GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Levofloxacin Tablet IP 250mg
B) Levofloxacin Tablet IP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Levofloxacin Tablet IP 250mg
Each Film-coated tablet contains:
Levofloxacin Hemihydrate IP
Eq. to Levofloxacin ……………………….….…...250mg
Excipients …………………………………..…….……q.s
Colour: Titanium Dioxide IP


B) Levofloxacin Tablet IP 500mg
Each Film-coated tablet contains:
Levofloxacin Hemihydrate IP
Eq. to Levofloxacin ……………………………...500mg
Excipients …………………………………..…….……q.s
Colour: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection after inhalational exposure. Levofloxacin is also used to treat and prevent plague (including pneumonic and septicemic plague) This is an antibiotic used to treat various bacterial infections, such as those in the lungs, urinary tract, kidneys, sinuses, and skin.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SCHEDULE: SCHEDULE H1 PRESCRIPTION DRUG CAUTION:
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Store in cool, dry & dark place Protect from Light & moisture.
Dosage: As directed by the Physician.

Levofloxacin Tablet IP 250mg Technical Specification:

Product Name:Levofloxacin Tablet IP 250mg
Brand Name:Levotaj
Strength:250mg, 500mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti-biotics (Quinolone)
Indication: Levofloxacin is used to treat bacterial infections in many different parts of the body. This is an antibiotic used to treat various bacterial infections, such as those in the lungs, urinary tract, kidneys, sinuses, and skin.
Storage:Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Levofloxacin Tablet IP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Levofloxacin Tablet IP 250mg
    Each Film-coated tablet contains:
    Levofloxacin Hemihydrate IP
    Eq. to Levofloxacin ……………………….….……250mg
    Excipients …………………………………..…….……q.s
    Colour: Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection after inhalational exposure. Levofloxacin is also used to treat and prevent plague (including pneumonic and septicemic plague) This is an antibiotic used to treat various bacterial infections, such as those in the lungs, urinary tract, kidneys, sinuses, and skin.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Read enclosed leaflet before use.

Keep medicine out of reach of children.

SCHEDULE: SCHEDULE H1 PRESCRIPTION DRUG CAUTION:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:  Store at 20° to 25°C (68° to 77°F). Store in cool, dry & dark place Protect from Light & moisture.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands out as a preferred choice for healthcare providers and patients seeking Levofloxacin Tablets due to several compelling reasons. Their unwavering commitment to maintaining high-quality standards in pharmaceutical manufacturing ensures the efficacy and safety of Levofloxacin Tablets, instilling confidence in their reliability. With extensive expertise in the pharmaceutical industry, Taj Pharmaceuticals brings valuable knowledge to the production and distribution of pharmaceutical products, establishing them as a trusted and dependable supplier. Their strict adherence to regulatory standards and robust quality control procedures further enhances patient safety. Taj Pharmaceuticals’ global presence and well-established distribution network guarantee the availability of Levofloxacin Tablets and other medications to healthcare providers and patients worldwide, elevating patient care on a global scale. Investment in research and development demonstrates their commitment to pharmaceutical innovation, potentially leading to improved formulations of Levofloxacin. Additionally, their focus on affordability ensures that essential medications remain accessible without financial barriers. Taj Pharmaceuticals places a strong emphasis on patient safety and well-being, aligning with the significance of antibiotics like Levofloxacin. This commitment reinforces trust in their products among healthcare providers and patients, ultimately contributing to enhanced patient care and outcomes globally. In summary, Taj Pharmaceuticals’ dedication to quality, compliance, research, affordability, and patient support positions them as a reliable supplier for Levofloxacin Tablets and other pharmaceutical needs, benefiting healthcare providers and patients alike.

