استرپتوسین
Streptomycin (Streptomycin)
استرپتوسین

نام ژنریک

Streptomycin Sulfate

شکل دارویی

اشكال دارويي:


Injection, Powder: 1g

موارد مصرف

موارد و مقدار مصرف


الف) درمان اوليه و كمكي سل.


بزرگسالان: از راه عضلاني، مقدار g/day 1 يا mg/kg 15 روزانه يا مقدار mg/kg 30-25 (تا 5/1 گرم) 3-2 بار در هفته به مدت حداقل يك سال تزريق شود. دارو در يك چهارم فوقاني خارجي عضله سريني به طور عمقي تزريق مي‌شود.


كودكان: از راه عضلاني، مقدار mg/kg/day 40-20 (تا 1 گرم) ياmg/kg 30-25 (تا g 1.5 ) 2 تا 3 بار در هفته به مدت حداقل يک سال، در داخل عضلات حجيم به طور عمقي تزريق مي‌شود.


سالمندان: دوز دارو بر اساس سن، عملكرد كليوي و عملكرد عصب زوج هشت جمجمه‌اي كاهش مي‌يابد. دوز پيشنهاد شده mg/kg 10 (تا mg 750) روزانه است.


اين دارو به طور همزمان با ساير داروهاي ضد سل استفاده مي‌شود، اما همراه با كاپرئومايسين مصرف نمي‌شود. مصرف دارو تا منفي شدن نمونه‌هاي خلط بيمار ادامه مي‌يابد.


ب) آندوكارديت آنتروكوكي.


بزرگسالان: از راه عضلاني، هر 12 ساعت مقدار يك گرم به مدت دو هفته، و سپس، هر 12 ساعت مقدار 500 ميلي‌گرم به مدت چهار هفته، همراه با پني‌سيلين، تزريق عضلاني مي‌شود.


پ) تولارمي.


بزرگسالان: از راه عضلاني، مقدار g/day 2-1 در مقادير منقسم ، در يك چهارم فوقاني خارجي عضله سريني به طور عمقي، تزريق مي‌شود. درمان بايد به مدت 14-7 روز يا تا زمان 7-5 روز پس از قطع تب بيمار ادامه يابد.


ت) طاعون (عفونت يرسينياپستيس).


بزرگسالان: مقدار 2 گرم (mg/kg 30) در روز از راه عضلاني در 2 دوز منقسم به مدت حداقل 10 روز مصرف مي‌شود.


كودكان: از راه عضلاني، مقدار mg/kg 30 روزانه در دو يا 3 دوز منقسم به مدت 10 روز مصرف مي‌شود.


ث) بروسلوز.


بزرگسالان: از راه عضلاني، مقدار يك گرم، يك يا 2 بار در روز همراه با داكسي‌سيكلين يا تتراسيكلين در طي هفته اول و يك بار در روز به مدت حداقل يك هفته ديگر مصرف مي‌شود.


كودكان با سن بالاتر از 8 سال: از راه عضلاني مقدار mg/kg 20 (تا يك گرم) به مدت 2 هفته همراه با تتراسيكلين يا كوتريموكسازول مصرف مي‌شود.


ج) اندوكارديت استرپتوكوكي حساس به پني‌سيلين.


بزرگسالان 60 سال و پايين‌تر: از راه عضلاني مقدار يك گرم 2 بار در روز به مدت يك هفته همراه با پني‌سيلين مصرف مي‌شود. سپس mg 500 دو بار در هفته به مدت يك هفته مصرف مي‌گردد.


بزرگسالان بالاي 60 سال: مقدار mg‌ 500 دو بار در روز به مدت 2 هفته همراه با پني‌سيلين مصرف مي‌شود.


