Streptomycin: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AJ}}
|authorTag={{AJ}}
|genericName=Streptomycin sulphate
|genericName=Streptomycin sulfate
|aOrAn=a
|aOrAn=an
|drugClass=[[antibiotic]]s, [[aminoglycosides]]
|drugClass=[[aminoglycosides]] and  [[tuberculosis|antitubercular antibiotic]]
|indicationType=treatment
|indicationType=treatment
|indication=Mycobacterium tuberculosis and Non-tuberculosis infections like [[plague]], [[tularemia]], Brucella, [[donovanosis]], [[granuloma inguinale]], [[chancroid]], [[H. influenzae]] (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent), [[K. pneumoniae]] pneumonia (concomitantly with another antibacterial agent), [[E.coli]], [[Proteus]], [[A. aerogenes]], [[K. pneumoniae]], and [[Enterococcus faecalis]] in urinary tract infections. [[Streptococcus viridans]], [[Enterococcus faecalis]] (in endocardial infections -concomitantly with penicillin), Gram-negative bacillary [[bacteremia]] (concomitantly with another antibacterial agent)
|indication=[[tuberculosis|Mycobacterium tuberculosis]] and [[tuberculosis|Non-tuberculosis infections]] like [[plague]], [[tularemia]], [[Brucella]], [[donovanosis]], [[granuloma inguinale]], [[chancroid]], [[H. influenzae]] (in [[respiratory]], [[endocardial]], and [[meningeal]] [[infections]]-concomitantly with another [[antibiotics|antibacterial agent]]), [[K. pneumoniae|K. pneumoniae pneumonia]] (concomitantly with another [[antibiotics|antibacterial agent]]), [[E.coli]], [[Proteus]], [[A. aerogenes]], [[K. pneumoniae]], and [[Enterococcus faecalis]] in [[urinary tract infections]]. [[Streptococcus viridans]], [[Enterococcus faecalis]] (in [[endocarditis|endocardial infections]] -concomitantly with [[penicillin]]), [[Gram-negative bacteria|Gram-negative bacillary bacteremia]] (concomitantly with another [[antibacterial|antibacterial agent]])
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=[[vestibular ototoxicity]] ([[nausea]], [[vomiting]], and [[vertigo]]), [[paresthesia]] of face, [[rash]], [[fever]], [[urticaria]], [[angioneurotic edema]] and [[eosinophilia]].
|adverseReactions=[[ototoxicity|vestibular ototoxicity]], [[nausea]], [[vomiting]], [[vertigo]], [[paresthesia|paresthesia of face]], [[rash]], [[fever]], [[urticaria]], [[angioneurotic edema]] and [[eosinophilia]].
|blackBoxWarningTitle=WARNING
|blackBoxWarningTitle=WARNING
|blackBoxWarningBody=* The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
|blackBoxWarningBody=* The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
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* The administration of streptomycin in parenteral form should be reserved for patients where adequate laboratory and audiometric testing facilities are available during therapy.
* The administration of streptomycin in parenteral form should be reserved for patients where adequate laboratory and audiometric testing facilities are available during therapy.
|fdaLIADAdult=* Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below:
|fdaLIADAdult=* Streptomycin is indicated for the treatment of individuals with moderate to severe [[infections]] caused by susceptibile [[strains]] of [[microorganisms]] in the specific conditions listed below:
=====Mycobacterium tuberculosis=====
* The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.                                                                                * Streptomycin is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings.


=====Non-tuberculosis infections=====
=====Mycobacterium Tuberculosis=====
* The Advisory Council for the Elimination of [[tuberculosis]], the [[American Thoracic Society]], and the [[Center for Disease Control]] recommend that either [[streptomycin]] or [[ethambutol]] be added as a fourth drug in a regimen containing [[isoniazid]] ([[INH]]), [[rifampin]] and [[pyrazinamide]] for initial treatment of [[tuberculosis]] unless the likelihood of [[INH]] or [[rifampin]] resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to [[isoniazid]] was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of [[INH|INH resistance]] are currently less than 4%, an initial treatment regimen with less than four drugs may be considered. 
                                                             
* Streptomycin is also indicated for therapy of [[tuberculosis]] when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of [[tuberculosis]] has become more complex as a consequence of increasing rates of [[drug resistance]] and concomitant [[HIV infection]]. Additional consultation from experts in the treatment of [[tuberculosis]] may be desirable in those settings.


* The use of streptomycin should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of streptomycin and which are not amenable to therapy with less potentially toxic agents.
=====Non-Tuberculosis infections=====


:* Pasteurella pestis (plague)
* The use of streptomycin should be limited to the treatment of [[infections]] caused by [[bacteria]] which have been shown to be susceptible to the [[antibacterial]] effects of streptomycin and which are not amenable to therapy with less potentially [[toxic|toxic agents]].
:* Francisella tularensis (tularemia)
:* Brucella
:* Calymmatobacterium granulomatis (donovanosis, granuloma inguinale)
:* H. ducreyi (chancroid)
:* H. influenzae (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent)
:* K. pneumoniae pneumonia (concomitantly with another antibacterial agent)
:* E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections
:* Streptococcus viridans, Enterococcus faecalis (in endocardial infections -concomitantly with penicillin)
:* Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent).


* To reduce the development of drug-resistant bacteria and maintain the effectiveness of streptomycin and other antibacterial drugs, streptomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
:* [[plague|Pasteurella pestis]] ([[plague]])
:* [[Francisella tularensis]] ([[tularemia]])
:* [[Brucella]]
:* [[Calymmatobacterium granulomatis]] ([[donovanosis]], [[granuloma inguinale]])
:* [[chancroid|H. ducreyi]] ([[chancroid]])
:* [[H. influenzae]] (in [[respiratory]], [[endocardial]], and [[meningitis|meningeal infections]]-concomitantly with another [[antibacterial]] agent)
:* [[K. pneumoniae|K. pneumoniae pneumonia]] (concomitantly with another [[antibacterial|antibacterial agent]])
:* [[E.coli]], [[Proteus]], [[A. aerogenes]], [[K. pneumoniae]], and [[Enterococcus faecalis]] in [[urinary tract infections]]
:* [[Streptococcus viridans]], [[Enterococcus faecalis]] (in [[endocarditis|endocardial infections]] -concomitantly with [[penicillin]])
:* [[Gram-negative bacteria|Gram-negative bacillary bacteremia]] (concomitantly with another [[antibacterial|antibacterial agent]]).
 
* To reduce the development of [[Antibiotic resistance|drug-resistant bacteria]] and maintain the effectiveness of streptomycin and other [[antibacterial|antibacterial drugs]], streptomycin should be used only to treat or prevent [[infections]] that are proven or strongly suspected to be caused by [[bacteria|susceptible bacteria]]. When [[culture]] and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local [[epidemiology]] and susceptibility patterns may contribute to the empiric selection of therapy.