What is Levofloxacin Tablet and its uses:

Levofloxacin Tablets are a medication that belongs to the fluoroquinolone class of antibiotics. They contain the active ingredient levofloxacin, which is an antimicrobial agent used to treat various bacterial infections. Here are some key uses and indications for Levofloxacin Tablets:

  • Respiratory Tract Infections: Levofloxacin is commonly prescribed to treat respiratory tract infections such as:
    Pneumonia: It is effective against both communities acquired pneumonia (CAP) and healthcare associated pneumonia (HCAP).
    Bronchitis: Levofloxacin may be used to treat acute exacerbations of chronic bronchitis.
  • Sinusitis: It can be prescribed for acute bacterial sinusitis.
  • Skin and Soft Tissue Infections: Levofloxacin may be used to treat various skin and soft tissue infections caused by susceptible bacteria, including cellulitis and abscesses.
  • Urinary Tract Infections (UTIs): Levofloxacin can be prescribed for uncomplicated and complicated UTIs, including pyelonephritis (kidney infection).
  • Prostatitis: Levofloxacin is sometimes used to treat bacterial prostatitis, an infection of the prostate gland.
  • Gastrointestinal Infections: It may be prescribed for certain gastrointestinal infections caused by susceptible bacteria, such as travellers’ diarrhea.
  • Intraabdominal Infections: Levofloxacin can be part of the treatment regimen for some intraabdominal infections when appropriate.
  • Bone and Joint Infections: In some cases, Levofloxacin may be considered for the treatment of bone and joint infections, although other antibiotics are often preferred.
  • Other Infections: Levofloxacin may also be used for various other infections when the causative bacteria are susceptible to this antibiotic. These may include certain eye and ear infections, as well as infections in immunocompromised patients.

How Does Levofloxacin Tablet work?

Levofloxacin Tablets work as a broad-spectrum antibiotic, primarily targeting bacterial infections. The active ingredient, levofloxacin, belongs to the fluoroquinolone class of antibiotics and exerts its antimicrobial effects through several mechanisms. Here’s how Levofloxacin Tablets work:

  • Inhibition of DNA Gyrase and Topoisomerase IV: Levofloxacin interferes with two crucial enzymes in bacteria, DNA gyrase, and topoisomerase IV. These enzymes are responsible for maintaining the structure and integrity of bacterial DNA. By binding to these enzymes, levofloxacin disrupts the normal coiling and uncoiling of bacterial DNA strands. This disruption prevents the bacteria from replicating their genetic material accurately and leads to the formation of faulty DNA. As a result, bacterial cell growth and reproduction are inhibited.
  • Bactericidal Action: Levofloxacin is bactericidal, meaning it kills bacteria rather than merely inhibiting their growth. The damage to bacterial DNA caused by levofloxacin is so severe that it triggers a cascade of events leading to cell death. This bactericidal action is essential in treating various bacterial infections.
  • Broad-Spectrum Activity: Levofloxacin exhibits a broad spectrum of activity, which means it is effective against a wide range of bacteria, including both Gram-positive and Gram-negative bacteria. It can target bacteria responsible for respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more.
  • Concentration-Dependent Killing: Levofloxacin’s effectiveness is often related to its concentration in the body. Higher concentrations of the antibiotic are associated with more effective bacterial killing. This property allows for once-daily dosing in many cases, as the antibiotic remains active for an extended period after ingestion.

Benefits of Levofloxacin Tablet:

  • Effective Antibiotic: Levofloxacin is a potent antibiotic that is effective against a wide range of bacteria, making it valuable in treating various bacterial infections, including respiratory tract infections, urinary tract infections, skin infections, and more.
  • Broad Spectrum: Levofloxacin has a broad spectrum of activity, meaning it can target both Gram-positive and Gram-negative bacteria. This versatility allows it to be used in a variety of clinical situations where the causative bacteria may not be immediately identified.
  • High Efficacy: Levofloxacin is bactericidal, meaning it kills bacteria rather than merely inhibiting their growth. This high efficacy can lead to rapid symptom relief and resolution of infections.
  • Once-Daily Dosing: In many cases, Levofloxacin can be administered once daily due to its concentration-dependent killing and extended duration of action. This dosing convenience can improve patient compliance.
  • Oral and Intravenous Formulations: Levofloxacin is available in both oral and intravenous formulations, providing flexibility in treatment options depending on the severity of the infection and the patient’s ability to take oral medication.

