What Can Streptomycin Do to a Developing Baby

What is Streptomycin and how is information technology used?

Streptomycin is a prescription medicine used to care for the symptoms of moderate-to-astringent infections such as Tuberculosis. Streptomycin may exist used alone or with other medications.

Streptomycin belongs to a class of drugs called Aminoglycosides.

What are the possible side furnishings of Streptomycin?

Streptomycin may cause serious side effects including:

• ringing or roaring in the ears,
• headache,
• hearing loss,
• rest problems,
• unusual drowsiness,
• dizziness,
• vision changes,
• numbness or tingling of the skin,
• fever,
• chills,
• body aches,
• muscle weakness,
• persistent diarrhea (even afterward stopping the medication),
• easy bleeding or bruising,
• fast heartbeat
• ,
• changes in the amount of urine, and
• unusual tiredness

Get medical help right abroad, if y'all have any of the symptoms listed above.

The well-nigh common side effects of Streptomycin include:

• nausea,
• vomiting,
• stomach upset,
• loss of appetite,
• spinning sensation (vertigo),
• injection site reaction (pain, irritation, and redness),
• tingling or prickling sensation in the face,
• rash,
• fever,
• hives, and
• swelling (edema)

Tell the doctor if you have any side effect that bothers yous or that does not go away.

These are non all the possible side effects of Streptomycin. For more information, inquire your md or pharmacist.

Telephone call your doctor for medical advice well-nigh side furnishings. You may report side effects to FDA at ane-800-FDA-1088.

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 simply to care for or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

THE RISK OF Astringent NEUROTOXIC REACTIONS IS SHARPLY INCREASED IN PATIENTSWITH IMPAIRED RENAL Part 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 Role SHOULD Exist MONITORED Carefully; PATIENTS WITH RENAL Harm AND/OR NITROGEN Retentivity SHOULD RECEIVE REDUCED DOSES. THE Pinnacle SERUM CONCENTRATION IN INDIVIDUALS WITH KIDNEY Impairment 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 Before long After THE Use OF ANESTHESIA OR MUSCLE RELAXANTS.

THE Assistants OF STREPTOMYCIN IN PARENTERAL Class SHOULD BE RESERVED FOR PATIENTS WHERE Acceptable LABORATORY AND AUDIOMETRIC TESTING FACILITIES ARE AVAILABLE DURING THERAPY.

DESCRIPTION

Streptomycin is a h2o-soluble aminoglycoside derived from Streptomyces griseus. It is marketed every bit the sulfate table salt of streptomycin. The chemical proper noun of streptomycin sulfate is D-Streptamine, O-2-deoxy-2-(methylamino)-α-L-glucopyranosyl-(1→2)-O-5-deoxy-3-C-formyl-α-Fifty-lyxofuranosyl-(one→four)-N,N¹-bis(aminoiminomethyl)-,sulfate (2:3) (table salt).The molecular formula for Streptomycin Sulfate is (C₂₁H₃₉N₇O₁₂)₂-3H₂SO_four and the molecular weight is 1457.41. It has the post-obit structural formula:

Streptomycin for Injection, equivalent to 1 gram streptomycin /vial is supplied equally a sterile nonpyrogenic lyophillized block for intramuscular use afterwards reconstitution. The lyophillized cake may reduce to a powder during aircraft.

After reconstitution the pH range for Streptomycin for Injection should be between iv.v and seven.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.

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INDICATIONS

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

1. Mycobacterium tuberculosis: The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Lodge, and the Center for Affliction 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 by when the national charge per unit of primary drug resistance to isoniazid was known to be less than four% 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 than of the higher up drugs is contraindicated considering of toxicity or intolerance. The management of tuberculosis has become more complex every bit a outcome of increasing rates of drug resistance and concomitant HIV infection. Boosted consultation from experts in the treatment of tuberculosis may exist desirable in those settings.

2. Non-tuberculosis infections: The use of streptomycin should be limited to the treatment of infections caused past bacteria which have been shown to be susceptible to the antibacterial effects of streptomycin and which are non 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. G. pneumoniae pneumonia (concomitantly with another antibacterial agent),
8. Due east.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 leaner and maintain the effectiveness of streptomycin and other antibacterial drugs, streptomycin should be used just to treat or prevent infections that are proven or strongly suspected to exist acquired past 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 choice of therapy.

