GENERIC NAME OF MEDICINAL PRODUCT:
B. Streptomycin for Injection USP (1g)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
a) Each vial contains:
Streptomycin Sulphate USP (Sterile)
Equivalent to Streptomycin…………………0.75gm
b) Sterile Water for Injection USP…………2mL or more
B. Streptomycin for Injection USP (1g)
Composition:
a) Each vial contains:
Streptomycin Sulphate USP (Sterile)
Equivalent to Streptomycin …………………1gm
b) Sterile Water for Injection USP…………2mL or more
THERAPEUTIC INDICATIONS:
DIRECTION OF USE:
The reconstituted solution should be used within 4 days when stored in a cool place.
CAUTION & WARNING:
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Sterile reconstituted solutions should be protected from light & may be stored at controlled room temperature up to 7 days.
Retain in carton until the time of use.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.
Streptomycin for Injection USP 1g Technical Specification:
Product Name: | Streptomycin for Injection USP |
Brand Name: | Generic |
Strength: | 0.75g, 1g |
Dosage Form: | Lyophilized, Dry Powder Injection (Sterile) *Preservative Free |
Packing: | 1 Vial + 1 Ampule + WFI Tray |
Route of Administration: | For IM use only |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antibiotics (aminoglycoside) |
Indication: | Moderate to severe susceptible infections, including plague, tularemia, and endocarditis. Second-line therapy for gram-negative bacillary bacteremia, meningitis, pneumonia, brucellosis, granuloma inguinale, chancroid, and UTIs. |
Storage: | Store dry powder at a controlled room temperature of 20° to 25° C. Sterile reconstituted solutions should be protected from light & may be stored at controlled room temperature for up to 7 days. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Streptomycin for Injection USP (1g)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Streptomycin for Injection USP (1g)
Composition:
Each vial contains:
Streptomycin Sulphate USP (Sterile)
Equivalent to Streptomycin…………………1g
Sterile Water for Injection USP…………2mL or more
THERAPEUTIC INDICATIONS:
Moderate to severe susceptible infections, including plague, tularemia, and endocarditis. Second-line therapy for gram-negative bacillary bacteremia, meningitis, pneumonia, brucellosis, granuloma inguinale, chancroid, and UTIs.
DIRECTION OF USE:
Add 2ml or more Sterile Water for Injection USP for reconstitution.
The reconstituted solution should be used within 4 days when stored in a cool place.
CAUTION & WARNING:
CAUTION: The reconstituted solution should not be used if it contains any visible particulate matter.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store dry powder at a controlled room temperature of 20° to 25° C.
Sterile reconstituted solutions should be protected from light & may be stored at controlled room temperature for up to 7 days.
Retain in a carton until the time of use.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
Why Taj Pharmaceuticals?
The choice of a pharmaceutical manufacturer for a specific medication like Streptomycin for Injection, such as Taj Pharmaceuticals, would typically depend on various factors, including the quality of the product, regulatory compliance, pricing, availability, and reputation. Here are some considerations that might lead someone to choose Taj Pharmaceuticals or another manufacturer for Streptomycin for Injection:
- Quality Assurance: One of the primary concerns when selecting a pharmaceutical manufacturer is the quality of their products. It is essential that medications meet rigorous quality standards to ensure their safety and effectiveness. Companies like Taj Pharmaceuticals are expected to adhere to Good Manufacturing Practices (GMP) and other regulatory standards to maintain product quality.
- Regulatory Compliance: Pharmaceuticals need to comply with the regulations and standards set by regulatory authorities like the FDA (in the United States), the European Medicines Agency (EMA), or the World Health Organization (WHO). Selecting a manufacturer with a track record of compliance can be important to ensure that the medication meets these regulatory requirements.
- Reputation: A manufacturer’s reputation within the pharmaceutical industry can be indicative of their reliability and product quality. You may want to choose a manufacturer with a strong reputation for producing safe and effective medications.
- Pricing: Cost considerations can also play a significant role in selecting a manufacturer. Different manufacturers may offer different pricing structures, and choosing one that fits your budget while still maintaining quality is important.
- Availability and Supply Chain: Ensuring a consistent and reliable supply of medications is crucial, especially for healthcare providers and institutions. Some manufacturers may have better distribution networks or supply chain capabilities than others.
- Packaging and Presentation: The way the medication is packaged and presented can also be a factor. Some manufacturers may offer more convenient packaging options or labeling that suits your specific needs.
- Customer Support: The level of customer support and assistance provided by the manufacturer can be important. This includes factors like order processing, technical support, and responsiveness to inquiries.