تنظيم دوز: دوز دارو بر اساس سطح سرمي تنظيم مي‌گردد، نبايد پيك دارو از mcg/ml 25-20 فراتر برود. در صورتي كه سطح سرمي در دسترس نباشد ، مي‌توان دوز را بر اساس كليرانس كراتينين تنظيم كرد. بعد از دادن يك گرم دوز لودينگ، در بيماراني كه كليرانس كراتينين ml‌ 80-50 در دقيقه دارند، مقدار mg/kg 5/7 در فواصل 24 ساعته دريافت مي‌كنند. در بيماراني كه كليرانس كراتينين ml 50-10 در دقيقه دارند فواصل تجويز به هر 24 تا 72 ساعت افزايش مي‌يابد و در كساني كه كليرانس كراتينين كمتر از ml 10 در دقيقه دارند ممكن است به فواصل 96-72 ساعته نياز باشد.


در صورت وجود نارسايي كليوي يا همودياليز، توصيه مي‌شود كه 75-50 درصد دوز لودينگ در پايان هر جلسه دياليز تجويز گردد. هر چند لازم است سطحي سرمي دارو مشخص شده و دوز بر اساس سطح سرمي مطلوب تنظيم گردد.

موارد منع مصرف

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط شناخته شده نسبت به اين دارو يا هر يك از آمينوگليكوزيدها. هرگز اين دارو از راه وريدي تجويز نمي‌ شود.


موارد احتياط : كاهش عملكرد كليوي، وزوز گوش، سرگيجه حقيقي و كاهش شنوايي فركانس بالا (اين بيماران مستعد ابتلا به اتوتوکسيسيته هستند)، دهيدراتا سيون، مياستني گراو، پاركينسونيسم، هيپو كلسيمي، نوزادان و شيرخواران، بيماران سالخورده. بيماريهاي عصبي - عضلاني، مصرف همزمان ساير ترکيبات نفروتوکسيک.

عوارض جانبی دارو

عوارض جانبي


اعصاب مرکزي: سردرد، لتارژي، بلوك عصبي - عضلاني.


گوش: اتوتوکسيسيته (وزوز گوش، سرگيجه، كاهش شنوايي).


دستگاه گوارش: اسهال، تهوع، استفراغ.


ادراري ـ تناسلي: تا حدي نفروتوکسيسيته (كمتر از ساير آمينوگليكوزيدها).


تنفسي: آپنه.


پوست: درماتيت اکسفولياتيو.


خون: آگرانولوسيتوز گذرا، لكوپني، ترومبوسيتوپني، ائوزينوفيلي.


موضعي: درد، تحريك و آبسه‌هاي استريل در محل تزريق.


ساير عوارض: واكنش‌هاي حساسيت مفرط (بثورات پوستي، تب، كهير، كهير غول‌آسا، آنافيلاكسي، عفونت ثانويه باكتريايي و قارچي، انسداد عصبي - عضلاني.


توجه: در صورت بروز علائم اتوتوکسيسيته، نفروتوکسيسيته، حساسيت مفرط، يا اسهال شديد ناشي از كوليت سودوممبران، بايد مصرف دارو قطع شود.


مسموميت و درمان


تظاهرات باليني: توکسيسيته گوشي، كليوي و عصبي - عضلاني.


درمان: دارو با همودياليز يا دياليز صفاقي از بدن خارج مي‌شود. انسداد عصبي - عضلاني را با املاح كليسم يا ضد كولين استرازها برطرف مي‌كنند.

موارد قابل توجه

-

تداخل دارویی

تداخل دارويي


مصرف همزمان با داروهاي زير ممكن است خطر توکسيسيتي كليوي ، گوشي و عصبي را افزايش دهد:


پلي‌ميكسين B، وانكومايسين، كاپرئومايسين، سيس‌پلاتين، سفالوسپورين‌ها، آمفوتريسين B، و ساير آمينوگليكوزيدها، متوکسي فلوران.


در صورت مصرف همزمان با اتاكرينيك اسيد، بومتانايد، اوره، فوروسمايد يا مانيتول، خطر اتوتوکسيسيته نيز افزايش مي‌يابد.


