Cefepime for Injection USP 1gm Technical Specification:

Product Name:Cefepime for Injection USP 1gm
Brand Name:Maximtaj
Strength:1gm, 2gm, 500mg, 250mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.M/I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Cephalosporin.
Indication: Cefepime is used to treat severe bacterial infections of the skin, lungs, stomach, urinary tract, and blood.
Storage:Store at 20° to 25°C (68° to 77°F). See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cefepime for Injection USP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefepime for Injection USP 1gm
    Each vial contains:
    (Sterile) Cefepime Hydrochloride USP
    Eq. to Cefepime …………1gm
    (Sterile mixture of Cefepime Hydrochloride and L-Arginine)
    Sterile Water for Injection BP ….…………… 10ml

THERAPEUTIC INDICATION:

Cefepime is used to treat severe bacterial infections of the skin, lungs, stomach, urinary tract, and blood.

DIRECTION OF USE:

For Intravenous Use: Dissolve the content of the vial in 10ml of Sterile Water for Injection BP.
For Intramuscular Use: Dissolve the content of the vial in 2.4ml of Sterile Water for Injection BP.
The reconstituted solution should be used immediately after preparation or used within 18 hours when stored at 15 to 25°C or used within 7 days when stored at 2-8°C.

CAUTION AND WARNING:

CAUTION:  Use a reconstituted solution if it is clear and devoid of particulate matter.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING: It is dangerous to take this preparation except in accordance with medical advice.
To be sold by retail on the prescribed of a registered medical partitioner only. 

STORAGE AND DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F). See USP-controlled room temperature.

Any unused reconstitution portion must be discarded.
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

  • Pharmaceutical Excellence: Taj Pharmaceuticals is renowned for its dedication to pharmaceutical excellence. With a legacy of producing high-quality medications, they have earned the trust of healthcare professionals and patients worldwide. Their commitment to delivering effective and safe pharmaceuticals makes them a reliable choice for infection management.
  • Stringent Quality Standards: Taj Pharmaceuticals adheres to stringent quality control measures to ensure that Cefepime Injection meets the highest pharmaceutical standards. Quality and safety are paramount in their production processes, guaranteeing the reliability and effectiveness of their medications.
  • Global Accessibility: Taj Pharmaceuticals’ extensive distribution network ensures that Cefepime Injection is readily available to individuals and healthcare systems across the globe. This global accessibility is crucial for addressing the worldwide challenges posed by bacterial infections.
  • Comprehensive Antibiotics Portfolio: Taj Pharmaceuticals offers a wide range of antibiotics and antimicrobial medications, allowing healthcare providers to choose the most suitable treatment options for bacterial infections. This comprehensive approach ensures personalized care for patients with varying infectious conditions.
  • Expertise in Infection Management: Taj Pharmaceuticals specializes in infection management and antimicrobial therapy. Their in-depth knowledge of infectious diseases ensures that individuals receive tailored solutions for effective treatment.
  • Affordability: Taj Pharmaceuticals is committed to providing cost-effective solutions for infection management. Their medications are designed to be accessible without compromising quality, making them an excellent choice for individuals seeking budget-friendly options.

In summary, Taj Pharmaceuticals is your dependable source for Cefepime Injection, offering pharmaceutical excellence, stringent quality standards, global accessibility, a comprehensive antibiotics portfolio, expertise in infection management, and affordability. When it comes to managing bacterial infections and safeguarding your health, trust Taj Pharmaceuticals for personalized, effective, and safe solutions that prioritize your well-being.

What is Cefepime Injection and its uses?

Cefepime Injection is a medication that contains the active ingredient cefepime, which belongs to a class of antibiotics known as cephalosporins. It is administered through intravenous (IV) infusion and is used to treat various bacterial infections. Here are its primary uses:

  • Serious Infections: Cefepime is commonly used to treat severe or life-threatening bacterial infections, including:
    Pneumonia: It can be effective against both community-acquired and hospital-acquired pneumonia.
    Intra-Abdominal Infections: Cefepime is used to treat infections within the abdominal cavity, such as peritonitis.
    Skin and Soft Tissue Infections: It can be prescribed for complicated skin and soft tissue infections, including cellulitis and diabetic foot infections.
    Urinary Tract Infections (UTIs): Cefepime may be used to treat complicated UTIs, particularly those caused by multidrug-resistant bacteria.
  • Septicemia: It is employed in cases of bloodstream infections or sepsis.
  • Febrile Neutropenia: Cefepime is sometimes prescribed to individuals with febrile neutropenia, a condition characterized by fever and a low white blood cell count, often seen in cancer patients undergoing chemotherapy.
  • Hospital-Acquired Infections: In hospital settings, Cefepime is used to treat infections that patients acquire during their hospital stay, such as ventilator-associated pneumonia or catheter-related bloodstream infections.
  • Empirical Treatment: Cefepime may be part of empiric therapy, where it is prescribed before the specific causative bacteria are identified through laboratory tests. This is often done in critically ill patients to start treatment promptly.
  • Treatment of Multi-Drug Resistant Infections: Cefepime is effective against some bacteria that have become resistant to other antibiotics, making it a valuable option in the management of certain drug-resistant infections.

