Rosebac
Generic Name
Ceftriaxone 1 gm Injection
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rosebac 1 gm injection | ৳ 1,300.00 | N/A |
Description
Overview of the medicine
Rosebac 1 gm Injection contains Ceftriaxone, a third-generation cephalosporin antibiotic used to treat a wide range of bacterial infections.
Uses & Indications
Dosage
Adults
Usual adult dose is 1-2 gm once daily (IM or IV), or in two divided doses. In severe infections, doses up to 4 gm daily may be given.
Elderly
No specific dosage adjustment is typically required for elderly patients unless there is severe renal or hepatic impairment.
Renal_impairment
Dosage adjustment is generally not necessary for mild to moderate renal impairment. For severe renal impairment (CrCl <10 mL/min), dosage should not exceed 2 gm daily. Monitor plasma concentrations in severe cases.
How to Take
Rosebac 1 gm Injection can be administered by deep intramuscular (IM) injection or by slow intravenous (IV) infusion/injection over 30 minutes. It should be reconstituted with an appropriate diluent (e.g., water for injection, lidocaine solution for IM).
Mechanism of Action
Ceftriaxone acts by inhibiting bacterial cell wall synthesis, leading to cell lysis and bacterial death. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall.
Pharmacokinetics
Onset
Rapid (within minutes for IV administration, within hours for IM)
Excretion
Approximately 50-60% excreted unchanged in urine via glomerular filtration and tubular secretion, and 40-50% excreted via biliary/fecal route.
Half life
6 to 9 hours (prolonged in neonates and elderly)
Absorption
Rapidly and completely absorbed after intramuscular (IM) injection. Peak plasma concentrations are reached within 2-3 hours.
Metabolism
Partially metabolized in the liver to inactive metabolites; approximately 33-67% of the dose is excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to ceftriaxone, any other cephalosporin, or penicillins (due to potential cross-reactivity)
- Neonates (≤28 days) with hyperbilirubinemia, especially premature neonates, due to the risk of bilirubin encephalopathy
- Concomitant use with calcium-containing IV solutions in neonates (≤28 days) due to the risk of ceftriaxone-calcium precipitation in lungs and kidneys.
Drug Interactions
Alcohol
No disulfiram-like reaction reported with ceftriaxone, unlike some other cephalosporins.
Aminoglycosides
May increase the risk of nephrotoxicity. Monitor renal function.
Calcium-containing solutions
Concomitant use with IV calcium-containing solutions is contraindicated in neonates due to precipitation risk. In other age groups, administer sequentially with flushing, if necessary.
Loop Diuretics (e.g., Furosemide)
May increase the risk of nephrotoxicity, particularly in patients with pre-existing renal impairment.
Oral Anticoagulants (e.g., Warfarin)
May potentiate the anticoagulant effect, increasing the risk of bleeding. Monitor INR/PT.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Reconstituted solutions are stable for a specific period (e.g., 6 hours at room temperature, 24 hours in a refrigerator) and should be used immediately or discarded after this period.
Overdose
In case of overdose, symptoms may include nausea, vomiting, and diarrhea. Management is primarily symptomatic and supportive. Hemodialysis or peritoneal dialysis are not effective in removing ceftriaxone from the body.
Pregnancy & Lactation
Pregnancy Category B. Animal reproduction studies have not demonstrated a fetal risk, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Ceftriaxone is excreted in low concentrations in breast milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to ceftriaxone, any other cephalosporin, or penicillins (due to potential cross-reactivity)
- Neonates (≤28 days) with hyperbilirubinemia, especially premature neonates, due to the risk of bilirubin encephalopathy
- Concomitant use with calcium-containing IV solutions in neonates (≤28 days) due to the risk of ceftriaxone-calcium precipitation in lungs and kidneys.
Drug Interactions
Alcohol
No disulfiram-like reaction reported with ceftriaxone, unlike some other cephalosporins.
Aminoglycosides
May increase the risk of nephrotoxicity. Monitor renal function.
Calcium-containing solutions
Concomitant use with IV calcium-containing solutions is contraindicated in neonates due to precipitation risk. In other age groups, administer sequentially with flushing, if necessary.
Loop Diuretics (e.g., Furosemide)
May increase the risk of nephrotoxicity, particularly in patients with pre-existing renal impairment.
Oral Anticoagulants (e.g., Warfarin)
May potentiate the anticoagulant effect, increasing the risk of bleeding. Monitor INR/PT.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Reconstituted solutions are stable for a specific period (e.g., 6 hours at room temperature, 24 hours in a refrigerator) and should be used immediately or discarded after this period.
Overdose
In case of overdose, symptoms may include nausea, vomiting, and diarrhea. Management is primarily symptomatic and supportive. Hemodialysis or peritoneal dialysis are not effective in removing ceftriaxone from the body.
Pregnancy & Lactation
Pregnancy Category B. Animal reproduction studies have not demonstrated a fetal risk, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Ceftriaxone is excreted in low concentrations in breast milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture (when stored as per instructions)
Availability
Pharmacies, Hospitals, Clinics
Approval Status
Approved by major regulatory bodies globally
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established Ceftriaxone's efficacy and safety across various bacterial infections, demonstrating its broad-spectrum activity and favorable pharmacokinetic profile.
Lab Monitoring
- Complete Blood Count (CBC) for prolonged therapy
- Liver function tests (LFTs) if abnormalities are suspected
- Renal function tests, especially in patients with pre-existing renal impairment or during prolonged high-dose therapy
- Coagulation parameters (INR/PT) in patients receiving concomitant anticoagulants or with vitamin K deficiency
Doctor Notes
- Always inquire about previous hypersensitivity reactions to beta-lactam antibiotics.
- Ceftriaxone should not be mixed or co-administered with calcium-containing solutions in the same IV line, particularly in neonates.
- Monitor for signs of superinfection, especially C. difficile-associated diarrhea, during and after treatment.
Patient Guidelines
- It is crucial to complete the entire course of the antibiotic as prescribed by your doctor, even if symptoms improve earlier.
- Report any severe or persistent side effects, such as severe diarrhea, rash, or difficulty breathing, to your healthcare provider immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
- Do not share this medication with others, and do not use it to treat other infections unless advised by a doctor.
Missed Dose Advice
If a dose is missed, it should be administered as soon as remembered, unless it is almost time for the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Ceftriaxone may cause dizziness in some patients. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- For IM injections, rotation of injection sites can help minimize discomfort.
- Avoid alcohol during treatment, although specific interactions with ceftriaxone are uncommon.
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