Rocephin 500 mg IM Injection (Ceftriaxone Sodium) — Single Vial

Description

Rocephin is a sterile, broad-spectrum antibiotic injection containing ceftriaxone sodium (a third-generation cephalosporin). This 500 mg vial is formulated for intramuscular (IM) administration after reconstitution with a suitable diluent (usually sterile water for injection or lidocaine solution for IM). It is widely used for the treatment of moderate to severe bacterial infections.

Ingredients

• Active ingredient: Ceftriaxone sodium (equivalent to 500 mg ceftriaxone base per vial).

• Excipients: Vial contains sterile powder; reconstituted with water for injection or lidocaine (for IM only).

Drug Class

• Third-generation cephalosporin antibiotic (β-lactam).

• Bactericidal: inhibits bacterial cell wall synthesis.

Dosage Form

• Powder for solution for injection.

• 500 mg single-use vial (IM route).

Uses / Indications

Rocephin is indicated for infections caused by susceptible organisms, including:

• Lower respiratory tract infections (pneumonia, bronchitis)

• Urinary tract infections (complicated/uncomplicated)

• Skin and soft tissue infections

• Bone and joint infections

• Intra-abdominal infections

• Septicemia and bacteremia

• Meningitis (higher doses, often IV)

• Gonorrhea (single-dose IM therapy)

• Surgical prophylaxis (perioperative use)

Dosage (General Guidance — follow prescriber orders)

• Adults: 1–2 g once daily (IV/IM), or divided every 12 hours. For certain infections (e.g., gonorrhea), a single IM dose of 250–500 mg is common.

• Children: 20–80 mg/kg/day depending on age/severity.

• Neonates: Dosing reduced; avoid calcium co-administration.

• Renal/Hepatic impairment: Usually no adjustment needed, except in combined severe dysfunction.

• Reconstitution for IM: Reconstitute 500 mg vial with 2 mL of 1% lidocaine (reduces pain at injection site).

In Case of Overdose

• May cause CNS effects (seizures, encephalopathy), GI upset, and electrolyte imbalance.

• No specific antidote; treatment is supportive. Hemodialysis is not very effective due to high protein binding.

Missed Dose

• If a dose is missed, administer as soon as remembered. Do not double dose. Follow the healthcare provider’s schedule.

How To Use / Administration

1. Reconstitute powder with recommended diluent (usually 2 mL of 1% lidocaine for IM injection).

2. Shake until fully dissolved.

3. Inject deep into a large muscle mass (e.g., gluteal).

4. Never administer IV solutions with calcium-containing fluids in neonates.

5. Administer under supervision of healthcare personnel.

When Not to Use / Contraindications

• Known hypersensitivity to ceftriaxone, cephalosporins, or severe penicillin allergy.

• Neonates (≤28 days) requiring calcium IV therapy (risk of precipitation/fatal reaction).

• History of severe allergic reaction to β-lactam antibiotics.

Side Effects

Common:

• Pain, redness, or swelling at injection site

• Diarrhea, nausea, vomiting

• Rash, itching

• Headache

Serious (rare):

• Severe allergic reactions (anaphylaxis)

• Clostridium difficile–associated diarrhea

• Hemolytic anemia

• Liver enzyme elevations, biliary sludging

• Seizures (with very high doses/renal impairment)

Precautions & Warnings

• Administer only under medical supervision.

• Monitor renal and hepatic function during prolonged therapy.

• Caution in patients with history of severe allergies.

• Prolonged use may result in superinfection, including fungal infections.

• Do not reconstitute or mix with calcium-containing IV solutions (especially in neonates).

Drug Interactions

• Calcium-containing IV fluids: Contraindicated (risk of precipitation).

• Oral anticoagulants (e.g., warfarin): May increase INR — monitor closely.

• Aminoglycosides: Additive nephrotoxicity risk.

• Chloramphenicol: May antagonize bactericidal effect.

Storage / Disposal

• Store powder vials below 25 °C, protected from light.

• Use reconstituted solution immediately (stability limited).

• Discard unused solution.

• Dispose of vials/needles in sharps container per biomedical waste guidelines.

Control Drug / Prescription Status

• Prescription Only Medicine

• Must be administered by healthcare professionals.

Quick Tips

• Reconstitute only with approved diluent (lidocaine for IM).

• Pain at injection site is common; lidocaine helps reduce discomfort.

• Complete the full course of therapy, even if symptoms improve.

• Report any allergic reactions or severe diarrhea immediately.

• Do not self-administer — always seek medical supervision.