=====Dosing Information=====
=====Dosing Information=====


* Intramuscular Route Only
* [[Intramuscular|Intramuscular Route Only]]
* Adults: The preferred site is the upper outer quadrant of the buttock, (i.e., gluteus maximus), or the mid-lateral thigh.
 
* Adults: The preferred site is the [[buttock|upper outer quadrant of the buttock]], (i.e., [[gluteus maximus]]), or the [[thigh|mid-lateral thigh]].


* The deltoid area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower and mid-third of the upper arm. As with all intramuscular injections, aspiration is necessary to help avoid inadvertent injection into a blood vessel.
* The [[deltoid]] area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid [[radial nerve|radial nerve injury]]. [[Intramuscular|Intramuscular injections]] should not be made into the [[upper arm|lower and mid-third of the upper arm]]. As with all [[intramuscular|intramuscular injections]], [[aspiration]] is necessary to help avoid inadvertent [[injection]] into a [[blood vessel]].


* Injection sites should be alternated. As higher doses or more prolonged therapy with streptomycin may be indicated for more severe or fulminating infections (endocarditis, meningitis, etc.), the physician should always take adequate measures to be immediately aware of any toxic signs or symptoms occurring in the patient as a result of streptomycin therapy.
* [[Injection|Injection sites]] should be alternated. As higher doses or more prolonged therapy with streptomycin may be indicated for more severe or fulminating [[infections]] ([[endocarditis]], [[meningitis]], etc.), the physician should always take adequate measures to be immediately aware of any toxic signs or symptoms occurring in the patient as a result of streptomycin therapy.


* TUBERCULOSIS:  
* [[Tuberculosis]]:  
:* The standard regimen for the treatment of drug susceptible tuberculosis has been two months of INH, rifampin and pyrazinamide followed by four months of INH and rifampin (patients with concomitant infection with tuberculosis and HIV may require treatment for a longer period). When streptomycin is added to this regimen because of suspected or proven drug resistance, the recommended dosing for streptomycin is as follows:
:* The standard regimen for the treatment of drug susceptible [[tuberculosis]] has been two months of [[INH]], [[rifampin]] and [[pyrazinamide]] followed by four months of [[INH]] and [[rifampin]] (patients with concomitant [[infection]] with [[tuberculosis]] and HIV may require treatment for a longer period). When streptomycin is added to this regimen because of suspected or proven [[drug resistance]], the recommended dosing for streptomycin is as follows:


[[File:Streptomycin Dosage Table 01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:Streptomycin Dosage Table 01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]


* Streptomycin is usually administered daily as a single intramuscular injection. A total dose of not more than 120 g over the course of therapy should be given unless there are no other therapeutic options. In patients older than 60 years of age the drug should be used at a reduced dosage due to the risk of increased toxicity. (See BOXED WARNING.)
* Streptomycin is usually administered daily as a single [[intramuscular|intramuscular injection]]. A total dose of not more than 120 g over the course of therapy should be given unless there are no other therapeutic options. In patients older than 60 years of age the drug should be used at a reduced dosage due to the risk of increased [[toxicity]].


* Therapy with streptomycin may be terminated when toxic symptoms have appeared, when impending toxicity is feared, when organisms become resistant, or when full treatment effect has been obtained. The total period of drug treatment of tuberculosis is a minimum of 1 year; however, indications for terminating therapy with streptomycin may occur at any time as noted above.
* Therapy with streptomycin may be terminated when [[toxic]] symptoms have appeared, when impending [[toxicity]] is feared, when organisms become [[resistant]], or when full treatment effect has been obtained. The total period of drug treatment of [[tuberculosis]] is a minimum of 1 year; however, indications for terminating therapy with streptomycin may occur at any time as noted above.


* TULAREMIA:  
* [[Tularemia|TULAREMIA]]:  
:* One to 2 g daily in divided doses for 7 to 14 days until the patient is afebrile for 5 to 7 days.
:* One to 2 g daily in divided doses for 7 to 14 days until the patient is afebrile for 5 to 7 days.


* PLAGUE:  
* [[plague|PLAGUE]]:  
:* Two grams of streptomycin daily in two divided doses should be administered intramuscularly. :* A minimum of 10 days of therapy is recommended.
:* Two grams of streptomycin daily in two divided doses should be administered [[intramuscularly]]. :* A minimum of 10 days of therapy is recommended.


* BACTERIAL ENDOCARDITIS:
* [[endocarditis|BACTERIAL ENDOCARDITIS]]:
:* Streptococcal Endocarditis
:* [[endocarditis|Streptococcal Endocarditis]]
:** In penicillin-sensitive alpha and non-hemolytic streptococcal endocarditis (penicillin MIC<0.1 mcg/mL), streptomycin may be used for 2-week treatment concomitantly with penicillin. The streptomycin regimen is 1 g b.i.d. for the first week, and 500 mg b.i.d. for the second week. If the patient is over  60 years of age, the dosage should be 500 mg b.i.d. for the entire 2- week period.
:** In [[endocarditis|penicillin-sensitive alpha and non-hemolytic streptococcal endocarditis]] ([[MIC|penicillin MIC]]<0.1 mcg/mL), streptomycin may be used for 2-week treatment concomitantly with [[penicillin]]. The streptomycin regimen is 1 g b.i.d. for the first week, and 500 mg b.i.d. for the second week. If the patient is over  60 years of age, the dosage should be 500 mg b.i.d. for the entire 2- week period.
:* Enterococcal Endocarditis
:* [[endocarditis|Enterococcal Endocarditis]]
:** Streptomycin in doses of 1 g b.i.d. for 2 weeks and 500 mg b.i.d. for an additional 4 weeks is given in combination with penicillin. Ototoxicity may require termination of the streptomycin prior to completion of the 6-week course of treatment.
:** Streptomycin in doses of 1 g b.i.d. for 2 weeks and 500 mg b.i.d. for an additional 4 weeks is given in combination with penicillin. [[Ototoxicity]] may require termination of the streptomycin prior to completion of the 6-week course of treatment.


* CONCOMITANT USE WITH OTHER AGENTS:  
* CONCOMITANT USE WITH OTHER AGENTS:  
:* For concomitant use with other agents to which the infecting organism is also sensitive:  
:* For concomitant use with other agents to which the infecting organism is also sensitive:  
:* Streptomycin is considered a secondline agent for the treatment of gram-negative bacillary bactermia, meningitis, and pneumonia; brucellosis; granuloma inguinale; chancroid, and urinary tract infection.
:* Streptomycin is considered a secondline agent for the treatment of [[Gram-negative bacteria|gram-negative bacillary bactermia]], [[meningitis]], and [[pneumonia]]; [[brucellosis]]; [[granuloma inguinale]]; [[chancroid]], and [[urinary tract infection]].
 
