Nilicon 250 mg/vial (IV 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. 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:
- 1 to 2 gm by intravenous or intramuscular administration once a day
- Maximum dose: 4 gm/day
- Infants and Children (01 month or older):
- 50 to 75 mg/kg intravenous or intramuscular administration once a day
- Maximum dose: 2 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
- 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
- Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, 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
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 cannot be ruled out even if a thorough patient history is taken
- Shadows suggesting sludge have been detected by sonograms of the gallbladder in rare cases
- 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 neonates 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.