Cefoperazone & Sulbactam for Injection 2gm Technical Specification:

Product Name:Cefoperazone and Sulbactam for Injection 2gm
Brand Name:TAJCEF FORTE
Strength:1.5gm, 3gm, 2gm, 1gm
Dosage Form:Sterile Dry Powder Injection
Packing:1 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 & Cephalosporins.
Indication: Cefoperazone +Sulbactam is used in the treatment of bacterial infections. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria.
Storage:Store at a temperature not exceeding 25°C. Do not freeze. Protect from light & moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cefoperazone & Sulbactam for Injection 2gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefoperazone & Sulbactam for Injection 2gm
    Each vial contains
    Cefoperazone Sodium (Sterile) USP
    equivalent to Anhydrous Cefoperazone…………….1000mg
    Sulbactam Sodium (Sterile) USP
    equivalent to Anhydrous Sulbactam………1000mg
    Sterile Water for Injection USP………20ml

THERAPEUTIC INDICATION:

Cefoperazone +Sulbactam is used in the treatment of bacterial infections. It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria.

DIRECTION OF USE:

Dissolve the content of the vial in Sterile Water for Injection USP included in this pack. Reconstitute solution should be used immediately after preparation. Reconstitution is to be carried out as per the instruction in the package.

CAUTION AND WARNING:

CAUTION:  It is dangerous to take this preparation except in accordance with medical advice.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE AND DOSAGE:

Storage:  Store at a temperature not exceeding 25°C, do not freeze, and protect from light & moisture.
The reconstituted solution should be used immediately after preparation.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Elevate Your Healthcare with Taj Pharma’s Cefoperazone & Sulbactam for Injection – Unrivaled Quality and Reliability

Discover the exceptional quality and reliability that sets Taj Pharma apart as your preferred provider for Cefoperazone & Sulbactam for Injection. Our commitment to excellence in pharmaceuticals ensures that you receive a product of unmatched purity and efficacy. With Taj Pharma, you’re not just receiving medication; you’re entrusting your well-being to a brand synonymous with trust and dependability. Count on us for all your healthcare needs, and experience the difference in pharmaceutical care that only Taj Pharma can deliver. Your health, our priority.

What is Cefoperazone & Sulbactam for Injection and its use?

Cefoperazone & Sulbactam for Injection is a combination medication that contains two active ingredients: cefoperazone and sulbactam. Let’s break down their uses and functions:

  • Cefoperazone: Cefoperazone is a third-generation cephalosporin antibiotic. It is effective against a wide range of bacteria, including both Gram-positive and Gram-negative bacteria. Cefoperazone works by interfering with the bacterial cell wall synthesis, leading to cell death. It is particularly useful in treating infections caused by susceptible bacteria, such as urinary tract infections, respiratory tract infections, skin and soft tissue infections, intra-abdominal infections, and septicemia.
  • Sulbactam: Sulbactam is a beta-lactamase inhibitor. It doesn’t have antibacterial activity on its own but works in combination with antibiotics like cefoperazone to protect them from degradation by beta-lactamase enzymes produced by some bacteria. This ensures that cefoperazone remains effective against bacteria that would otherwise have become resistant to it due to beta-lactamase production.

Uses:

Cefoperazone & Sulbactam for Injection is primarily used to treat serious bacterial infections caused by susceptible microorganisms. Some common uses include:

  • Respiratory Infections: It can be used to treat pneumonia, bronchitis, and other respiratory tract infections.
  • Intra-Abdominal Infections: Cefoperazone & Sulbactam is effective against infections in the abdominal area, such as peritonitis.
  • Urinary Tract Infections: It is used for complicated urinary tract infections.
  • Skin and Soft Tissue Infections: It can be employed in treating cellulitis, abscesses, and wound infections.
  • Septicemia: Cefoperazone & Sulbactam is often used for severe bloodstream infections.

this medication should only be used under the supervision of a qualified healthcare professional who can determine the appropriate dosage and duration of treatment based on the specific infection and patient factors. Additionally, as with all antibiotics, it’s essential to complete the full course of treatment even if symptoms improve to prevent the development of antibiotic resistance.

How does Cefoperazone & Sulbactam for Injection Work?