* For adults: 1 to 2 grams in divided doses every six to twelve hours for [[infections|moderate to severe infections]]. Doses should generally not exceed 2 grams per day.


* For adults: 1 to 2 grams in divided doses every six to twelve hours for moderate to severe infections. Doses should generally not exceed 2 grams per day.
* For children: 20 to 40 mg/kg/day (8 to 20 mg/lb/day) in divided doses every 6 to 12 hours. (Particular care should be taken to avoid excessive dosage in children).
* For children: 20 to 40 mg/kg/day (8 to 20 mg/lb/day) in divided doses every 6 to 12 hours. (Particular care should be taken to avoid excessive dosage in children).


* The dry lyophillized cake is dissolved by adding Water for Injection USP in an amount to yield the desired concentration as indicated in the following table:
* The dry lyophillized cake is dissolved by adding Water for Injection USP in an amount to yield the desired concentration as indicated in the following table:


[[File:Streptomycin Dosage Table 02.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:Streptomycin Dosage Table 02.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]


* Sterile reconstituted solutions should be protected from light and may be stored at room temperature for one week without significant loss of potency.
* [[sterile|Sterile reconstituted solutions]] should be protected from light and may be stored at room temperature for one week without significant loss of potency.


* Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
* [[Parenteral]] drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Streptomycin sulphate in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Streptomycin in adult patients.
|offLabelAdultNoGuideSupport=* Glanders
* [[Mycobacterium avium complex infection]], [[Lung disease]]
* Rat bite fever


<!--Non–Guideline-Supported Use (Adult)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Streptomycin sulphate in adult patients.
|fdaLIADPed======Mycobacterium Tuberculosis=====
* Dosing Information


<!--Pediatric Indications and Dosage-->
:* It is recommended that [[intramuscular|intramuscular injections]] be given preferably in the [[thigh|mid-lateral muscles of the thigh]]. In infants and small children the [[Gluteal muscles|periphery of the upper outer quadrant of the gluteal region]] should be used only when necessary, such as in [[burn]] patients, in order to minimize the possibility of damage to the [[sciatic nerve]].


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
[[File:Streptomycin Dosage Table 01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|fdaLIADPed=* It is recommended that intramuscular injections be given preferably in the mid-lateral muscles of the thigh. In infants and small children the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nerve.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Streptomycin sulfate in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Streptomycin sulphate in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Streptomycin sulphate in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Streptomycin sulfate in pediatric patients.
 
|contraindications=* A history of clinically significant [[hypersensitivity]] to streptomycin is a contraindication to its use. Clinically significant [[hypersensitivity]] to other [[aminoglycosides]] may contraindicate the use of streptomycin because of the known cross-sensitivity of patients to drugs in this class.
<!--Contraindications-->
|warnings=====Ototoxicity=====
|contraindications=* A history of clinically significant hypersensitivity to streptomycin is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of streptomycin because of the known cross-sensitivity of patients to drugs in this class.
|warnings======Ototoxicity=====


* Both vestibular and auditory dysfunction can follow the administration of streptomycin. The degree of impairment is directly proportional to the dose and duration of streptomycin administration, to the age of the patient, to the level of renal function and to the amount of underlying existing auditory dysfunction. The ototoxic effects of the aminoglycosides, including streptomycin, are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.
* Both [[Vestibular system|vestibular]] and [[Vestibular system|auditory dysfunction]] can follow the administration of streptomycin. The degree of impairment is directly proportional to the dose and duration of streptomycin administration, to the age of the patient, to the level of [[renal function]] and to the amount of underlying existing [[Vestibular systema|uditory dysfunction]]. The [[ototoxic]] effects of the [[aminoglycosides]], including streptomycin, are potentiated by the co-administration of [[ethacrynic acid]], [[mannitol]], [[furosemide]] and possibly other [[diuretics]].


* The vestibulotoxic potential of streptomycin exceeds that of its capacity for cochlear toxicity. Vestibular damage is heralded by headache, nausea, vomiting and disequilibrium. Early cochlear injury is demonstrated by the loss of high frequency hearing. Appropriate monitoring and early discontinuation of the drug may permit recovery prior to irreversible damage to the sensorineural cells.
* The [[ototoxic|vestibulotoxic]] potential of streptomycin exceeds that of its capacity for cochlear toxicity. [[ototoxic|Vestibular damage]] is heralded by [[headache]], [[nausea]], [[vomiting]] and [[disequilibrium]]. Early cochlear injury is demonstrated by the loss of high frequency [[hearing]]. Appropriate monitoring and early discontinuation of the drug may permit recovery prior to irreversible damage to the [[vestibular system|sensorineural cells]].


=====Pregnancy=====
=====Pregnancy=====


* Streptomycin can cause fetal harm when administered to a pregnant woman. Because streptomycin readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
* Streptomycin can cause fetal harm when administered to a [[pregnant]] woman. Because streptomycin readily crosses the [[placenta|placental barrier]], caution in use of the drug is important to prevent [[ototoxicity]] in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.


=====Clostridium difficile associated diarrhea (CDAD)=====
=====Clostridium difficile associated diarrhea (CDAD)=====
* Clostridium difficile associated diarrhea (CDAD) as been reported with use of nearly all antibacterial agents, including Streptomycin for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
 
* C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
* [[Clostridium difficile associated diarrhea]] ([[CDAD]]) as been reported with use of nearly all [[Antibiotic|antibacterial agents]], including Streptomycin for Injection, and may range in severity from [[diarrhea|mild diarrhea]] to [[colitis|fatal colitis]]. Treatment with [[antibiotics|antibacterial agents]] alters the [[normal flora]] of the [[colon]] leading to overgrowth of [[C. difficile]].
* If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difjicile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difjicile, and surgical evaluation should be instituted as clinically indicated.
 
* [[C. difficile]] produces [[C. difficile|toxins A and B]] which contribute to the development of [[CDAD]]. Hypertoxin producing strains of [[C. difficile]] cause increased morbidity and mortality, as these [[infections]] can be refractory to [[antibiotics|antimicrobial therapy]] and may require [[colectomy]]. [[CDAD]] must be considered in all patients who present with diarrhea following [[antibiotic]] use. Careful medical history is necessary since [[CDAD]] has been reported to occur over two months after the administration of [[antibiotics|antibacterial agents]].
 
* If [[CDAD]] is suspected or confirmed, ongoing [[antibiotic]] use not directed against [[C. difficile]] may need to be discontinued. Appropriate fluid and [[electrolyte]] management, protein supplementation, [[antibiotic]] treatment of [[C difficile]], and surgical evaluation should be instituted as clinically indicated.


