Imacef 500 mg/vial (IM Injection)

500 mg vial: ৳ 200.00

Medicine Details

Category Details
Generic Ceftriaxone sodium
Company General pharmaceuticals ltd
Also available as
Imacef 1 gm injection Imacef 2 gm injection

Indications

  • Lower respiratory tract infections
  • Acute Bacterial Otitis Media
  • Skin and skin structure infections
  • Urinary tract infections
  • Gonorrhea
  • Bacterial Septicemia
  • Bone and joint infections
  • Meningitis
  • Prevention of postoperative infections
  • Perioperative prophylaxis of infections associated with surgery

Pharmacology

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Dosage

  • Adult:
    • Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis:
      • 1 to 2 g IV or IM once a day
      • Maximum dose: 4 gm/day
    • Uncomplicated gonococcal infections: 250 mg IM as a single dose
    • Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery
  • Infants and Children (01 month or older):
    • Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections:
      • 50 to 75 mg/kg IV or IM once a day
      • Maximum dose: 2 gm/day
    • Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
    • Meningitis:
      • 100 mg/kg IV or IM in single daily dose
      • Maximum dose: 4 gm/day
  • Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Administration

  • Preparation of Solutions for Intramuscular/Intravenous Injections:
    • For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
    • For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.
  • Injection administration: The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL

Interaction

No drug interactions have been reported.

Contraindications

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

Side Effects

  • Gastro-intestinal effects:
    • diarrhea
    • nausea
    • vomiting
    • stomatitis
    • glossitis
  • Cutaneous reactions:
    • rash
    • pruritus
    • urticaria
    • edema
    • erythema multiforme
  • Hematologic reactions:
    • eosinophilia
    • thrombocytopenia
    • leucopenia
    • anemia
    • neutropenia
  • Hepatic reactions:
    • elevations of SGOT or SGPT
    • bilirubinemia
  • CNS reactions:
    • nervousness
    • confusion
    • sleep disturbances
    • headache
    • hyperactivity
    • convulsion
    • hypertonia
    • dizziness
  • Local phlebitis: Rare following intravenous administration but can be minimized by slow injections over 2-4 minutes

Pregnancy & Lactation

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Precautions & Warnings

  • Anaphylactic shock: Anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid should be given.
  • Gallbladder conditions: Shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Imacef therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended.
  • Blood picture check: During prolonged treatment, the blood picture should be checked at regular intervals.

Use in Special Populations

Imacef must not be given to neonates if the neonate is premature and newborn (up to 28 days of age).

Overdose Effects

There is no specific antidote. Treatment of overdosage should be symptomatic.

Therapeutic Class

Third generation Cephalosporins

Storage Conditions

Vial store in a cool, dry place (below 30° C), away from light & moisture. Keep out of the reach of children.

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