Usage
This combination drug is prescribed for mixed vaginal infections, including bacterial vaginosis, candidiasis (yeast infection), and trichomoniasis. It is also effective against certain skin, respiratory, and sexually transmitted infections caused by susceptible microorganisms. It offers a broad-spectrum approach to target and eliminate bacteria, fungi, and protozoa.
It’s pharmacological classifications are:
- Azithromycin: Macrolide antibiotic
- Fluconazole: Azole antifungal
- Ornidazole: Nitroimidazole antibiotic and antiprotozoal
Alternate Names
No widely recognized alternate names exist for this specific combination, but it’s often referred to as “AF Kit.” Brand names may vary regionally.
How It Works
Pharmacodynamics:
- Azithromycin: Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thus halting bacterial growth.
- Fluconazole: Inhibits fungal cytochrome P450 enzyme 14α-demethylase, disrupting ergosterol synthesis, leading to fungal cell membrane damage and death.
- Ornidazole: Damages DNA of susceptible anaerobic bacteria and protozoa, inhibiting nucleic acid synthesis and causing cell death.
Pharmacokinetics:
Each component has distinct pharmacokinetic properties:
- Azithromycin: Good tissue penetration and a long half-life, allowing for once-daily dosing. Primarily eliminated via biliary excretion and partly in urine.
- Fluconazole: Good oral bioavailability. Primarily excreted renally.
- Ornidazole: Well-absorbed orally. Metabolized in the liver and its metabolites are excreted renally.
Mechanism of Action (Cellular/Molecular):
- Azithromycin: Binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis.
- Fluconazole: Inhibits the cytochrome P450 enzyme 14α-demethylase, essential for ergosterol synthesis in fungal cell membranes.
- Ornidazole: Forms reactive metabolites that interact with DNA, leading to strand breakage and cell death.
Dosage
Standard Dosage
Adults:
One AF Kit (Azithromycin 1000mg, Fluconazole 150mg, Ornidazole 750mg, given as separate tablets) is typically prescribed as a single dose or for a short duration as per the doctor’s recommendation. The dosage may change depending on individual factors like the severity of the condition and the patient’s response to the treatment.
Children:
The safety and efficacy of this combination have not been established in children. Use with caution and only under strict medical supervision. Dosage adjustments are needed and should be determined by a doctor.
Special Cases:
- Elderly Patients: Use with caution due to potential age-related decline in organ function. Dose adjustments may be needed.
- Patients with Renal Impairment: Close monitoring is required. Reduce dosage in severe renal impairment.
- Patients with Hepatic Dysfunction: Use with caution. Dosage adjustments may be necessary.
- Patients with Comorbid Conditions: Close monitoring and dose adjustments may be needed for patients with cardiac conditions, especially QT prolongation.
Clinical Use Cases
The combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or ICU/emergency situations. Its primary use is in outpatient treatment of specific infections.
Dosage Adjustments
Dose adjustments may be based on renal/hepatic function, patient response, and potential drug interactions.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, headache, dizziness, stomach pain, indigestion, loss of appetite, metallic taste.
Rare but Serious Side Effects:
Allergic reactions (including anaphylaxis), liver dysfunction, cardiac arrhythmias (including QT prolongation), seizures, blood disorders.
Long-Term Effects:
No significant long-term effects have been reported with short-term use. Prolonged or repeated use may increase the risk of antibiotic resistance.
Adverse Drug Reactions (ADR):
Severe allergic reactions, hepatotoxicity, QT prolongation, Stevens-Johnson syndrome.
Contraindications
Hypersensitivity to any component, severe hepatic or renal impairment, QT prolongation, concomitant use with drugs known to prolong the QT interval, certain blood disorders, first trimester of pregnancy.
Drug Interactions
Antacids (reduce azithromycin absorption), warfarin, sulfonylureas, alcohol (disulfiram-like reaction with ornidazole and fluconazole), CYP3A4 substrates (fluconazole interaction). Many other potential interactions exist; consult a comprehensive drug interaction database.
Pregnancy and Breastfeeding
Avoid during pregnancy unless the benefits clearly outweigh the risks. Azithromycin is generally considered safe during breastfeeding, but fluconazole and ornidazole should be used with caution. Consult a doctor before use.
Drug Profile Summary
- Mechanism of Action: See “How It Works.”
- Side Effects: See “Side Effects.”
- Contraindications: See “Contraindications.”
- Drug Interactions: See “Drug Interactions.”
- Pregnancy & Breastfeeding: Avoid unless benefits outweigh risks.
- Dosage: See “Dosage.”
- Monitoring Parameters: Liver function tests, renal function tests, ECG (for QT prolongation), complete blood count.
Popular Combinations
This specific combination is itself a common combination used for managing mixed infections in gynecological practice.
Precautions
Screen for allergies and pre-existing medical conditions, especially liver/kidney disease and cardiac conditions. Exercise caution in pregnant/breastfeeding women, children, and the elderly. Avoid alcohol during treatment. May cause dizziness, affecting the ability to drive or operate machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Azithromycin + Fluconazole + Ornidazole?
A: One AF Kit (Azithromycin 1000mg, Fluconazole 150mg, Ornidazole 750mg) is typically prescribed as a single dose or for a short duration. This can vary based on individual patient factors.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, headache, dizziness, stomach pain, and metallic taste.
Q3: Can this combination be used in pregnancy?
A: It’s generally avoided during pregnancy unless the benefits clearly outweigh the risks.
Q4: What are the major drug interactions?
A: Significant interactions can occur with antacids, warfarin, sulfonylureas, alcohol, and CYP3A4 substrates.
Q5: What conditions is this combination used to treat?
A: Primarily mixed vaginal infections (bacterial vaginosis, candidiasis, trichomoniasis).
Q6: What should patients avoid while taking this medication?
A: Avoid alcohol, and inform their doctor of any other medications they are taking.
Q7: Are there any serious side effects I should be aware of?
A: While rare, serious side effects can include allergic reactions, liver dysfunction, cardiac arrhythmias, and seizures.
Q8: What if a patient misses a dose?
A: If a dose is missed, take it as soon as remembered unless it is close to the next scheduled dose. Do not double the dose.
Q9: Can this combination be used in patients with liver or kidney disease?
A: It should be used with caution, and dose adjustments are often necessary. In severe liver or kidney impairment, it may be contraindicated.
Q10: What if a patient experiences side effects?
A: Patients should inform their doctor of any side effects they experience, especially if they are severe or persistent.
