Cefixime + Clavulanic Acid

Usage

Cefixime + Clavulanic Acid is a combination antibiotic used to treat a variety of bacterial infections. It is prescribed for upper and lower respiratory tract infections (including bronchitis, pneumonia, sinusitis, pharyngitis, and tonsillitis), otitis media, urinary tract infections, skin and soft tissue infections, uncomplicated gonorrhea, and typhoid fever.

• Pharmacological Classification: Antibiotic (Cephalosporin + Beta-lactamase inhibitor)
• Mechanism of Action: Cefixime inhibits bacterial cell wall synthesis, while Clavulanic Acid protects Cefixime from degradation by bacterial enzymes (beta-lactamases).

Alternate Names

While “Cefixime + Clavulanic Acid” is the standard generic name, variations may exist internationally. Brand names include Cfxclav 325, Assso-CV and Afrixime CLV.

How It Works

• Pharmacodynamics: Cefixime, a third-generation cephalosporin, disrupts bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This leads to cell lysis and bacterial death. Clavulanic acid, a beta-lactamase inhibitor, irreversibly binds to and inactivates beta-lactamase enzymes produced by some bacteria. These enzymes would normally break down Cefixime, rendering it ineffective. The combination allows Cefixime to act against a broader range of bacteria, including those that produce beta-lactamases.
• Pharmacokinetics: Cefixime is orally administered and has incomplete absorption (around 40-50%). It is minimally metabolized and primarily excreted unchanged in the urine via glomerular filtration. Clavulanic acid enhances Cefixime’s activity by inhibiting beta-lactamases. The serum half-life of Cefixime is approximately 3-4 hours, but can extend up to 9 hours.

Dosage

Standard Dosage

Adults:

• 200-400 mg daily, administered as a single dose or in two divided doses every 12 hours. For uncomplicated gonorrhea, a single 400 mg dose is often sufficient.

Children (6 months and older):

• 8 mg/kg/day, administered as a single daily dose or in two divided doses every 12 hours. Safety and efficacy have not been established in children younger than 6 months. Pediatric dosages are usually adjusted based on body weight.

Special Cases:

• Elderly Patients: The same dose as adults can be administered, but renal function should be assessed.

• Patients with Renal Impairment: Dose adjustments are necessary. For creatinine clearances less than 20 ml/min, the daily dose should not exceed 200 mg.

• Patients with Hepatic Dysfunction: Although not explicitly mentioned in the sources, caution should be exercised, and monitoring is recommended.

• Patients with Comorbid Conditions: Dosage adjustments may be necessary in specific cases.

Clinical Use Cases

The provided sources do not give specific dosage recommendations for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Dosage should be determined based on the specific infection being treated, following standard dosing guidelines and adjusting for patient-specific factors.

Dosage Adjustments

Dose modifications may be needed for renal/hepatic impairment or other medical conditions. Always consider individual patient factors when determining the optimal dosage.

Side Effects

Common Side Effects:

• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• Headache
• Dizziness

Rare but Serious Side Effects:

• Allergic reactions (rash, itching, hives, swelling, difficulty breathing, anaphylaxis)
• Clostridium difficile-associated diarrhea (CDAD)
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Long-Term Effects:

No specific long-term side effects were mentioned in the provided sources.

Adverse Drug Reactions (ADR):

Serious allergic reactions (anaphylaxis) require immediate medical intervention. CDAD is a significant ADR and requires discontinuation of the drug and appropriate treatment.

Contraindications

• Known allergy to Cefixime, Clavulanic acid, or any cephalosporin antibiotic.
• History of severe gastrointestinal diseases, especially colitis.

Drug Interactions

• Anticoagulants (e.g., warfarin): Cefixime may increase prothrombin time, potentially increasing bleeding risk.

• Uricosuric agents (e.g., probenecid): May reduce the excretion of Cefixime, leading to increased serum levels.

• Oral contraceptives: Efficacy of oral contraceptives may be reduced.

• Carbamazepine: Cefixime may elevate carbamazepine levels.

Pregnancy and Breastfeeding

Animal studies have not shown adverse fetal effects, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit outweighs the risk to the fetus. Cefixime is excreted in breast milk, so caution is advised during breastfeeding.

Drug Profile Summary

• Mechanism of Action: Cefixime inhibits bacterial cell wall synthesis; Clavulanic acid inhibits beta-lactamases.
• Side Effects: Diarrhea, nausea, vomiting, abdominal pain, headache. Rarely, serious allergic reactions or CDAD.
• Contraindications: Hypersensitivity to cephalosporins or clavulanate.
• Drug Interactions: Anticoagulants, uricosuric agents, oral contraceptives, carbamazepine.
• Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
• Dosage: Adults: 200-400 mg/day; Children: 8 mg/kg/day. Adjust for renal impairment.
• Monitoring Parameters: Renal function, signs of allergic reactions, gastrointestinal symptoms.

Popular Combinations

Cefixime + Clavulanic Acid itself is a popular combination. Specific combinations with other drugs for certain infections may exist, but were not described in the sources.

Precautions

• Assess renal function, especially in elderly patients and those with renal impairment.
• Monitor for allergic reactions and gastrointestinal symptoms.
• Caution in patients with a history of colitis.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Cefixime + Clavulanic Acid?

A: Adults: 200-400 mg/day. Children: 8 mg/kg/day. Adjust dosage based on renal function and patient-specific factors.

Q2: What infections does Cefixime + Clavulanic Acid treat?

A: It treats various bacterial infections, including respiratory tract infections, otitis media, urinary tract infections, skin infections, gonorrhea, and typhoid fever.

Q3: What are the common side effects?

A: Common side effects include diarrhea, nausea, vomiting, abdominal pain, and headache.

Q4: Are there any serious side effects?

A: Rarely, serious allergic reactions (including anaphylaxis) and Clostridium difficile-associated diarrhea (CDAD) can occur.

Q5: Can Cefixime + Clavulanic Acid be used during pregnancy or breastfeeding?

A: Use with caution if the potential benefits outweigh the risks. Consult a doctor before use during pregnancy or breastfeeding.

Q6: What are the contraindications?

A: Contraindicated in patients with known allergies to cephalosporins or clavulanate and those with a history of severe gastrointestinal diseases, especially colitis.

Q7: How does Cefixime + Clavulanic Acid work?

A: Cefixime inhibits bacterial cell wall synthesis, and Clavulanic acid protects Cefixime from being broken down by bacterial enzymes.

Q8: Are there any drug interactions I should be aware of?

A: Yes, it can interact with anticoagulants, uricosuric agents, oral contraceptives and Carbamazepine. Consult a doctor before combining it with other medications.

Q9: What should I do if I miss a dose?

A: Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Q10: How should Cefixime + Clavulanic Acid be stored?

A: Store at room temperature away from excess moisture and heat. Keep out of the reach of children. Dispose of any unused suspension after 14 days.