Nilicon 250 mg/vial (IM Injection)
Medicine Details
Category | Details |
---|---|
Generic | Ceftriaxone sodium |
Company | Ethical drugs limited |
Also available as |
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 with potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. It kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a relatively long plasma elimination half-life of about 6 to 9 hours, allowing for single or once-daily dosage. It is not metabolized in the body and 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 (or in equally divided doses twice 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 (or in equally divided doses twice 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 or (or in equally divided doses twice a day); 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
- Intramuscular Injection:
- 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection
- 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection
- Intravenous Injection:
- 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection
- 1 g Ceftriaxone in 10 ml of Water for injection USP
- 2 g Ceftriaxone in 20 ml of Water for injection
- Injection Time: 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. Freshly reconstituted solution is recommended, or it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C.
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 including diarrhea, nausea and vomiting, stomatitis and glossitis
- Cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme
- Hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia
- Hepatic reactions including elevations of SGOT or SGPT, bilirubinemia
- CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness
- Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.
Pregnancy & Lactation
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
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. Shadows suggesting sludge have been detected by sonograms of the gallbladder. During prolonged treatment, the blood picture should be checked at regular intervals.
Use in Special Populations
Nilicon 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.