Ofloxacin Intravenous Infusion BP 2mg/ml (OFOXATAJ) Technical Specification:
Product Name: | Ofloxacin Intravenous Infusion BP 2mg/ml |
Brand Name: | OFOXATAJ |
Strength: | (0.2%w/v or 200mg/100ml or 2mg/ml) |
Dosage Form: | I.V. Infusion Bottle (LVP) |
Packing: | 100mL, 200mL 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 & Antibiotics (fluoroquinolone antibiotics) |
Indication: | Ofloxacin is indicated in adults for the treatment of the following bacterial infections: Pyelonephritis and complicated UTIs. Prostatitis, epididymo-orchitis. Pelvic inflammatory disease, in combination treatment. |
Storage: | Store below 25°C. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ofloxacin Intravenous Infusion BP (0.2%w/v or 200mg/100ml) (OFOXATAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ofloxacin Intravenous Infusion BP (0.2% W/V or 200mg/100ml)
Composition:
Each 100 ml contains:
Ofloxacin BP……………………………200mg
Sodium chloride BP………………… 0.9gm
Water for Injection BP……………… q.s.
mEq/L: Na 154, CI 154
mOsmol/L.: 314
THERAPEUTIC INDICATIONS:
Ofloxacin is indicated in adults for the treatment of the following bacterial infections: Pyelonephritis and complicated UTIs. Prostatitis, epididymo-orchitis. Pelvic inflammatory disease, in combination treatment.
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, content not clear or contains visible solid particle.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
Storage: Store below 25°C. Protect from light. Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.
Why Taj Pharmaceuticals?
Taj Pharmaceuticals is a reputable pharmaceutical company known for its commitment to quality, innovation, and patient well-being. When it comes to Ofloxacin Intravenous Infusion, there are several reasons why Taj Pharma is a trusted choice:
- Quality Assurance: Taj Pharmaceuticals prioritizes the highest standards of quality in the manufacturing and distribution of pharmaceuticals. Their Ofloxacin Intravenous Infusion is produced in state-of-the-art facilities that adhere to stringent quality control measures, ensuring the safety and efficacy of the medication.
- Proven Expertise: Taj Pharma boasts a legacy of pharmaceutical expertise and a strong track record in producing a wide range of pharmaceutical products. This experience translates into the development of reliable and effective medications like Ofloxacin Intravenous Infusion.
- Patient-Centric Approach: Taj Pharmaceuticals places patients at the center of its mission. They are dedicated to creating pharmaceutical solutions that improve the health and well-being of individuals. Ofloxacin Intravenous Infusion is designed with patient needs in mind.
- Compliance with Regulatory Standards: Taj Pharma complies with all regulatory requirements and industry standards, ensuring that their products meet the necessary safety and efficacy criteria. This commitment to compliance provides healthcare professionals and patients with confidence in the product.
- Research and Development: Taj Pharmaceuticals invests in research and development to continually enhance its pharmaceutical offerings. This commitment to innovation ensures that their products, like Ofloxacin Intravenous Infusion, incorporate the latest advancements in pharmaceutical science.
- Global Reach: Taj Pharma’s products are distributed internationally, making them accessible to patients and healthcare providers around the world. This global reach demonstrates their dedication to addressing healthcare needs on a global scale.
- Reliability and Trust: Over the years, Taj Pharmaceuticals has built a reputation for reliability and trustworthiness. Healthcare professionals and patients alike rely on their pharmaceutical products for safe and effective treatment.
- Comprehensive Pharmaceutical Portfolio: Taj Pharma offers a diverse range of pharmaceutical products, allowing healthcare providers to address various medical conditions and treatment needs. This comprehensive portfolio includes medications like Ofloxacin Intravenous Infusion.
What is Ofloxacin Intravenous Infusion and its uses:
Ofloxacin Intravenous Infusion is a medication that is administered through an intravenous (IV) drip directly into a patient’s bloodstream. It contains the active ingredient ofloxacin, which belongs to a class of drugs known as fluoroquinolones. Ofloxacin is an antibiotic with a broad spectrum of activity against various bacteria.
Uses of Ofloxacin Intravenous Infusion:
- Treatment of Infections: Ofloxacin is primarily used to treat serious bacterial infections in cases where oral antibiotics may not be effective or appropriate. It is commonly prescribed for the treatment of infections caused by susceptible bacteria, including:
- Urinary Tract Infections (UTIs): Ofloxacin can be used to treat complicated UTIs, including pyelonephritis (kidney infection) and infections caused by multidrug-resistant bacteria.
- Respiratory Tract Infections: It is effective against lower respiratory tract infections such as pneumonia, bronchitis, and exacerbations of chronic obstructive pulmonary disease (COPD).