QUESTION

About how much does an adult homo brain counterbalance? See Answer

DOSAGE AND Assistants

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 exist 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 but when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nervus.

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

Injection sites should exist alternated. Every bit higher doses or more prolonged therapy with streptomycin may be indicated for more astringent or fulminating infections (endocarditis, meningitis, etc.), the physician should e'er accept acceptable measures to be immediately aware of any toxic signs or symptoms occurring in the patient every bit a upshot 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 menses).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 equally follows:

	Daily	Twice Weekly	Twice Weekly
Chil dren	twenty-40mg /kg	25-xxx mg/kg	25-xxx mg/kg
	Max i 1000	Max i.5 g	Max i.five m
Adults	fifteen mg/kg	25-30 mg/kg	25-thirty mg/kg
	Max one g	Max 1.5 1000	Max 1.5 1000

Streptomycin is unremarkably administered daily as a unmarried intramuscular injection. A total dose of non more than 120 g over the course of therapy should be given unless there are no other therapeutic options. In patients older than sixty years of age the drug should be used at a reduced dosage due to the risk of increased toxicity. (Meet BOXED WARNING.)

Therapy with streptomycin may be terminated when toxic symptoms accept appeared, when impending toxicity is feared, when organisms go resistant, or when full treatment effect has been obtained. The total period of drug handling of tuberculosis is a minimum of 1 yr; yet, indications for terminating therapy with streptomycin may occur at any time equally noted above.

2. TULAREMIA: One to two g daily in divided doses for vii to xiv days until the patient is afebrile for 5 to vii days.

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

4. BACTERIAL ENDOCARDITIS:

1. Streptococcal endocarditis ; in penicillin-sensitive alpha and not-hemolytic streptococcal endocarditis (penicillin MIC ≤0.1 mcg/mL), streptomycin may be used for two-week treatment concomitantly with penicillin. The streptomycin regimen is 1 k b.i.d. for the outset 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 unabridged 2-week catamenia.
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 handling.

5. CONCOMITANT Use WITH OTHER AGENTS: For concomitant use with other agents to which the infecting organism is also sensitive: Streptomycin is considered a 2nd-line agent for the treatment of gram-negative bacillary bacteremia, meningitis, and pneumonia; brucellosis; granuloma inguinale; chancroid, and urinary tract infection.

For adults: one to 2 grams in divided doses every 6 to twelve hours for moderate to severe infections. Doses should generally not exceed 2 grams per twenty-four hours.

For children: 20 to 40 mg/kg/day (8 to twenty 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 calculation Water for Injection USP in an corporeality to yield the desired concentration every bit indicated in the following tabular array:

Approx. Conc . mg/mL	Volume ( mL) of Solvent
200	4.two
250	3.two
400	1.8

Sterile reconstituted solutions should be protected from light and may exist stored at room temperature for one calendar 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 ane gram NDC 39822-0706-1. Boxes of ten vials use NDC 39822-0706-ii.

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

Side Effects & Drug Interactions

SIDE Furnishings

The following reactions are common: vestibular ototoxicity (nausea, vomiting, and vertigo); paresthesia of confront; rash; fever; urticaria; angioneurotic edema; and eosinophilia.

The post-obit 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 assistants of streptomycin is cumulatively related to the total daily dose. When one.8 to 2 g/day are given, symptoms are probable to develop in the big percentage of patients - especially in the elderly or patients with impaired renal function - inside four weeks. Therefore, it is recommended that caloric and audiometric tests be washed prior to, during, and post-obit intensive therapy with streptomycin in society to facilitate detection of any vestibular dysfunction and/or impairment of hearing which may occur.

Vestibular symptoms generally appear early and commonly are reversible with early on detection and cessation of streptomycin assistants. Two to three months later on stopping the drug, gross vestibular symptoms usually disappear, except from the relative inability to walk in full darkness or on very crude 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.