=====PRECAUTIONS=====
=====PRECAUTIONS=====
* General
* General
:* Prescribing streptomycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
:* Prescribing streptomycin in the absence of a proven or strongly [[bacterial infection|suspected bacterial infection]] or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of [[Antibiotic resistance|drug-resistant bacteria]].


:* Baseline and periodic caloric stimulation tests and audiometric tests are advisable with extended streptomycin therapy. Tinnitus, roaring noises, or a sense of fullness in the ears indicates need for audiometric examination or termination of streptomycin therapy or both.
:* Baseline and periodic caloric stimulation tests and [[Auditory|audiometric]] tests are advisable with extended streptomycin therapy. [[Tinnitus]], roaring noises, or a sense of fullness in the ears indicates need for [[Auditory|audiometric examination]] or termination of streptomycin therapy or both.


:* Care should be taken by individuals handling streptomycin for injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Streptomycin Sulfate Injection should be injected well within the body of a relatively large muscle and care should be taken to minimize the possibility of damage to peripheral nerves. (See DOSAGE AND ADMINISTRATION.)
:* Care should be taken by individuals handling streptomycin for injection to avoid [[hypersensitivity|skin sensitivity reactions]]. As with all [[intramuscular]] preparations, Streptomycin Sulfate Injection should be injected well within the body of a relatively large muscle and care should be taken to minimize the possibility of damage to [[peripheral nerves]].


:* Extreme caution must be exercised in selecting a dosage regimen in the presence of pre-existing renal insufficiency. In severely uremic patients a single dose may produce high blood levels for several days and the cumulative effect may produce ototoxic sequelae. When streptomycin must be given for prolonged periods of time alkalinization of the urine may minimize or prevent renal irritation.
:* Extreme caution must be exercised in selecting a dosage regimen in the presence of pre-existing [[renal insufficiency]]. In severely uremic patients a single dose may produce high blood levels for several days and the cumulative effect may produce [[ototoxic]] sequelae. When streptomycin must be given for prolonged periods of time alkalinization of the urine may minimize or prevent [[renal|renal irritation]].


:* A syndrome of apparent central nervous system depression, characterized by stupor and flaccidity, occasionally coma and deep respiratory depression, has been reported in very young infants in whom streptomycin dosage had exceeded the recommended limits. Thus, infants should not receive streptomycin in excess of the recommended dosage.
:* A syndrome of apparent [[central nervous system|central nervous system depression]], characterized by [[stupor]] and [[flaccidity]], occasionally [[coma]] and [[respiratory depression|deep respiratory depression]], has been reported in very young infants in whom streptomycin dosage had exceeded the recommended limits. Thus, [[infants]] should not receive streptomycin in excess of the recommended dosage.


:* In the treatment of venereal infections such as granuloma inguinale, and chancroid, if concomitant syphilis is suspected, suitable laboratory procedures such as a dark field examination should be performed before the start of treatment, and monthly serologic tests should be done for at least four months.
:* In the treatment of venereal infections such as [[granuloma inguinale]], and [[chancroid]], if concomitant syphilis is suspected, suitable laboratory procedures such as a [[Dark field microscopy|dark field examination]] should be performed before the start of treatment, and monthly [[serologic|serologic tests]] should be done for at least four months.


:* As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.
:* As with other [[antibiotics]], use of this drug may result in overgrowth of nonsusceptible organisms, including [[fungi]]. If superinfection occurs, appropriate therapy should be instituted.
|clinicalTrials=* The following reactions are common: vestibular ototoxicity (nausea, vomiting, and vertigo); paresthesia of face; rash; fever; urticaria; angioneurotic edema; and eosinophilia.
|clinicalTrials=* The following reactions are common: [[ototoxicity|vestibular ototoxicity]] ([[nausea]], [[vomiting]], and [[vertigo]]); [[paresthesia|paresthesia of face]]; [[rash]]; [[fever]]; [[urticaria]]; [[angioneurotic edema]]; and [[eosinophilia]].


* The following reactions are less frequent: cochlear ototoxicity (deafness); exfoliative dermatitis; anaphylaxis; azotemia; leucopenia; thrombocytopenia; pancytopenia; hemolytic anemia; muscular weakness; and amblyopia.
* The following reactions are less frequent: [[otoxicity|cochlear ototoxicity]] ([[deafness]]); [[exfoliative dermatitis]]; [[anaphylaxis]]; [[azotemia]]; [[leucopenia]]; [[thrombocytopenia]]; [[pancytopenia]]; [[hemolytic anemia]]; [[muscular weakness]]; and [[amblyopia]].


* Vestibular dysfunction resulting from the parenteral administration of streptomycin is cumulatively related to the total daily dose. When 1.8 to 2 g/day are given, symptoms are likely to develop in the large percentage of patients - especially in the elderly or patients with impaired renal function - within four weeks. Therefore, it is recommended that caloric and audiometric tests be done prior to, during, and following intensive therapy with streptomycin in order to facilitate detection of any vestibular dysfunction and/or impairment of hearing which may occur.
* [[otooxicity|Vestibular dysfunction]] resulting from the [[parenteral|parenteral administration]] of streptomycin is cumulatively related to the total daily dose. When 1.8 to 2 g/day are given, symptoms are likely to develop in the large percentage of patients - especially in the elderly or patients with [[impaired renal function]] - within four weeks. Therefore, it is recommended that caloric and [[vestibular system|audiometric tests]] be done prior to, during, and following intensive therapy with streptomycin in order to facilitate detection of any [[ototoxicity|vestibular dysfunction]] and/or [[impairment of hearing]] which may occur.


* Vestibular symptoms generally appear early and usually are reversible with early detection and cessation of streptomycin administration. Two to three months after stopping the drug, gross vestibular symptoms usually disappear, except from the relative inability to walk in total darkness or on very rough terrain.
* [[Vestibular system|Vestibular symptoms]] generally appear early and usually are reversible with early detection and cessation of streptomycin administration. Two to three months after stopping the drug, gross [[Vestibular system|Vestibular symptoms]] usually disappear, except from the relative inability to walk in total darkness or on very rough terrain.


* Although streptomycin is the least nephrotoxic of the aminoglycosides, nephrotoxicity does occur rarely.
* Although streptomycin is the least [[nephrotoxic]] of the [[aminoglycosides]], [[nephrotoxicity]] does occur rarely.


