Registered Kenya · PPB

FYTOBACT 2GM

SALBACTAM SODIUM USP & CEFOPERAZONE SODIUM USP

H2016/CTD2284/816 SALBACTAM SODIUM USP 1G & CEFOPERAZONE SODIUM USP 1G GENERIC/BIOSIMILARS antiinfectives for systemic use INN generic

What it does

Cefoperazone is an antibiotic used to treat various infections caused by bacteria.

Commonly used for: infections of the lungs (pneumonia), infections of the urinary tract, infections of the skin, bacterial infections in the bloodstream

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
H2016/CTD2284/816
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
SALBACTAM SODIUM USP & CEFOPERAZONE SODIUM USP
Strength
-
Pack size
PACKED IN IN 20 ML, 20 MM FLINT USP TYPE III VIALS. THE VIALS ARE FURTHER STOPPERED AND SEALED WITH 20 MM GREY BUTYL RUBBER STOPPER & 20 MM GREEN COLOURED AL. FLIP-OFF SEAL RESPECTIVELY. EACH VIAL IS PLACED IN A CARTON.
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
J01DD - Third-generation cephalosporins
RxNorm RxCUI
2184
Manufacturer / MAH
Cadila Pharmaceuticals
Country of origin
FOREIGN
Manufacturer location
Bhat, Sarkhej-Dholka Road, Ahmedabad, Bhat, Gujarat 382210, India

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:28:20 · updated 2026-07-26 09:27:31

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About cefoperazone

Cefoperazone is an antibiotic used to treat various infections caused by bacteria.

What it treats

  • infections of the lungs (pneumonia)
  • infections of the urinary tract
  • infections of the skin
  • bacterial infections in the bloodstream

How it works

It works by stopping the growth of bacteria, helping the body to fight off the infection.

Who it's for

Cefoperazone is for individuals with bacterial infections who need antibiotic treatment.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About salbactam

Salbactam is a medication that helps to fight bacterial infections by preventing bacteria from breaking down antibiotics.

What it treats

  • bacterial infections
  • infections caused by resistant bacteria

How it works

Salbactam works by blocking enzymes that bacteria use to resist antibiotics, making the antibiotics more effective.

Who it's for

Salbactam is usually given to people with infections that are hard to treat or caused by specific bacteria.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: cefoperazone

BNF-referenced

Cefoperazone is a third generation cephalosporin antibiotic that is effective against a variety of Gram-negative and some Gram-positive bacteria. It is primarily used in the treatment of serious infections due to its broad-spectrum activity and resistance to certain beta-lactamases. It is often utilized in hospital settings for infections such as pneumonia, sepsis, and infections caused by resistant organisms.

Indications

  • Bacterial infections
  • Pneumonia
  • Sepsis
  • Intra-abdominal infections
  • Skin and soft tissue infections
  • Urinary tract infections

Dosage

Children: Refer to the BNF for Children for specific dosage information.

Adults: Refer to the BNF for specific dosage information.

Mechanism of action

Cefoperazone binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding inhibits the third and final stage of bacterial cell wall synthesis. The result is cell lysis, which is facilitated by bacterial cell wall autolytic enzymes such as autolysins.

Pharmacodynamics

As a third generation cephalosporin, cefoperazone exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. This mechanism is critical for its effectiveness against a range of pathogens, particularly those that are resistant to other antibiotics.

Pharmacokinetics

Cefoperazone is administered parenterally and has a half-life that allows for once or twice daily dosing. It is widely distributed in body tissues and fluids, including the central nervous system. Cefoperazone is primarily eliminated by the kidneys, with a portion also excreted in bile, making it suitable for treating infections in patients with renal impairment, although dosage adjustments may be necessary.

Contra-indications

  • Hypersensitivity to cefoperazone or other beta-lactam antibiotics
  • History of severe allergic reactions to any cephalosporin

Adverse effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Rash
  • Elevated liver enzymes
  • Thrombocytopenia
  • Neutropenia

Interactions

  • Probenecid may increase cefoperazone levels by reducing renal excretion
  • Concurrent use with aminoglycosides may enhance nephrotoxicity
  • Potential interaction with anticoagulants leading to increased bleeding risk

Precautions

  • Use with caution in patients with renal impairment
  • Monitor liver function tests during therapy
  • May cause false-positive results for urine glucose tests

Pregnancy

Cefoperazone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Cefoperazone is excreted in breast milk; caution should be exercised when administered to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Reconstituted solutions should be stored in the refrigerator and used within a specified time frame as per manufacturer guidelines.

Formulations

  • Cefoperazone sodium for injection

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: salbactam

Salbactam is a beta-lactamase inhibitor that is used in combination with beta-lactam antibiotics to enhance their efficacy against resistant bacterial strains. It is particularly effective against certain gram-negative bacteria that produce beta-lactamase enzymes, which would otherwise inactivate the antibiotics. Salbactam works by binding to the active site of these enzymes, preventing them from breaking down the beta-lactam structure of the antibiotics, thus allowing the antibiotics to exert their antibacterial effects.

Indications

  • Complicated urinary tract infections
  • Complicated intra-abdominal infections
  • Skin and soft tissue infections caused by beta-lactamase producing organisms

Dosage

Children: Refer to the BNF for Children for appropriate dosing information based on age and weight.

Adults: Refer to specific guidelines or the BNF for appropriate dosing information based on the antibiotic with which salbactam is combined.

Mechanism of action

Salbactam inhibits the activity of class A beta-lactamases by covalently binding to the serine residue at the active site of the enzyme. This binding prevents the beta-lactam antibiotics from being hydrolyzed, thereby protecting them from enzymatic degradation and allowing them to remain effective against susceptible bacteria.

Pharmacodynamics

Salbactam, when used in combination with beta-lactam antibiotics, enhances the spectrum of activity of these antibiotics against beta-lactamase-producing bacteria. The combination therapy leads to increased bacterial cell wall disruption and ultimately bacterial cell death. The effectiveness of salbactam is contingent upon the presence of beta-lactam antibiotics, and its action is synergistic, improving the overall efficacy of the treatment.

Pharmacokinetics

Salbactam is generally administered intravenously and has a relatively rapid onset of action. It is widely distributed in body tissues and fluids. The elimination half-life of salbactam is approximately 1 hour, and it is primarily excreted unchanged in the urine. Renal impairment may affect the clearance of salbactam, necessitating dose adjustments in patients with renal dysfunction.

Adverse effects

  • Allergic reactions
  • Nausea
  • Vomiting
  • Diarrhea
  • Rash
  • Elevated liver enzymes

Interactions

  • May enhance the effects of anticoagulants
  • Potential interaction with other beta-lactam antibiotics

Precautions

  • Use cautiously in patients with a history of allergic reactions to beta-lactam antibiotics
  • Monitor liver function during prolonged therapy
  • Assess renal function prior to administration

Pregnancy

Salbactam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether salbactam is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from light. Protect from moisture.

Formulations

  • Salbactam sodium injection
  • Combination preparations with beta-lactam antibiotics

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: cefoperazone

PubChem CID 44187

Molecular formula: C25H27N9O8S2

Mechanism of action

Like all beta-lactam antibiotics, cefoperazone binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins.

Pharmacodynamics

Cefoperazone is a third generation cephalosporin antibiotic. Cefoperazone exerts its bactericidal effect by inhibiting the bacterial cell wall synthesis

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.