ديمن هيدرينات و ساير داروهاي ضد استفراغ و ضد سرگيجه حقيقي ممكن است اتوتوکسيسيته ناشي از مصرف استرپتومايسين را پنهان سازد.


مصرف همزمان استرپتومايسين با آتراكوريوم، پانكورونيوم، روكرونيوم و وكرونيوم مي‌توانند منجر به افزايش اثرات شل‌كننده عضلاني غيردپلاريزان اين داروها شامل دپرسيون تنفسي طول كشيده گردد. تنها زماني همزمان استفاده شوند كه نياز باشد.


مصرف همزمان با پني‌سيلين‌ها موجب بروز اثر سينرژيك باكتري‌كش در مقابل سودوموناس آئروژينوزا، اشريشياكلي، كلبسيلا، سيتروباكتر، آنتروباكتر، سراشيا و پروتئوس ميرابيليس مي‌شود. با اين وجود، اين داروها از لحاظ فيزيكي و شيميايي ناسازگار هستند و در صورت مخلوط شدن يا مصرف همزمان غيرفعال مي‌شوند. در مطالعات in vivo، غيرفعال شدن دارو در صورت مصرف همزمان آمينوگليگكوزيدها و پني‌سيلين‌ها گزارش شده است.


استرپتومايسين ممكن است انسداد عصبي - عضلاني ناشي از مصرف بيهوش‌كننده‌هاي عمومي يا داروهاي مسدودكننده عصبي - عضلاني ، مانند سوكسينيل كولين و توبوكورارين را تشديد كند.

مکانیزم اثر

تداخل دارويي


مصرف همزمان با داروهاي زير ممكن است خطر توکسيسيتي كليوي ، گوشي و عصبي را افزايش دهد:


پلي‌ميكسين B، وانكومايسين، كاپرئومايسين، سيس‌پلاتين، سفالوسپورين‌ها، آمفوتريسين B، و ساير آمينوگليكوزيدها، متوکسي فلوران.


در صورت مصرف همزمان با اتاكرينيك اسيد، بومتانايد، اوره، فوروسمايد يا مانيتول، خطر اتوتوکسيسيته نيز افزايش مي‌يابد.


ديمن هيدرينات و ساير داروهاي ضد استفراغ و ضد سرگيجه حقيقي ممكن است اتوتوکسيسيته ناشي از مصرف استرپتومايسين را پنهان سازد.


مصرف همزمان استرپتومايسين با آتراكوريوم، پانكورونيوم، روكرونيوم و وكرونيوم مي‌توانند منجر به افزايش اثرات شل‌كننده عضلاني غيردپلاريزان اين داروها شامل دپرسيون تنفسي طول كشيده گردد. تنها زماني همزمان استفاده شوند كه نياز باشد.


مصرف همزمان با پني‌سيلين‌ها موجب بروز اثر سينرژيك باكتري‌كش در مقابل سودوموناس آئروژينوزا، اشريشياكلي، كلبسيلا، سيتروباكتر، آنتروباكتر، سراشيا و پروتئوس ميرابيليس مي‌شود. با اين وجود، اين داروها از لحاظ فيزيكي و شيميايي ناسازگار هستند و در صورت مخلوط شدن يا مصرف همزمان غيرفعال مي‌شوند. در مطالعات in vivo، غيرفعال شدن دارو در صورت مصرف همزمان آمينوگليگكوزيدها و پني‌سيلين‌ها گزارش شده است.


استرپتومايسين ممكن است انسداد عصبي - عضلاني ناشي از مصرف بيهوش‌كننده‌هاي عمومي يا داروهاي مسدودكننده عصبي - عضلاني ، مانند سوكسينيل كولين و توبوكورارين را تشديد كند.

فارماكوكینتیك

فارماكوكينتيك


جذب: به ميزان بسيار جزئي از دستگاه گوارش جذب و معمولاً پس از تزريق عضلاني پيک غلظت سرمي طي 2-1 ساعت حاصل مي‌شود.


