Emixef 50ml

Indications

Emixef is an orally administered cephalosporin antibiotic renowned for its significant in-vitro bactericidal activity against a diverse range of Gram-positive and Gram-negative bacteria. It is prescribed for the treatment of various acute infections caused by susceptible microorganisms.

Upper Respiratory Tract Infections (URTI): This includes conditions such as otitis media and other upper respiratory infections, particularly when the causative organism is identified or suspected to be resistant to commonly used antibiotics, or where treatment failure poses a considerable risk.

Lower Respiratory Tract Infections: Such as bronchitis.

Urinary Tract Infections: Including conditions like cystitis, cystourethritis, and pyelonephritis. Clinical efficacy has been established against prevalent pathogens, including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (both beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), and Enterobacter species. Emixef is notably stable in the presence of beta-lactamase enzymes.

Always use as directed by a registered healthcare professional.

Pharmacology

Cefixime is a third-generation semi-synthetic cephalosporin antibiotic for oral use, exhibiting bactericidal properties against a broad spectrum of Gram-positive and Gram-negative bacteria at easily achievable plasma concentrations. It functions by disrupting the synthesis of the bacterial cell wall. Due to its high stability in the presence of beta-lactamase enzymes, many bacteria resistant to penicillins and certain cephalosporins may remain susceptible to Cefixime. Approximately 40% to 50% of the drug is absorbed, regardless of food intake.

Dosage & Administration

Cefixime absorption is not significantly affected by food intake. The typical treatment duration is 7 days, which may be extended to 14 days if necessary.

• Adults and Children over 10 Years: The standard adult dosage ranges from 200 to 400 mg daily, depending on infection severity, administered as either a single dose or two divided doses.
• Elderly Patients: Dosage is generally the same as for adults, but renal function should be evaluated, and adjustments made in cases of severe renal impairment.
• Children: The recommended dosage for children is 8 mg/kg/day, given as a single dose or in two divided doses. Suggested daily doses for children are as follows:
  • 6 Months to 1 Year: 3.75 ml daily
  • 1 to 4 Years: 5 ml daily
  • 5 to 10 Years: 10 ml daily

In cases of typhoid, the recommended dose for children is 5 mg/kg body weight twice daily for 10 to 14 days.

Children weighing more than 50 kg or those older than 10 years should receive the recommended adult dose of 200 to 400 mg daily, adjusted for infection severity.

Caution in Young Children: Safety and efficacy in children under 6 months have not been established.

Renal Impairment: Cefixime can be used in patients with impaired renal function. Normal dosing can be given for those with creatinine clearances of 20 ml/min or higher. For patients with creatinine clearance below 20 ml/min, the maximum recommended dose is 200 mg once daily. The same recommendations apply to patients undergoing chronic ambulatory peritoneal dialysis or hemodialysis.

Always use as directed by a registered healthcare professional.

Interactions

As with other cephalosporins, some patients may experience increased prothrombin times. Therefore, caution is advised for those undergoing anticoagulant therapy.

Contraindications

Emixef is contraindicated in individuals with a known hypersensitivity to cephalosporin antibiotics.

Side Effects

Emixef is generally well tolerated, with most adverse reactions reported in clinical trials being mild and self-limiting. Common gastrointestinal side effects include diarrhea and changes in stool consistency, particularly at higher doses. Other gastrointestinal issues may include nausea, abdominal pain, dyspepsia, vomiting, and flatulence, with rare reports of pseudomembranous colitis.

Central Nervous System: Headaches and dizziness may occur.

Hypersensitivity Reactions: Allergic responses may manifest as rashes, pruritus, urticaria, drug fever, and arthralgia, which typically resolve upon discontinuation of the medication.

Hematological and Clinical Chemistry: Instances of thrombocytopenia, leukopenia, and eosinophilia have been documented, though these are infrequent and reversible. Mild, transient alterations in liver and renal function tests may also be observed. Other potential reactions include genital pruritus and vaginitis.

Pregnancy & Lactation

Currently, there are insufficient well-controlled studies involving pregnant women. Since animal reproduction studies do not always predict human responses, Emixef should only be used during pregnancy when absolutely necessary. The excretion of Cefixime in human breast milk is not well established; therefore, caution is advised when administering the drug to nursing mothers.

Precautions & Warnings

Emixef should be used with caution in patients with known hypersensitivity to other medications. Cephalosporins must be administered carefully to individuals with penicillin allergies due to potential cross-reactivity. Severe reactions, including anaphylaxis, have been reported in patients sensitive to both drug classes. Should any allergic reactions occur during Emixef treatment, discontinue the drug and provide appropriate treatment as needed. Caution is also warranted for patients with significantly impaired renal function. Broad-spectrum antibiotics can alter the normal gut flora, potentially leading to Clostridium difficile overgrowth, which is a known cause of antibiotic-associated diarrhea.

Use in Pregnancy and Lactation: As previously noted, there are no adequate studies in pregnant women, so Emixef should not be used in pregnancy or during breastfeeding unless deemed essential by a healthcare professional.

Overdose Effects

In cases of overdose, gastric lavage may be necessary; however, no specific antidote exists. Emixef is not significantly removed from the bloodstream via hemodialysis or peritoneal dialysis. Adverse effects observed in healthy adult volunteers receiving single doses up to 2 g were similar to those seen in patients treated at recommended doses.

Therapeutic Class

Third-generation Cephalosporins

Storage Conditions

Store below 30ºC, away from light and moisture. Keep out of reach of children.