Usage
- This combination drug is prescribed for the treatment of diarrhea and dysentery, particularly those caused by bacterial or parasitic infections. It is also used for other gastrointestinal infections.
- Pharmacological classification: Antibiotic and Probiotic combination.
- Mechanism of Action: This combination targets gastrointestinal infections through multiple actions. Ofloxacin and Ornidazole are antibiotics. Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. Ornidazole damages bacterial and parasitic DNA. Lactobacillus and Saccharomyces boulardii are probiotics that help restore the natural gut flora, which may be disrupted by the infection or antibiotic use.
Alternate Names
This combination medication is often referred to by brand names, which vary depending on the manufacturer. Some examples include:
- S Pro OZ
- Qinomil-OZ
- Oflarge OZ Plus
- Ofem Plus
- Open Ols
- FLOCARE OZ
- Tyflo OZ
- Get It Plus
- Antof Plus
There aren’t established international non-proprietary names for this specific four-drug combination.
How It Works
- Pharmacodynamics: Ofloxacin and Ornidazole exert bactericidal effects by disrupting DNA replication and damaging DNA, respectively. Lactobacillus and Saccharomyces boulardii improve gut health by competing with pathogenic bacteria, producing beneficial substances, and enhancing intestinal barrier function.
- Pharmacokinetics: Ofloxacin is well-absorbed orally and widely distributed in the body. It’s primarily excreted renally. Ornidazole is also well-absorbed orally and extensively metabolized in the liver, with metabolites excreted in urine. Lactobacillus and Saccharomyces boulardii primarily act within the gastrointestinal tract.
- Mode of Action: Ofloxacin inhibits topoisomerase II (DNA gyrase) and topoisomerase IV, essential enzymes for bacterial DNA replication and repair. Ornidazole interacts with DNA, causing strand breakage and inhibiting nucleic acid synthesis. Lactobacillus and Saccharomyces boulardii compete with pathogens for resources and adhesion sites, produce antimicrobial substances, and modulate the immune response.
- Elimination pathways: Ofloxacin is predominantly eliminated through renal excretion. Ornidazole is metabolized in the liver, and its metabolites are excreted in the urine.
Dosage
The dosage is dependent upon the patient’s condition and response to treatment and should be determined by a physician.
Standard Dosage
Adults: One tablet twice a day for 5-7 days is the standard dose and frequency for adults. The maximum dosage limit should be determined by the physician.
Children: This medication is generally not recommended for children and adolescents under 18 years old. If used, dosing should be carefully determined by a physician based on weight and age, with careful monitoring for potential side effects.
Special Cases:
- Elderly Patients: Dose adjustments may be necessary based on renal function and overall health.
- Patients with Renal Impairment: Dose reduction may be required depending on the degree of impairment.
- Patients with Hepatic Dysfunction: Dose adjustment may be necessary, as Ornidazole is metabolized in the liver.
- Patients with Comorbid Conditions: Careful consideration of other medical conditions is necessary, particularly for patients with neurological disorders or a history of tendon disorders.
Clinical Use Cases
This medication isn’t typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, or the ICU. Its use is mainly focused on treating specific types of diarrhea and dysentery. Emergency situations are typically addressed with other medications.
Dosage Adjustments
Dose adjustments are made based on renal or hepatic function, age, and other relevant factors. Genetic polymorphisms affecting drug metabolism should be considered, particularly for Ofloxacin.
Side Effects
Common Side Effects
Nausea, vomiting, abdominal pain, bloating, dizziness, headache, skin rash, loss of appetite.
Rare but Serious Side Effects
Peripheral neuropathy, tendon rupture, seizures, Clostridium difficile-associated diarrhea.
Long-Term Effects
Long-term use of this drug combination can lead to antibiotic resistance and alterations in gut microbiota.
Adverse Drug Reactions (ADR)
Severe allergic reactions (anaphylaxis), Stevens-Johnson syndrome, toxic epidermal necrolysis, QT prolongation.
