Levofloxacin Intravenous Infusion USP 500mg (Levotaj) Technical Specification:
Product Name: | Levofloxacin Intravenous Infusion USP 500mg |
Brand Name: | Levoxtaj |
Strength: | (0.5% W/V or 500mg/100ml or 5mg/ml) |
Dosage Form: | I.V. Infusion Bottle (LVP) |
Packing: | 100mL IV Bottle |
Route of Administration: | For I.V. 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: | Anti-bacterial & Quinolone Anti-biotics |
Indication: | Levofloxacin Infusion treats bacterial infections in many different parts of the body. |
Storage: | Keep in a cool place, temperature not exceeding 25°C. Do not freeze or refrigerate. |
Levofloxacin Intravenous Infusion USP 500mg Manufacturers, Suppliers in India:
Taj Pharmaceuticals is of the prominent Levofloxacin Intravenous Infusion USP 500mg Manufacturers in India, bringing the best quality products. Our company Taj Pharma has rich experience in the niche manufacturing of Levofloxacin Intravenous Infusion USP 500mg.
Taj Pharmaceuticals is a reputed manufacturer and Levofloxacin Intravenous Infusion USP 500mg Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.
Taj Pharma is a well-known Levofloxacin Intravenous Infusion USP 500mg Manufacturer in India that assures high- quality and standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Levofloxacin Intravenous Infusion USP 500mg manufactured at Taj Pharma follows ISH; i.e., the product is manufactured to comply with USP quality standards, considered the Best in the world. Further, Taj Pharma uses Levofloxacin Intravenous Infusion USP 500mg grade best active ingredient to manufacture its Injections to comply with international standards of European products.
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Levofloxacin Intravenous Infusion USP 500mg (0.5% W/V or 500mg/100ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Levofloxacin Intravenous Infusion USP 500mg (0.5% W/V or 500mg/100ml)
Composition:
Each 100 ml contains:
Levofloxacin Hemihydrate USP
Eq. to Levofloxacin …………………….500mg
Dextrose Anhydrous USP……………5gm
Water for Injection USP…………………q.s
THERAPEUTIC INDICATIONS:
Levofloxacin injection treats bacterial infections in many different parts of the body. It is also used to prevent an anthrax infection after inhalational exposure. This medicine is also used to treat and prevent plague (including pneumonic and septicemic plague).
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.
CAUTION & WARNING:
CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, contents not clear or contains visible solid particles.
WARNING: To be sold by the retailers on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Keep in a cool place, temperature not exceeding 25°C.
Do not freeze or refrigerate.
Keep all medicines out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use
Dosage: As directed by Physician.
Why Taj Pharmaceuticals?
When it comes to Levofloxacin Intravenous Infusion USP, Taj Pharma is your partner in healthcare you can rely on. We stand out as a trusted pharmaceutical provider for several compelling reasons.
- Pharmaceutical Excellence: Taj Pharma is dedicated to producing high-quality pharmaceuticals. Our Levofloxacin Intravenous Infusion USP is no exception, meeting stringent quality and safety standards. We prioritize your well-being above all else.
- Stringent Quality Standards: Our commitment to quality is unwavering. We adhere to rigorous manufacturing and quality control processes to ensure that every infusion is safe, effective, and consistent in its performance.
- Proven Safety and Efficacy: Taj Pharma’s Levofloxacin Intravenous Infusion USP has a track record of proven safety and efficacy. It has been trusted by healthcare professionals worldwide to treat a range of bacterial infections effectively.
- Patient-Centric Approach: We prioritize your health and convenience. Our intravenous infusion is designed for ease of use in clinical settings, making it a reliable choice for healthcare providers and patients alike.
Taj Pharma is your trusted partner for Levofloxacin Intravenous Infusion USP due to our unwavering commitment to pharmaceutical excellence, quality assurance, safety, and efficacy. Choose Taj Pharma for your healthcare needs and experience the difference in our products.”
What is Levofloxacin Intravenous Infusion USP and Its Use?
Levofloxacin Intravenous Infusion USP is a medication used for intravenous (IV) administration, and it contains the active ingredient levofloxacin. Here’s information about Levofloxacin Intravenous Infusion USP and its typical uses:
- Active Ingredient: Levofloxacin is a fluoroquinolone antibiotic. It works by inhibiting the growth of bacteria by interfering with their DNA replication and protein synthesis.
- Use: Levofloxacin Intravenous Infusion USP is primarily used for the treatment of various bacterial infections. It is typically reserved for situations where oral administration of antibiotics is not feasible, and a more rapid and direct introduction of the medication into the bloodstream is required.
- Respiratory Infections: Levofloxacin can be used to treat community-acquired pneumonia, chronic bronchitis exacerbations, and other respiratory tract infections caused by susceptible bacteria.
- Skin and Soft Tissue Infections: It is effective against certain skin and soft tissue infections, including cellulitis and abscesses.
- Urinary Tract Infections (UTIs): Levofloxacin may be prescribed for uncomplicated UTIs and more severe cases such as pyelonephritis.
- Intra-abdominal Infections: It can be used for certain intra-abdominal infections, such as complicated appendicitis or peritonitis.
