Usage
Ofloxacin + Satranidazole is prescribed for the treatment of diarrhoea and dysentery caused by mixed bacterial and parasitic infections, particularly amoebic dysentery. It is also used for bacterial infections, including intra-abdominal, gynaecological, pelvic, foot ulcers in diabetes, post-operative, dental, and infections in immunocompromised patients.
Pharmacological Classification: Antibiotic (Quinolone and Nitroimidazole); Antiprotozoal.
Mechanism of Action: This combination drug acts synergistically. Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication. Satranidazole, a nitroimidazole derivative, damages the DNA, RNA, and proteins of anaerobic bacteria and protozoa, leading to their death.
Alternate Names
Satrogyl-O is a common brand name. Other brand names may exist regionally. Furotil has been mentioned as a potential alternate name, but this requires verification.
How It Works
Pharmacodynamics: Ofloxacin, a fluoroquinolone, disrupts bacterial DNA replication by inhibiting DNA gyrase and topoisomerase IV. Satranidazole, a nitroimidazole, forms reactive metabolites that damage the DNA, RNA, and proteins of susceptible anaerobic bacteria and protozoa.
Pharmacokinetics: Both drugs are absorbed orally. Ofloxacin is primarily eliminated renally, while satranidazole is metabolized in the liver and excreted in urine and feces. Specific details on CYP enzyme involvement are not available from the current sources.
Mode of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Satranidazole’s reduced form damages microbial DNA, RNA, and proteins. Specific details on receptor binding, enzyme inhibition, or neurotransmitter modulation beyond those mentioned above aren’t clarified in the provided sources. Elimination pathways include renal excretion for ofloxacin and hepatic metabolism with urinary and fecal excretion for satranidazole.
Dosage
Standard Dosage
Adults:
The typical adult dosage is one tablet of Ofloxacin 200mg + Satranidazole 300mg twice daily. Dosages may vary based on the severity and type of infection. The typical treatment duration is 5-7 days but may be longer depending on the infection. It’s essential to complete the entire prescribed course.
Children:
This combination is generally not recommended for children and growing adolescents due to the potential risk of cartilage damage. Safety and efficacy in pediatric populations have not been fully established.
Special Cases:
- Elderly Patients: Dose adjustments may be needed due to age-related metabolic changes or decreased organ function, particularly renal function.
- Patients with Renal Impairment: Dose modifications are necessary based on creatinine clearance. Specific adjustments should be determined by a physician.
- Patients with Hepatic Dysfunction: Adjustments are necessary for impaired liver metabolism. Specific recommendations should be determined by a physician.
- Patients with Comorbid Conditions: Exercise caution in patients with pre-existing conditions like epilepsy, tendonitis, glucose-6-phosphate dehydrogenase deficiency, liver/kidney/heart problems, and history of mental illness.
Clinical Use Cases
Dosage information for specific clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations is not available from the provided resources.
Dosage Adjustments
Dose modifications may be required for renal/hepatic dysfunction, but further details are not provided in the sources.
Side Effects
Common Side Effects
Nausea, vomiting, stomach pain, loss of appetite, diarrhea, headache, dizziness, metallic taste, dry mouth.
Rare but Serious Side Effects
Allergic reactions, visual impairment, Stevens-Johnson syndrome, bronchospasm, hearing loss, peripheral neuropathy, tendon disorders (tendonitis, tendon rupture), seizures, hypoglycemia, psychotic reactions.
Long-Term Effects
Potential long-term effects are not clearly defined in the provided sources.
Adverse Drug Reactions (ADR)
Clinically significant ADRs requiring immediate intervention include severe allergic reactions, Steven-Johnson Syndrome, bronchospasm, and seizures.
Contraindications
Hypersensitivity to quinolones or nitroimidazoles, pregnancy, breastfeeding, children and growing adolescents, history of epilepsy or lowered seizure threshold, myasthenia gravis, blood dyscrasias, and organic neurological disorders.
Drug Interactions
Antacids (magnesium/aluminum hydroxide), sucralfate, zinc or iron preparations, other antibiotics (ciprofloxacin), drugs that affect liver enzymes (rifampin, phenytoin), warfarin, theophylline, alcohol. Avoid alcohol until 72 hours after discontinuation.
Pregnancy and Breastfeeding
Contraindicated in pregnancy and breastfeeding due to potential harm to the fetus or nursing infant.
Drug Profile Summary
- Mechanism of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Satranidazole damages DNA, RNA, and proteins of anaerobic bacteria and protozoa.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, rash; rarely, allergic reactions, peripheral neuropathy, tendon disorders.
- Contraindications: Hypersensitivity, pregnancy, breastfeeding, children/adolescents, epilepsy.
- Drug Interactions: Antacids, other antibiotics, alcohol.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: Ofloxacin 200mg + Satranidazole 300mg twice daily. Pediatric use is not recommended.
- Monitoring Parameters: Monitor for signs of tendonitis, peripheral neuropathy, and other adverse reactions.
Popular Combinations
Information on popular drug combinations used in clinical practice along with their rationale is not available from the provided information.
Precautions
Screen for allergies, epilepsy, tendonitis, glucose-6-phosphate dehydrogenase deficiency, renal/hepatic issues, and history of mental illness. Avoid alcohol during treatment and up to 72 hours after. Avoid strong sunlight and UV rays. Caution in patients with myasthenia gravis, heart conditions, and psychotic disorders. Use with caution in elderly patients.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ofloxacin + Satranidazole?
A: The usual adult dose is one tablet of Ofloxacin 200mg + Satranidazole 300mg twice daily, but it may vary depending on the infection. This combination is not generally recommended for children.
Q2: What are the primary uses of this drug?
A: It is mainly used to treat mixed bacterial and parasitic infections causing diarrhoea and dysentery, including amoebic dysentery.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, stomach pain, loss of appetite, diarrhea, headache, and dizziness.
Q4: Are there any serious side effects I should be aware of?
A: Yes, although rare, serious side effects such as allergic reactions, tendon rupture, peripheral neuropathy, and seizures can occur.
Q5: Can I take this medication if I am pregnant or breastfeeding?
A: No, it is contraindicated during pregnancy and breastfeeding.
Q6: What are the major drug interactions?
A: Significant interactions can occur with antacids, certain other antibiotics, and alcohol. Consult a healthcare professional for a complete list.
Q7: Should I avoid any specific activities while taking this medicine?
A: Avoid driving or operating machinery if you experience dizziness or other side effects that impair alertness. Avoid excessive sun exposure.
Q8: 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 your next dose. Do not double the dose to catch up.
Q9: Are there any dietary restrictions while on this medication?
A: Avoid alcohol during treatment and for 72 hours after the last dose. Maintain adequate hydration, particularly if diarrhoea occurs.
Q10: How should this medication be stored?
A: Store at room temperature, away from moisture and direct light. Keep out of reach of children.