Cefoperazone & Sulbactam for Injection works through a combination of two active components: cefoperazone and sulbactam. These two substances have distinct mechanisms of action that complement each other to effectively combat bacterial infections:

Cefoperazone (Cephalosporin Antibiotic):

Inhibition of Cell Wall Synthesis: Cefoperazone belongs to the cephalosporin class of antibiotics. Its primary mechanism of action is to inhibit the synthesis of the bacterial cell wall. Bacterial cells have a protective outer structure called the cell wall, which maintains their shape and integrity. Cefoperazone interferes with the formation of this cell wall by binding to specific proteins called penicillin-binding proteins (PBPs) present in the bacterial cell membrane. By disrupting cell wall synthesis, cefoperazone weakens the bacterial cell wall, making it more susceptible to rupture and ultimately leading to the death of the bacteria.

Sulbactam (Beta-Lactamase Inhibitor):

Protection Against Beta-Lactamase: Sulbactam is a beta-lactamase inhibitor. Beta-lactamases are enzymes produced by some bacteria as a defense mechanism against antibiotics like cephalosporins. Beta-lactamases can break down the beta-lactam ring structure found in many antibiotics, rendering them ineffective. Sulbactam, when used in combination with cefoperazone, acts as a beta-lactamase inhibitor. It binds to and inactivates beta-lactamase enzymes, preventing them from breaking down cefoperazone. This protective action allows cefoperazone to remain active and continue its attack on bacterial cell walls.

Cefoperazone & Sulbactam for Injection works by disrupting the synthesis of bacterial cell walls through cefoperazone and simultaneously protecting cefoperazone from degradation by beta-lactamase enzymes through sulbactam. This combination ensures that the medication remains effective against a broad spectrum of susceptible bacteria, ultimately leading to the inhibition of bacterial growth and the eradication of the infection

Cefoperazone and sulbactam for injection is a combination medication used to treat various bacterial infections. It contains two active ingredients: cefoperazone, a cephalosporin antibiotic, and sulbactam, a beta-lactamase inhibitor. Below are some of the benefits and potential side effects of this medication:

Benefits:

  • Treatment of Bacterial Infections: Cefoperazone and sulbactam are effective against a wide range of bacterial infections, including respiratory, urinary tract, skin and soft tissue, intra-abdominal, and bone infections.
  • Broad Spectrum: This combination has a broad spectrum of activity, meaning it can target both Gram-positive and Gram-negative bacteria, making it suitable for a variety of infections.
  • Beta-Lactamase Inhibition: The sulbactam component of the medication helps to inhibit beta-lactamase enzymes produced by some bacteria. Beta-lactamases can break down antibiotics like cephalosporins, rendering them ineffective. Sulbactam helps protect cefoperazone from degradation by these enzymes.
  • Well-Tolerated: Cefoperazone and sulbactam are generally well-tolerated by most patients when used as prescribed by a healthcare professional.

Side Effects:

It’s important to note that not everyone will experience side effects, and some individuals may experience mild side effects while others may experience more severe ones. Common side effects of cefoperazone and sulbactam may include:

  • Gastrointestinal Disturbances: These can include nausea, vomiting, diarrhea, and abdominal pain. Taking the medication with food may help alleviate these symptoms.
  • Allergic Reactions: Some individuals may develop allergic reactions such as skin rash, itching, swelling, or difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.
  • Injection Site Reactions: Pain, redness, or swelling at the injection site may occur.
  • Liver Function Abnormalities: In rare cases, this medication can cause liver function abnormalities, which may manifest as jaundice (yellowing of the skin and eyes), dark urine, or changes in liver enzyme levels.
  • Kidney Function Abnormalities: In rare instances, cefoperazone and sulbactam may affect kidney function, leading to changes in urine output or composition.
  • Blood Disorders: There is a possibility of changes in blood cell counts, such as a decrease in white blood cells (leukopenia) or platelets (thrombocytopenia).
  • Central Nervous System Effects: Some patients may experience headache, dizziness, or confusion.
  • Clostridium difficile Infection: Prolonged use of antibiotics can sometimes lead to the overgrowth of the bacterium Clostridium difficile, causing diarrhea and colitis.
  • Seizures: In rare cases, cephalosporin antibiotics like cefoperazone have been associated with seizures.

Frequently asked questions (FAQs) about Cefoperazone and Sulbactam for Injection:

  1. What is Cefoperazone and Sulbactam for Injection used for?

Cefoperazone and Sulbactam for Injection is used to treat various bacterial infections, including respiratory, urinary tract, skin and soft tissue, intraabdominal, and bone infections.