- Geographic Considerations: The geographic location of the manufacturer may also be a consideration for some buyers, especially if they want to reduce shipping times and costs.
What is Streptomycin for Injection and its uses?
Streptomycin for Injection is a medication that contains the active ingredient streptomycin sulfate. It is an antibiotic used to treat various bacterial infections. Here’s an overview of Streptomycin for Injection and its uses:
Uses:
- Treatment of Tuberculosis (TB): Streptomycin has historically been a vital component of the multidrug therapy used to treat tuberculosis (TB), particularly drug-susceptible TB strains. It is often used in combination with other anti-TB medications to effectively combat the infection.
- Treatment of Other Bacterial Infections: In addition to TB, streptomycin may be used to treat certain other bacterial infections when the causative bacteria are susceptible to this antibiotic. These infections may include those affecting the urinary tract, respiratory tract, or skin, among others.
- Plague: Streptomycin has also been used to treat plague, a severe bacterial infection caused by the bacterium Yersinia pestis. It is considered one of the antibiotics of choice for this potentially life-threatening disease.
- Tularemia: Streptomycin may be used to treat tularemia, a rare infectious disease caused by the bacterium Francisella tularensis. It is effective against this bacterium and is used in severe cases.
It’s important to note that streptomycin is used in combination with other antibiotics to treat TB to reduce the risk of drug resistance. The choice of antibiotics and treatment regimen for TB is guided by factors such as the type of TB (drug-susceptible or drug-resistant) and the patient’s medical history. Streptomycin for Injection is typically administered by healthcare professionals in clinical settings due to its intramuscular or intravenous administration route. It is essential to use this medication only as prescribed by a healthcare provider, complete the full course of treatment, and follow the recommended monitoring and safety precautions, as streptomycin can have potential side effects and may interact with other medications.
How Does Streptomycin for Injection Work?
Streptomycin for Injection is an antibiotic medication that works by inhibiting bacterial protein synthesis. Its mechanism of action is specifically directed at bacterial cells and involves disrupting the normal process of protein production. Here’s how Streptomycin works:
- Binding to the Ribosome: Streptomycin binds to the bacterial ribosome, which is the cellular structure responsible for assembling proteins. Bacterial ribosomes consist of two subunits: the 30S subunit and the 50S subunit. Streptomycin binds to the 30S subunit.
- Interfering with Protein Synthesis: Once bound to the ribosome, Streptomycin interferes with the accuracy of translating genetic information from messenger RNA (mRNA) into protein. This interference occurs during the initiation of protein synthesis.
- Misreading the Genetic Code: Streptomycin causes the ribosome to misread the genetic code on the mRNA. Normally, the ribosome accurately reads the sequence of codons on the mRNA and assembles the corresponding amino acids into a growing protein chain. However, under the influence of Streptomycin, the ribosome may insert incorrect amino acids into the protein chain, leading to the production of faulty and nonfunctional proteins.
- Bactericidal Action: The interference with protein synthesis caused by Streptomycin is bactericidal, meaning it kills susceptible bacteria rather than merely inhibiting their growth. By producing defective proteins, Streptomycin disrupts essential cellular processes in bacteria, ultimately leading to their death.
- Selective Toxicity: Streptomycin’s action is selective for bacterial ribosomes. This selectivity arises from differences in the structure of bacterial ribosomes compared to those in human cells. Human ribosomes are structurally distinct, reducing the likelihood of adverse effects on human protein synthesis.
Streptomycin’s effectiveness is primarily against Gram-negative bacteria, although it can also affect some Gram-positive bacteria. It has historically been a valuable antibiotic in the treatment of tuberculosis (TB), where it is used in combination with other anti-TB medications to combat the infection. The combination of antibiotics helps reduce the risk of developing drug resistance in TB bacteria. It’s important to use Streptomycin for Injection under the guidance of a healthcare provider, as improper or excessive use of antibiotics can contribute to antibiotic resistance. Additionally, healthcare professionals monitor patients receiving Streptomycin for potential side effects and ensure that the medication is used safely and effectively.\
Benefits of Streptomycin for Injection:
- Effective Against Tuberculosis: Streptomycin has been a cornerstone in the treatment of tuberculosis, especially when the bacteria are resistant to other antibiotics. It can be a life-saving medication for individuals with drug-resistant TB.
- Combination Therapy: Streptomycin is often used in combination with other anti-TB drugs to enhance treatment efficacy and reduce the risk of resistance development. This combination therapy is crucial in TB management.
- Bacterial Infections: Streptomycin can also be used to treat other bacterial infections, such as certain types of urinary tract infections and enteric infections caused by Salmonella.
