Streptomycin 1gm Vial For Injection

Manufacturer X-GEN PHARMACEUTICALS, INC Active Ingredient Streptomycin(strep toe MYE sin) Pronunciation strep-toe-MYE-sin
WARNING: This drug may cause severe nerve problems. The risk is higher if you have kidney problems. Other severe problems like eyesight problems, trouble keeping your balance, certain brain problems, and hearing problems (like long-lasting hearing loss) may also happen. The risk of hearing problems is higher if you have kidney problems or already have hearing problems, with high doses or long-term use, or if you are dehydrated. The risk is also higher in older people and infants. Tell your doctor if you have kidney problems or hearing problems. You will be watched closely and may need to have hearing and kidney tests.Do not use this drug if you are taking or have recently taken any drugs that can cause nerve, kidney, or hearing problems. This may be drugs like amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, cyclosporine, ethacrynic acid, furosemide, paromomycin, polymyxin B, vancomycin, viomycin, or other drugs like this one. There are many other drugs that can do this. Ask your doctor or pharmacist if you are not sure.Muscle problems (muscle weakness) and severe breathing problems have happened with drugs like this one. The risk is higher in people who already have nerve or muscle problems like myasthenia gravis. The risk is also higher in people who are getting other drugs like those that are used to put you to sleep or to relax muscles. If you have questions, talk with the doctor. @ COMMON USES: It is used to treat TB (tuberculosis). It is used to treat bacterial infections.
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Drug Class
Antibiotic, Antitubercular
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Pharmacologic Class
Aminoglycoside
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Pregnancy Category
Category D
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FDA Approved
Jan 1947
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Streptomycin is an antibiotic used to treat serious bacterial infections, including tuberculosis. It works by stopping the growth of bacteria. It is given as an injection, usually into a muscle or a vein.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection into a muscle, typically in the thigh or upper buttocks. Unless your doctor advises you to limit fluid intake, it is essential to drink plenty of non-caffeinated liquids.

For proper storage and disposal of this medication, consult with your doctor, nurse, or pharmacist if you need to keep it at home.

If you miss a dose, contact your doctor promptly to determine the best course of action.
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Lifestyle & Tips

  • Report any changes in hearing, ringing in the ears, dizziness, or problems with balance immediately.
  • Report any decrease in urine output, swelling, or unusual tiredness.
  • Report any muscle weakness or difficulty breathing.
  • Stay well-hydrated unless otherwise instructed by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Tuberculosis (initial phase): 15 mg/kg IM or IV daily (max 1 g/day) or 25-30 mg/kg (max 1.5 g) 2-3 times per week. Bacterial Endocarditis (in combination): 1 g IM or IV every 12 hours for 2 weeks, then 500 mg every 12 hours for 4 weeks.
Dose Range: 500 - 1500 mg

Condition-Specific Dosing:

tuberculosis: 15 mg/kg IM/IV daily (max 1g) or 25-30 mg/kg (max 1.5g) 2-3 times/week.
bacterialEndocarditis: 1g IM/IV q12h for 2 weeks, then 500mg q12h for 4 weeks (in combination with penicillin).
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Pediatric Dosing

Neonatal: Not established for routine use; consult specialized guidelines for severe infections (e.g., congenital TB).
Infant: Tuberculosis: 20-40 mg/kg/day IM or IV (max 1 g/day) in 1-2 divided doses.
Child: Tuberculosis: 20-40 mg/kg/day IM or IV (max 1 g/day) in 1-2 divided doses.
Adolescent: Tuberculosis: 15 mg/kg IM or IV daily (max 1 g/day) or 25-30 mg/kg (max 1.5 g) 2-3 times per week.
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Dose Adjustments

Renal Impairment:

Mild: CrCl 50-79 mL/min: Administer 7.5 mg/kg every 24 hours or extend interval.
Moderate: CrCl 30-49 mL/min: Administer 7.5 mg/kg every 48 hours or reduce dose and extend interval.
Severe: CrCl <30 mL/min: Administer 7.5 mg/kg every 72-96 hours or reduce dose significantly and extend interval. Dosing should be guided by serum drug concentrations.
Dialysis: Hemodialysis: Administer 7.5 mg/kg after each dialysis session. Peritoneal Dialysis: Not well established, generally avoided or used with extreme caution and drug level monitoring.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Streptomycin is an aminoglycoside antibiotic. It binds to the 30S ribosomal subunit of susceptible bacteria, interfering with protein synthesis by causing misreading of the mRNA template and premature termination of translation. This leads to the production of non-functional proteins and ultimately bacterial cell death (bactericidal effect).
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Pharmacokinetics

Absorption:

Bioavailability: Not absorbed orally (negligible); nearly 100% after IM injection.
Tmax: 1-2 hours (IM injection)
FoodEffect: Not applicable (parenteral administration).

