Cefoperazone and Sulbactam for Injection is a sterile, lyophilized powder for veterinary parenteral use. It combines Cefoperazone, a broad-spectrum third-generation cephalosporin antibiotic, with Sulbactam, a β-lactamase inhibitor that enhances Cefoperazone's effectiveness against resistant bacterial strains.

This 2:1 ratio (3 gm Cefoperazone + 1.5 gm Sulbactam) offers synergistic action, targeting both β-lactamase-producing and non-producing Gram-positive and Gram-negative pathogens. Ideal for severe systemic infections in food-producing and companion animals.

•  Dosage Form: Sterile lyophilized powder for injection

•  Appearance (Dry Powder): White to pale yellow crystalline powder

•  Appearance (After Reconstitution): Clear to slightly yellowish solution

•  pH of Reconstituted Solution: Approx. 5.0 – 7.0

•  Sterility: Must comply with USP sterility test

•  Bacterial Endotoxins: NMT (Not More Than) allowable USP limits

•  Assay (Cefoperazone and Sulbactam): 90%–110% of label claim

•  Moisture Content: NMT 6% (USP limits)

•  Reconstitution Time: < 3 minutes in sterile water

•  Container Closure: Type I USP vial, rubber stopper, aluminium seal

Each 4.5 gm vial contains:

•  Cefoperazone Sodium U.S.P., equivalent to Cefoperazone – 3.0 gm

•  Sulbactam Sodium U.S.P., equivalent to Sulbactam – 1.5 gm

•  Excipients – q.s. (to ensure solubility and stability)

•  Sterile Water for Injection – Included in the pack for reconstitution

• Antibacterial Agent – Cephalosporin + β-lactamase Inhibitor

• Cefoperazone: Inhibits bacterial cell wall synthesis (bactericidal)

• Sulbactam: Inhibits β-lactamase enzymes, preventing drug degradation

• Activity: Broad-spectrum (Gram-positive, Gram-negative, anaerobes)

Used in animals for treatment of bacterial infections including:

• Respiratory infections (pneumonia, bronchitis)

• Urinary tract infections

• Peritonitis and septicaemia

• Post-operative infections

• Mastitis, metritis

• Gastrointestinal infections

• Wound, skin, and soft tissue infections

Recommended for use in:

Cattle, Buffalo, Sheep, Goats, Pigs, Dogs, and Cats

Route:

• Intramuscular (I.M.) or

• Intravenous (I.V.) after reconstitution

Dosage (General Guidance):

• Large Animals: 20–30 mg/kg body weight once or twice daily

• Small Animals: 25–50 mg/kg body weight once or twice daily

Treatment Duration: Typically 3–7 days depending on infection severity and species

Note: Adjust based on clinical response and veterinary guidance

• Form: Sterile Dry Powder for Injection

• Pack Size: 4.5 gm vial (3 gm Cefoperazone + 1.5 gm Sulbactam)

• Contents:

o 1 Vial of dry powder

o 1 Ampoule or Vial of Sterile Water for Injection (free)

• Effective against β-lactamase producing bacteria

• Rapid clinical recovery in resistant or severe infections

• Excellent tissue and body fluid penetration

• Suitable for once or twice daily dosing

• Can be used in various animal species

• Local site irritation or pain

• Allergic reactions: rash, urticaria, anaphylaxis (rare)

• Gastrointestinal effects: vomiting, diarrhoea

• Transient liver enzyme elevation (rare)

• Contraindicated in animals allergic to cephalosporins or penicillin’s

• Use cautiously in renal or hepatic compromised animals

• Avoid mixing with calcium-containing solutions (I.V. use)

• Not intended for prophylactic use

• For veterinary use only – under prescription

• Meat: 28 days

• Milk: 7 days

Strictly observe local regulations regarding drug residues in food-producing animals.

• Store below 25°C, in a dry, dark place

• Protect from moisture and direct sunlight

• Do not freeze

• Reconstitute just before administration

• Use immediately after mixing

• Discard any unused reconstituted solution safely

• Prescription Only Medicine (Veterinary)

• Regulated under Schedule H1 or equivalent (depending on country)

• Must be sold by licensed retailers and used under veterinary supervision

• HS Code: 3004.20 (Antibiotic preparations for retail sale)

• HSN Code (India): 3004.20.90 (Other antibiotics)

Note: Classification may vary depending on country and packaging

• Use full prescribed dose and duration to avoid bacterial resistance

• Do not split or reuse vials

• Ensure aseptic preparation and administration

• Store reconstitution water separately if ampoule is opened

• Use only as directed by a qualified veterinary professional

Q1: What is U.S.P.?

A: United States Pharmacopeia – the official quality standard for pharmaceutical substances.

Q2: Why combine Cefoperazone with Sulbactam?

A: Sulbactam inhibits β-lactamase enzymes, which destroy Cefoperazone. The combination improves

efficacy against resistant strains.

Q3: Is this safe for pregnant or lactating animals?

A: Use only under strict veterinary guidance. Observe withdrawal periods for milk.

Q4: Can I use the reconstituted solution later?

A: No. Use immediately after reconstitution. Do not store.

Q5: Is this safe for all animal types?

A: Indicated for major livestock and companion animals. Use only in species and dosages recommended

by a veterinarian.

Q6: What happens in case of overdose?

A: Discontinue use immediately and seek veterinary care. Overdose may cause gastrointestinal or

neurological signs in some species.