PINCEF 1.GM ( VAIL )

Pinecef 1 g IV Injection

(Ceftriaxone for Injection IP/USP)

Generic Name:

• Ceftriaxone Sodium

Strength:

• Ceftriaxone 1 g (1000 mg)

Dosage Form:

• Sterile powder for Intravenous (IV) Injection
• Single-dose vial

Therapeutic Class:

• Third-Generation Cephalosporin Antibiotic

Composition

Each vial contains:

• Ceftriaxone Sodium equivalent to Ceftriaxone 1000 mg
• Excipients: q.s.

Indications (Uses)

Pinecef 1 g IV is indicated for the treatment of susceptible bacterial infections, including:

• Community-acquired pneumonia
• Hospital-acquired respiratory tract infections
• Septicemia (bloodstream infections)
• Meningitis
• Urinary tract infections (UTIs)
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Pelvic inflammatory disease
• Gonorrhea
• Surgical infection prophylaxis (before certain surgeries)

Note: Ceftriaxone is effective only against bacterial infections and should not be used for viral infections such as the common cold or influenza.

Mechanism of Action

Ceftriaxone inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial cell death.

Dosage & Administration

• Adults: 1–2 g IV once daily or divided into two doses, depending on the severity of infection.
• Severe infections may require up to 4 g/day as directed by the physician.
• Administer only by intravenous injection or infusion after proper reconstitution.
• Dosage should be adjusted according to the patient’s clinical condition and renal/hepatic function when appropriate.

Common Side Effects

• Pain or inflammation at the injection site
• Diarrhea
• Nausea
• Vomiting
• Headache
• Skin rash
• Mild elevation of liver enzymes

Serious Adverse Effects

Seek immediate medical attention if any of the following occur:

• Severe allergic reaction (anaphylaxis)
• Persistent or bloody diarrhea (Clostridioides difficile-associated diarrhea)
• Severe skin reactions (Stevens–Johnson syndrome/TEN)
• Blood disorders (anemia, leukopenia, thrombocytopenia)
• Gallbladder sludge or biliary complications
• Seizures (rare, especially in renal impairment)

Contraindications

• Hypersensitivity to ceftriaxone, cephalosporins, or any component of the product.
• Neonates with hyperbilirubinemia.
• Neonates requiring calcium-containing IV solutions due to the risk of precipitation.

Warnings & Precautions

• Administer only under the supervision of a qualified healthcare professional.
• Use cautiously in patients with severe renal or hepatic impairment.
• Use with caution in patients with a history of penicillin allergy.
• Prolonged use may result in fungal or resistant bacterial overgrowth.
• Use during pregnancy and breastfeeding only if clearly needed and prescribed.

Drug Interactions

May interact with:

• Calcium-containing IV solutions (avoid simultaneous administration)
• Warfarin and other anticoagulants
• Aminoglycoside antibiotics
• Chloramphenicol
• Probenecid

Storage

• Store below 30°C.
• Protect from light and moisture.
• Use the reconstituted solution within the recommended time according to hospital protocols.
• Keep out of the reach of children.

Pack Size:

• 1 vial containing Ceftriaxone 1 g sterile powder for IV injection.