پخش: پس از تزريق به طور گسترده انتشار مي‌يابد. نفوذ دارو به داخل چشم بسيار اندك است. نفوذ اين دارو به داخل مايع مغزي - نخاعي (CSF) (حتي در بيماران مبتلا به مننژيت) كم است. از جفت عبور مي‌كند. حدود 36 درصد به پروتئين پيوند مي‌يابد.


متابوليسم: متابوليزه نمي‌شود.


دفع: عمدتاً توسط فيلتراسيون گلومرولي و از طريق ادرار دفع مي‌شود. مقادير كمي از دارو ممكن است در صفرا و شير ترشح شود ، نيمه عمر دفع دارو در بزگسالان 3-2 ساعت است. در نارسايي شديد كليوي، نيمه عمر دارو ممكن است به 110 ساعت برسد.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: آمينوگليكوزيد.


طبقه‌بندي درماني: آنتي‌بيوتيك.


طبقه‌بندي مصرف در بارداري: رده D


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي آمينوگليكوزيدها، رعايت موارد زير نيز توصيه مي‌شود:


1- به هنگام تهيه دارو، بايد دست‌ها محافظت شوند؛ دارو موجب تحريك پوست مي‌شود.


2- در درمان اوليه سل، در صورت منفي بودن نتايج آزمون نمونه‌هاي خلط، بايد مصرف استرپتومايسين قطع شود.


3- از آنجايي كه استرپتومايسين قابل دياليز است، ممكن است مقدار مصرف آن در بيماران تحت همودياليز احتياج به تنظيم داشته باشد.


اثر بر آزمايشهاي تشخيصي


استرپتومايسين ممكن است موجب واكنش مثبت كاذب در سنجش گلوكز ادرار با استفاده از روش سولفات مس (معرف بنديكت) شود.


در صورت بروز نفروتوکسيسيته ناشي از مصرف استرپتومايسين، ممكن است غلظت BUN، كرآتينين سرم و دفع کاستهاي ادراري افزايش يابد.

Streptomycin (Streptomycin)

Streptomycin
for Injection USP

1 gram* / vial
*Each vial contains Streptomycin Sulfate USP equivalent to 1 gram Streptomycin.

For Intramuscular Use

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 bacteria.

WARNING

THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTSWITH 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, ESPECIALLYWHEN 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.

DRUG DESCRIPTION

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:

Streptomycin  Structural Formula Illustration

Streptomycin for Injection, equivalent to 1 gram streptomycin /vial is supplied as a sterile nonpyrogenic lyophillized cake for intramuscular use after reconstitution. The lyophillized cake may reduce to a powder during shipping.

After reconstitution the pH range for Streptomycin for Injection should be between 4.5 and 7.0 in a solution containing 200 mg of streptomycin activity per mL.

What are the precautions when taking streptomycin (Streptomycin)?

See also Warning section.

Before using streptomycin injection, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (e.g., tobramycin, gentamicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, hearing problems, severe loss of body water (dehydration), a certain muscle problem (myasthenia gravis), burns over a large area of skin, cystic fibrosis.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug...

Read All Potential Precautions of Streptomycin »

*Each vial contains Sterile Streptomycin Sulfate USP equivalent to 1 gram of Streptomycin.

What are the precautions when taking streptomycin (Streptomycin)?

See also Warning section.

Before using streptomycin injection, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (e.g., tobramycin, gentamicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, hearing problems, severe loss of body water (dehydration), a certain muscle problem (myasthenia gravis), burns over a large area of skin, cystic fibrosis.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug...

Read All Potential Precautions of Streptomycin »

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Streptomycin is indicated for the treatment of individuals with moderate to severe infections caused by susceptible strains of microorganisms in the specific conditions listed below:

1. 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.

2. 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.

