAL symptoms. These may include nausea, vomiting, dizziness, and tremors.

Possible side effects of Thorazine Suppositories:

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:

Agitation; constipation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

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); changes in menstrual period; changes in sexual ability; confusion; dark urine; difficulty swallowing; drooling; fainting; fast or irregular heartbeat; fever, chills, or sore throat; inability to move eyes; involuntary movements or spasms of the arms and legs; involuntary movements of tongue, face, mouth, or jaw (eg, sticking out of tongue, puffing of cheeks, puckering of mouth, lip-smacking, chewing movements); mask-like face; mental or mood changes, including lack of response to your surroundings; muscle restlessness; prolonged or painful erection; restlessness; seizures; severe constipation; severe or persistent dizziness; shuffling walk; sleeplessness; stiff or rigid muscles; stomach pain; sweating; tremor; trouble urinating; unusual bruising or bleeding; unusual eye movements; unusual tiredness or weakness; unusually pale skin; vision changes; yellowing of the skin or eyes.

See also: Thorazine 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. Symptoms may include agitation; fainting; involuntary movements or muscle spasms; irregular heartbeat; light-headedness; loss of consciousness; restlessness; seizures; severe drowsiness or dizziness; tremors; twitching.

Proper storage of Thorazine Suppositories:

Store Thorazine Suppositories at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Thorazine Suppositories out of the reach of children and away from pets.

General information:

If you have any questions about Thorazine Suppositories, please talk with your doctor, pharmacist, or other health care provider.

Thorazine Suppositories are 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 Thorazine Suppositories. 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

More Thorazine resources

Thorazine Side Effects (in more detail)
Thorazine Use in Pregnancy & Breastfeeding
Drug Images
Thorazine Drug Interactions
Thorazine Support Group
7 Reviews for Thorazine - Add your own review/rating

Compare Thorazine with other medications

Hiccups
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Mania
Nausea/Vomiting
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Porphyria
Psychosis
Schizophrenia
Tetanus