Aciphin
Generic Name
Ceftriaxone
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
aciphin 1 gm injection | ৳ 200.00 | N/A |
Description
Overview of the medicine
Aciphin 1 gm Injection contains Ceftriaxone, a broad-spectrum, third-generation cephalosporin antibiotic. It is used to treat a wide range of bacterial infections affecting various parts of the body, including respiratory tract, urinary tract, skin, and soft tissues. It is effective against both Gram-positive and Gram-negative bacteria.
Uses & Indications
Dosage
Adults
Usual dose is 1-2 gm once daily (or in two equally divided doses) via IM or IV administration, depending on the severity and type of infection. Maximum dose is 4 gm/day.
Elderly
No specific dose adjustment is required unless there is severe renal or hepatic impairment. Monitor renal and hepatic function.
Renal_impairment
No dose adjustment needed for mild to moderate impairment. For severe renal impairment (creatinine clearance <10 mL/min), the daily dose should not exceed 2 gm. Monitoring of plasma concentrations may be beneficial.
How to Take
Aciphin 1 gm Injection should be reconstituted with an appropriate sterile diluent (e.g., sterile water for injection, 1% Lidocaine for IM administration) according to manufacturer guidelines. It can be administered via deep intramuscular injection or slow intravenous injection (over 2-4 minutes) or intravenous infusion (over 30 minutes). Avoid rapid intravenous bolus injection.
Mechanism of Action
Ceftriaxone inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) located in the bacterial cytoplasmic membrane. This binding interferes with the transpeptidation step of peptidoglycan synthesis, leading to cell wall disruption and subsequent bacterial cell lysis and death.
Pharmacokinetics
Onset
Within 2-3 hours after administration.
Excretion
Mainly via renal (33-67%) and biliary/fecal routes.
Half life
Approximately 6-9 hours in adults (prolonged in neonates and elderly, especially those with renal/hepatic impairment).
Absorption
Rapidly and completely absorbed after intramuscular (IM) administration; bioavailability is nearly 100%. Peak plasma concentrations are reached within 2-3 hours after IM or IV administration.
Metabolism
Not extensively metabolized in the liver; about 33-67% is excreted unchanged in the urine, with the remainder primarily excreted in the bile and feces as microbiologically inactive compounds.
Side Effects
Contraindications
- Known hypersensitivity to ceftriaxone, any other cephalosporin antibiotics, or any component of the formulation.
- Patients with a history of severe hypersensitivity reactions to any other beta-lactam antibiotic (e.g., penicillins).
- Neonates (especially premature) with hyperbilirubinemia, as ceftriaxone can displace bilirubin from albumin binding sites, increasing the risk of kernicterus.
- Neonates (≤28 days) receiving calcium-containing intravenous solutions (e.g., Ringer's solution, parenteral nutrition) due to the risk of ceftriaxone-calcium precipitation in the lungs and kidneys.
Drug Interactions
Aminoglycosides
Although often used in combination for synergistic effects, there is a theoretical increased risk of nephrotoxicity. Monitor renal function.
Calcium-containing solutions
Concomitant use is contraindicated in neonates. In other age groups, if calcium administration is necessary, infuse ceftriaxone and calcium solutions sequentially through different infusion lines or at different sites, or flush the line thoroughly between infusions.
Loop diuretics (e.g., Furosemide)
High doses of ceftriaxone with loop diuretics may increase ceftriaxone levels and potentially increase adverse effects.
Oral anticoagulants (e.g., Warfarin)
Ceftriaxone may enhance the anticoagulant effect of vitamin K antagonists. Close monitoring of INR and prothrombin time is recommended, and anticoagulant dose adjustment may be necessary.
Live bacterial vaccines (e.g., Typhoid vaccine)
Antibiotics may diminish the therapeutic effect of live bacterial vaccines. Administer the vaccine at least 24 hours after discontinuing ceftriaxone.
Storage
Store the un-reconstituted powder for injection below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children. Reconstituted solutions should be used immediately or stored as per manufacturer's instructions.
Overdose
In case of overdose, symptoms may include nausea, vomiting, diarrhea. Management is primarily supportive and symptomatic. Hemodialysis and peritoneal dialysis are not effective for removing ceftriaxone from the body.
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 should be used during pregnancy only if clearly needed. It is excreted in low concentrations in breast milk. Caution should be exercised when Aciphin is administered to a nursing woman. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis, or allergic reactions.
Side Effects
Contraindications
- Known hypersensitivity to ceftriaxone, any other cephalosporin antibiotics, or any component of the formulation.
