Usage
This combination medication is primarily prescribed for bacterial infections susceptible to both cefpodoxime and ofloxacin. These infections commonly include respiratory tract infections, urinary tract infections, and some sexually transmitted infections. The addition of Lactobacillus sporogenes, a probiotic, aims to prevent or reduce the severity of antibiotic-associated diarrhea, a common side effect of antibiotic therapy.
Pharmacological Classification:
- Cefpodoxime Proxetil: Third-generation cephalosporin antibiotic
- Ofloxacin: Fluoroquinolone antibiotic
- Lactobacillus Sporogenes: Probiotic
Mechanism of Action:
- Cefpodoxime: Interferes with bacterial cell wall synthesis by binding to penicillin-binding proteins. This weakens the cell wall, leading to bacterial cell death.
- Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, resulting in bacterial cell death.
- Lactobacillus sporogenes: Competes with pathogenic bacteria for resources in the gut and supports the restoration of healthy gut flora.
Alternate Names
This combination medication is often referred to by brand names like Doxtil-OF, Podeck O, Podomes O, and Aproxe O. There are no widely recognized international non-proprietary names for the combination product itself, though the individual components have their established generic names.
How It Works
Pharmacodynamics:
Cefpodoxime and ofloxacin exert bactericidal effects through distinct mechanisms targeting bacterial cell wall synthesis and DNA replication, respectively. Lactobacillus sporogenes does not have a direct antibacterial action but helps prevent antibiotic-associated diarrhea.
Pharmacokinetics:
- Cefpodoxime Proxetil: Administered orally, it is absorbed in the gastrointestinal tract and converted to the active form, cefpodoxime. Food enhances absorption. Cefpodoxime is partially protein-bound (22–33%). Excretion primarily occurs via the kidneys.
- Ofloxacin: Well-absorbed orally. Peak serum concentrations are typically reached within 1-2 hours. Ofloxacin undergoes some hepatic metabolism but is mostly excreted unchanged in the urine. It has a long half-life, permitting twice-daily dosing.
- Lactobacillus sporogenes: Given its probiotic nature, it colonizes the gut, primarily exerting local effects in the intestinal tract. It does not get absorbed.
Mode of Action: See “Mechanism of Action” in the Usage section.
Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation:
- Cefpodoxime: Binds to penicillin-binding proteins (PBPs).
- Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV.
- Lactobacillus sporogenes: Primarily modulates gut flora composition rather than impacting specific receptors, enzymes, or neurotransmitters.
Elimination Pathways:
- Cefpodoxime: Predominantly renal excretion.
- Ofloxacin: Mainly renal excretion with some hepatic metabolism.
- Lactobacillus sporogenes: Not systemically absorbed; eliminated through feces.
Dosage
Standard Dosage
This combination is typically available in fixed-dose tablets, often containing 200mg of cefpodoxime proxetil and 200mg of ofloxacin, along with Lactobacillus sporogenes (e.g. 60 million spores). Typical dosage is one tablet twice daily. However, it’s crucial to consult the specific product’s prescribing information.
Adults:
The usual dose for adults is one tablet twice a day. Duration of treatment varies with the infection. Always consult the product’s prescribing information.
Children:
This combination is generally not recommended for children due to the risk of musculoskeletal adverse events associated with ofloxacin in growing individuals. Individual components may be used in children, but dosing will differ and is determined by the physician.
Special Cases:
- Elderly Patients: Dosage adjustments may be necessary based on renal function.
- Patients with Renal Impairment: Dose reduction or increased dosing intervals may be required based on creatinine clearance.
- Patients with Hepatic Dysfunction: Cefpodoxime dosage adjustment might be considered in severe hepatic impairment.
- Patients with Comorbid Conditions: Individualized dosing should be considered based on specific comorbid conditions and potential drug interactions.
Clinical Use Cases
The dosage for this specific combination in these clinical settings isn’t standardized and should be determined by the physician based on individual patient needs and local guidelines. The provided scenarios mostly relate to critical care, where this fixed-dose combination may not be the preferred approach, and individual component antibiotics at higher doses, intravenous administration, or different choices altogether would be more common.
Dosage Adjustments
Dosage adjustments may be needed based on the patient’s renal function, hepatic function, and potential drug interactions.
Side Effects
Common Side Effects
Diarrhea, nausea, vomiting, abdominal pain, headache, dizziness, and vaginitis.
Rare but Serious Side Effects
- Clostridium difficile infection, allergic reactions (including anaphylaxis), tendonitis or tendon rupture (particularly with ofloxacin), peripheral neuropathy (especially with ofloxacin), QT interval prolongation (ofloxacin).
