Usage
This combination drug is primarily prescribed for the syndromic management of vaginal infections, including:
- Bacterial vaginosis (BV)
- Candidiasis (Yeast infection)
- Trichomoniasis
- Mixed infections with Chlamydia and Neisseria
Pharmacological Classification:
This is a combination product containing:
- Azithromycin: Macrolide antibiotic
- Fluconazole: Azole antifungal
- Secnidazole: Antiprotozoal, antibacterial (amoebicide)
- Lactobacillus: Probiotic
Mechanism of Action:
This combination targets different pathogens responsible for vaginal infections. Azithromycin inhibits bacterial protein synthesis. Fluconazole disrupts fungal cell membrane synthesis. Secnidazole damages protozoan and bacterial DNA and disrupts their energy production. Lactobacillus helps restore the normal vaginal flora.
Alternate Names
No specific alternate generic names are listed in the provided sources, however this combination is typically referred to by the names of its individual drug components. Numerous brand names for this combination exist and vary regionally. One example listed is “Saflab Kit”.
How It Works
Pharmacodynamics:
- Azithromycin: Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.
- Fluconazole: Inhibits fungal cytochrome P450-dependent enzymes, particularly 14-alpha-demethylase, which is necessary for ergosterol synthesis, a critical component of the fungal cell membrane.
- Secnidazole: Metabolized to cytotoxic compounds which damage microbial DNA.
Pharmacokinetics:
- Azithromycin: Well absorbed orally, widely distributed in tissues, hepatic metabolism, primarily biliary excretion.
- Fluconazole: Well absorbed orally, high bioavailability, hepatic metabolism, primarily renal excretion.
- Secnidazole: Well absorbed orally, high bioavailability, hepatic metabolism, both renal and fecal excretion.
Elimination Pathways: Primarily hepatic metabolism for all three antimicrobial agents. Azithromycin is mainly excreted in bile, Fluconazole is renally cleared, and Secnidazole has both renal and fecal elimination.
Dosage
Standard Dosage
Adults:
This combination is typically administered as a single dose regimen:
- Azithromycin: 1g orally.
- Fluconazole: 150mg orally.
- Secnidazole: 2g orally (two 1g tablets).
- Lactobacillus: As directed on the product labeling (varies by product)
Children:
This combination is generally not recommended for children under 12 years of age. Consultation with a pediatrician is crucial if considering its use.
Special Cases:
- Elderly Patients: Dosage adjustments are not typically necessary unless there is significant renal or hepatic impairment.
- Patients with Renal Impairment: Caution advised; dose adjustments may be necessary for severe renal impairment.
- Patients with Hepatic Dysfunction: Caution advised; dose adjustments may be necessary for severe hepatic impairment.
Clinical Use Cases
The provided sources focus on using this drug combination for the syndromic management of vaginal discharge. Dosing for other clinical scenarios isn’t described.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Taste changes
- Indigestion
- Loss of appetite
Rare but Serious Side Effects:
- Hepatotoxicity (rare)
- Clostridium difficile-associated diarrhea
- QT interval prolongation
- Stevens-Johnson syndrome (rare)
- Pseudomembranous colitis (rare)
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), hepatotoxicity, QT interval prolongation, Clostridium difficile-associated diarrhea.
Contraindications
- Hypersensitivity to any component of the combination (azithromycin, fluconazole, secnidazole, or lactobacillus).
- History of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use.
Drug Interactions
- Antacids (aluminum or magnesium-containing): May reduce absorption of azithromycin and fluconazole.
- Warfarin: Azithromycin may enhance anticoagulant effects.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): May increase fluconazole levels.
- CYP3A4 inducers (e.g., rifampin): May reduce fluconazole levels.
- Alcohol: Disulfiram-like reaction with secnidazole (flushing, nausea, vomiting, etc.).
- QT prolonging drugs (e.g., amiodarone, quinidine): Additive effects with azithromycin, increasing risk of torsades de pointes.
Pregnancy and Breastfeeding
- Pregnancy: Use with caution. It’s generally advised to avoid use during the first trimester.
- Breastfeeding: Caution is advised as the drugs can be excreted in breast milk. Interruption of breastfeeding may be recommended during treatment.
Drug Profile Summary
- Mechanism of Action: Azithromycin (protein synthesis inhibitor), fluconazole (ergosterol synthesis inhibitor), secnidazole (DNA disruptor), lactobacillus (probiotic).
- Side Effects: Nausea, vomiting, diarrhea, headache, abdominal pain.
- Contraindications: Hypersensitivity, history of cholestatic jaundice with azithromycin.
- Drug Interactions: Antacids, warfarin, alcohol. See detailed section above.
- Pregnancy & Breastfeeding: Caution advised, especially during the first trimester of pregnancy.
- Dosage: Single dose regimen: Azithromycin 1g, Fluconazole 150mg, Secnidazole 2g.
- Monitoring Parameters: Liver function tests, renal function tests, and ECG in some cases.
Popular Combinations
This particular combination is often prescribed as a single kit.
Precautions
- Alcohol should be avoided.
- Caution in patients with liver or kidney disease.
- Monitor for signs of allergic reactions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Azithromycin + Fluconazole + Lactobacillus + Secnidazole?
A: The typical adult dosage is a single dose of Azithromycin 1g, Fluconazole 150mg, and Secnidazole 2g. Lactobacillus dosage varies by product.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, and taste changes.
Q3: Can this combination be used in pregnant or breastfeeding women?
A: It should be used with caution. Avoid use during the first trimester of pregnancy. Discuss the risks and benefits with the patient’s doctor. Interruption of breastfeeding may be recommended during treatment.
Q4: What are the major drug interactions to be aware of?
A: Significant interactions can occur with antacids, warfarin, some antifungals (azole class), and alcohol.
Q5: What are the contraindications for this drug combination?
A: Contraindications include hypersensitivity to any component and a history of cholestatic jaundice/hepatic dysfunction associated with azithromycin use.
Q6: How does this combination work against vaginal infections?
A: Each component targets different pathogens. Azithromycin targets bacteria, fluconazole targets fungi, and secnidazole targets protozoa and anaerobic bacteria. Lactobacillus helps restore a healthy vaginal flora.
Q7: Are there any special considerations for patients with renal or hepatic impairment?
A: Yes, caution should be exercised in patients with significant renal or hepatic impairment. Dosage adjustments may be needed. Consult a specialist for dosage recommendations.
Q8: What should patients be advised regarding alcohol consumption while taking this medication?
A: Alcohol should be strictly avoided while taking this medication, especially secnidazole, due to potential disulfiram-like reactions.
Q9: What is the role of Lactobacillus in this combination?
A: Lactobacillus is a probiotic that helps restore the natural balance of beneficial bacteria in the vagina, aiding in preventing recurrent infections.
