Usage
- This combination medication is prescribed for the treatment of acute diarrhea, dysentery, and gastrointestinal infections caused by susceptible bacteria and protozoa. It’s particularly effective against mixed infections. It is also used to manage conditions such as travellers’ diarrhoea, infectious diarrhoea, acute diarrhoeal episodes in irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), and acute diarrhoea of unspecified aetiology.
- Pharmacological Classification: Antibiotic (Ofloxacin and Ornidazole), Antisecretory/Antidiarrheal (Racecadotril).
- Mechanism of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, preventing bacterial replication. Ornidazole damages bacterial and protozoal DNA, leading to cell death. Racecadotril inhibits enkephalinase, reducing intestinal fluid secretion and thus alleviating diarrhea.
Alternate Names
- No widely recognized alternate names exist for this specific three-drug combination.
- Brand Names: Ofcrom-OR, Oflocure-OZR, Obnetic OR, Actoflox Forte, Offry OR, PC OZ, Racoser, Fexitage
How It Works
- Pharmacodynamics: Ofloxacin and Ornidazole exert bactericidal and antiprotozoal effects, while Racecadotril reduces intestinal fluid and electrolyte secretion without affecting bowel motility.
- Pharmacokinetics:
- Ofloxacin: Well-absorbed orally, metabolized in the liver, excreted renally.
- Ornidazole: Well-absorbed orally, metabolized in the liver, excreted renally and in feces.
- Racecadotril: Rapidly absorbed orally, hydrolyzed to the active metabolite thiorphan, primarily excreted renally.
- Mode of Action:
- Ofloxacin and Ornidazole target bacterial/protozoal DNA, disrupting replication.
- Racecadotril inhibits enkephalinase, decreasing intestinal water and electrolyte secretion.
- Elimination Pathways: Primarily renal excretion for all three components.
Dosage
The dosage information below is for general guidance only and may not apply to all clinical situations. It’s crucial to consult up-to-date, region-specific guidelines and tailor dosages to the individual patient’s needs and condition. Always refer to the specific product’s prescribing information for the most accurate dosing instructions.
Standard Dosage
The information on specific standard dosages for adults and children, especially regarding this particular combination, is not readily accessible in a consistent format. Dosages may vary depending on the brand name and formulation. It’s crucial to consult the product’s prescribing information and tailor dosages to the individual patient’s needs and clinical situation.
Adults:
- Information on adult dosage based on weight and condition is not readily available. Specific dosage information should be confirmed using manufacturer’s inserts.
Children:
- Specific dosage information for children of particular ages and weights is not readily available. Specific dosage information should be confirmed using manufacturer’s inserts.
Special Cases:
The impact of factors such as advanced age, impaired renal and hepatic function, comorbid conditions, and drug metabolism requires careful consideration. Dosage adjustments in these situations must be tailored to the individual patient and their specific needs. Consult up-to-date, region-specific guidelines for more information.
Clinical Use Cases
Dosage recommendations for specific medical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergencies are not consistently available or established across clinical practices. Dosages should be determined on a case-by-case basis, taking into account patient factors and local guidelines.
Dosage Adjustments
- Dose modifications are essential for patients with renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms impacting drug metabolism. Due to the limited access to a standardized dosing schedule across different scenarios, a personalized approach to dosing is necessary, particularly in special populations. Consult relevant and recent guidelines for the best course of action.
Side Effects
Common Side Effects
- Nausea, vomiting, abdominal pain, headache, dizziness, dry mouth, sleepiness, fatigue, skin rash, itching.
Rare but Serious Side Effects
- Allergic reactions (angioedema, bronchospasm), Steven-Johnson syndrome, visual impairment, hearing loss, seizures, hallucinations, severe diarrhea, tendon damage, peripheral neuropathy, liver dysfunction.
Long-Term Effects
- Potential long-term effects from prolonged use are not well-documented but may include peripheral neuropathy and tendon damage.
Adverse Drug Reactions (ADR)
- Clinically significant ADRs include severe allergic reactions, seizures, tendon rupture, and severe liver dysfunction.
Contraindications
- Hypersensitivity to any component of the drug, history of tendon disorders related to fluoroquinolone use, epilepsy or seizure disorders, conditions causing prolonged QT intervals, G6PD deficiency.
Drug Interactions
- Antacids containing magnesium or aluminum, sucralfate, antiarrhythmics (amiodarone, sotalol), antipsychotics (haloperidol, pimozide), anticonvulsants (phenytoin), anticoagulants (warfarin), antivirals (ritonavir), macrolides (erythromycin, azithromycin).
Pregnancy and Breastfeeding
- The safety of this combination during pregnancy and breastfeeding is not well-established. It’s generally recommended to avoid its use unless the potential benefit outweighs the risk to the fetus/infant.
Drug Profile Summary
Refer to the sections above for detailed information on the mechanism of action, side effects, contraindications, drug interactions, pregnancy & breastfeeding safety, dosage, and monitoring parameters. The Drug Profile Summary is simply a condensed reiteration of data provided earlier in the response.
Popular Combinations
- This particular combination is itself a popular combination. Its use is tailored for specific conditions, making it challenging to recommend additional drug combinations without specific clinical context.
Precautions
Refer to earlier sections for precautions regarding pre-screening, specific populations (pregnant women, breastfeeding mothers, children, elderly), and lifestyle considerations (alcohol, smoking, diet, driving restrictions).
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ofloxacin + Ornidazole + Racecadotril?
A: Please refer to the Dosage section of this document, and remember that standardized dosing information is not readily available and varies by brand and formulation. Always consult the product insert and consider patient-specific factors.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, abdominal pain, headache, dizziness, and skin rash.
Q3: What are the serious side effects?
A: Serious side effects may include allergic reactions, seizures, and tendon damage.
Q4: Can this combination be used in pregnancy?
A: The combination is generally avoided during pregnancy unless absolutely necessary. Consult regional guidelines and carefully consider the potential benefits and risks.
Q5: What are the drug interactions I should be aware of?
A: This combination can interact with antacids, certain antibiotics, and some other medications. Always review the patient’s medication list and consult appropriate references.
Q6: How does Racecadotril work in this combination?
A: Racecadotril reduces the secretion of fluids in the intestine, thereby decreasing the severity of diarrhea.
Q7: What infections is this combination effective against?
A: It’s typically used for gastrointestinal infections caused by susceptible bacteria and protozoa, including mixed infections causing diarrhea and dysentery.
Q8: What if a patient misses a dose?
A: The patient should take the missed dose as soon as they remember, unless it is close to the time for the next dose. They should not double the dose.
Q9: Should patients avoid driving while taking this medication?
A: This combination may cause dizziness, so caution should be exercised when driving or operating machinery. Patients should avoid these activities if they experience dizziness.
