Onefix-DS
Generic Name
Cefixime
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| onefix ds 200 mg suspension | ৳ 280.00 | N/A |
Description
Overview of the medicine
Onefix-DS 200 mg Suspension contains Cefixime, a third-generation cephalosporin antibiotic. It is used to treat a wide range of bacterial infections in children, including respiratory tract infections, urinary tract infections, otitis media, and pharyngitis/tonsillitis.
Uses & Indications
Dosage
Elderly
No specific dosage adjustment is required in elderly patients with normal renal function. For those with renal impairment, dosage should be adjusted as for adults with renal impairment.
Children
Children (6 months to 12 years): 8 mg/kg/day administered as a single dose or in two divided doses every 12 hours. For example, 200 mg (10 ml) once daily or 100 mg (5 ml) every 12 hours. Duration usually 7-14 days.
Renal_impairment
Creatinine clearance 21-60 ml/min or patients on continuous ambulatory peritoneal dialysis (CAPD): 75% of the standard daily dose. Creatinine clearance <20 ml/min or patients on hemodialysis: 50% of the standard daily dose.
How to Take
Administer orally with or without food. Shake the suspension well before each use. Use a calibrated measuring spoon or cup for accurate dosing.
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 prevents the cross-linking of peptidoglycan chains, leading to cell lysis and bacterial death.
Pharmacokinetics
Onset
Peak plasma concentrations usually occur within 2-6 hours after administration.
Excretion
Approximately 50% of the absorbed dose is excreted unchanged in the urine over 24 hours; a small portion is excreted via the biliary route.
Half life
Plasma elimination half-life is typically 3-4 hours.
Absorption
Approximately 30-50% orally absorbed. Food may delay absorption but does not significantly affect the total absorbed amount.
Metabolism
Not extensively metabolized in the body. Primary elimination is via renal excretion.
Side Effects
Contraindications
- Known hypersensitivity to Cefixime, other cephalosporins, or to any component of the formulation.
- History of serious hypersensitivity reactions to penicillin (e.g., anaphylaxis).
Drug Interactions
Nefidipine
May increase the Cefixime peak plasma concentration and AUC.
Carbamazepine
Concomitant administration with Cefixime may increase carbamazepine plasma levels.
Oral Anticoagulants (e.g., Warfarin)
Cefixime may increase the prothrombin time (PT) with or without bleeding. Close monitoring of coagulation parameters is recommended.
Storage
Store unreconstituted powder below 30°C, protected from light and moisture. Keep the reconstituted suspension refrigerated (2-8°C) and discard after 7 or 14 days (check specific product leaflet). Do not freeze.
Overdose
Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Management should be supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Cefixime is excreted in human milk in small amounts; use with caution in nursing mothers.
Side Effects
Contraindications
- Known hypersensitivity to Cefixime, other cephalosporins, or to any component of the formulation.
- History of serious hypersensitivity reactions to penicillin (e.g., anaphylaxis).
Drug Interactions
Nefidipine
May increase the Cefixime peak plasma concentration and AUC.
Carbamazepine
Concomitant administration with Cefixime may increase carbamazepine plasma levels.
Oral Anticoagulants (e.g., Warfarin)
Cefixime may increase the prothrombin time (PT) with or without bleeding. Close monitoring of coagulation parameters is recommended.
Storage
Store unreconstituted powder below 30°C, protected from light and moisture. Keep the reconstituted suspension refrigerated (2-8°C) and discard after 7 or 14 days (check specific product leaflet). Do not freeze.
Overdose
Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Management should be supportive and symptomatic.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Cefixime is excreted in human milk in small amounts; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Unreconstituted powder: typically 2-3 years. Reconstituted suspension: stable for 7-14 days when stored in the refrigerator (2-8°C).
Availability
Available in pharmacies and hospitals
Approval Status
Approved (internationally)
Patent Status
Patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of Cefixime in treating various bacterial infections in both adult and pediatric populations.
Lab Monitoring
- Periodic monitoring of renal function may be advisable during prolonged therapy.
- Complete blood counts (CBC) may be monitored in patients receiving prolonged therapy.
Doctor Notes
- Emphasize the importance of completing the full course of therapy to prevent resistance.
- Advise parents/caregivers on proper reconstitution and administration of the suspension.
- Be alert for signs of C. difficile-associated diarrhea, especially with prolonged use.
Patient Guidelines
- Complete the entire prescribed course of treatment, even if symptoms improve.
- Do not share this medicine with others, even if they have similar symptoms.
- Shake the suspension well before each use and use the provided measuring device.
- Contact your doctor if symptoms do not improve or worsen.
- Store reconstituted suspension in the refrigerator and discard after the recommended period (usually 7-14 days).
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Onefix-DS is generally not expected to impair the ability to drive or operate machinery. However, if side effects like dizziness occur, caution should be exercised.
Lifestyle Advice
- Maintain good hygiene to prevent reinfection.
- Ensure adequate hydration while on antibiotic therapy.
- Avoid self-medication with antibiotics.
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