- Skin and Soft Tissue Infections: Ofloxacin may be prescribed for skin and soft tissue infections like cellulitis and abscesses.
- Intra-Abdominal Infections: It can be used to treat intra-abdominal infections like peritonitis and abscesses.
- Prophylaxis: In certain medical procedures, especially those involving urological or gastrointestinal surgery, Ofloxacin Intravenous Infusion may be administered prophylactically to reduce the risk of postoperative infections.
It’s important to note that Ofloxacin Intravenous Infusion is typically reserved for severe infections or cases where oral antibiotics are not suitable. The choice of antibiotic and the duration of treatment should be determined by a healthcare provider based on the specific type of infection and the susceptibility of the causative bacteria. As with all antibiotics, it’s essential to use Ofloxacin as prescribed and to complete the full course of treatment, even if symptoms improve before the medication is finished. This helps prevent the development of antibiotic resistance and ensures the infection is fully treated. Patients should also inform their healthcare provider about any allergies, medical conditions, or other medications they are taking to minimize the risk of potential interactions or adverse effects.
How does Ofloxacin Intravenous Infusion work?
Ofloxacin Intravenous Infusion works as an antibiotic to treat bacterial infections. It contains the active ingredient ofloxacin, which belongs to the fluoroquinolone class of antibiotics. The mechanism of action of ofloxacin involves interfering with the DNA replication and repair processes within bacteria, ultimately leading to their death. Here’s how it works:
- Inhibition of DNA Gyrase: Bacteria have a crucial enzyme called DNA gyrase (also known as topoisomerase II) that plays a vital role in maintaining the supercoiled structure of bacterial DNA. This supercoiled DNA is necessary for various cellular processes, including replication and transcription. Ofloxacin binds to DNA gyrase and inhibits its activity. This prevents the relaxation of supercoiled DNA, causing DNA strand breaks and interfering with DNA replication.
- Inhibition of Topoisomerase IV: In addition to targeting DNA gyrase, ofloxacin also inhibits another bacterial enzyme called topoisomerase IV. This enzyme is involved in the separation of daughter DNA strands during cell division. By inhibiting topoisomerase IV, ofloxacin disrupts the process of DNA segregation and cell division in bacteria.
- Accumulation of Double-Strand DNA Breaks: The combined inhibition of DNA gyrase and topoisomerase IV by ofloxacin leads to the accumulation of double-strand DNA breaks in bacterial cells. These breaks are lethal to the bacteria because they cannot repair the damage effectively.
- Bacterial Cell Death: As a result of the extensive DNA damage and inability to repair it, the bacterial cells are unable to replicate properly and eventually die. This action of ofloxacin is bactericidal, meaning it directly kills the bacteria rather than merely inhibiting their growth.
It’s important to note that Ofloxacin Intravenous Infusion is effective against a wide range of bacteria but is not effective against viruses. Therefore, it should only be used for bacterial infections as prescribed by a healthcare provider. Additionally, the choice of antibiotic should be based on the specific type of infection and the susceptibility of the causative bacteria to ensure optimal treatment outcomes. Patients should always follow their healthcare provider’s instructions for the correct dosage and duration of treatment.
Benefits of Ofloxacin Intravenous Infusion:
- Effective Treatment: Ofloxacin Intravenous Infusion is effective in treating a wide range of severe bacterial infections, including urinary tract infections, respiratory tract infections, skin and soft tissue infections, and intra-abdominal infections.
- Broad Spectrum: It has a broad spectrum of activity, meaning it can target and treat a variety of bacteria, making it useful in cases where the exact cause of the infection is unknown.
- IV Administration: The intravenous route of administration allows for the rapid delivery of the medication directly into the bloodstream, ensuring quick and effective action against the infection.
- Prophylactic Use: In certain surgical procedures, it can be administered prophylactically to prevent postoperative infections, reducing the risk of complications.
Side Effects of Ofloxacin Intravenous Infusion:
- Common Side Effects: While many people tolerate Ofloxacin well, some may experience common side effects, including nausea, diarrhea, headache, dizziness, and stomach upset.
- Photosensitivity: Ofloxacin can increase the skin’s sensitivity to sunlight, potentially leading to sunburn more easily. Patients are advised to take precautions, such as wearing sunscreen and protective clothing, when exposed to sunlight.
- Gastrointestinal Effects: In some cases, Ofloxacin may lead to gastrointestinal side effects like abdominal pain, vomiting, or changes in bowel habits.
- Tendon Damage: Rarely, fluoroquinolone antibiotics like Ofloxacin may be associated with tendon damage, including tendonitis and tendon rupture. This risk is higher in certain populations, such as the elderly and those on corticosteroid therapy.
- Central Nervous System Effects: Some individuals may experience central nervous system side effects, such as confusion, hallucinations, or mood changes. These are relatively uncommon but should be reported to a healthcare provider if they occur.