- Patients with a history of severe hypersensitivity reactions to any other beta-lactam antibiotic (e.g., penicillins).
- Neonates (especially premature) with hyperbilirubinemia, as ceftriaxone can displace bilirubin from albumin binding sites, increasing the risk of kernicterus.
- Neonates (≤28 days) receiving calcium-containing intravenous solutions (e.g., Ringer's solution, parenteral nutrition) due to the risk of ceftriaxone-calcium precipitation in the lungs and kidneys.
Drug Interactions
Aminoglycosides
Although often used in combination for synergistic effects, there is a theoretical increased risk of nephrotoxicity. Monitor renal function.
Calcium-containing solutions
Concomitant use is contraindicated in neonates. In other age groups, if calcium administration is necessary, infuse ceftriaxone and calcium solutions sequentially through different infusion lines or at different sites, or flush the line thoroughly between infusions.
Loop diuretics (e.g., Furosemide)
High doses of ceftriaxone with loop diuretics may increase ceftriaxone levels and potentially increase adverse effects.
Oral anticoagulants (e.g., Warfarin)
Ceftriaxone may enhance the anticoagulant effect of vitamin K antagonists. Close monitoring of INR and prothrombin time is recommended, and anticoagulant dose adjustment may be necessary.
Live bacterial vaccines (e.g., Typhoid vaccine)
Antibiotics may diminish the therapeutic effect of live bacterial vaccines. Administer the vaccine at least 24 hours after discontinuing ceftriaxone.
Storage
Store the un-reconstituted powder for injection below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children. Reconstituted solutions should be used immediately or stored as per manufacturer's instructions.
Overdose
In case of overdose, symptoms may include nausea, vomiting, diarrhea. Management is primarily supportive and symptomatic. Hemodialysis and peritoneal dialysis are not effective for removing ceftriaxone from the body.
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 should be used during pregnancy only if clearly needed. It is excreted in low concentrations in breast milk. Caution should be exercised when Aciphin is administered to a nursing woman. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis, or allergic reactions.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Unreconstituted powder: 24-36 months from manufacturing date when stored properly. Reconstituted solution: Stability is limited; typically stable for 6 hours at room temperature (25°C) or 24 hours when refrigerated (2-8°C), depending on the diluent.
Availability
Hospitals, Pharmacies
Approval Status
Approved by major regulatory bodies
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ceftriaxone has been extensively studied in numerous clinical trials since its development, demonstrating its efficacy and safety in treating a wide range of bacterial infections. Ongoing research continues to evaluate its role in emerging resistant strains and new therapeutic strategies.
Lab Monitoring
- Complete Blood Count (CBC) with differential, especially during prolonged therapy.
- Renal function tests (e.g., serum creatinine, BUN) periodically, particularly in patients with pre-existing renal impairment or those on concomitant nephrotoxic drugs.
- Liver function tests (e.g., ALT, AST, bilirubin) to monitor for potential hepatotoxicity.
- Coagulation parameters (e.g., PT/INR) if patients are on concurrent anticoagulants or have clotting disorders.
Doctor Notes
- Prior to initiating therapy, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibiotics.
- Administer intramuscular injections deeply into a large muscle mass (e.g., gluteus maximus or lateral thigh).
- For intravenous administration, infuse slowly over 2-4 minutes (for bolus) or 30 minutes (for infusion) to minimize vein irritation.
- Monitor for signs of superinfection, especially CDAD.
- Exercise caution in patients with hepatic or renal impairment, although dose adjustment is usually not required unless severe impairment is present.
Patient Guidelines
- It is crucial to complete the entire prescribed course of Aciphin 1 gm Injection, even if symptoms improve, to prevent recurrence and development of antibiotic resistance.
- Inform your doctor about any known allergies, especially to penicillins or other antibiotics.
- Report any severe or persistent side effects, such as severe diarrhea, rash, or breathing difficulties, immediately to your healthcare provider.
- Do not use this medicine if the reconstituted solution is discolored or contains any particles.
Missed Dose Advice
If a dose of Aciphin 1 gm Injection is missed, it should be administered as soon as possible. However, if it is almost time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not administer a double dose to compensate for a missed one.
Driving Precautions
Ceftriaxone may cause dizziness or lightheadedness 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 adequate hydration by drinking plenty of fluids during the treatment period.
- Avoid alcohol consumption during the course of antibiotic treatment, as it may exacerbate side effects.
- Practice good personal hygiene to help prevent the spread of infection.
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