Common Side Effects of Levofloxacin Tablet:

  • Gastrointestinal Disturbances: Levofloxacin can cause gastrointestinal side effects such as nausea, vomiting, diarrhea, and abdominal pain. Taking the medication with food or a full glass of water may help reduce these symptoms.
  • Central Nervous System Effects: Some individuals may experience side effects related to the central nervous system, including dizziness, headache, and insomnia. These effects are usually mild but can affect some users.
  • Tendonitis and Tendon Rupture: Levofloxacin and other fluoroquinolone antibiotics have been associated with an increased risk of tendonitis and tendon rupture, particularly in the Achilles tendon. This risk is more significant in older adults and those with a history of tendon disorders.
  • Photosensitivity: Levofloxacin can make the skin more sensitive to sunlight, potentially leading to sunburn or skin rash. Patients are advised to avoid excessive sun exposure and use sunscreen while taking the medication.
  • Cardiovascular Effects: Rarely, Levofloxacin can have cardiovascular side effects, such as QT interval prolongation, which can increase the risk of arrhythmias (irregular heartbeats).
  • Allergic Reactions: Some individuals may experience allergic reactions to Levofloxacin, which can include skin rash, itching, swelling, and difficulty breathing. Allergic reactions are rare but require immediate medical attention if they occur.
  • Digestive System Effects: Levofloxacin may rarely cause more severe digestive system effects, such as pseudomembranous colitis (a severe intestinal condition), which can lead to diarrhea with blood and mucus.
  • Hypoglycemia: Levofloxacin has been associated with low blood sugar levels (hypoglycemia), which can be a concern for individuals with diabetes.

It’s important to use Levofloxacin strictly as prescribed by a healthcare provider and to report any unusual or severe side effects promptly. Additionally, healthcare providers carefully consider the benefits and risks of using Levofloxacin for each patient, taking into account factors such as the type and severity of the infection, bacterial susceptibility, and the patient’s overall health.

Frequently Asked Questions About Levofloxacin Tablet:

Certainly, here are some frequently asked questions (FAQs) about Levofloxacin Tablets:

  1. What is Levofloxacin used for?

Levofloxacin is an antibiotic used to treat a wide range of bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more.

  1. How does Levofloxacin work?

Levofloxacin works by inhibiting enzymes in bacteria responsible for maintaining the structure of bacterial DNA. This disruption leads to the inability of bacteria to replicate and results in their death.

  1. Is Levofloxacin effective against viral infections?

No, Levofloxacin is specifically designed to target bacterial infections and is not effective against viral infections such as the common cold or flu.

  1. Can Levofloxacin be used to treat all types of bacterial infections?

Levofloxacin is effective against a wide range of bacteria, but its use should be determined by a healthcare provider based on the specific type of infection and bacterial susceptibility testing.

  1. How should I take Levofloxacin Tablets?

Levofloxacin Tablets should be taken exactly as prescribed by your healthcare provider. It is essential to complete the full course of antibiotics, even if you start feeling better, to ensure the infection is fully treated.

  1. Are there any special precautions or warnings associated with Levofloxacin?

Levofloxacin is associated with some safety concerns, including an increased risk of tendonitis and tendon rupture, especially in older adults and those with a history of tendon disorders. It can also cause central nervous system effects, photosensitivity, and cardiovascular effects. Consult your healthcare provider for personalized guidance and to discuss any potential risks.

  1. Can Levofloxacin be taken with food?

Yes, Levofloxacin can be taken with or without food. However, taking it with a full glass of water can help reduce the risk of gastrointestinal side effects.

  1. Can I drink alcohol while taking Levofloxacin?

It is generally advisable to avoid alcohol while taking antibiotics, including Levofloxacin, as alcohol can interfere with the medication’s effectiveness and may exacerbate side effects.

  1. Can Levofloxacin interact with other medications or supplements?

Levofloxacin can interact with certain medications and supplements. Inform your healthcare provider about all medications and supplements you are taking to assess potential interactions.

  1. What should I do if I miss a dose of Levofloxacin?

If you miss a dose, take it as soon as you remember. If it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double dose to make up for a missed one.

  1. Can Levofloxacin be used during pregnancy or breastfeeding?

Levofloxacin is generally not recommended during pregnancy or breastfeeding unless the potential benefits outweigh the risks. Consult your healthcare provider for guidance.

Always consult with your healthcare provider or pharmacist if you have questions or concerns about Levofloxacin Tablets or if you experience any unusual or severe side effects while taking the medication.

As Levofloxacin Tablet Exporters; We can cater to export business queries from the following geographies. We are exporting our Levofloxacin Tablet 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

Levofloxacin Tablet 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 Tablet, 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