* Clinical judgment as to termination of therapy must be exercised when side effects occur.
* Clinical judgment as to termination of therapy must be exercised when side effects occur.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Streptomycin sulphate in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Streptomycin sulfate in the drug label.
 
|drugInteractions=* The [[ototoxic]] effects of the [[aminoglycosides]], including streptomycin, are potentiated by the co-administration of [[ethacrynic acid]], [[furosemide]], [[mannitol]] and possibly other [[diuretics]].
 
|drugInteractions=* The ototoxic effects of the aminoglycosides, including streptomycin, are potentiated by the co-administration of ethacrynic acid, furosemide, mannitol and possibly other diuretics.
|FDAPregCat=D
|FDAPregCat=D
|useInPregnancyFDA=* Streptomycin can cause fetal harm when administered to a pregnant woman. Because streptomycin readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
|useInPregnancyFDA=* Streptomycin can cause fetal harm when administered to a [[pregnant]] woman. Because streptomycin readily crosses the [[placenta|placental barrier]], caution in use of the drug is important to prevent [[ototoxicity]] in the fetus. If this drug is used during [[pregnancy]], or if the patient becomes [[pregnant]] while taking this drug, the patient should be apprised of the potential hazard to the fetus.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Streptomycin sulphate in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Streptomycin sulfate in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of Streptomycin sulphate during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of Streptomycin sulfate during labor and delivery.
|useInNursing=* Because of the potential for serious adverse reactions in nursing infants from streptomycin, 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.
|useInNursing=* Because of the potential for serious adverse reactions in nursing infants from streptomycin, 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.
|useInPed=There is no FDA guidance on the use of Streptomycin sulphate with respect to pediatric patients.
|useInPed=There is no FDA guidance on the use of Streptomycin sulfate with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of Streptomycin sulphate with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of Streptomycin sulfate with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of Streptomycin sulphate with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of Streptomycin sulfate with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of Streptomycin sulphate with respect to specific racial populations.
|useInRace=There is no FDA guidance on the use of Streptomycin sulfate with respect to specific racial populations.
|useInRenalImpair=* The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
|useInRenalImpair=* The risk of severe [[neurotoxic]] reactions is sharply increased in patients with [[impaired renal function]] or [[azotemia|pre-renal azotemia]]. These include disturbances of [[vestibular system|vestibular]] and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible [[vestibular system|vestibular damage]] is particularly high in patients treated with streptomycin.


* Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
* [[Renal function]] should be monitored carefully; patients with [[renal impairment]] and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.


* The concurrent or sequential use of other neurotoxic and/or nephrotoxic drugs with streptomycin sulfate, including neomycin, kanamycin, gentamicin, cephaloridine, paromomycin, viomycin, polymyxin b, colistin, tobramycin and cyclosporine should be avoided.
* The concurrent or sequential use of other [[neurotoxic]] and/or [[nephrotoxic]] drugs with streptomycin sulfate, including [[neomycin]], [[kanamycin]], [[gentamicin]], [[cephaloridine]], [[paromomycin]], [[viomycin]], [[polymyxin b]], [[colistin]], [[tobramycin]] and [[cyclosporine]] should be avoided.


* Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
* [[Renal function]] should be monitored carefully; patients with [[renal impairment]] and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with [[kidney damage]] should not exceed 20 to 25 mcg/ml.
|useInHepaticImpair=There is no FDA guidance on the use of Streptomycin sulphate in patients with hepatic impairment.
|useInHepaticImpair=There is no FDA guidance on the use of Streptomycin sulfate in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of Streptomycin sulphate in women of reproductive potentials and males.
|useInReproPotential=There is no FDA guidance on the use of Streptomycin sulfate in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of Streptomycin sulphate in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of Streptomycin sulfate in patients who are immunocompromised.
|administration=* [[Intramuscular]]


<!--Administration and Monitoring-->
* [[Intravenous]]
|administration=* Intravenous
|monitoring======Nephrotoxicity=====
|monitoring======Nephrotoxicity=====


* The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
* The risk of severe [[neurotoxic]] reactions is sharply increased in patients with impaired renal function or [[azotemia|pre-renal azotemia]]. These include disturbances of [[vestibular system|vestibular and cochlear function]], [[optic nerve|optic nerve dysfunction]], [[peripheral neuritis]], [[arachnoiditis]], and [[encephalopathy]] may also occur. The incidence of clinically detectable, [[ototoxicity|irreversible vestibular damage]] is particularly high in patients treated with streptomycin.


* Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
* [[Renal function]] should be monitored carefully; patients with [[renal impairment]] and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.


=====Ototoxicity=====
=====Ototoxicity=====


* Both vestibular and auditory dysfunction can follow the administration of streptomycin. The degree of impairment is directly proportional to the dose and duration of streptomycin administration, to the age of the patient, to the level of renal function and to the amount of underlying existing auditory dysfunction. The ototoxic effects of the aminoglycosides, including streptomycin, are potentiated by the co-administration of ethacrynic acid, mannitol, furosemide and possibly other diuretics.
* Both [[Ototoxicity|vestibular and auditory dysfunction]] can follow the administration of streptomycin. The degree of impairment is directly proportional to the dose and duration of streptomycin administration, to the age of the patient, to the level of [[renal function]] and to the amount of underlying [[Ototoxicity|existing auditory dysfunction]]. The [[Ototoxicity|ototoxic effects]] of the [[aminoglycosides]], including streptomycin, are potentiated by the co-administration of [[ethacrynic acid]], [[mannitol]], [[furosemide]] and possibly other [[diuretics]].
 
* The vestibulotoxic potential of streptomycin exceeds that of its capacity for cochlear toxicity. Vestibular damage is heralded by headache, nausea, vomiting and disequilibrium. Early cochlear injury is demonstrated by the loss of high frequency hearing. Appropriate monitoring and early discontinuation of the drug may permit recovery prior to irreversible damage to the sensorineural cells.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of Streptomycin sulphate in the drug label.