Cefepime works by interfering with the cell wall synthesis of bacteria, weakening their structure, and ultimately leading to the death of the bacterial cells. It has a broad spectrum of activity against both Gram-positive and Gram-negative bacteria, which makes it suitable for a wide range of infections. It’s crucial to use Cefepime Injection as prescribed by a healthcare provider, follow the recommended dosage and duration of treatment, and complete the entire course of antibiotics, even if symptoms improve before the medication is finished. This helps prevent the development of antibiotic resistance and ensures the complete eradication of the infection.

How does Cefepime Injection work?

Cefepime Injection is a cephalosporin antibiotic used to treat bacterial infections. It works by interfering with the bacterial cell wall synthesis, ultimately leading to the death of the bacteria. Here’s how Cefepime Injection works:

  • Inhibition of Cell Wall Synthesis: Bacterial cells are surrounded by a protective cell wall that gives them structural integrity. This cell wall is crucial for their survival. Cefepime works by inhibiting the synthesis of the bacterial cell wall.
  • Transpeptidase Inhibition: Cefepime interferes with an enzyme called transpeptidase, which plays a key role in cross-linking the structural components of the bacterial cell wall. By inhibiting transpeptidase, Cefepime prevents the formation of strong and stable cross-links in the cell wall.
  • Weakening of Cell Wall: As a result of transpeptidase inhibition, the bacterial cell wall becomes weak and less able to withstand the internal pressure of the bacterial cell. This weakening of the cell wall causes it to rupture or burst.
  • Cell Lysis: With a compromised cell wall, the bacterial cell is unable to maintain its structural integrity. The internal pressure becomes too much for the weakened cell wall to contain, leading to the lysis or bursting of the bacterial cell.
  • Bacterial Death: Once the bacterial cell has lysed, its contents are released, and it cannot survive. This process effectively kills the bacteria and halts the infection’s progression.

Cefepime Injection has a broad spectrum of activity, making it effective against a wide range of bacteria, including both Gram-positive and Gram-negative strains. Its ability to disrupt bacterial cell wall synthesis is a key mechanism in its bactericidal action, which means it directly kills the bacteria rather than merely inhibiting their growth. It’s important to note that Cefepime Injection is prescribed by healthcare providers based on the specific bacterial infection and the susceptibility of the bacteria to this antibiotic. It should be used as directed, with the recommended dosage and duration of treatment, to ensure the most effective and complete eradication of the infection.

Benefits of Cefepime Injection:

  • Effective Treatment: Cefepime is effective against a wide range of bacterial infections, including serious and life-threatening conditions. It is often used in hospital settings to combat infections that may be resistant to other antibiotics.
  • Broad Spectrum: Cefepime has a broad spectrum of activity, making it effective against both Gram-positive and Gram-negative bacteria. This versatility allows it to treat a variety of infections caused by different types of bacteria.
  • Resistant Infection Management: In cases of bacterial infections that are resistant to other antibiotics, Cefepime can be a valuable treatment option. It is often used when the causative bacteria are known or suspected to be multidrug-resistant.
  • Empirical Therapy: Cefepime can be part of empiric therapy, where it is prescribed before the specific bacteria responsible for the infection are identified. This is important in critically ill patients to initiate treatment promptly.
  • Clinical Improvement: Patients with bacterial infections often experience relief from symptoms and a reduction in fever and inflammation after starting Cefepime treatment.

Side Effects of Cefepime Injection:

  • Gastrointestinal Disturbances: Common side effects include nausea, vomiting, diarrhea, and abdominal pain. These symptoms are usually mild and temporary.
  • Hypersensitivity Reactions: Some individuals may develop allergic reactions to Cefepime, which can include skin rash, itching, swelling, or more severe reactions like anaphylaxis. Allergic reactions require immediate medical attention.
  • Injection Site Reactions: Pain, redness, or swelling at the injection site can occur, but these symptoms are typically not serious.
  • Neurological Symptoms: In rare cases, Cefepime may lead to neurological side effects, especially in patients with kidney impairment. These symptoms can include confusion, hallucinations, and seizures.
  • Blood Disorders: Cefepime may affect blood cell counts, leading to leukopenia (reduced white blood cells) or thrombocytopenia (reduced platelets). Regular blood tests may be required to monitor for these effects.
  • Renal Impairment: Kidney function should be monitored while taking Cefepime, as it can lead to renal impairment in some individuals.
  • Clostridium difficile Infection: Antibiotic use, including Cefepime, can lead to the overgrowth of the bacterium Clostridium difficile in the colon, causing colitis. Symptoms include severe diarrhea, abdominal pain, and fever.
  • Superinfections: Like other antibiotics, Cefepime can lead to superinfections with resistant bacteria or fungi.

