Usage
Ofloxacin + Racecadotril is prescribed for the treatment of acute diarrhea, particularly in cases caused by bacterial infections. It’s specifically indicated for diarrhea in children. It is beneficial in managing diarrhea symptoms in patients with gastrointestinal infections caused by susceptible bacterial strains. This combination medication falls under two pharmacological classifications:
- Ofloxacin: Fluoroquinolone antibiotic
- Racecadotril: Antisecretory agent (Enkephalinase inhibitor)
Ofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair. This action prevents bacterial growth and helps clear the infection. Racecadotril, on the other hand, reduces the secretion of water and electrolytes into the intestine by inhibiting enkephalinase, an enzyme that breaks down enkephalins. This helps decrease the frequency and volume of diarrheal stools without affecting normal gut motility.
Alternate Names
There are no widely recognized alternate names for the combination itself. However, it’s available under various brand names, some of which include:
- Oflonida-R Oral Suspension
- Enuff-O Dry Syp
- Racejan O Syrup
- Oshin Roz Oral Suspension
- Mapcin RD Oral Suspension
- Lee Dott-RC Oral Suspension Strawberry
- Oflover R Oral Suspension
- OFLARGE OR
- POLO-R
- Raceril O Oral Suspension
- Offry OR Suspension
How It Works
Pharmacodynamics:
Ofloxacin, a fluoroquinolone antibiotic, inhibits bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication, transcription, and repair. This inhibition prevents bacterial growth and helps to eliminate the infection. Racecadotril is an enkephalinase inhibitor. Enkephalinase is responsible for the degradation of enkephalins in the small intestine. Enkephalins stimulate water and electrolyte secretion in the intestine. By inhibiting enkephalinase, Racecadotril increases local concentrations of enkephalins, which reduce the hypersecretion of water and electrolytes into the intestinal lumen, thus mitigating diarrhea. It is considered a safer and better-tolerated antidiarrheal alternative to loperamide. This combined action of these two drugs helps treat diarrhea effectively.
Pharmacokinetics:
- Ofloxacin: Well-absorbed orally, achieving peak plasma concentrations within 1-2 hours. It is widely distributed throughout the body. Primarily excreted by the kidneys, with some metabolism occurring in the liver.
- Racecadotril: Rapidly absorbed after oral administration, and its active metabolite, thiorphan, reaches peak plasma levels in approximately 1.5 hours. It is hydrolyzed to thiorphan, its active metabolite. Thiorphan is primarily eliminated through the kidneys.
Elimination Pathways:
- Ofloxacin: Primarily renal excretion, some hepatic metabolism.
- Racecadotril: Renal excretion of the active metabolite, thiorphan.
Dosage
Dosage information for Ofloxacin + Racecadotril specifically is limited. Available information focuses on the individual components, especially Racecadotril. The combination is available as a suspension intended mainly for pediatric use. Always follow the prescribed dosage and consult a pediatrician for appropriate dosage based on the child’s age, weight, and specific condition.
Standard Dosage
Adults:
Dosage information for adults is limited as this combination is mainly used in children. Consulting a physician is necessary for individual cases.
Children:
This drug has mainly been studied and used in children. It’s administered orally three times daily until the frequency of loose/watery stools return to normal, and in most cases, the infection is treated as well. Racecadotril dosage is generally based on weight:
- Infants (>3 months) <9 kg: 10 mg three times daily.
- 9-<13 kg: 20 mg three times daily.
- 13-27 kg: 30 mg three times daily.
-
27 kg: 60 mg three times daily.
- Ofloxacin is typically dosed at 50mg three times daily for children.
Maximum duration of treatment: 7 days
Special Cases:
Because this combination is primarily for children, specific dosing modifications for the elderly or those with renal/hepatic impairment aren’t well-defined. Physician consultation is essential.
Clinical Use Cases
The primary clinical use case is acute diarrhea, typically of bacterial origin, in children. Specific dosage modifications for settings like ICU or emergency situations are not defined.
Dosage Adjustments
Consult a healthcare professional to adjust the dosage based on individual patient-specific factors. Close monitoring is necessary for patients with kidney or liver problems.
Side Effects
Common Side Effects
- Nausea
- Vomiting
- Abdominal pain
- Headache
- Dry mouth
- Sleepiness
- Fatigue
- Dizziness
- Skin rash
Rare but Serious Side Effects
- Allergic reactions (including angioedema, bronchospasm)
- Seizures (with overdose)
- Tendon disorders (rare but serious, associated with fluoroquinolones)
- Steven-Johnson syndrome
- Visual impairment
- Hearing loss
Long-Term Effects
Limited data exist on long-term effects. However, prolonged use of fluoroquinolones like ofloxacin can rarely lead to tendon issues, peripheral neuropathy, and other serious side effects.