    1. Pasteurella pestis (plague),
    2. Francisella tularensis (tularemia),
    3. Brucella,
    4. Calymmatobacterium granulomatis (donovanosis, granuloma inguinale),
    5. H. ducreyi (chancroid),
    6. H. influenzae (in respiratory, endocardial, and meningeal infections - concomitantly with another antibacterial agent),
    7. K. pneumoniae pneumonia (concomitantly with another antibacterial agent),
    8. E.coli, Proteus, A. aerogenes, K. pneumoniae, and Enterococcus faecalis in urinary tract infections,
    9. Streptococcus viridans, Enterococcus faecalis (in endocardial infections - concomitantly with penicillin),
    10. 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.

DOSAGE AND ADMINISTRATION

Intramuscular Route Only

Adults: The preferred site is the upper outer quadrant of the buttock, (i.e., gluteus maximus), or the mid-lateral thigh.

Children: 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.

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.

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.

1. 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 (see INDICATIONS AND USAGE section), the recommended dosing for streptomycin is as follows:

  Daily Twice Weekly Twice Weekly
Chil dren 20-40mg /kg 25-30 mg/kg 25-30 mg/kg
Max 1 g Max 1.5 g Max 1.5 g
Adults 15 mg/kg 25-30 mg/kg 25-30 mg/kg
Max 1 g Max 1.5 g Max 1.5 g

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.)

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.

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

3. PLAGUE: Two grams of streptomycin daily in two divided doses should be administered intramuscularly. A minimum of 10 days of therapy is recommended.

4. BACTERIAL ENDOCARDITIS:

  1. 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.
  2. 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.

5. CONCOMITANT USE WITH OTHER AGENTS: For concomitant use with other agents to which the infecting organism is also sensitive: Streptomycin is considered a second-line agent for the treatment of gram-negative bacillary bacteremia, 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 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:

Approx. Conc . mg/mL Volume ( mL) of Solvent
200 4.2
250 3.2
400 1.8

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.

HOW SUPPLIED

Streptomycin for Injection USP is available in vials containing 1 gram NDC 39822-0706-1. Boxes of ten vials use NDC 39822-0706-2.

Store dry powder at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT.

Manufactured for: Northport, NY 11768. Revised September 2006. FDA revision date: 7/23/2001

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following reactions are common: vestibular ototoxicity (nausea, vomiting, and vertigo); 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.

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.

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.

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.

Read the Streptomycin (streptomycin) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

The ototoxic effects of the aminoglycosides, including streptomycin, are potentiated by the co-administration of ethacrynic acid, furosemide, mannitol and possibly other diuretics.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

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.

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.

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.

PRECAUTIONS

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.

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 for 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.)

Extreme caution must be exercised in selecting a dosage regimen in the presence of preexisting 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.

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.

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.

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.

Pregnancy: Category D: See WARNINGS section.

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: (See DOSAGE AND ADMINISTRATION.)

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

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.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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 600 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.

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. (See INDICATIONS AND USAGE.):

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, endocardial, and meningeal infections - concomitantly with another antibacterial agent),
Klebsiella pneumoniae
pneumonia (concomitantly with another antibacterial agent),
Mycobacterium tuberculosis
,
Pasteurella pestis

Streptococcus
viridans, Enterococcus faecalis (in endocardial infectionsconcomitantly 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 antimicrobial agents. One such standard procedure1 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:

Zone Diameter (mm) Interpretation
≥15 (S) Susceptible
11- 12 (I) Intermediate
≤10 (R )Resistant

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 diameter:

Organism Zone Diameter (mm)
E. coli ATCC 25922 12-20
S. aureus ATCC 259 23 14-22

Methods Section

Two standardized in vitro susceptibility methods are available for testing streptomycin against Mycobancerium tuberculosis organisms. The agar proportion method (CDC or NCCLS M24-P) utilizes middlebrook 7H10 medium impregnated with streptomycin at two final concentrations, 2.0 and 10.0 mcg/mL. MIC90 values are calculated by comparing the quantity of organisms growing in the medium containing drug to the control cultures. Mycobacterial growth in the presence of drug ≥1% of the control indicates resistance.

