Usage
- Cefixime + Sulbactam is prescribed for bacterial infections, including respiratory tract infections (e.g., pneumonia, bronchitis, sinusitis), urinary tract infections (UTIs), skin and soft tissue infections, otitis media (middle ear infection), and sexually transmitted infections (e.g., gonorrhea). It is also utilized for surgical prophylaxis and in managing preterm premature rupture of membranes (PPROM).
- Pharmacological classification: Antibiotic combination (cephalosporin antibiotic + beta-lactamase inhibitor).
- Mechanism of action: Cefixime inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), leading to bacterial cell lysis and death. Sulbactam, a beta-lactamase inhibitor, enhances cefixime’s activity by preventing its degradation by bacterial beta-lactamases.
Alternate Names
- No widely recognized alternate generic names.
- Brand names: Numerous brand names exist internationally and regionally. Some examples include Takefix-S, Sulbacin, and Fixim.
How It Works
- Pharmacodynamics: Cefixime exerts bactericidal action by disrupting bacterial cell wall synthesis. Sulbactam extends Cefixime’s spectrum of activity by inhibiting beta-lactamases, enzymes produced by some bacteria that can inactivate beta-lactam antibiotics.
- Pharmacokinetics:
- Absorption: Both cefixime and sulbactam are absorbed orally, although cefixime’s absorption is not affected by food, whereas it’s recommended that sulbactam be taken with food.
- Distribution: Cefixime is about 65% bound to serum proteins, while sulbactam has around 38% protein binding.
- Metabolism: Cefixime is partially metabolized in the liver, while sulbactam is primarily excreted unchanged.
- Elimination: Cefixime is excreted mainly via urine, and sulbactam is also primarily eliminated unchanged through renal excretion. Both drugs’ half-lives necessitate dosage adjustment in renal impairment.
- Mode of action: Cefixime targets PBPs essential for bacterial cell wall cross-linking. Sulbactam irreversibly binds to and inhibits bacterial beta-lactamases.
- Receptor binding/Enzyme inhibition: Cefixime binds to PBPs, inhibiting cell wall synthesis. Sulbactam inhibits beta-lactamase enzymes.
- Elimination pathways: Primarily renal excretion for both drugs.
Dosage
Standard Dosage
Adults:
- 200-400 mg of cefixime component orally once daily or divided every 12 hours, in combination with sulbactam in a fixed ratio (usually 1:1 or 2:1 cefixime:sulbactam).
Children:
- 6 months - 12 years (≤45 kg): 8 mg/kg of cefixime component orally once daily or divided every 12 hours.
-
45 kg: Adult dose.
- <6 months: Use with caution; dosage must be determined by the doctor. Pediatric safety considerations include potential for renal and hepatic impairment, requiring dose adjustments.
Special Cases:
- Elderly Patients: Use with caution, consider renal function. Dose adjustments based on creatinine clearance may be necessary.
- Patients with Renal Impairment: Dosage adjustment is crucial. Refer to guidelines based on creatinine clearance for appropriate modifications.
- Patients with Hepatic Dysfunction: Use with caution in patients with hepatic dysfunction and significant renal disease, the dosage should not exceed a maximum of 6g (2 g cefixime / 1 g sulbactam, administered every 12 hours) daily without close monitoring of serum concentrations.
- Patients with Comorbid Conditions: Consider pre-existing conditions like colitis, which may require extra vigilance due to potential for pseudomembranous colitis. Close monitoring is recommended for patients with diabetes, cardiovascular disease, or other conditions that could influence drug metabolism or elimination.
Clinical Use Cases
- Intubation/Surgical Procedures/Mechanical Ventilation/ICU Use: IV formulations of similar cephalosporin/beta-lactamase inhibitor combinations like ceftriaxone/sulbactam are more common in these settings. Dosages are adjusted per severity of infection and patient condition, typically starting with 1.5-3 g every 6-12 hours. Pre-operative doses may be given as prophylaxis.
- Emergency Situations: Parenteral antibiotics are generally preferred in emergencies.