- Other Infections: Levofloxacin may also be considered for treating other infections, like acute bacterial sinusitis and complicated skin infections.
- Administration: Levofloxacin Intravenous Infusion USP is administered through a vein (intravenously) under the supervision of a healthcare professional. The dosage and duration of treatment will depend on the type and severity of the infection, as well as individual patient factors.
- Precautions: Levofloxacin is a prescription medication and should only be used under the guidance of a healthcare provider. It is important to complete the full course of treatment as prescribed, even if symptoms improve before the medication is finished, to prevent antibiotic resistance.
- Side Effects: Like all medications, Levofloxacin Intravenous Infusion USP may have side effects. Common side effects can include nausea, diarrhea, headache, dizziness, and changes in taste. It’s important to report any unusual or severe side effects to your healthcare provider.
It’s crucial to use Levofloxacin Intravenous Infusion USP only as prescribed by a healthcare professional, as misuse or overuse of antibiotics can lead to antibiotic resistance. If you have any questions or concerns about this medication or its use, consult with your healthcare provider for personalized guidance.
How does Levofloxacin Intravenous Infusion USP work?
Levofloxacin Intravenous Infusion USP contains the active ingredient levofloxacin, which is a fluoroquinolone antibiotic. This medication works by targeting and inhibiting the growth and replication of bacteria responsible for infections. Here’s how Levofloxacin Intravenous Infusion USP works:
- Inhibition of Bacterial DNA Replication: Levofloxacin interferes with the DNA replication process in bacterial cells. Bacteria rely on DNA replication to multiply and spread. Levofloxacin specifically inhibits an enzyme called DNA gyrase and another enzyme called topoisomerase IV, which are essential for unwinding and repairing bacterial DNA.
- Disruption of DNA Structure: By inhibiting DNA gyrase and topoisomerase IV, Levofloxacin causes structural damage to the bacterial DNA. This damage prevents the bacterial DNA from properly replicating and repairing itself.
- Cell Growth Inhibition: As a result of DNA damage and impaired replication, the affected bacteria are unable to grow, divide, or reproduce. This leads to a halt in the multiplication of bacterial cells.
- Bacterial Cell Death: Inhibition of DNA replication and damage to the bacterial DNA ultimately leads to the death of the bacterial cells. The bacteria are unable to survive or thrive in the presence of Levofloxacin.
- Resolution of Infection: By preventing bacterial growth and causing bacterial cell death, Levofloxacin Intravenous Infusion USP helps the body’s immune system to effectively clear the infection. As a result, symptoms of the infection improve, and the patient begins to recover.
Levofloxacin specifically targets bacterial DNA replication processes and does not affect human cells in the same way. This specificity is one reason why antibiotics like Levofloxacin can effectively treat bacterial infections while sparing human cells.
Levofloxacin Intravenous Infusion USP is typically administered intravenously to achieve rapid and direct delivery of the medication into the bloodstream. The choice to use Levofloxacin and the specific dosage will depend on the type and severity of the bacterial infection, as well as individual patient factors. It’s essential to follow the prescribed treatment regimen and complete the full course of antibiotics as directed by a healthcare professional to ensure the successful eradication of the infection and to prevent antibiotic resistance.
Benefits and Side effects of Levofloxacin Intravenous Infusion USP :
Levofloxacin Intravenous Infusion USP is a medication used to treat bacterial infections. Like any medication, it has both benefits and potential side effects. Here’s an overview:
Benefits:
- Effective Antibacterial Treatment: Levofloxacin is effective against a wide range of bacteria, making it a valuable tool in treating various bacterial infections, including respiratory, urinary tract, skin, and soft tissue infections, among others.
- Intravenous Administration: The intravenous formulation of levofloxacin allows for rapid and direct delivery of the medication into the bloodstream. This can be especially beneficial when immediate action is required or when oral administration is not feasible.
- Broad Spectrum: Levofloxacin is considered a broad-spectrum antibiotic, meaning it can target a wide array of bacterial species. This makes it a versatile choice for empiric therapy when the specific bacteria causing the infection are not yet identified.
- High Bioavailability: When administered intravenously, levofloxacin has good bioavailability, which means a significant portion of the drug reaches the bloodstream, enhancing its effectiveness.
- Convenience in Severe Infections: In severe bacterial infections or when a patient cannot tolerate oral medications, intravenous infusions of levofloxacin can be a lifesaving option.
Common Side Effects:
- Nausea and Vomiting: Some individuals may experience nausea or vomiting while receiving Levofloxacin Intravenous Infusion USP.
- Diarrhea: Diarrhea can occur as a side effect of levofloxacin treatment. It is important to stay hydrated if diarrhea occurs.
- Headache: Headaches are a common side effect and are usually mild in nature.
- Dizziness: Levofloxacin may cause dizziness or lightheadedness, especially when standing up quickly. Be cautious when driving or operating machinery.
- Changes in Taste: Some people may notice a metallic or unusual taste in their mouth while taking this medication.
- Rash: Skin rash or itching may occur in some individuals as a side effect.
- Photosensitivity: Levofloxacin can increase sensitivity to sunlight, making the skin more prone to sunburn. It’s important to use sunscreen and protect your skin when outdoors.
