Usage
Fluconazole + Ornidazole is prescribed for the treatment of mixed fungal and bacterial infections, including vaginal candidiasis, bacterial vaginosis, trichomoniasis, amoebiasis, giardiasis, and anaerobic bacterial infections. It’s also used prophylactically during surgical procedures, especially those involving the colon and gynecological operations.
Its pharmacological classifications are: antifungal (Fluconazole) and antiprotozoal/antibacterial (Ornidazole).
Fluconazole inhibits the synthesis of ergosterol, a crucial component of fungal cell membranes. Ornidazole damages bacterial and protozoal DNA, inhibiting their growth and replication.
Alternate Names
No widely recognized alternate names exist for the combination. However, the individual components are sometimes referred to by their chemical names. Brand names vary depending on the manufacturer and region. Some popular brand names include Flucazole Plus and Fluconazole Ornidazole.
How It Works
Pharmacodynamics: Fluconazole inhibits fungal cytochrome P-450 14α-demethylase, disrupting ergosterol synthesis. This weakens the fungal cell membrane, leading to cell death. Ornidazole forms reactive metabolites that damage bacterial and protozoal DNA, preventing cell division and leading to cell death.
Pharmacokinetics:
- Absorption: Fluconazole is well-absorbed orally, with bioavailability exceeding 90%. Food does not significantly affect absorption. Ornidazole is also well-absorbed orally.
- Metabolism: Fluconazole is minimally metabolized. Ornidazole is metabolized in the liver.
- Elimination: Fluconazole is primarily excreted unchanged in the urine. Ornidazole is excreted in urine, with a small amount in feces.
Mode of Action: Fluconazole inhibits fungal cell membrane synthesis. Ornidazole causes DNA damage in bacteria and protozoa. This combination provides broad-spectrum coverage against both fungi and bacteria.
Dosage
Dosages are highly variable and depend on the specific infection being treated, patient age, and organ function. Always consult local guidelines and individualize therapy.
Standard Dosage
Adults:
Dosing varies depending on the infection. For example, a single 150mg oral dose of Fluconazole is commonly used for uncomplicated vaginal candidiasis. For other infections, higher doses and longer durations are required. Ornidazole dosing also varies depending on the infection.
Children:
Pediatric dosages are weight-based and should be determined by a physician. Safety and efficacy in children under a certain age have not been established for all indications.
Special Cases:
- Elderly Patients: Renal function should be assessed and dosage adjustments may be needed.
- Patients with Renal Impairment: Dosage adjustments are necessary based on creatinine clearance.
- Patients with Hepatic Dysfunction: Caution is advised and dosage modifications may be required.
- Patients with Comorbid Conditions: Dosage adjustments may be necessary depending on the specific comorbidity.
Clinical Use Cases
Specific dosage recommendations for clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations should be guided by local protocols and the patient’s individual circumstances.
Dosage Adjustments
Dosage adjustments are essential in patients with renal or hepatic dysfunction and other comorbid conditions.
Side Effects
Common Side Effects
Nausea, headache, vomiting, diarrhea, abdominal pain, rash, dizziness.
Rare but Serious Side Effects
Hepatotoxicity, Stevens-Johnson syndrome, seizures, QT prolongation, angioedema, anaphylaxis.
Long-Term Effects
Chronic liver damage may occur with prolonged use.
Adverse Drug Reactions (ADR)
Anaphylaxis, hepatotoxicity, Stevens-Johnson syndrome, QT prolongation.
Contraindications
Hypersensitivity to Fluconazole, Ornidazole, or other azole antifungals; concomitant use with drugs known to prolong the QT interval (e.g. erythromycin, pimozide, quinidine); certain hepatic and renal conditions; certain neurological conditions; first trimester of pregnancy.
Drug Interactions
Fluconazole inhibits CYP450 enzymes and can interact with numerous drugs metabolized by this system (e.g. warfarin, phenytoin, some statins, sulfonylureas). Ornidazole can interact with warfarin and vecuronium bromide. Alcohol should be avoided due to a disulfiram-like reaction with Ornidazole. Consult a drug interaction database for a comprehensive list.
Pregnancy and Breastfeeding
Fluconazole is generally avoided during pregnancy, especially in the first trimester, due to potential teratogenic effects. Ornidazole’s safety during pregnancy is not well-established. Both drugs are excreted in breast milk and should be used with caution during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Fluconazole inhibits ergosterol synthesis; Ornidazole damages microbial DNA.
- Side Effects: Nausea, headache, vomiting, diarrhea, abdominal pain, rash, dizziness. Rarely: hepatotoxicity, Stevens-Johnson syndrome.
- Contraindications: Hypersensitivity, QT prolonging drugs, certain hepatic/renal conditions, first trimester pregnancy.
- Drug Interactions: Numerous CYP450 interactions (Fluconazole); warfarin, vecuronium (Ornidazole); alcohol.
- Pregnancy & Breastfeeding: Use with caution; potential fetal risks.
- Dosage: Variable depending on infection and patient factors.
- Monitoring Parameters: Liver function tests, renal function, electrolyte levels, ECG in patients at risk of QT prolongation.
Popular Combinations
This combination itself is a popular one, but individual components may be combined with other drugs depending on the specific infection.
Precautions
Assess renal and hepatic function, screen for drug allergies and relevant medical history. Advise against alcohol consumption during treatment with Ornidazole. Caution in patients with cardiac conditions. Monitor for adverse events, particularly hepatic dysfunction.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Fluconazole + Ornidazole?
A: The dosage varies widely depending on the infection, patient age, weight, and organ function. Always consult local guidelines.
Q2: What are the most common side effects?
A: Nausea, vomiting, diarrhea, headache, abdominal pain, skin rash.
Q3: Is Fluconazole + Ornidazole safe during pregnancy?
A: Generally avoided, especially during the first trimester, due to potential fetal risks. Discuss risks and benefits with a physician.
Q4: Can I drink alcohol while taking Fluconazole + Ornidazole?
A: No. Avoid alcohol due to the risk of a disulfiram-like reaction with Ornidazole.
Q5: What are the serious side effects I should watch out for?
A: Hepatotoxicity, Stevens-Johnson syndrome, seizures, QT prolongation, allergic reactions.
Q6: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember unless it is almost time for the next dose. Do not double the dose.
Q7: What if I have renal impairment?
A: Dosage adjustments are necessary. Consult with a nephrologist or physician experienced in managing medication dosing in renal impairment.
Q8: What infections are treated with this combination?
A: Vaginal candidiasis, bacterial vaginosis, trichomoniasis, amoebiasis, giardiasis, anaerobic bacterial infections.
Q9: How does Fluconazole work differently from Ornidazole?
A: Fluconazole targets fungal cell membrane synthesis, while Ornidazole damages the DNA of bacteria and protozoa.
Q10: Are there any drug interactions I should be aware of?
A: Yes, numerous. Fluconazole interacts with many drugs metabolized by the CYP450 system. Ornidazole interacts with warfarin and vecuronium. Always consult a drug interaction database.
