Fixbac DS200 mg/5 ml

Fixbac DS 200 mg/5 ml is a third-generation cephalosporin antibiotic used to treat infections caused by susceptible bacteria. Indications are classified below by strength of evidence:

Established / approved uses

• Uncomplicated urinary tract infections caused by susceptible Escherichia coli and Proteus mirabilis
• Pharyngitis and tonsillitis caused by Streptococcus pyogenes (note: penicillin is generally considered the drug of first choice for streptococcal pharyngitis, including prevention of rheumatic fever)
• Acute otitis media caused by susceptible Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
• Acute exacerbations of chronic bronchitis and other lower respiratory tract infections caused by susceptible organisms
• Uncomplicated cervical/urethral gonorrhea caused by susceptible non-penicillinase- and penicillinase-producing Neisseria gonorrhoeae, given as a single dose

Guideline-supported use

• Typhoid fever (enteric fever) caused by susceptible Salmonella typhi, where Fixbac DS 200 mg/5 ml is a recognized oral treatment option, particularly for multidrug-resistant strains

Use of Fixbac DS 200 mg/5 ml should be guided by culture and susceptibility information where possible, and by local antimicrobial resistance patterns, to ensure appropriate use of this antibiotic.

Each capsule/tablet contains Fixbac DS 200 mg/5 ml INN equivalent to Cefixime 200 mg or 400 mg. Fixbac DS 200 mg/5 ml is also available as a powder for oral suspension, providing Cefixime 100 mg per 5 mL (and other strengths such as 100 mg/mL) after reconstitution with water.

Fixbac DS 200 mg/5 ml is an orally administered, semi-synthetic, third-generation cephalosporin antibiotic. It exerts a bactericidal effect by inhibiting bacterial cell wall synthesis and is notably stable against hydrolysis by many common bacterial beta-lactamase enzymes, giving it activity against a broad range of Gram-negative and certain Gram-positive organisms.

Fixbac DS 200 mg/5 ml is well established and widely marketed in Bangladesh, available as capsules/tablets (100 mg, 200 mg, 400 mg) and as oral suspension for use in children and patients who cannot swallow solid dosage forms. It is commonly prescribed for respiratory tract infections, ear infections, urinary tract infections, gonorrhea, and typhoid fever.

Third-generation Cephalosporin antibiotic

Fixbac DS 200 mg/5 ml is a third-generation cephalosporin that exerts a bactericidal effect by binding to penicillin-binding proteins (PBPs) located on the bacterial cell wall, thereby inhibiting the final transpeptidation step of bacterial cell wall (peptidoglycan) synthesis. This leads to cell wall instability, lysis, and death of susceptible bacteria.

Fixbac DS 200 mg/5 ml is highly stable in the presence of many bacterial beta-lactamase enzymes, which broadens its activity against Gram-negative organisms such as Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Moraxella catarrhalis, and Neisseria gonorrhoeae, as well as some Gram-positive organisms such as Streptococcus pyogenes and Streptococcus pneumoniae. Following oral administration, bioavailability is roughly 40-50%, largely unaffected by food, with peak plasma concentrations reached in 2-6 hours; a substantial proportion is excreted unchanged in the urine.

Fixbac DS 200 mg/5 ml can be taken by mouth with or without food. Swallow capsules/tablets whole; shake the oral suspension well before measuring each dose with an accurate measuring device (not a household spoon). Take Fixbac DS 200 mg/5 ml at evenly spaced intervals and complete the full course prescribed by your physician, even if you feel better before the course is finished.

Warfarin and other oral anticoagulants: Fixbac DS 200 mg/5 ml may increase prothrombin time and enhance the effect of anticoagulants, raising bleeding risk; monitor coagulation status closely if co-administered.

Carbamazepine: Concurrent use with Fixbac DS 200 mg/5 ml has been reported to increase plasma carbamazepine concentrations, which may increase the risk of carbamazepine toxicity.

Probenecid: Inhibits renal tubular excretion of Fixbac DS 200 mg/5 ml, increasing and prolonging its plasma concentration.

Estrogen-containing oral contraceptives: Antibiotics, including Fixbac DS 200 mg/5 ml, may theoretically reduce contraceptive efficacy; an additional non-hormonal contraceptive method is advisable during treatment.

Laboratory test interference: Fixbac DS 200 mg/5 ml may cause false-positive results in urine glucose tests using copper-reduction methods (e.g. Clinitest) and a false-positive direct Coombs' test.

The most commonly reported side effects of Fixbac DS 200 mg/5 ml are gastrointestinal:

• Diarrhea (most common)
• Nausea and vomiting
• Abdominal pain
• Dyspepsia and loose stools
• Flatulence

Less common effects include headache, dizziness, and skin reactions such as rash, pruritus, and urticaria. Reversible hematologic changes (eosinophilia, thrombocytopenia, leukopenia) have been reported. Rare but serious effects include hypersensitivity reactions (including anaphylaxis and serious skin reactions), Clostridioides difficile-associated diarrhea/pseudomembranous colitis (see Precautions and Warnings), and reversible elevations in liver enzymes.