  1. How does Cefoperazone and Sulbactam work?

Cefoperazone is an antibiotic that kills or inhibits the growth of bacteria, while sulbactam is a betalactamase inhibitor that helps protect cefoperazone from degradation by betalactamase enzymes produced by some bacteria.

  1. What bacteria are susceptible to Cefoperazone and Sulbactam?

This medication has a broad spectrum of activity and is effective against both Grampositive and Gramnegative bacteria.

  1. How is Cefoperazone and Sulbactam administered?

It is typically administered as an intravenous (IV) injection or infusion by a healthcare professional in a hospital setting.

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

Since this medication is administered by healthcare providers, there is usually no concern about missing a dose. However, if you have concerns, discuss them with your healthcare provider.

  1. Are there any common side effects of Cefoperazone and Sulbactam?

Common side effects may include gastrointestinal symptoms like nausea, vomiting, diarrhea, and abdominal pain. Other side effects can include injection site reactions, allergic reactions, and changes in liver or kidney function.

  1. Is Cefoperazone and Sulbactam safe during pregnancy and breastfeeding?

It should be used during pregnancy and breastfeeding only if the potential benefits outweigh the potential risks. Consult with your healthcare provider for guidance.

  1. Can I drink alcohol while taking Cefoperazone and Sulbactam?

It’s generally advisable to avoid alcohol when taking antibiotics as it can interfere with the effectiveness of the medication and may increase the risk of side effects.

  1. Can I drive or operate heavy machinery while taking this medication?

Some individuals may experience dizziness or confusion as side effects. If you experience these symptoms, it’s advisable to avoid activities that require mental alertness until you know how the medication affects you.

  1. How long should I take Cefoperazone and Sulbactam?

The duration of treatment will be determined by your healthcare provider based on the type and severity of the infection. It’s essential to complete the full course of treatment even if you start feeling better before it’s finished.

  1. What should I do if I experience an allergic reaction while taking this medication?

If you experience symptoms like skin rash, itching, swelling, or difficulty breathing, seek immediate medical attention.

  1. Can I take other medications while on Cefoperazone and Sulbactam?

Inform your healthcare provider of all the medications you are taking, including overthecounter drugs and supplements, as there can be potential drug interactions.

As Cefoperazone & Sulbactam for Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Cefoperazone & Sulbactam 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

Cefoperazone & Sulbactam 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 Cefoperazone & Sulbactam 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

GENERIC NAME OF MEDICINAL PRODUCT:

A. Cefoperazone and Sulbactam for Injection 1.5gm (TAJCEF FORTE)
B. Cefoperazone and Sulbactam for Injection 3gm (TAJCEF FORTE)
C. Cefoperazone and Sulbactam for Injection 2gm (TAJCEF FORTE)
D. Cefoperazone and Sulbactam for Injection 1gm (TAJCEF FORTE)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Cefoperazone and Sulbactam for Injection 1.5gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….1000mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………500mg
b. Sterile Water for Injection USP………10ml

B. Cefoperazone and Sulbactam for Injection 3gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….2000 mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………1000 mg
b. Sterile Water for Injection USP……….20ml

C. Cefoperazone and Sulbactam for Injection 2gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….1000 mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………1000 mg
b. Sterile Water for Injection USP………20ml


D. Cefoperazone and Sulbactam for Injection 1gm (TAJCEF FORTE)
a. Each vial contains:
Cefoperazone Sodium (Sterile) USP
equivalent to Anhydrous Cefoperazone…………….500mg
Sulbactam Sodium (Sterile) USP
equivalent to Anhydrous Sulbactam………500mg
b. Sterile Water for Injection USP………10ml

THERAPEUTIC INDICATION:

Cefoperazone & Sulbactam is used in the treatment of bacterial infections.
It works by preventing the formation of the bacterial protective covering which is essential for the survival of bacteria.

DIRECTION OF USE:

Dissolve the content of the vial in Sterile Water for Injection USP included in this pack. Reconstitute solution should be used immediately after preparation.
Reconstitution is to be carried out as per the instruction in the package.

CAUTION AND WARNING:

CAUTION: It is dangerous to take this preparation except in accordance with the medical advice.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE AND DOSAGE:

Storage: Store at a temperature not exceeding 25°C, do not freeze, protect from light & moisture.
Reconstituted solution should be used immediately after preparation.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.