Less Common but Serious Side Effects:
- Tendon Injury: Rarely, levofloxacin may increase the risk of tendonitis or tendon rupture, especially in older adults and those with a history of tendon disorders.
- Allergic Reactions: Serious allergic reactions to levofloxacin, although rare, can occur. Seek immediate medical attention if you experience symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing.
- Central Nervous System Effects: Levofloxacin may rarely cause central nervous system side effects, including confusion, hallucinations, and seizures.
- Cardiac Effects: In some cases, levofloxacin may affect heart rhythm. It’s important to notify your healthcare provider if you have a history of heart conditions.
It’s crucial to use Levofloxacin Intravenous Infusion USP only as prescribed by a healthcare professional, and to report any unusual or severe side effects promptly. Additionally, this medication should be reserved for bacterial infections as deemed appropriate by a healthcare provider, as the overuse or misuse of antibiotics can contribute to antibiotic resistance.
Frequently asked questions (FAQs) about Levofloxacin Intravenous Infusion USP:
- What is Levofloxacin Intravenous Infusion used for?
Levofloxacin Intravenous Infusion is primarily used to treat a wide range of bacterial infections, including respiratory, urinary tract, skin, and soft tissue infections. It is typically reserved for situations where immediate, intravenous delivery of the medication is necessary.
- How does Levofloxacin Intravenous Infusion work?
Levofloxacin is an antibiotic that inhibits bacterial DNA replication and protein synthesis, leading to the prevention of bacterial growth and ultimately causing bacterial cell death.
- Is Levofloxacin Intravenous Infusion available overthecounter (OTC)?
No, Levofloxacin Intravenous Infusion is a prescription medication, and it is not available overthecounter. It should only be used under the guidance and prescription of a healthcare professional.
- How is Levofloxacin Intravenous Infusion administered?
Levofloxacin Intravenous Infusion is administered directly into the bloodstream through an intravenous (IV) line. Healthcare professionals typically administer it in a clinical setting.
- Can Levofloxacin Intravenous Infusion be used to treat viral infections or nonbacterial conditions?
No, Levofloxacin is an antibiotic specifically designed to target and treat bacterial infections. It is not effective against viral infections such as the common cold or flu.
- What should I do if I miss a dose of Levofloxacin Intravenous Infusion?
If you miss a dose, it’s important to consult with your healthcare provider for guidance. In some cases, the missed dose may be administered as soon as possible, or the treatment plan may need to be adjusted.
- Are there any dietary restrictions or specific food interactions with Levofloxacin Intravenous Infusion?
Levofloxacin can be taken with or without food, but it may be less effective if taken with certain minerals like calcium, magnesium, aluminum, or iron. It’s advisable to consult with your healthcare provider about dietary considerations while taking this medication.
- What are the common side effects of Levofloxacin Intravenous Infusion?
Common side effects can include nausea, vomiting, diarrhea, headache, dizziness, and changes in taste. Be sure to report any unusual or severe side effects to your healthcare provider.
- Can Levofloxacin Intravenous Infusion be used during pregnancy or breastfeeding?
It is important to discuss the use of Levofloxacin Intravenous Infusion with your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding, as there may be potential risks and benefits to consider.
- Can I drink alcohol while taking Levofloxacin Intravenous Infusion ?
It is generally recommended to avoid alcohol while taking Levofloxacin, as alcohol can interact with the medication and increase the risk of side effects.
As Levofloxacin Intravenous Infusion USP 5mg/ml Exporters; We can cater to export business queries from the following geographies. We are exporting our Levofloxacin Intravenous Infusion BP 5mg/ml product in 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, 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
Levofloxacin Intravenous Infusion USP 5mg/ml 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 Levofloxacin Intravenous Infusion USP, 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
GENERIC NAME OF THE MEDICINAL PRODUCT:
Levofloxacin Intravenous Infusion USP (0.5% W/V or 500mg/100ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Levofloxacin Intravenous Infusion USP (0.5% W/V or 500mg/100ml)
Composition:
Each 100 ml contains:
Levofloxacin Hemihydrate
Eq. to Levofloxacin ………………...….0.5gm
Dextrose Anhydrous USP……………5%w/v
Water for Injection USP…………………q.s.
Composition:
Each 100 ml contains:
Levofloxacin Hemihydrate
Eq. to Levofloxacin ………………...….0.5gm
Dextrose Anhydrous USP……………5%w/v
Water for Injection USP…………………q.s.
THERAPEUTIC INDICATIONS:
Levofloxacin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent an anthrax infection after inhalational exposure. This medicine is also used to treat and prevent plague (including pneumonic and septicemic plague).
DIRECTION OF USE:
To be used with Non-pyrogenic I.V. administration set with aseptic technique.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.
CAUTION & WARNING:
CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, contents not clear or contains visible solid particles.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Keep in a cool place, temperature not exceeding 25°C.
Do not freeze or refrigerate.
Keep all medicines out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use
Dosage: As directed by Physician.
Do not freeze or refrigerate.
Keep all medicines out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use
Dosage: As directed by Physician.