Distribution:

Vd: 0.26 L/kg (adults)
ProteinBinding: 20-30%
CnssPenetration: Limited (poor penetration into CSF unless meninges are inflamed).

Elimination:

HalfLife: 2-3 hours (normal renal function); significantly prolonged in renal impairment.
Clearance: Primarily renal clearance, proportional to creatinine clearance.
ExcretionRoute: Renal (glomerular filtration).
Unchanged: Approximately 90% excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Rapid (within minutes to hours after administration).
PeakEffect: Correlates with peak serum concentrations (1-2 hours post-IM/IV).
DurationOfAction: Concentration-dependent killing with a post-antibiotic effect, allowing for once-daily dosing in some cases despite short half-life.

Safety & Warnings

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BLACK BOX WARNING

Streptomycin can cause irreversible ototoxicity (vestibular and auditory) and nephrotoxicity. The risk of ototoxicity is increased with higher doses, prolonged therapy, and in patients with renal impairment. Neuromuscular blockade, leading to respiratory paralysis, has been reported, especially after rapid intravenous administration or in patients with pre-existing neuromuscular disorders. Serum concentrations should be monitored, and dosage adjusted in patients with impaired renal function.
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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Balance problems
Confusion
Dizziness or fainting
Headache
Muscle weakness
New or worsening trouble breathing
Abnormal burning, numbness, or tingling sensations
Twitching
Seizures
Upset stomach or vomiting
Ringing in the ears, hearing loss, or other changes in hearing
Feeling of fullness in the ears
Changes in eyesight
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. In rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience any of the following symptoms, contact your doctor immediately:

Stomach pain
Cramps
Very loose, watery, or bloody stools

Do not treat diarrhea without consulting your doctor first.

Other Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:

Diarrhea

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Ringing in the ears (tinnitus)
  • Hearing loss or difficulty hearing
  • Dizziness or vertigo
  • Unsteadiness or difficulty with balance
  • Decreased urination
  • Swelling in the ankles, feet, or hands
  • Unusual muscle weakness
  • Difficulty breathing
  • Rash, itching, or hives
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms that occurred.

This medication may interact with other medications or exacerbate existing health conditions. To ensure safe use, disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. Carefully review your medication list and health history to confirm that it is safe to take this medication in conjunction with your other medications and health conditions.

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regularly undergo blood tests, hearing assessments, and other laboratory tests as directed by your doctor to ensure safe treatment. Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection.

If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects. Women who are pregnant or become pregnant while taking this medication should be aware that it may harm the unborn baby. If you are pregnant or suspect you may be pregnant, notify your doctor immediately.

If you are breastfeeding, consult your doctor to discuss potential risks to your baby and determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Severe ototoxicity (hearing loss, vertigo)
  • Severe nephrotoxicity (renal failure)
  • Neuromuscular blockade (respiratory depression, paralysis)
  • Hypotension

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include hemodialysis to remove the drug, calcium salts to reverse neuromuscular blockade, and respiratory support.

Drug Interactions

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Major Interactions

  • Other nephrotoxic drugs (e.g., amphotericin B, cisplatin, cyclosporine, loop diuretics, NSAIDs, vancomycin): Increased risk of nephrotoxicity.
  • Other ototoxic drugs (e.g., loop diuretics, cisplatin, vancomycin): Increased risk of ototoxicity.
  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium): Potentiation of neuromuscular blockade, leading to respiratory depression/paralysis.
  • Botulinum toxin: Increased risk of neuromuscular blockade.
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Moderate Interactions

  • Cephalosporins (some): May increase risk of nephrotoxicity.
  • Oral anticoagulants (e.g., warfarin): May potentiate anticoagulant effect (rare, due to gut flora alteration).
  • Digoxin: Reduced absorption of digoxin (theoretical, due to gut flora alteration).

Monitoring

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Baseline Monitoring

Renal function (BUN, serum creatinine, CrCl)

Rationale: Streptomycin is primarily renally eliminated and is nephrotoxic. Baseline assessment is crucial for dosing and monitoring.

Timing: Prior to initiation of therapy.

Audiometry (pure tone and speech discrimination)

Rationale: Streptomycin is ototoxic (vestibular and auditory). Baseline assessment helps identify pre-existing impairment and monitor for new onset.

Timing: Prior to initiation of therapy.

Electrolytes (Potassium, Magnesium, Calcium)

Rationale: Aminoglycosides can cause electrolyte disturbances.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Renal function (BUN, serum creatinine)

Frequency: At least twice weekly, or more frequently in patients with impaired renal function or receiving concomitant nephrotoxic drugs.