- Allergic Reactions: Allergic reactions to Ofloxacin, though rare, can occur. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if you suspect an allergic reaction.
- Clostridium difficile Infection: Prolonged use of antibiotics like Ofloxacin can sometimes lead to the overgrowth of the bacterium Clostridium difficile, causing severe diarrhea and colitis.
- Drug Interactions: Ofloxacin may interact with other medications, so it’s important to inform your healthcare provider about all the drugs you are taking to avoid potential interactions.
It’s crucial to follow your healthcare provider’s guidance regarding the use of Ofloxacin Intravenous Infusion, including the correct dosage and duration of treatment. If you experience severe or persistent side effects, contact your healthcare provider promptly. Additionally, inform your healthcare provider of any underlying medical conditions or allergies before starting the medication.
Frequently Asked Questions About Ofloxacin Intravenous Infusion:
Frequently Asked Questions (FAQs) About Ofloxacin Intravenous Infusion:
- What is Ofloxacin Intravenous Infusion used for?
Ofloxacin Intravenous Infusion is used to treat severe bacterial infections, including urinary tract infections, respiratory tract infections, skin and soft tissue infections, and intra-abdominal infections. It may also be used prophylactically in certain surgical procedures.
- How is Ofloxacin Intravenous Infusion administered?
Ofloxacin Intravenous Infusion is administered through an intravenous (IV) line directly into the bloodstream. It should be administered by a healthcare professional in a clinical setting.
- What is the recommended dosage of Ofloxacin Intravenous Infusion?
The dosage of Ofloxacin Intravenous Infusion varies depending on the type and severity of the infection. Your healthcare provider will determine the appropriate dosage and duration of treatment.
- How quickly does Ofloxacin Intravenous Infusion work?
The onset of action of Ofloxacin can vary depending on the individual, the type of infection, and its severity. Some patients may experience symptom relief within a day or two, while others may take longer.
- Can Ofloxacin Intravenous Infusion be used for viral infections like the flu or common cold?
No, Ofloxacin is an antibiotic and is only effective against bacterial infections. It does not treat viral infections like the flu or common cold.
- What should I do if I miss a dose of Ofloxacin Intravenous Infusion?
If you miss a dose, contact your healthcare provider or nurse immediately to schedule the missed dose. It’s essential to complete the full course of treatment as prescribed.
- Are there any food or drug interactions with Ofloxacin Intravenous Infusion?
Ofloxacin may interact with certain foods, minerals, and other medications. It’s important to inform your healthcare provider about all the medications and supplements you are taking to avoid potential interactions.
- Can Ofloxacin Intravenous Infusion be used during pregnancy or breastfeeding?
The use of Ofloxacin during pregnancy or breastfeeding is generally discouraged unless the potential benefits outweigh the risks. Consult with your healthcare provider for personalized guidance.
- What should I do if I experience side effects from Ofloxacin Intravenous Infusion?
If you experience severe or persistent side effects, contact your healthcare provider promptly. Do not discontinue the medication without consulting your healthcare provider.
- Can Ofloxacin Intravenous Infusion be used in pediatric patients?
Ofloxacin may be used in pediatric patients for certain infections, but dosing and usage should be determined by a pediatrician or healthcare provider.
It’s essential to consult with your healthcare provider for specific information and guidance regarding the use of Ofloxacin Intravenous Infusion, as individual circumstances and medical conditions can vary.
As Ofloxacin Intravenous Infusion Exporters; We can cater to export business queries from the following geographies. We are exporting our Ofloxacin Intravenous Infusion 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
Ofloxacin Intravenous Infusion 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 Ofloxacin Intravenous Infusion, 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:
Ofloxacin Intravenous Infusion BP (0.2%w/v or 200mg/100ml) (OFOXATAJ)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Ofloxacin Intravenous Infusion BP (0.2% W/V or 200mg/100ml)
Composition:
Each 100 ml contains:
Ofloxacin BP……………………………200mg
Sodium chloride BP………………… 0.9gm
Water for Injection BP……………… q.s.
mEq/L: Na 154, CI 154
mOsmol/L.: 314
Composition:
Each 100 ml contains:
Ofloxacin BP……………………………200mg
Sodium chloride BP………………… 0.9gm
Water for Injection BP……………… q.s.
mEq/L: Na 154, CI 154
mOsmol/L.: 314
THERAPEUTIC INDICATIONS:
Ofloxacin is indicated in adults for the treatment of the following bacterial infections: Pyelonephritis and complicated UTIs. Prostatitis, epididymo-orchitis. Pelvic inflammatory disease, in combination treatment.
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, content not clear or contains visible solid particle.
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: Store below 25°C.
Protect from light.
Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.
Protect from light.
Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.