Dosage Adjustments
- Dosage modifications are essential for patients with renal and hepatic impairment, metabolic disorders, or relevant genetic polymorphisms. Consult dosing guidelines based on creatinine clearance.
Side Effects
Common Side Effects:
- Diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Headache
- Rash or itching
Rare but Serious Side Effects:
- Severe allergic reactions (anaphylaxis)
- Pseudomembranous colitis
- Jaundice
- Cerebral irritation (leading to convulsions in overdose cases)
Long-Term Effects:
- Potential for Clostridium difficile infection with prolonged use.
Adverse Drug Reactions (ADR):
- Stevens-Johnson syndrome (rare)
- Toxic epidermal necrolysis (rare)
Contraindications
- Hypersensitivity to cephalosporins or beta-lactam antibiotics.
- History of severe allergic reactions to penicillin or other beta-lactams.
Drug Interactions
- Anticoagulants (e.g., warfarin): May enhance anticoagulant effect.
- Anticonvulsants (e.g., carbamazepine): Potential interaction, monitor closely.
- Probenecid: Can decrease renal excretion of cefixime.
- Vaccines (e.g., BCG, cholera, typhoid): May decrease vaccine efficacy.
- Alcohol: Exercise caution, potential for adverse effects.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: B (consult physician if benefits outweigh potential risks to the fetus; limited human data available)
- Fetal risks: Although animal studies haven’t shown teratogenicity, human data is limited.
- Breastfeeding: Small amounts may be excreted in breast milk. Exercise caution.
Drug Profile Summary
- Mechanism of Action: Cefixime inhibits bacterial cell wall synthesis; sulbactam inhibits beta-lactamases.
- Side Effects: Diarrhea, abdominal pain, nausea, vomiting, headache, rash, allergic reactions.
- Contraindications: Hypersensitivity to cephalosporins or beta-lactams.
- Drug Interactions: Anticoagulants, anticonvulsants, probenecid.
- Pregnancy & Breastfeeding: Use with caution; consult physician.
- Dosage: Adults: 200-400 mg cefixime component daily; Children: 8 mg/kg/day (adjust for renal/hepatic impairment).
- Monitoring Parameters: Renal function, liver function, signs of allergic reaction, resolution of infection.
Popular Combinations
Often used alone. The combination with sulbactam already enhances its spectrum of activity.
Precautions
- Assess for allergies to beta-lactams, penicillin, or cephalosporins.
- Evaluate renal and hepatic function.
- Caution in patients with a history of colitis.
- Caution in pregnancy and breastfeeding.
- Caution when driving or operating machinery due to potential dizziness or fatigue.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cefixime + Sulbactam?
A: Adults: 200-400 mg of cefixime component daily. Children (6 months-12 years): 8 mg/kg/day. Adjust for renal/hepatic dysfunction.
Q2: What infections does Cefixime + Sulbactam treat?
A: Respiratory tract infections, UTIs, skin infections, otitis media, gonorrhea, and other susceptible bacterial infections. Surgical prophylaxis and PPROM.
Q3: Is Cefixime + Sulbactam safe during pregnancy?
A: Consult a physician. Category B, use with caution if benefits outweigh risks.
Q4: What are the common side effects?
A: Diarrhea, abdominal pain, nausea, vomiting, headache, rash, itching.
Q5: What are the serious side effects?
A: Severe allergic reactions (anaphylaxis), pseudomembranous colitis, jaundice, cerebral irritation (in overdose).
Q6: Can I take Cefixime + Sulbactam if I’m allergic to penicillin?
A: No, cross-reactivity is possible. Inform your doctor about any penicillin allergy.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as remembered, unless close to the next scheduled dose. Do not double the dose.
Q8: Does Cefixime + Sulbactam interact with other medications?
A: Yes, potential interactions exist with anticoagulants, anticonvulsants, and probenecid. Consult a doctor about other medications you’re taking.
Q9: Can Cefixime + Sulbactam affect my ability to drive?
A: Cefixime may cause dizziness or fatigue, which could impair driving ability. Use caution.
Q10: Can this medication be used in children below 6 months old?
A: Use with caution, dosage must be determined by a doctor based on individual factors, and the potential benefits and risks must be considered.
