Ceftriaxone and Tazobactam for Injection is a sterile dry powder combination formulated for parenteral use in veterinary species. The product contains Ceftriaxone, a third-generation cephalosporin with broad-spectrum bactericidal activity, and Tazobactam, a β-lactamase inhibitor that protects Ceftriaxone from enzymatic degradation.

The formulation is designed for once-daily dosing and provides effective therapy against both Gram-positive and Gram-negative organisms, including β-lactamase producing strains.

After reconstitution with sterile water, the solution is administered via intramuscular or intravenous injection in animals. It is used in livestock and companion animals for a wide range of bacterial infections.

•  Dosage Form: Sterile lyophilized powder for injection

•  Appearance (Dry): White to off-white crystalline powder

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

•  pH of Reconstituted Solution: 6.0 to 8.0 (typically)

•  Sterility: Must comply with pharmacopeial sterility tests

•  Bacterial Endotoxins: Within pharmacopeial limits

•  Assay (Active Content): 90–110% of labelled claim

•  Moisture Content: Within specified pharmacopeial limits

•  Container Closure System: Type I glass vial sealed with rubber stopper and aluminium cap

•  Packaging Integrity: Must maintain sterility and prevent contamination under storage conditions

Each vial contains:

•  Ceftriaxone Sodium U.S.P., equivalent to Ceftriaxone: 3.0 gm or 4.0 gm

•  Tazobactam Sodium U.S.P., equivalent to Tazobactam: 375 mg or 500 mg

•  Excipients: q.s. (bulking agents, stabilizers, buffers as required)

•  Sterile Water for Injection: Supplied in a separate ampoule or vial for reconstitution

•  Therapeutic Class: Antimicrobial agent

•  Drug Class: β-lactam antibiotic (cephalosporin) + β-lactamase inhibitor

•  Mechanism of Action:

o  Ceftriaxone: Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins

o  Tazobactam: Inhibits β-lactamase enzymes, preventing the inactivation of Ceftriaxone

Indicated for use in animals (large and small) for the treatment of infections caused by susceptible bacteria, including:

•  Respiratory tract infections

•  Urinary tract infections

•  Skin and soft tissue infections

•  Mastitis, metritis, and reproductive tract infections

•  Post-operative and post-parturient infections

•  Septicaemia

•  Gastrointestinal tract infections

Applicable for species such as: cattle, buffalo, sheep, goats, pigs, dogs, and cats.

Route:

•  Intramuscular (I.M.)

•  Intravenous (I.V.)

Dosage Guidelines:

•  Large Animals (e.g., cattle, buffalo): 20–30 mg/kg body weight once daily

•  Small Animals (e.g., dogs, cats): 25–50 mg/kg body weight once daily

Duration of Treatment: 3–5 days or as advised by a registered veterinary practitioner Reconstitution: Use the entire contents of sterile water ampoule to dissolve the powder immediately before use.

•  Form: Sterile dry powder for injection

•  Pack Sizes:

o  3.375 gm vial (Ceftriaxone 3 gm + Tazobactam 375 mg)

o  4.5 gm vial (Ceftriaxone 4 gm + Tazobactam 500 mg)

•  Each pack contains:

o  1 vial of sterile powder

o  1 ampoule/vial of sterile water for reconstitution

•  Broad-spectrum antibacterial activity

•  Effective against β-lactamase producing organisms

•  Once-daily dosing improves compliance

•  Rapid onset with high tissue penetration

•  Can be used in both companion and food-producing animals

•  Supports faster clinical recovery in severe infections

•  Local reactions: Pain, redness, swelling at injection site

•  Allergic responses: Rash, hypersensitivity, anaphylaxis (rare)

•  Gastrointestinal effects: Vomiting, diarrhoea (especially in small animals)

•  Prolonged use may affect liver or kidney function (monitor in long-term cases)

•  Do not use in animals with known allergy to cephalosporins or penicillin’s

•  Use with caution in animals with impaired kidney or liver function

•  Avoid concurrent administration with calcium-containing IV fluids

•  Not for prophylactic use unless explicitly indicated by a veterinarian

•  Use only under prescription and supervision of a registered veterinarian

•  Meat: 28 days after last administration

•  Milk: 7 days after last administration

Ensure full compliance with local withdrawal period regulations for food-producing animals.

•  Store below 25°C in a dry place, away from light and moisture

•  Do not freeze

•  Use immediately after reconstitution

•  Discard unused reconstituted solution

•  Handle using aseptic precautions

•  Prescription Drug – Veterinary

•  Schedule H1 / equivalent (varies by country)

•  For use only by or on the order of a licensed veterinary practitioner

•  HS Code (International): 3004.20 – Antibiotics for retail

•  HSN Code (India): 3004.20.90 – Other antibiotic formulations

•  Reconstitute using only the sterile water provided

•  Use culture and sensitivity data where possible before initiating therapy

•  Complete the full course as prescribed to avoid resistance

•  Do not reuse partially used vials

•  Follow all local regulations on antibiotic stewardship and veterinary medicine use

•  Dispose of used containers and medical waste responsibly

Q1: What is U.S.P.?

 A: United States Pharmacopeia – an official standard-setting authority for drug quality and purity.

Q2: Why is Tazobactam combined with Ceftriaxone?

A: Tazobactam inhibits β-lactamase enzymes that can degrade Ceftriaxone, enhancing the drug’s spectrum and efficacy.

Q3: Can it be used in lactating animals?

A: Yes, but only under veterinary advice. Observe milk withdrawal periods strictly.

Q4: Can this formulation be used in all animals?

A: It is formulated for use in commonly treated veterinary species like cattle, sheep, goats, dogs, and cats. Avoid extra-label use without veterinary prescription.

Q5: What if the animal shows an allergic reaction?

A: Stop treatment immediately and administer appropriate antihistamines or corticosteroids as directed by a veterinarian.

Q6: Can the reconstituted solution be stored?

A: No. It must be used immediately after preparation unless otherwise stated by the manufacturer.

Q7: What is the purpose of the withdrawal period?

A: To ensure that animal-derived food products (milk, meat) are free of drug residues, protecting public health.