Usage
- Diloxanide + Ornidazole is prescribed for the treatment of intestinal amoebiasis, including both symptomatic and asymptomatic cases. It is particularly effective against the Entamoeba histolytica parasite, which causes amoebic dysentery and other gastrointestinal infections. It is also used to treat giardiasis and trichomoniasis, as well as anaerobic bacterial infections.
- Pharmacological classification: Antiprotozoal, antibacterial, amoebicide.
- Mechanism of Action: Ornidazole acts as an antiprotozoal and antibacterial agent by damaging the DNA of susceptible microorganisms, leading to their death. Diloxanide furoate is an amoebicide primarily active in the lumen of the intestine, working synergistically with Ornidazole to eliminate the parasitic infection.
Alternate Names
- While Diloxanide + Ornidazole itself doesn’t have a specific international nonproprietary name (INN), its individual components do: ornidazole and diloxanide furoate.
- Brand Names: Amicline Plus, Amirid. Several brand names incorporate combinations of the components with other drugs such as simethicone, e.g. Metrogyl Compound Plus.
How It Works
- Pharmacodynamics: Ornidazole inhibits nucleic acid synthesis by disrupting microbial DNA. It exhibits activity against Entamoeba histolytica, Trichomonas vaginalis, Giardia lamblia, and anaerobic bacteria like Bacteroides and Clostridium. Diloxanide furoate acts directly on amoebae in the intestinal lumen, although its precise mechanism is not fully elucidated.
- Pharmacokinetics: Ornidazole is well-absorbed orally, reaching peak plasma concentrations within a few hours. It’s metabolized in the liver and excreted mainly in the urine. Diloxanide furoate is minimally absorbed, concentrating its action within the gut before being excreted primarily in the urine as the glucuronide conjugate.
- Mode of Action: Not applicable
- Elimination Pathways: Primarily renal excretion for both drugs. Hepatic metabolism for Ornidazole.
Dosage
Standard Dosage
Adults:
- Ornidazole 500-1000 mg twice daily for 3-5 days, taken after meals. Diloxanide furoate is typically given concurrently at 500 mg thrice daily for 10 days. The duration of treatment might vary according to the medical condition and the judgment of the clinician.
Children:
- Diloxanide: >25 kg: 20 mg/kg daily in 3 divided doses for 10 days, repeated if necessary. Pediatric ornidazole dosing is usually determined by body weight with close monitoring. Safety and efficacy in children below 12 years are not fully established for the combination.
Special Cases:
- Elderly Patients: Dose adjustments based on renal and hepatic function.
- Patients with Renal Impairment: Modification based on creatinine clearance for Ornidazole.
- Patients with Hepatic Dysfunction: Dose reduction and interval prolongation may be necessary for Ornidazole due to reduced clearance.
- Patients with Comorbid Conditions: Cautious use in patients with epilepsy, multiple sclerosis, or other neurological conditions.
Clinical Use Cases
- The combination is not typically used in these clinical settings. Dosages specified are for amoebiasis unless specifically mentioned otherwise.
Dosage Adjustments
- Dose modifications may be needed based on patient-specific factors like hepatic or renal insufficiency and other comorbid conditions.
Side Effects
Common Side Effects
- Nausea, vomiting, headache, dizziness, flatulence, metallic taste, dry mouth, abdominal pain.
Rare but Serious Side Effects
- Peripheral neuropathy, seizures, severe skin reactions.
Long-Term Effects
- Long-term side effects are not well-documented, but some patients report persistent gastrointestinal upset.
Adverse Drug Reactions (ADR)
- Drug rash with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS).
Contraindications
- Hypersensitivity to ornidazole, diloxanide furoate, or any component of the formulation.
- First trimester of pregnancy.
- Neurological disorders (e.g., epilepsy, multiple sclerosis).
- Severe hepatic impairment.
Drug Interactions
- Alcohol (disulfiram-like reaction with ornidazole).
- Anticoagulants (warfarin – enhanced effect).
- Antiepileptics (phenytoin, phenobarbital – reduced ornidazole levels).
- Cimetidine (reduced ornidazole metabolism).
- Lithium (increased lithium toxicity with ornidazole).
- Vecuronium bromide (prolonged neuromuscular blockade with ornidazole).
Pregnancy and Breastfeeding
- Pregnancy: Contraindicated in the first trimester. Use with caution in the second and third trimesters only if clearly needed.
- Breastfeeding: Not recommended as ornidazole is excreted in breast milk. Consider interrupting breastfeeding or using an alternative treatment.
Drug Profile Summary
- Mechanism of Action: Ornidazole: Disrupts DNA synthesis; Diloxanide furoate: Direct luminal amoebicidal effect.
- Side Effects: Nausea, vomiting, headache, dizziness, metallic taste.
- Contraindications: Hypersensitivity, first trimester of pregnancy, neurological disorders.
- Drug Interactions: Alcohol, anticoagulants, antiepileptics.
- Pregnancy & Breastfeeding: Avoid in the first trimester and during breastfeeding.
- Dosage: Adults: Ornidazole 500-1000mg BID, Diloxanide furoate 500mg TID. Pediatric dosing needs to be adjusted according to body weight.
- Monitoring Parameters: Liver function tests, renal function tests, complete blood count.
Popular Combinations
- Diloxanide + Ornidazole is often combined with simethicone to alleviate gas and bloating associated with gastrointestinal infections.
Precautions
- Evaluate renal and hepatic function before initiating treatment.
- Monitor for neurological symptoms.
- Advise patients to avoid alcohol during treatment and for a few days afterward.
- Pregnant or lactating women should consult their doctor before taking this drug combination.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Diloxanide + Ornidazole?
A: Adults: Ornidazole 500-1000 mg twice daily and Diloxanide furoate 500 mg thrice daily. Pediatric dosages should be weight based and determined by a doctor.
Q2: How long should the treatment last?
A: Treatment duration typically ranges from 3 to 10 days, depending on the infection and the clinical response.
Q3: What are the common side effects?
A: Nausea, vomiting, dizziness, headache, and metallic taste are among the commonly reported side effects.
Q4: Can Diloxanide + Ornidazole be used during pregnancy?
A: It’s contraindicated during the first trimester. Use with caution in the second and third trimesters only if the benefits outweigh the risks.
Q5: Are there any drug interactions I should be aware of?
A: Yes, significant interactions exist with alcohol, anticoagulants, and some antiepileptics.
Q6: What should I do if a dose is missed?
A: Take the missed dose as soon as you remember, unless it’s almost time for the next dose.
Q7: Can this combination be used in children?
A: The combination is generally not recommended for children under 12 years of age, with pediatric dosing being weight-based when prescribed.
Q8: Is it safe to drink alcohol while taking this medication?
A: No, alcohol should be strictly avoided as it can cause a disulfiram-like reaction with Ornidazole.
Q9: What should I tell my patients about taking this medicine?
A: Advise patients to take the medication with food, complete the entire course even if symptoms improve, avoid alcohol, and report any adverse effects promptly.
Q10: How should Diloxanide + Ornidazole be stored?
A: Store in a cool, dry place, away from direct sunlight and out of the reach of children.
