Zolibac
Generic Name
Ceftriaxone 1 gm injection
Manufacturer
Meditopix Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| zolibac 1 gm injection | ৳ 200.00 | N/A |
Description
Overview of the medicine
Zolibac 1 gm Injection contains Ceftriaxone, a broad-spectrum third-generation cephalosporin antibiotic used to treat various bacterial infections.
Uses & Indications
Dosage
Adults
Typical dosage is 1-2 gm once daily, administered intravenously (IV) or intramuscularly (IM). In severe infections, the dose may be increased to 4 gm once daily.
Elderly
Similar to adult dosage; no specific dose adjustment is needed based solely on age, but renal function should be assessed.
Renal_impairment
No dose adjustment is typically required for mild to moderate renal impairment. For severe renal impairment (creatinine clearance <10 mL/min), the dose should not exceed 2 gm daily. Monitor plasma concentrations if necessary.
How to Take
Zolibac 1 gm Injection is administered either by deep intramuscular (IM) injection or by slow intravenous (IV) injection/infusion. For IM injection, reconstitute with lidocaine. For IV, reconstitute with sterile water for injection and administer slowly over 30 minutes for infusion or 2-4 minutes for direct injection.
Mechanism of Action
Ceftriaxone acts by inhibiting the bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which interferes with the transpeptidation step of peptidoglycan synthesis, leading to bacterial cell lysis and death.
Pharmacokinetics
Onset
Rapid, within minutes for IV administration and within 2-3 hours for IM administration.
Excretion
Approximately 50-60% is excreted unchanged in the urine, and 40-50% is excreted in the bile and feces.
Half life
Approximately 6-9 hours in adults, allowing for once-daily dosing.
Absorption
Rapid and complete absorption after intramuscular (IM) or intravenous (IV) administration. Peak plasma concentrations are reached within 2-3 hours after IM injection.
Metabolism
Limited hepatic metabolism; primarily metabolized into inactive compounds by gut flora.
Side Effects
Contraindications
- Hypersensitivity to ceftriaxone, any other cephalosporin, or any excipients in the formulation.
- Previous severe hypersensitivity reaction to any other type of beta-lactam antibacterial agents (e.g., penicillins, monobactams, carbapenems).
- Neonates with hyperbilirubinemia, especially premature neonates, due to the risk of bilirubin encephalopathy.
- Neonates (≤28 days) who require or are expected to require intravenous calcium-containing solutions, due to the risk of precipitation.
Drug Interactions
Loop diuretics
High doses of furosemide may increase ceftriaxone levels.
Aminoglycosides
Although generally not associated with increased nephrotoxicity, concurrent use should be monitored, especially in patients with impaired renal function.
Oral anticoagulants
Ceftriaxone can enhance the anticoagulant effect of vitamin K antagonists (e.g., warfarin), requiring careful monitoring of INR.
Calcium-containing solutions
Concomitant use with IV calcium-containing solutions is contraindicated in neonates (≤28 days old) due to precipitation risk. In other age groups, a sequential administration with flushing between is recommended.
Storage
Store the unreconstituted powder for injection below 30°C, protected from light and moisture. Reconstituted solutions should be used immediately or stored as per specific instructions (e.g., refrigerated for a short period).
Overdose
In case of overdose, symptoms may include nausea, vomiting, diarrhea, and potentially neurological effects like convulsions. Treatment is primarily symptomatic and supportive. Ceftriaxone is not effectively removed by hemodialysis or peritoneal dialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Ceftriaxone is excreted in low concentrations in breast milk. Use during pregnancy and lactation should only be considered if the potential benefit outweighs the potential risk to the fetus or infant.
Side Effects
Contraindications
- Hypersensitivity to ceftriaxone, any other cephalosporin, or any excipients in the formulation.
- Previous severe hypersensitivity reaction to any other type of beta-lactam antibacterial agents (e.g., penicillins, monobactams, carbapenems).
- Neonates with hyperbilirubinemia, especially premature neonates, due to the risk of bilirubin encephalopathy.
- Neonates (≤28 days) who require or are expected to require intravenous calcium-containing solutions, due to the risk of precipitation.
Drug Interactions
Loop diuretics
High doses of furosemide may increase ceftriaxone levels.
Aminoglycosides
Although generally not associated with increased nephrotoxicity, concurrent use should be monitored, especially in patients with impaired renal function.
Oral anticoagulants
Ceftriaxone can enhance the anticoagulant effect of vitamin K antagonists (e.g., warfarin), requiring careful monitoring of INR.
Calcium-containing solutions
Concomitant use with IV calcium-containing solutions is contraindicated in neonates (≤28 days old) due to precipitation risk. In other age groups, a sequential administration with flushing between is recommended.
Storage
Store the unreconstituted powder for injection below 30°C, protected from light and moisture. Reconstituted solutions should be used immediately or stored as per specific instructions (e.g., refrigerated for a short period).
Overdose
In case of overdose, symptoms may include nausea, vomiting, diarrhea, and potentially neurological effects like convulsions. Treatment is primarily symptomatic and supportive. Ceftriaxone is not effectively removed by hemodialysis or peritoneal dialysis.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Ceftriaxone is excreted in low concentrations in breast milk. Use during pregnancy and lactation should only be considered if the potential benefit outweighs the potential risk to the fetus or infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years for the unreconstituted powder, when stored as per manufacturer instructions.
Availability
Available in hospitals and pharmacies
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent (generic available)
WHO Essential Medicine
YesClinical Trials
Ceftriaxone has undergone extensive clinical trials demonstrating its efficacy and safety in treating a wide range of bacterial infections across various patient populations since its initial development.
Lab Monitoring
- Complete Blood Count (CBC) for prolonged therapy
- Renal function tests (BUN, creatinine) in patients with pre-existing renal impairment or during prolonged therapy
- Liver function tests (AST, ALT, bilirubin) in patients with hepatic impairment or during prolonged therapy
- Coagulation parameters (INR/PT) in patients on concomitant anticoagulants or with vitamin K deficiency
Doctor Notes
- Confirm bacterial susceptibility prior to initiation of therapy if possible, or initiate empiric therapy based on local epidemiological data.
- Avoid co-administration with calcium-containing solutions in neonates and infants up to 28 days of age.
- Monitor for signs of C. difficile infection if diarrhea occurs post-treatment.
- Adjust dose in severe hepatic or renal impairment where co-existing conditions exist, though usually not required for single organ impairment.
Patient Guidelines
- Complete the full course of treatment as prescribed by your doctor, even if you start feeling better.
- Do not share this medication with others.
- Report any severe or persistent side effects to your doctor immediately.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If a dose is missed, administer it as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose.
Driving Precautions
Ceftriaxone may cause dizziness in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain adequate hydration during treatment.
- Avoid alcohol consumption as it may exacerbate some side effects.
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