Target: Maintain within normal limits or stable baseline.

Action Threshold: Increase in serum creatinine by >0.5 mg/dL or >50% from baseline, or significant decrease in urine output.

Audiometry

Frequency: Periodically during therapy, especially in patients on prolonged treatment or with risk factors for ototoxicity.

Target: No significant change from baseline.

Action Threshold: New onset or worsening of hearing loss or vestibular symptoms (e.g., vertigo, tinnitus).

Serum drug concentrations (peak and trough levels)

Frequency: For certain indications (e.g., endocarditis) or in patients with renal impairment, obesity, or prolonged therapy. Trough levels before 3rd or 4th dose, peak levels 30-60 min after end of infusion (IV) or 1 hour after IM injection.

Target: Trough: <5 mcg/mL; Peak: 20-30 mcg/mL (for once-daily dosing, trough may be undetectable). Specific targets vary by indication and dosing regimen.

Action Threshold: Trough levels >5 mcg/mL (increased risk of toxicity); Peak levels outside therapeutic range (suboptimal efficacy or increased toxicity).

Electrolytes (Potassium, Magnesium, Calcium)

Frequency: Weekly or as clinically indicated.

Target: Within normal limits.

Action Threshold: Significant hypokalemia, hypomagnesemia, or hypocalcemia.

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Symptom Monitoring

  • Hearing loss (difficulty hearing, ringing in ears/tinnitus)
  • Vertigo, dizziness, nystagmus, ataxia (vestibular toxicity)
  • Decreased urine output, swelling (nephrotoxicity)
  • Muscle weakness, difficulty breathing (neuromuscular blockade)
  • Rash, fever, itching (hypersensitivity reactions)

Special Patient Groups

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Pregnancy

Category D. Streptomycin crosses the placenta and has been associated with irreversible congenital deafness in infants whose mothers received the drug during pregnancy. Use only if the potential benefit justifies the potential risk to the fetus, especially in life-threatening situations where safer alternatives are not available (e.g., multi-drug resistant TB).

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though specific data on first-trimester exposure and deafness is limited. Risk of ototoxicity is generally considered throughout pregnancy.
Second Trimester: Highest risk of fetal ototoxicity (irreversible congenital deafness) due to development of the fetal auditory system.
Third Trimester: Continued risk of fetal ototoxicity. May also cause neuromuscular blockade in the neonate if administered close to delivery.
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Lactation

L3 (Moderately Safe). Streptomycin is excreted into breast milk in low concentrations. While oral absorption by the infant is poor, there is a theoretical risk of altering infant gut flora or direct toxicity. Monitor breastfed infants for diarrhea, candidiasis, or signs of ototoxicity/nephrotoxicity. Use with caution; consider alternative agents if possible.

Infant Risk: Low systemic absorption by infant, but theoretical risk of gut flora disruption, diarrhea, or candidiasis. Risk of ototoxicity/nephrotoxicity is very low but not zero.
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Pediatric Use

Use with caution. Dosing must be carefully calculated based on weight and renal function. Children, especially infants, may be more susceptible to ototoxicity and nephrotoxicity. Close monitoring of renal function and auditory function is essential.

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Geriatric Use

Elderly patients are at increased risk for ototoxicity and nephrotoxicity due to age-related decline in renal function and pre-existing hearing impairment. Dosing should be adjusted based on creatinine clearance, and close monitoring of renal function and auditory function is crucial. Lower doses or extended dosing intervals may be necessary.

Clinical Information

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Clinical Pearls

  • Streptomycin is a critical component of multi-drug regimens for tuberculosis, especially drug-resistant forms.
  • Due to its significant toxicity (ototoxicity, nephrotoxicity), careful patient selection, dose adjustment based on renal function, and rigorous monitoring are essential.
  • Peak and trough levels are often monitored to optimize efficacy and minimize toxicity, particularly in patients with renal impairment or on prolonged therapy.
  • Patients should be counseled extensively on the signs and symptoms of ototoxicity and nephrotoxicity and instructed to report them immediately.
  • Administer IM injections deep into a large muscle mass to minimize local irritation.
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Alternative Therapies

  • For tuberculosis: Isoniazid, Rifampin, Pyrazinamide, Ethambutol (first-line agents); Bedaquiline, Delamanid, Linezolid, Clofazimine, Cycloserine, p-Aminosalicylic acid (second-line/newer agents for MDR-TB).
  • For bacterial endocarditis: Gentamicin (another aminoglycoside) is commonly used in combination with beta-lactams.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 1gm vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.