<!--Overdosage-->
* The [[Ototoxicity|vestibulotoxic]] potential of streptomycin exceeds that of its capacity for [[Ototoxicity|cochlear toxicity]]. [[Ototoxicity|Vestibular damage]] is heralded by [[headache]], [[nausea]], [[vomiting]] and [[disequilibrium]]. Early [[Ototoxicity|cochlear injury]] is demonstrated by the [[hearing loss|loss of high frequency hearing]]. Appropriate monitoring and early discontinuation of the drug may permit recovery prior to [[ototoxicity|irreversible damage to the sensorineural cells]].
|overdose=There is limited information regarding <i>Chronic Overdose</i> of Streptomycin sulphate in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of Streptomycin sulfate in the drug label.
|overdose=There is limited information regarding <i>Chronic Overdose</i> of Streptomycin sulfate in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->
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<!--Pharmacokinetic data-->
<!--Pharmacokinetic data-->
| bioavailability = 84% to 88% (est.)<ref name="Zhu2001">{{cite journal | author = Zhu M, Burman WJ, Jaresko GS, Berning SE, Jelliffe RW, Peloquin CA. | date =October 2001 | title = Population pharmacokinetics of intravenous and intramuscular streptomycin in patients with tuberculosis | journal = [[Pharmacotherapy (journal)|Pharmacotherapy]] | volume = 21 | issue = 9 | pages = 1037–1045 | pmid = 11560193 | doi = 10.1592/phco.21.13.1037.34625 | url = http://www.medscape.com/viewarticle/409778 | accessdate = 2010-05-25}}</ref>
| bioavailability = 84% to 88% (est.)<ref name="Zhu2001">{{cite journal | author = Zhu M, Burman WJ, Jaresko GS, Berning SE, Jelliffe RW, Peloquin CA. | date =October 2001 | title = Population pharmacokinetics of intravenous and intramuscular streptomycin in patients with [[tuberculosis]] | journal = [[Pharmacotherapy (journal)|Pharmacotherapy]] | volume = 21 | issue = 9 | pages = 1037–1045 | pmid = 11560193 | doi = 10.1592/phco.21.13.1037.34625 | url = http://www.medscape.com/viewarticle/409778 | accessdate = 2010-05-25}}</ref>
| elimination_half-life = 5 to 6 hours
| elimination_half-life = 5 to 6 hours
| excretion = [[Kidney|Renal]]
| excretion = [[Kidney|Renal]]
Line 239: Line 244:
| melting_point = 12
| melting_point = 12
}}
}}
|mechAction=
|mechAction=* Streptomycin sulfate is a bactericidal antibiotic. It acts by interfering with normal protein synthesis.
<!--Structure-->
|structure=* Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus. It is marketed as the sulfate salt of streptomycin. The chemical name of streptomycin sulfate is D-Streptamine, O-2-deoxy-2-(methylamino)-α-L-glucopyranosyl-(1→2)-O-5-deoxy-3-C-formyl-α-L-lyxofuranosyl-(1→4)-N,N1-bis(aminoiminomethyl)-,sulfate (2:3) (salt). The molecular formula for Streptomycin Sulfate is (C21H39N7O12)2 -3H2SO4 and the molecular weight is 1457.41. It has the following structural formula:
|structure=* Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus. It is marketed as the sulfate salt of streptomycin. The chemical name of streptomycin sulfate is D-Streptamine, O-2-deoxy-2-(methylamino)-α-L-glucopyranosyl-(1→2)-O-5-deoxy-3-C-formyl-α-L-lyxofuranosyl-(1→4)-N,N1-bis(aminoiminomethyl)-,sulfate (2:3) (salt). The molecular formula for Streptomycin Sulfate is (C21H39N7O12)2 -3H2SO4 and the molecular weight is 1457.41. It has the following structural formula:


[[File:Streptomycin structure.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:Streptomycin structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
 
|PD=====Microbiology====
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of Streptomycin sulphate in the drug label.


<!--Pharmacokinetics-->
* Streptomycin sulfate is a bactericidal antibiotic. It acts by interfering with normal protein synthesis.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of Streptomycin sulphate in the drug label.


<!--Nonclinical Toxicology-->
* Streptomycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infection.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Streptomycin sulphate in the drug label.
:* [[Brucella]] ([[brucellosis]]),
:* [[Calymmatobacterium granulomatis]] ([[donovanosis]], [[granuloma inguinale]]),
:* [[Escherichia coli]], [[Proteus spp]]., Aerobacter aerogenes, [[Klebsiella pneumoniae]], and
:* [[Enterococcus faecalis]] in [[urinary tract infections]],
:* [[Francisella tularensis]],
:* [[Haemophilus ducreyi]] ([[chancroid]]),
:* [[Haemophilus influenzae]] (in [[respiratory infections|respiratory]], [[endocarditis|endocardial]], and [[meningitis|meningeal infections]] - concomitantly with another [[antibiotics|antibacterial agent]]),
:* [[Klebsiella pneumoniae|Klebsiella pneumoniae pneumonia]] (concomitantly with another [[antibiotics|antibacterial drugs]]),
:* tuberculosis
|PK=* Following intramuscular injection of 1 g of streptomycin as the sulfate, a peak serum level of 25 to 50 mcg/mL is reached within 1 hour, diminishing slowly to about 50 percent after 5 to 6 hours.


<!--Clinical Studies-->
* Appreciable concentrations are found in all organ tissues except the brain. Significant amounts have been found in [[pleural fluid]] and [[tuberculosis|tuberculous cavities]]. Streptomycin passes through the placenta with serum levels in the cord blood similar to maternal levels. Small amounts are excreted in [[milk]], [[saliva]], and [[sweat]].
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Streptomycin sulphate in the drug label.


<!--How Supplied-->
* Streptomycin is excreted by [[glomerular filtration]]. In patients with normal kidney function, between 29% and 89% of a single 400 mg dose is excreted in the urine within 24 hours. Any reduction of [[glomerular filtration|glomerular function]] results in decreased excretion of the drug and concurrent rise in serum and tissue levels.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Streptomycin sulfate in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Streptomycin sulfate in the drug label.
|howSupplied=* Streptomycin for Injection USP is available in single vials containing 1 gram NDC 39822-0706-1 packaged as boxes of ten vials NDC 39822-0706-2.
|howSupplied=* Streptomycin for Injection USP is available in single vials containing 1 gram NDC 39822-0706-1 packaged as boxes of ten vials NDC 39822-0706-2.
|storage=* Store dry powder under controlled room temperature 15° to 30°C (59° to 86°F)
|storage=* Store dry powder under controlled room temperature 15° to 30°C (59° to 86°F)
Line 275: Line 286:
10 Vial carton
10 Vial carton
X-GEN Pharmaceuticals, Inc.
X-GEN Pharmaceuticals, Inc.
|fdaPatientInfo=* Patients should be counseled that antibacterial drugs including streptomycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When streptomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by streptomycin or other antibacterial drugs in the future.
|fdaPatientInfo=* Patients should be counseled that [[antibiotics|antibacterial drugs]] including streptomycin should only be used to treat [[bacterial infections]]. They do not treat [[viral infections]] (e.g., the [[common cold]]). When streptomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by streptomycin or other [[antibiotics|antibacterial drugs]] in the future.


* Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose ofthe antibiotic. If this occurs, patients should contact their physician as soon as possible.
* Diarrhea is a common problem caused by [[antibiotics]] which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with [[antibiotics]], patients can develop [[diarrhea|watery]] and [[bloody stools]] (with or without [[abdominal pain|stomach cramps]] and [[fever]]) even as late as two or more months after having taken the last dose of the [[antibiotic]]. If this occurs, patients should contact their physician as soon as possible.
|alcohol=* Alcohol-Streptomycin sulphate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-Streptomycin sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->
<!--Brand Names-->
|endocardial infections]] - concomitantly with [[penicillin]])_=====SUSCEPTIBILITY TESTS: Diffusion Techniques=====
* Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of [[bacteria]] to [[antibiotics|antibacterial drugs]]. One such standard procedure 1 which has been recommended for use with disks to test susceptibility of organisms to streptomycin uses the 10 mcg streptomycin disk. Interpretation involves the correlation of the diameter obtained in the disk test with the [[minimum inhibitory concentration]] ([[MIC]]) for streptomycin.
* Reports from the laboratory giving results of the standard single disk susceptibility test with a 10 mcg streptomycin disk should be interpreted according to the following criteria:
* Interpretive Criteria for Enterobacteriaceae
[[File:Streptomycin Pharmaco Table 01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
A report of “Susceptible” indicates that the pathogen is likely to respond to monotherapy with streptomycin. A report of “Intermediate” indicates that the result be considered equivocal, and, if the organism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretations. A report of “Resistant” indicates that achievable drug concentrations are unlikely to be inhibitory and other therapy should be selected.
Standardized procedures require the use of laboratory control organisms. The 10 mcg streptomycin disk should give the following zone diameter2:
[[File:Streptomycin Pharmaco Table 02.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|drugShortage=
|drugShortage=
}}
}}
Line 293: Line 319:
}}
}}
<!--Pill Image-->
<!--Pill Image-->


<!--Label Display Image-->
<!--Label Display Image-->


<!--Category-->
<!--Category-->


[[Category:Drug]]
[[Category:Drug]]

Latest revision as of 14:21, 10 March 2015

Streptomycin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
* The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
  • Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
  • The concurrent or sequential use of other neurotoxic and/or nephrotoxic drugs with streptomycin sulfate, including neomycin, kanamycin, gentamicin, cephaloridine, paromomycin, viomycin, polymyxin b, colistin, tobramycin and cyclosporine should be avoided.
  • The neurotoxicity of streptomycin can result in respiratory paralysis from neuromuscular blockage, especially when the drug is given soon after the use of anesthesia or muscle relaxants.
  • The administration of streptomycin in parenteral form should be reserved for patients where adequate laboratory and audiometric testing facilities are available during therapy.

Overview

Streptomycin is an aminoglycosides and antitubercular antibiotic that is FDA approved for the treatment of Mycobacterium tuberculosis and Non-tuberculosis infections like plague, tularemia, Brucella, donovanosis, granuloma inguinale, chancroid, H. influenzae (in respiratory, endocardial, and meningeal infections-concomitantly with another antibacterial agent), K. pneumoniae pneumonia (concomitantly with another antibacterial agent), E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections. Streptococcus viridans, Enterococcus faecalis (in endocardial infections -concomitantly with penicillin), Gram-negative bacillary bacteremia (concomitantly with another antibacterial agent). There is a Black Box Warning for this drug as shown here. Common adverse reactions include vestibular ototoxicity, nausea, vomiting, vertigo, paresthesia of face, rash, fever, urticaria, angioneurotic edema and eosinophilia..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptibile strains of microorganisms in the specific conditions listed below:
Mycobacterium Tuberculosis
  • The Advisory Council for the Elimination of tuberculosis, the American Thoracic Society, and the Center for Disease Control recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH or rifampin resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. In the past when the national rate of primary drug resistance to isoniazid was known to be less than 4% and was either stable or declining, therapy with two and three drug regimens was considered adequate. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.
  • Streptomycin is also indicated for therapy of tuberculosis when one or more of the above drugs is contraindicated because of toxicity or intolerance. The management of tuberculosis has become more complex as a consequence of increasing rates of drug resistance and concomitant HIV infection. Additional consultation from experts in the treatment of tuberculosis may be desirable in those settings.
Non-Tuberculosis infections
  • The use of streptomycin should be limited to the treatment of infections caused by bacteria which have been shown to be susceptible to the antibacterial effects of streptomycin and which are not amenable to therapy with less potentially toxic agents.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of streptomycin and other antibacterial drugs, streptomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosing Information
  • Injection sites should be alternated. As higher doses or more prolonged therapy with streptomycin may be indicated for more severe or fulminating infections (endocarditis, meningitis, etc.), the physician should always take adequate measures to be immediately aware of any toxic signs or symptoms occurring in the patient as a result of streptomycin therapy.
  • The standard regimen for the treatment of drug susceptible tuberculosis has been two months of INH, rifampin and pyrazinamide followed by four months of INH and rifampin (patients with concomitant infection with tuberculosis and HIV may require treatment for a longer period). When streptomycin is added to this regimen because of suspected or proven drug resistance, the recommended dosing for streptomycin is as follows:
This image is provided by the National Library of Medicine.
  • Streptomycin is usually administered daily as a single intramuscular injection. A total dose of not more than 120 g over the course of therapy should be given unless there are no other therapeutic options. In patients older than 60 years of age the drug should be used at a reduced dosage due to the risk of increased toxicity.
  • Therapy with streptomycin may be terminated when toxic symptoms have appeared, when impending toxicity is feared, when organisms become resistant, or when full treatment effect has been obtained. The total period of drug treatment of tuberculosis is a minimum of 1 year; however, indications for terminating therapy with streptomycin may occur at any time as noted above.
  • One to 2 g daily in divided doses for 7 to 14 days until the patient is afebrile for 5 to 7 days.
  • Two grams of streptomycin daily in two divided doses should be administered intramuscularly. :* A minimum of 10 days of therapy is recommended.
  • CONCOMITANT USE WITH OTHER AGENTS:
  • For adults: 1 to 2 grams in divided doses every six to twelve hours for moderate to severe infections. Doses should generally not exceed 2 grams per day.
  • For children: 20 to 40 mg/kg/day (8 to 20 mg/lb/day) in divided doses every 6 to 12 hours. (Particular care should be taken to avoid excessive dosage in children).
  • The dry lyophillized cake is dissolved by adding Water for Injection USP in an amount to yield the desired concentration as indicated in the following table:
This image is provided by the National Library of Medicine.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Streptomycin in adult patients.

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Mycobacterium Tuberculosis
  • Dosing Information
This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Streptomycin sulfate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Streptomycin sulfate in pediatric patients.

Contraindications

  • A history of clinically significant hypersensitivity to streptomycin is a contraindication to its use. Clinically significant hypersensitivity to other aminoglycosides may contraindicate the use of streptomycin because of the known cross-sensitivity of patients to drugs in this class.

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
* The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
  • Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
  • The concurrent or sequential use of other neurotoxic and/or nephrotoxic drugs with streptomycin sulfate, including neomycin, kanamycin, gentamicin, cephaloridine, paromomycin, viomycin, polymyxin b, colistin, tobramycin and cyclosporine should be avoided.
  • The neurotoxicity of streptomycin can result in respiratory paralysis from neuromuscular blockage, especially when the drug is given soon after the use of anesthesia or muscle relaxants.
  • The administration of streptomycin in parenteral form should be reserved for patients where adequate laboratory and audiometric testing facilities are available during therapy.