Adverse Drug Reactions (ADR)
ADRs requiring urgent medical attention include severe allergic reactions, seizures, and severe gastrointestinal issues.
Contraindications
- Hypersensitivity to ofloxacin, racecadotril, or any fluoroquinolone.
- History of tendon disorders related to fluoroquinolone use.
- Epilepsy or other seizure disorders.
- Conditions causing QT prolongation.
- G6PD deficiency.
- Pregnancy (use with extreme caution and only if absolutely necessary).
- Breastfeeding (consult a doctor before use).
Drug Interactions
- Antacids: Reduce ofloxacin absorption.
- Sucralfate: Reduces ofloxacin absorption.
- Antiarrhythmics (Class IA and III): May prolong QT interval.
- Tricyclic Antidepressants: Risk of CNS effects.
- Antipsychotics: Risk of CNS effects.
- Macrolides: Potential QT prolongation.
- Anticoagulants: May enhance anticoagulant effects.
- Antidiabetics: May affect blood sugar levels.
- NSAIDs: May increase seizure risk.
- Theophylline: May elevate theophylline levels.
- Corticosteroids: May increase risk of tendon rupture.
Pregnancy and Breastfeeding
Avoid use during pregnancy and breastfeeding unless absolutely necessary and under strict medical supervision. Ofloxacin is excreted in breast milk; racecadotril’s effects on breastfeeding are not well-established. The risks to the fetus or infant must be weighed against the benefits to the mother.
Drug Profile Summary
- Mechanism of Action: Ofloxacin: Inhibits bacterial DNA gyrase. Racecadotril: Inhibits enkephalinase.
- Side Effects: Nausea, vomiting, abdominal pain, headache, rash; rarely, severe allergic reactions, seizures.
- Contraindications: Hypersensitivity, tendon disorders related to fluoroquinolone use, epilepsy, QT prolongation, G6PD deficiency, pregnancy, breastfeeding.
- Drug Interactions: Multiple, including antiarrhythmics, antidepressants, antipsychotics, antacids.
- Pregnancy & Breastfeeding: Avoid unless absolutely necessary.
- Dosage: Pediatric dosage: Racecadotril varies by weight; Ofloxacin commonly 50mg. Adult usage is limited, requiring physician guidance.
- Monitoring Parameters: Hydration status, frequency and consistency of stools, electrolyte balance, signs of allergic reactions.
Popular Combinations
Ofloxacin + Racecadotril itself is a combination. It may be used alongside oral rehydration salts (ORS) to maintain electrolyte balance.
Precautions
- General Precautions: Monitor for dehydration, allergic reactions, and other adverse effects.
- Specific Populations: Avoid in pregnancy/breastfeeding unless absolutely necessary. Use with caution in patients with liver or kidney impairment. Dosage adjustment may be needed for children.
- Lifestyle Considerations: Avoid alcohol; stay hydrated.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ofloxacin + Racecadotril in children?
A: Racecadotril dosage varies by weight (see dosage section). Ofloxacin is typically dosed at 50 mg three times daily. Maximum duration of treatment is 7 days. Consult a pediatrician for appropriate dosing based on the child’s individual needs.
Q2: Can this medication be used in adults?
A: Data on adult use are limited. Consult a physician if considering this combination for adult patients.
Q3: What are the common side effects?
A: Common side effects include nausea, vomiting, abdominal pain, headache, dry mouth, sleepiness, fatigue, dizziness, and skin rash.
Q4: What are the serious side effects to watch out for?
A: Serious side effects include severe allergic reactions, seizures (with overdose), tendon disorders, and Stevens-Johnson syndrome. Seek immediate medical attention if any of these occur.
Q5: Can this medication be used during pregnancy or breastfeeding?
A: It’s generally contraindicated. Consult a doctor; the potential risks to the fetus/infant must be weighed against the benefits to the mother.
A: Discontinue the medication and consult a doctor immediately as this could indicate a more serious condition.
Q7: What if a dose is missed?
A: Administer the missed dose as soon as possible, unless it is almost time for the next dose. Do not double the dose.
Q8: Can I give this medication with other antibiotics?
A: Consult a doctor before co-administering with other antibiotics, as interactions may occur.
Q9: How long does it take for diarrhoea to improve with Ofloxacin + Racecadotril?
A: Improvement typically occurs within 48 hours. If symptoms persist beyond this, consult a doctor.
Q10: Should patients take ORS along with this medication?
A: Yes, to maintain hydration, oral rehydration solution (ORS) is typically recommended alongside this medication.
Q11: Can this medication be taken with food?
A: The medication can be taken with or without food, though its efficacy and side effect profile are not significantly impacted by food intake. However, ORS should be taken with sufficient boiled water.