Contraindications
Hypersensitivity to any component, history of tendon disorders with quinolone antibiotics, epilepsy, myasthenia gravis, pregnancy (unless benefits outweigh risks), breastfeeding (generally avoided).
Drug Interactions
- Antacids, sucralfate, metal cations (calcium, magnesium, iron, zinc) can reduce the absorption of Ofloxacin.
- Probenecid can decrease the renal excretion of Ofloxacin.
- Warfarin and other anticoagulants: Ornidazole can potentiate their effects, increasing bleeding risk.
- Drugs that prolong the QT interval: Ofloxacin can increase the risk of QT prolongation.
- Other antibiotics: May alter the effectiveness of the Lactobacillus component.
- Alcohol: Can exacerbate dizziness and other CNS effects.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not well-established. Animal studies have shown adverse effects. Use only if clearly needed and the potential benefits outweigh the risks.
- Breastfeeding: The safety during breastfeeding is not established. It is generally advised to avoid or discontinue breastfeeding while taking this medication.
Drug Profile Summary
- Mechanism of Action: Ofloxacin and Ornidazole: antibacterial. Lactobacillus and Saccharomyces boulardii: Restore gut flora.
- Side Effects: Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, rash. Rarely: tendon rupture, seizures, peripheral neuropathy.
- Contraindications: Hypersensitivity, tendon disorders with quinolones, epilepsy, myasthenia gravis, pregnancy (generally avoided), breastfeeding (generally avoided).
- Drug Interactions: Antacids, sucralfate, metal cations, probenecid, warfarin, QT prolonging drugs, alcohol.
- Pregnancy & Breastfeeding: Generally avoided unless benefits clearly outweigh risks.
- Dosage: As directed by the physician.
- Monitoring Parameters: Observe for gastrointestinal side effects, signs of hypersensitivity, and potential neurological or tendinous adverse effects.
Popular Combinations
This specific combination itself includes an antibiotic, antiprotozoal, and probiotics. Therefore, it is not generally combined with other drugs.
Precautions
- Assess for allergies, renal and hepatic function, history of seizures or tendon disorders before initiating treatment.
- Pregnant Women: Use with extreme caution only if the benefits outweigh the risks.
- Breastfeeding Mothers: Generally avoided. If used, monitor the infant for potential side effects.
- Children & Elderly: Not recommended for children under 18. Elderly patients may require dosage adjustments.
- Lifestyle Considerations: Avoid alcohol. Monitor for dizziness and avoid driving or operating machinery if affected.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Lactobacillus + Ofloxacin + Ornidazole + Saccharomyces boulardii?
A: The dosage should be individualized based on the patient’s specific condition and determined by a physician. A common adult dosage is one tablet twice daily for 5-7 days.
Q2: What are the primary uses of this medication?
A: Primarily for treating bacterial and parasitic diarrhea and dysentery.
Q3: Can this medication be used in children?
A: Generally not recommended for children under 18. If necessary, the dosage should be carefully adjusted by a physician.
Q4: What are the common side effects?
A: Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, and skin rash.
Q5: What are the serious side effects to watch out for?
A: Tendon rupture, seizures, peripheral neuropathy, Clostridium difficile infection.
Q6: What are the key drug interactions?
A: Antacids, sucralfate, multivitamins with minerals, probenecid, warfarin, other antibiotics, and alcohol.
Q7: Can this medication be used during pregnancy or breastfeeding?
A: Generally avoided unless the benefits clearly outweigh the risks, especially during pregnancy. Its safety during breastfeeding has not been definitively established.
Q8: What are the contraindications for this medication?
A: Hypersensitivity, history of tendon problems with quinolone antibiotics, epilepsy, and myasthenia gravis. It’s also generally contraindicated in pregnancy and breastfeeding.
Q9: How should this medication be taken?
A: Orally with food, as directed by the physician.
Q10: What should patients do if they miss a dose?
A: Take the missed dose as soon as remembered, unless it’s almost time for the next dose. Do not double the dose.
