Ultrasef
Generic Name
Cefixime
Manufacturer
ACI Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ultrasef 125 mg pediatric drop | ৳ 50.35 | N/A |
Description
Overview of the medicine
Ultrasef 125 mg Pediatric Drop contains Cefixime, a broad-spectrum third-generation cephalosporin antibiotic. It is primarily used to treat various bacterial infections in children.
Uses & Indications
Dosage
Adults
This formulation (Pediatric Drop) is not intended for adult use. Adult dosage for Cefixime is typically 200-400 mg daily.
Elderly
This formulation is not intended for elderly use. Dosage adjustment may be required for elderly patients with significant renal impairment if using adult formulations.
Pediatrics
Children 6 months to 10 years or under 50 kg: 8 mg/kg/day administered as a single dose or in two divided doses for 5 to 10 days, depending on the infection. For infants under 6 months, effectiveness and safety have not been established.
Renal_impairment
For pediatric patients with creatinine clearance less than 20 mL/min, the dose should be halved. Regular monitoring is advised for patients with severe renal impairment.
How to Take
Administer orally, with or without food. Shake the bottle well before each use. Use the provided calibrated dropper to measure the exact dose. Discard any unused portion after the recommended period.
Mechanism of Action
Cefixime works by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, which are essential for its integrity and structure, leading to bacterial cell lysis and death.
Pharmacokinetics
Onset
Rapid, typically within 1-2 hours of administration.
Excretion
Approximately 50% excreted unchanged in urine within 24 hours, and some in bile.
Half life
About 3-4 hours.
Absorption
Approximately 40-50% orally absorbed. Food may delay but not significantly affect the extent of absorption.
Metabolism
Limited hepatic metabolism; primarily eliminated as unchanged drug.
Side Effects
Contraindications
- Known hypersensitivity to cefixime or any other cephalosporin antibiotics.
- Known hypersensitivity to penicillin antibiotics (due to potential cross-sensitivity).
Drug Interactions
Probenecid
May increase cefixime plasma concentrations by decreasing renal tubular secretion.
Carbamazepine
Elevated carbamazepine levels have been reported with concomitant cefixime administration.
Warfarin and other Anticoagulants
Concomitant administration may increase prothrombin time (INR). Close monitoring of coagulation parameters is recommended.
Storage
Store the dry powder below 30°C in a dry place, away from light and moisture. Keep the reconstituted suspension refrigerated (2-8°C) and discard any unused portion after 14 days. Do not freeze. Keep out of reach of children.
Overdose
In case of overdose, gastric lavage may be indicated. There is no specific antidote for cefixime. Treatment should be symptomatic and supportive. Hemodialysis or peritoneal dialysis is generally not effective in removing cefixime from the body.
Pregnancy & Lactation
Pregnancy Category B. Animal reproduction studies have not shown a risk. Use in pregnant women should only be when clearly needed. Cefixime is excreted in small amounts in human milk; use with caution in nursing mothers.
Side Effects
Contraindications
- Known hypersensitivity to cefixime or any other cephalosporin antibiotics.
- Known hypersensitivity to penicillin antibiotics (due to potential cross-sensitivity).
Drug Interactions
Probenecid
May increase cefixime plasma concentrations by decreasing renal tubular secretion.
Carbamazepine
Elevated carbamazepine levels have been reported with concomitant cefixime administration.
Warfarin and other Anticoagulants
Concomitant administration may increase prothrombin time (INR). Close monitoring of coagulation parameters is recommended.
Storage
Store the dry powder below 30°C in a dry place, away from light and moisture. Keep the reconstituted suspension refrigerated (2-8°C) and discard any unused portion after 14 days. Do not freeze. Keep out of reach of children.
Overdose
In case of overdose, gastric lavage may be indicated. There is no specific antidote for cefixime. Treatment should be symptomatic and supportive. Hemodialysis or peritoneal dialysis is generally not effective in removing cefixime from the body.
Pregnancy & Lactation
Pregnancy Category B. Animal reproduction studies have not shown a risk. Use in pregnant women should only be when clearly needed. Cefixime is excreted in small amounts in human milk; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months for unreconstituted powder. Once reconstituted, the suspension is stable for 7 days at room temperature or 14 days under refrigeration.
Availability
Pharmacies nationwide
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Cefixime has undergone extensive clinical trials demonstrating its efficacy and safety in treating various bacterial infections, particularly in pediatric populations. These trials support its broad use in respiratory, urinary, and ear infections.
Lab Monitoring
- Periodic monitoring of renal function (creatinine clearance) is recommended during prolonged therapy or in patients with pre-existing renal impairment.
- Complete blood count (CBC) and liver function tests may be considered in cases of prolonged therapy or if abnormalities are suspected.
Doctor Notes
- Educate parents on the importance of completing the full antibiotic course to prevent resistance and ensure complete eradication of infection.
- Instruct on proper reconstitution and accurate measurement using the provided dropper, emphasizing discarding leftover suspension after 14 days (if refrigerated).
- Advise parents to monitor for signs of allergic reactions, severe diarrhea, or other unusual side effects and to seek medical attention immediately if they occur.
Patient Guidelines
- Ensure the child completes the full course of treatment as prescribed by the doctor, even if symptoms improve.
- Do not stop the medication prematurely, as it may lead to recurrence of infection or development of antibiotic resistance.
- Use the provided calibrated dropper for accurate dosing to avoid underdosing or overdosing.
- Store the medicine properly as instructed and keep it out of reach of children.
Missed Dose Advice
If a dose is missed, administer it as soon as you remember. However, if it is almost time for the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
This medication is for pediatric use. If an adult (e.g., caregiver) needs to administer it and is experiencing a rare side effect like dizziness, caution should be exercised when driving or operating machinery.
Lifestyle Advice
- Encourage good hygiene practices to prevent the spread of infection.
- Ensure the child receives adequate fluids to stay hydrated, especially if experiencing diarrhea.
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