The radiometric broth method employs the BACTEC 460 machine to compare the growth index from untreated control cultures to cultures grown in the presence of 6.0 mcg/mL of streptomycin. Strict adherence to the manufacturer's instructions for sample processing and data interpretation is required for this assay.

Susceptibility test results obtained by these two different methods cannot be compared unless equivalent drug concentrations are evaluated.

The clinical relevance of in vitro susceptibility test results for mycobacterial species other than M. tuberculosis using either the BACTEC or the proportion method has not been determined.

REFERENCES

'National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests-Fourth Edition. Approved Standard NCCLS Document M2-A4.Vol.10, No.7, NCCLS, Villanova, PA 1990.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT 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.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT 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.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Streptomycin Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

STREPTOMYCIN - INJECTION

(strep-toe-MYE-sin)

WARNING: This medication can sometimes cause serious nerve damage, possibly resulting in permanent hearing loss and balance problems. The risk is higher if you have kidney disease, if you are receiving high doses of this medication, if you use this drug for a long time, if you are an older adult (e.g., older than 60 years), or if you develop a severe loss of body water (become dehydrated). To reduce the risk of dehydration, drink plenty of fluids while using this medication unless your doctor directs you otherwise. Before starting streptomycin, tell your doctor if you already have kidney or hearing problems.

Tell your doctor immediately if you notice ringing/roaring in the ears, headache, hearing loss, balance problems, unusual drowsiness, dizziness, vision changes, or numbness/tingling of the skin.

Your doctor will monitor your progress to reduce the risk of these side effects and may test your hearing, kidneys, and streptomycin blood level. This medication may be stopped if you develop kidney problems or hearing problems.

If possible, you should avoid using any other medications that may harm the kidneys or nerves while using streptomycin (e.g., cidofovir, cisplatin, cyclosporine, other aminoglycoside antibiotics such as gentamicin/tobramycin, among others). Strong "water pills"/diuretics (e.g., furosemide, ethacrynic acid) should also be avoided if possible.

Before having surgery, tell your doctor or dentist that you are using this medication. This drug may affect many of the drugs used during surgery and may increase your risk of side effects.

USES: This medication is used with other medications to treat active tuberculosis (TB) infection if you cannot take other drugs for TB or if you have a type of TB that cannot be treated with other drugs (drug-resistant TB). Streptomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by killing the organisms that cause the infection.

This drug may also be used to treat other serious infections (e.g., Mycobacterium avium complex-MAC, tularemia, endocarditis, plague) along with other medications.

HOW TO USE: This medication is given by injection, usually into a muscle as directed by your doctor. When you start treatment for TB, it is usually given once a day or as directed by your doctor. It is important to change the location of the injection site daily to avoid problem areas under the skin. If you have any questions about using this medication properly, consult your doctor or pharmacist.

Dosage is based on the kind of infection, your weight, medical condition, streptomycin blood levels, and side effects. How often you receive injections and the length of your treatment will depend on the type of infection you have and your response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Medication to treat tuberculosis is usually used for 9 months or longer. After you receive streptomycin daily for 1 to 2 months, your doctor may direct you to receive this medication less often (e.g., 2 to 3 times a week). Your doctor may direct you to stop using this medication before stopping your other TB medications. It is very important to continue using streptomycin and your other medications exactly as prescribed by your doctor.

Do not stop taking this medication (or other TB medicines/antibiotics) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may worsen side effects or make the infection (especially TB) more difficult to treat (resistant). If TB becomes resistant to this medication, it might also become resistant to other TB medications. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, be sure to keep all appointments for receiving this drug.

Tell your doctor immediately if your infection symptoms return (e.g., fever, chills, body aches) while you are using this medication or after you stop using it.

Disclaimer

Streptomycin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, stomach upset, or loss of appetite may occur. Pain/irritation/redness may occur at the injection site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle weakness, persistent diarrhea even after stopping this medication, easy bleeding/bruising, fast heartbeat, new signs of infections (e.g., high fever, persistent cough), change in the amount of urine, unusual tiredness.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Streptomycin (streptomycin) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: See also Warning section.