Ototoxicity=

Pregnancy
  • Streptomycin can cause fetal harm when administered to a pregnant woman. Because streptomycin readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Clostridium difficile associated diarrhea (CDAD)
  • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.
PRECAUTIONS
  • General
  • Baseline and periodic caloric stimulation tests and audiometric tests are advisable with extended streptomycin therapy. Tinnitus, roaring noises, or a sense of fullness in the ears indicates need for audiometric examination or termination of streptomycin therapy or both.
  • Care should be taken by individuals handling streptomycin for injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Streptomycin Sulfate Injection should be injected well within the body of a relatively large muscle and care should be taken to minimize the possibility of damage to peripheral nerves.
  • Extreme caution must be exercised in selecting a dosage regimen in the presence of pre-existing renal insufficiency. In severely uremic patients a single dose may produce high blood levels for several days and the cumulative effect may produce ototoxic sequelae. When streptomycin must be given for prolonged periods of time alkalinization of the urine may minimize or prevent renal irritation.
  • As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

Adverse Reactions

Clinical Trials Experience

  • Vestibular symptoms generally appear early and usually are reversible with early detection and cessation of streptomycin administration. Two to three months after stopping the drug, gross Vestibular symptoms usually disappear, except from the relative inability to walk in total darkness or on very rough terrain.
  • Clinical judgment as to termination of therapy must be exercised when side effects occur.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Streptomycin sulfate in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): D

  • Streptomycin can cause fetal harm when administered to a pregnant woman. Because streptomycin readily crosses the placental barrier, caution in use of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Streptomycin sulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Streptomycin sulfate during labor and delivery.

Nursing Mothers

  • Because of the potential for serious adverse reactions in nursing infants from streptomycin, 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

There is no FDA guidance on the use of Streptomycin sulfate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Streptomycin sulfate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Streptomycin sulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Streptomycin sulfate with respect to specific racial populations.

Renal Impairment

  • The risk of severe neurotoxic reactions is sharply increased in patients with impaired renal function or pre-renal azotemia. These include disturbances of vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis, and encephalopathy may also occur. The incidence of clinically detectable, irreversible vestibular damage is particularly high in patients treated with streptomycin.
  • Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
  • Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.

Hepatic Impairment

There is no FDA guidance on the use of Streptomycin sulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Streptomycin sulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Streptomycin sulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

Nephrotoxicity
  • Renal function should be monitored carefully; patients with renal impairment and/or nitrogen retention should receive reduced doses. The peak serum concentration in individuals with kidney damage should not exceed 20 to 25 mcg/ml.
Ototoxicity

IV Compatibility

There is limited information regarding IV Compatibility of Streptomycin sulfate in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Streptomycin sulfate in the drug label.

Pharmacology

Template:Px
Template:Px
Streptomycin
Systematic (IUPAC) name
5-(2,4-diguanidino-
3,5,6-trihydroxy-cyclohexoxy)- 4-[4,5-dihydroxy-6-(hydroxymethyl)
-3-methylamino-tetrahydropyran-2-yl] oxy-3-hydroxy-2-methyl
-tetrahydrofuran-3-carbaldehyde
Identifiers
CAS number 57-92-1
ATC code A07AA04 J01GA01 (WHO)
PubChem 19649
DrugBank DB01082
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 581.574 g/mol
SMILES eMolecules & PubChem
Physical data
Melt. point 12 °C (54 °F)
Pharmacokinetic data
Bioavailability 84% to 88% (est.)[1]
Metabolism ?
Half life 5 to 6 hours
Excretion Renal
Therapeutic considerations
Pregnancy cat.

D(US)

Legal status

POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes Intramuscular, intravenous

Mechanism of Action

  • Streptomycin sulfate is a bactericidal antibiotic. It acts by interfering with normal protein synthesis.

Structure

  • Streptomycin is a water-soluble aminoglycoside derived from Streptomyces griseus. It is marketed as the sulfate salt of streptomycin. The chemical name of streptomycin sulfate is D-Streptamine, O-2-deoxy-2-(methylamino)-α-L-glucopyranosyl-(1→2)-O-5-deoxy-3-C-formyl-α-L-lyxofuranosyl-(1→4)-N,N1-bis(aminoiminomethyl)-,sulfate (2:3) (salt). The molecular formula for Streptomycin Sulfate is (C21H39N7O12)2 -3H2SO4 and the molecular weight is 1457.41. It has the following structural formula:
This image is provided by the National Library of Medicine.

Pharmacodynamics

Microbiology

  • Streptomycin sulfate is a bactericidal antibiotic. It acts by interfering with normal protein synthesis.
  • Streptomycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infection.

Pharmacokinetics

  • Following intramuscular injection of 1 g of streptomycin as the sulfate, a peak serum level of 25 to 50 mcg/mL is reached within 1 hour, diminishing slowly to about 50 percent after 5 to 6 hours.
  • Appreciable concentrations are found in all organ tissues except the brain. Significant amounts have been found in pleural fluid and tuberculous cavities. Streptomycin passes through the placenta with serum levels in the cord blood similar to maternal levels. Small amounts are excreted in milk, saliva, and sweat.
  • Streptomycin is excreted by glomerular filtration. In patients with normal kidney function, between 29% and 89% of a single 400 mg dose is excreted in the urine within 24 hours. Any reduction of glomerular function results in decreased excretion of the drug and concurrent rise in serum and tissue levels.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Streptomycin sulfate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Streptomycin sulfate in the drug label.

How Supplied

  • Streptomycin for Injection USP is available in single vials containing 1 gram NDC 39822-0706-1 packaged as boxes of ten vials NDC 39822-0706-2.

Storage

  • Store dry powder under controlled room temperature 15° to 30°C (59° to 86°F)

Images

Drug Images

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Package and Label Display Panel

NDC 39822-0706-1 Streptomycin for Injection, USP 1 gram*/ vial For Intramuscular Use Rx Only 1 Vial X-GEN Pharmaceuticals, Inc.

NDC 39822-0706-2 Streptomycin for Injection, USP 1 gram*/ vial For Intramuscular Use Rx Only 10 Vial carton X-GEN Pharmaceuticals, Inc. {{#ask: Label Page::Streptomycin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • Patients should be counseled that antibacterial drugs including streptomycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When streptomycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by streptomycin or other antibacterial drugs in the future.
  • Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Precautions with Alcohol

  • Alcohol-Streptomycin sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Streptomycin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Streptomycin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Zhu M, Burman WJ, Jaresko GS, Berning SE, Jelliffe RW, Peloquin CA. (October 2001). "Population pharmacokinetics of intravenous and intramuscular streptomycin in patients with [[tuberculosis]]". Pharmacotherapy. 21 (9): 1037–1045. doi:10.1592/phco.21.13.1037.34625. PMID 11560193. Retrieved 2010-05-25. URL–wikilink conflict (help)

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