Pregnancy: There are no adequate and well-controlled studies of Fixbac DS 200 mg/5 ml in pregnant women. Fixbac DS 200 mg/5 ml should be used during pregnancy only if clearly needed, with the potential benefit justifying the potential risk to the fetus; consult a physician before use in pregnancy or suspected pregnancy.

Lactation: It is not known whether Fixbac DS 200 mg/5 ml is excreted in human breast milk in clinically significant amounts. Caution is advised, and Fixbac DS 200 mg/5 ml should be used while breastfeeding only if the treating physician considers it necessary, weighing the benefit to the mother against any potential risk to the infant (e.g. disturbance of infant gut flora).

Hypersensitivity and penicillin cross-reactivity: Serious, occasionally fatal, hypersensitivity reactions have been reported with cephalosporins, including Fixbac DS 200 mg/5 ml. There is evidence of partial cross-allergenicity between penicillins and cephalosporins; use Fixbac DS 200 mg/5 ml with caution in patients with a history of penicillin allergy that is not severe, and discontinue immediately if a hypersensitivity reaction occurs (see Contraindications).

Clostridioides difficile-associated diarrhea (CDAD): Fixbac DS 200 mg/5 ml, like other broad-spectrum antibiotics, can permit overgrowth of C. difficile, ranging from mild diarrhea to fatal colitis. Consider this diagnosis in patients who develop diarrhea during or after treatment with Fixbac DS 200 mg/5 ml.

Renal impairment: Dose adjustment is required in patients with significant renal impairment (see Dosage and Administration).

Antibiotic stewardship: Take Fixbac DS 200 mg/5 ml exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice. Using Fixbac DS 200 mg/5 ml in the absence of a proven or strongly suspected bacterial infection, or failing to complete the prescribed course, increases the risk of drug-resistant bacteria and reduces the future effectiveness of Fixbac DS 200 mg/5 ml and other antibiotics.

See Interactions, Pregnancy and Lactation, and Use in Special Populations for further important safety information.

In case of a suspected overdose of Fixbac DS 200 mg/5 ml, seek immediate medical attention or contact a poison control center/emergency services right away. There is no specific antidote for Fixbac DS 200 mg/5 ml. Management is supportive and symptomatic; gastric lavage may be considered by a physician if presentation is early. Fixbac DS 200 mg/5 ml is not significantly removed by hemodialysis or peritoneal dialysis.

Store at room temperature (below 30°C), away from light and moisture. If reconstituted as an oral suspension, store as directed on the label (typically at room temperature, and discard after 14 days). Keep out of reach of children.

Renal impairment: Dose reduction is required for patients with creatinine clearance below 60 mL/min; see Dosage and Administration for the specific adjustment schedule.

Hepatic impairment: No specific dose adjustment of Fixbac DS 200 mg/5 ml is well established for hepatic impairment; use with routine clinical monitoring.

Elderly: No specific dose adjustment beyond assessment of renal function is generally required for Fixbac DS 200 mg/5 ml in elderly patients, as renal function commonly declines with age.

Children: See Pediatric Uses.

Pregnancy and breastfeeding: See Pregnancy and Lactation.

Duration of Fixbac DS 200 mg/5 ml therapy depends on the indication: a single dose for uncomplicated gonorrhea; 7 to 14 days for most respiratory tract, ear, and urinary tract infections (with streptococcal pharyngitis/tonsillitis requiring a minimum of 10 days to reduce the risk of rheumatic fever); and 10 to 14 days for typhoid fever. The full course of Fixbac DS 200 mg/5 ml prescribed by the physician should always be completed.

Fixbac DS 200 mg/5 ml powder for oral suspension should be reconstituted by adding the specified amount of water to the powder in the bottle, then shaking well until fully dispersed, following the instructions printed on the product label. The reconstituted suspension should be shaken well before each use, stored as directed (generally at room temperature), and any unused portion discarded after 14 days.

Cephalosporin antibiotic; Third-generation cephalosporin; Beta-lactam antibiotic

Fixbac DS 200 mg/5 ml inhibits bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) in the bacterial cell membrane, blocking the transpeptidation (cross-linking) step of peptidoglycan synthesis. This weakens the cell wall, leading to osmotic instability, lysis, and death of the susceptible bacterium. Fixbac DS 200 mg/5 ml is highly resistant to hydrolysis by many common bacterial beta-lactamase enzymes, broadening its spectrum of bactericidal activity.

B

Fixbac DS 200 mg/5 ml is approved for use in children 6 months of age and older for susceptible infections such as otitis media, pharyngitis/tonsillitis, and urinary tract infections, dosed at 8 mg/kg/day using the oral suspension formulation, either once daily or divided every 12 hours. Fixbac DS 200 mg/5 ml is also commonly used, at weight-based doses, in guideline-supported regimens for typhoid fever in children.

Safety and efficacy of Fixbac DS 200 mg/5 ml have not been established in infants below 6 months of age; use in this age group is not recommended outside specific specialist guidance.