DRUG INTERACTIONS

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

SLIDESHOW

Digestive Disorders: Common Misconceptions Run into Slideshow

WARNINGS

Ototoxicity: Both vestibular and auditory dysfunction can follow the assistants of streptomycin. The degree of harm is directly proportional to the dose and elapsing of streptomycin assistants, to the historic period 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 past the co-administration of ethacrynic acid, mannitol, furosemide and maybe other diuretics.

The vestibulotoxic potential of streptomycin exceeds that of its capacity for cochlear toxicity. Vestibular damage is heralded past headache, nausea, airsickness and disequilibrium. Early cochlear injury is demonstrated by the loss of high frequency hearing. Appropriate monitoring and early on discontinuation of the drug may allow recovery prior to irreversible damage to the sensorineural cells.

Pregnancy: Streptomycin can cause fetal harm when administered to a significant woman. Considering streptomycin readily crosses the placental barrier, caution in employ of the drug is important to prevent ototoxicity in the fetus. If this drug is used during pregnancy, or if the patient becomes meaning while taking this drug, the patient should be apprised of the potential gamble 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 do good to the patient and increases the risk of the development of drug-resistant leaner.

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 test or termination of streptomycin therapy or both.

Care should exist taken by individuals handling Streptomycin for Injection to avoid skin sensitivity reactions. As with all intramuscular preparations, Streptomycin for Injection should exist injected well within the torso of a relatively large muscle and care should exist taken to minimize the possibility of damage to peripheral nerves. (See DOSAGE AND Assistants.)

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 loftier blood levels for several days and the cumulative effect may produce ototoxic sequelae. When streptomycin must be given for prolonged periods of fourth dimension alkalinization of the urine may minimize or forbid renal irritation.

A syndrome of apparent central nervous system low, characterized by stupor and flaccidity, occasionally coma and deep respiratory low, 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 every bit a dark field exam should be performed earlier the start of treatment, and monthly serologic tests should exist done for at least 4 months.

As with other antibiotics, use of this drug may event in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.

Pregnancy: Category D: See WARNINGS section.

Nursing Mothers: Considering of the potential for serious adverse reactions in nursing infants from streptomycin, a decision should be fabricated whether to discontinue nursing or to discontinue the drug, taking into business relationship the importance of the drug to the mother.

Pediatric Use: (Encounter DOSAGE AND ADMINISTRATION.)

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

Following intramuscular injection of 1 g of streptomycin as the sulfate, a tiptop serum level of 25 to fifty mcg/mL is reached within 1 hr, diminishing slowly to near 50 percent after five to vi hours.

Observable concentrations are found in all organ tissues except the brain. Pregnant amounts have been found in pleural fluid and tuberculous cavities. Streptomycin passes through the placenta with serum levels in the string blood similar to maternal levels. Pocket-sized 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 inside 24 hours. Whatever 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 past interfering with normal protein synthesis. Streptomycin has been shown to be active confronting almost strains of the post-obit organisms both in vitro and in clinical infection. (Run into 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 about precise judge 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 x mcg streptomycin disk should be interpreted according to the following criteria:

Zone Diameter (mm)	Interpretation
≥15	(S) Susceptible
eleven- 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 exist considered equivocal, and, if the organism is not fully susceptible to alternative clinically feasible drugs, the exam 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 post-obit zone diameter:

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

Methods Department

Ii 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 comparison the quantity of organisms growing in the medium containing drug to the command 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 alphabetize from untreated control cultures to cultures grown in the presence of 6.0 mcg/mL of streptomycin. Strict adherence to the manufacturer'southward instructions for sample processing and data interpretation is required for this analysis.

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

The clinical relevance of in vitro susceptibility exam results for mycobacterial species other than One thousand. tuberculosis using either the BACTEC or the proportion method has non been determined.

REFERENCES

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

PATIENT INFORMATION

Patients should be counseled that antibacterial drugs including streptomycin should only be used to care for bacterial infections. They do not care for viral infections (east.g., the common cold).When streptomycin is prescribed to treat a bacterial infection, patients should be told that although it is mutual to feel better early on 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 volition not be treatable by streptomycin or other antibacterial drugs in the future.

From

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