- Quick Onset of Action: When administered properly, Streptomycin can provide a rapid onset of action, which can be crucial in managing severe infections.
Side Effects of Streptomycin for Injection:
- Ototoxicity: One of the most significant concerns with Streptomycin is its potential to cause damage to the inner ear, leading to hearing loss or balance problems. This side effect is more likely to occur with higher doses or prolonged use.
- Nephrotoxicity: Streptomycin can harm the kidneys, potentially leading to kidney dysfunction. Monitoring kidney function is important during treatment.
- Neurotoxicity: In some cases, Streptomycin can lead to neurological symptoms such as numbness, tingling, muscle twitching, or difficulty coordinating movements.
- Allergic Reactions: Like any medication, Streptomycin can cause allergic reactions in some individuals. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing.
- Gastrointestinal Issues: Common side effects include nausea, vomiting, and diarrhea.
- Injection Site Reactions: Pain, redness, or swelling at the injection site can occur.
- Superinfections: Prolonged or inappropriate use of antibiotics like Streptomycin can lead to the development of superinfections, where new infections resistant to treatment emerge.
- Neuromuscular Blockade: Streptomycin can affect neuromuscular transmission, potentially leading to muscle weakness or respiratory depression, particularly in high doses.
- Liver Toxicity: Rarely, Streptomycin can affect liver function, causing elevated liver enzymes and jaundice.
It’s essential to use Streptomycin under the guidance of a qualified healthcare professional who can assess the benefits versus the risks of the medication. The choice to use Streptomycin and the dosage will depend on the specific infection being treated, the patient’s overall health, and any potential contraindications or interactions with other medications. Regular monitoring of hearing, kidney function, and neurological status is crucial during Streptomycin treatment to detect and manage any adverse effects promptly.
Frequently Asked Questions About Streptomycin for Injection:
Certainly, here are some frequently asked questions (FAQs) about Streptomycin for injection:
- What is Streptomycin for injection used for?
Streptomycin is primarily used to treat bacterial infections, particularly tuberculosis (TB). It is also used in some cases to treat other bacterial infections, such as certain urinary tract infections and enteric infections.
- How does Streptomycin work?
Streptomycin works by inhibiting the growth and replication of bacteria. It does this by disrupting protein synthesis in the bacterial cells, ultimately leading to their death.
- Is Streptomycin used alone for TB treatment?
No, Streptomycin is typically used in combination with other anti-TB drugs. This combination therapy helps prevent the development of drug-resistant TB and increases treatment efficacy.
- What are the common side effects of Streptomycin for injection?
Common side effects include nausea, vomiting, diarrhea, pain at the injection site, and dizziness. However, more severe side effects like hearing loss, kidney dysfunction, and neurological symptoms can occur in some cases.
- How is Streptomycin administered?
Streptomycin is usually administered as an intramuscular injection, often into the buttocks or thigh. It should be administered by a healthcare professional to ensure proper dosing and minimize the risk of complications.
- How long does Streptomycin treatment last?
The duration of Streptomycin treatment varies depending on the type and severity of the infection being treated. In TB treatment, it is typically used for the initial phase of therapy, which can last for several months.
- Can Streptomycin be used during pregnancy or breastfeeding?
Streptomycin should be used during pregnancy or breastfeeding only when the potential benefits outweigh the risks. Consult with a healthcare provider for individualized guidance.
- Can I drink alcohol while on Streptomycin treatment?
It is generally recommended to avoid alcohol while taking antibiotics, including Streptomycin, as alcohol can interfere with the effectiveness of the medication and increase the risk of side effects.
- Can Streptomycin cause allergic reactions?
Yes, like any medication, Streptomycin can cause allergic reactions in some individuals. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing.
- Is it necessary to monitor hearing during Streptomycin treatment?
Yes, hearing should be regularly monitored during Streptomycin treatment, as it can cause ototoxicity (hearing loss or balance problems). Any changes in hearing should be reported to a healthcare provider promptly.
- Can Streptomycin interact with other medications?
Yes, Streptomycin can interact with certain medications, such as diuretics or other drugs that affect kidney function. It’s important to inform your healthcare provider of all the medications you are taking to avoid potential interactions.
- Is it safe to stop Streptomycin treatment early if I feel better?
No, it is essential to complete the full course of Streptomycin treatment as prescribed by your healthcare provider. Stopping treatment early can lead to incomplete eradication of the infection and may contribute to antibiotic resistance.
Always consult with a healthcare professional for specific guidance regarding Streptomycin treatment, potential side effects, and any concerns you may have.
As Streptomycin for injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Streptomycin for injection product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Streptomycin for injection Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Streptomycin for injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274