Long-Term Effects
Peripheral neuropathy, tendon damage, and Clostridium difficile-associated colitis may persist after discontinuation of the medication.
Adverse Drug Reactions (ADR)
Severe allergic reactions, Clostridium difficile infection, tendon rupture, and severe skin reactions (e.g., Stevens-Johnson syndrome) are ADRs requiring immediate medical intervention.
Contraindications
Hypersensitivity to cephalosporins or fluoroquinolones, history of tendon disorders related to fluoroquinolone use, epilepsy, myasthenia gravis, pregnancy (unless benefits clearly outweigh risks), breastfeeding (unless benefits clearly outweigh risks). Use in children and adolescents is generally avoided due to the ofloxacin component.
Drug Interactions
Antacids, H2 blockers, sucralfate, multivitamins/minerals containing metal cations (iron, calcium, magnesium, zinc), probenecid, anticoagulants (e.g., warfarin), NSAIDs, theophylline, cyclosporine. Ofloxacin can interact with drugs that prolong the QT interval.
Pregnancy and Breastfeeding
Cefpodoxime is pregnancy category B (animal studies haven’t shown fetal harm, but adequate human studies are lacking). Ofloxacin is generally avoided during pregnancy. Both are present in breast milk, so consult a physician before use during breastfeeding. Safer alternatives may exist.
Drug Profile Summary
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Mechanism of Action: Cefpodoxime inhibits bacterial cell wall synthesis. Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Lactobacillus sporogenes helps prevent antibiotic-associated diarrhea by promoting gut flora balance.
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Side Effects: Diarrhea, nausea, vomiting, abdominal pain, headache; rarely tendon rupture, peripheral neuropathy, C. difficile infection, allergic reactions.
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Contraindications: Hypersensitivity, tendon disorders (with fluoroquinolones), epilepsy, myasthenia gravis, pregnancy/breastfeeding (generally avoided), pediatric use.
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Drug Interactions: Antacids, H2 blockers, metal cations, probenecid, anticoagulants, NSAIDs, theophylline, cyclosporine, QT-prolonging drugs.
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Pregnancy & Breastfeeding: Generally avoided due to potential risks; consult physician.
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Dosage: See Dosage section.
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Monitoring Parameters: Renal function, liver function, signs of allergic reactions, signs of tendonitis/tendon rupture, presence of diarrhea.
Popular Combinations
This combination itself represents a popular combination. There are no standardized recommendations for combining this specific triple therapy with other drugs beyond what’s mentioned in the Drug Interactions section.
Precautions
Pre-screen for allergies, metabolic disorders, and organ dysfunction. Use caution in pregnant/breastfeeding women, children, and the elderly. Avoid alcohol, monitor for musculoskeletal symptoms, and consider driving restrictions if dizziness occurs.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cefpodoxime Proxetil + Lactobacillus Sporogenes + Ofloxacin?
A: The usual adult dose is one tablet containing 200mg of cefpodoxime proxetil and 200mg ofloxacin, along with the probiotic, twice daily. Consult the specific product’s prescribing information. Not generally recommended for children.
Q2: What infections does this combination typically treat?
A: Respiratory tract infections, urinary tract infections, and some sexually transmitted infections susceptible to both components.
Q3: Why is Lactobacillus sporogenes included in this combination?
A: It’s a probiotic included to help prevent antibiotic-associated diarrhea.
Q4: Can this combination be used in children?
A: It’s generally not recommended for children due to the risk of musculoskeletal problems associated with ofloxacin in developing individuals.
Q5: What are the most important drug interactions to consider?
A: Interactions can occur with antacids, H2 blockers, metal cations, probenecid, anticoagulants, NSAIDs, theophylline, and cyclosporine. Ofloxacin can interact with drugs that prolong the QT interval.
Q6: What are the serious side effects to watch out for?
A: Clostridium difficile infection, allergic reactions, tendonitis or tendon rupture, peripheral neuropathy, and QT prolongation.
Q7: Can this combination be used during pregnancy or breastfeeding?
A: Generally avoided unless benefits clearly outweigh risks. Consult a physician for guidance and potential alternative options.
Q8: Should dosage be adjusted for patients with renal impairment?
A: Yes, dosage adjustment is usually necessary in patients with renal impairment, often involving dose reduction or increased dosing intervals.
Q9: Can patients drink alcohol while taking this medication?
A: Alcohol is best avoided due to the potential for increased dizziness and other adverse effects.