Before using streptomycin injection, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (e.g., tobramycin, gentamicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, hearing problems, severe loss of body water (dehydration), a certain muscle problem (myasthenia gravis), burns over a large area of skin, cystic fibrosis.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in older adults because they may have decreased kidney function. Therefore, older adults may be more sensitive to the kidney and hearing side effects.

Streptomycin is not recommended for use during pregnancy. Consult your doctor for more details.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Streptomycin Consumer (continued)

DRUG INTERACTIONS: See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This drug should not be used with certain live bacterial vaccines (e.g., BCG, typhoid) because the vaccines may not be effective. If you have recently received or are planning to receive any vaccinations, tell your doctor or pharmacist before starting streptomycin.

Some products that may interact with this drug include: amphotericin B, "water pills"/diuretics (e.g., hydrochlorothiazide), high doses of aspirin/NSAIDs such as ibuprofen/naproxen.

If your doctor has directed you to take low doses of aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue to take the aspirin. Consult your doctor or pharmacist for more details.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms may include: extreme drowsiness, slow/shallow breathing, inability to move.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., kidney tests, hearing tests, streptomycin levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Store unmixed medication at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2012. Copyright(c) 2012 First Databank, Inc.

Streptomycin
for Injection USP

1 gram* / vial
*Each vial contains Streptomycin Sulfate USP equivalent to 1 gram Streptomycin.

For Intramuscular Use

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 bacteria.

WARNING

THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTSWITH 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, ESPECIALLYWHEN 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.

DRUG DESCRIPTION

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:

Streptomycin  Structural Formula Illustration

Streptomycin for Injection, equivalent to 1 gram streptomycin /vial is supplied as a sterile nonpyrogenic lyophillized cake for intramuscular use after reconstitution. The lyophillized cake may reduce to a powder during shipping.

After reconstitution the pH range for Streptomycin for Injection should be between 4.5 and 7.0 in a solution containing 200 mg of streptomycin activity per mL.

*Each vial contains Sterile Streptomycin Sulfate USP equivalent to 1 gram of Streptomycin.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Streptomycin
for Injection USP

1 gram* / vial
*Each vial contains Streptomycin Sulfate USP equivalent to 1 gram Streptomycin.

For Intramuscular Use

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 bacteria.

WARNING

THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTSWITH 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, ESPECIALLYWHEN 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.

DRUG DESCRIPTION

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:

Streptomycin  Structural Formula Illustration

Streptomycin for Injection, equivalent to 1 gram streptomycin /vial is supplied as a sterile nonpyrogenic lyophillized cake for intramuscular use after reconstitution. The lyophillized cake may reduce to a powder during shipping.

After reconstitution the pH range for Streptomycin for Injection should be between 4.5 and 7.0 in a solution containing 200 mg of streptomycin activity per mL.

*Each vial contains Sterile Streptomycin Sulfate USP equivalent to 1 gram of Streptomycin.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Streptomycin
for Injection USP

1 gram* / vial
*Each vial contains Streptomycin Sulfate USP equivalent to 1 gram Streptomycin.

For Intramuscular Use

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 bacteria.

WARNING

THE RISK OF SEVERE NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTSWITH 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, ESPECIALLYWHEN 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.

DRUG DESCRIPTION

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:

Streptomycin  Structural Formula Illustration

Streptomycin for Injection, equivalent to 1 gram streptomycin /vial is supplied as a sterile nonpyrogenic lyophillized cake for intramuscular use after reconstitution. The lyophillized cake may reduce to a powder during shipping.

After reconstitution the pH range for Streptomycin for Injection should be between 4.5 and 7.0 in a solution containing 200 mg of streptomycin activity per mL.

*Each vial contains Sterile Streptomycin Sulfate USP equivalent to 1 gram of Streptomycin.

Last reviewed on RxList: 6/20/2008
This monograph has been modified to include the generic and brand name in many instances.

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