It’s essential to use Cefepime Injection as prescribed by a healthcare provider, adhere to the recommended dosage and treatment duration, and report any severe or persistent side effects promptly. Most side effects are mild and transient, but serious reactions require immediate medical attention. The benefits of Cefepime in treating bacterial infections often outweigh the potential risks, especially when used under medical supervision.

Frequently Asked Questions About Cefepime Injection:

Certainly, here are some frequently asked questions (FAQs) about Cefepime Injection:

  1. What is Cefepime Injection, and what is it used for?

Cefepime Injection is a medication containing the antibiotic cefepime. It is used to treat a wide range of bacterial infections, including respiratory, urinary tract, skin, and intraabdominal infections, as well as serious and life-threatening infections.

  1. How does Cefepime Injection work?

Cefepime works by inhibiting the synthesis of bacterial cell walls, leading to the death of the bacteria. It has a broad spectrum of activity against both Gram-positive and Gram-negative bacteria.

  1. Is Cefepime Injection safe to use during pregnancy and breastfeeding?

Pregnant or breastfeeding individuals should consult their healthcare provider before using Cefepime Injection. The decision to use this medication during pregnancy or breastfeeding should be based on individual circumstances and the potential benefits versus risks.

  1. Can Cefepime Injection be given to children?

Cefepime may be prescribed to children, but the dosage is determined based on the child’s weight and specific infection. It should only be used under the guidance of a pediatrician.

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

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

  1. Are there any drug interactions with Cefepime Injection?

Cefepime may interact with other medications or substances. Inform your healthcare provider about all the medications, supplements, and herbal products you are taking to avoid potential interactions.

  1. What are the common side effects of Cefepime Injection?

Common side effects may include gastrointestinal symptoms like nausea, vomiting, and diarrhea. Other possible side effects include injection site reactions, hypersensitivity reactions, and neurological symptoms (rarely).

  1. How long does it take for Cefepime Injection to start working?

The onset of action may vary, but some individuals experience relief from symptoms within hours to a few days of starting treatment. However, it’s important to complete the full course of antibiotics as prescribed, even if symptoms improve.

  1. Can I consume alcohol while taking Cefepime Injection?

It’s generally recommended to avoid alcohol while on antibiotics like Cefepime. Alcohol can interact with medications and may reduce their effectiveness.

  1. Is it safe to drive or operate machinery while using Cefepime Injection?

Cefepime may cause dizziness or confusion as a side effect in some individuals. If you experience these symptoms, it’s advisable to avoid activities that require mental alertness, such as driving or operating heavy machinery, until you feel fully alert.

These FAQs provide general information about Cefepime Injection, but individual recommendations and usage may vary. Always consult with a healthcare provider for personalized advice and guidance on the use of this medication, including potential benefits and risks.

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

Cefepime 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 Cefepime 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

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Cefepime for Injection USP 1gm (Maximtaj)
(B) Cefepime for Injection USP 2gm (Maximtaj)
(C) Cefepime for Injection USP 500mg (Maximtaj)
(D) Cefepime for Injection USP 250mg (Maximtaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Cefepime for Injection USP 1gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………1gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ….…………… 10ml

2. Cefepime for Injection USP 2gm
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………2gm
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ….…………… 20ml

3. Cefepime for Injection USP 500mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………500mg
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP…………5ml

4. Cefepime for Injection USP 250mg
A. Each vial contains:
(Sterile) Cefepime Hydrochloride USP
Eq. to Cefepime …………250mg
(Sterile mixture of Cefepime Hydrochloride and L-Arginine)
B. Sterile Water for Injection BP ………….… 5ml

THERAPEUTIC INDICATION:

Cefepime is used to treat severe bacterial infections of the skin, lungs, stomach, urinary tract, and blood.

DIRECTION OF USE:

For Intravenous Use: Dissolve the content of vial in 10ml of Sterile Water for Injection BP.
For Intramuscular Use: Dissolve the content of vial in 2.4ml of Sterile Water for Injection BP.
Reconstituted solution should be used immediately after preparation or use within 18 hours when stored at 15 to 25°C or use within 7 days when stored at 2-8°C.

CAUTION AND WARNING:

CAUTION: Use reconstituted solution if it is clear and devoid of particulate matter.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Keep medicine out of reach of children.
Discard the unused portion.
Read enclosed leaflet before use.
Dosage: As directed by Physician. Refer the package insert for dosage, direction of use & administration.