Usage
This combination medication is primarily prescribed for treating intestinal amoebiasis, a parasitic infection of the intestines caused by Entamoeba histolytica. It also addresses associated gastrointestinal symptoms like bloating, abdominal pain, flatulence, stomach pain, and diarrhea.
Pharmacological Classification: This is a combination drug with components belonging to the following classifications:
- Tinidazole: Antiprotozoal, antibiotic
- Diloxanide furoate: Luminal amoebicide
- Dicyclomine: Antispasmodic, anticholinergic
- Simethicone: Anti-flatulent
Mechanism of Action:
- Tinidazole: Interferes with DNA synthesis and structure in susceptible anaerobic microorganisms, ultimately leading to cell death.
- Diloxanide furoate: Acts within the intestinal lumen to eradicate amoebae. The precise mechanism is not fully elucidated.
- Dicyclomine: Relaxes smooth muscle in the gastrointestinal tract by inhibiting the action of acetylcholine at muscarinic receptors, reducing spasms and pain.
- Simethicone: Reduces the surface tension of gas bubbles, allowing them to coalesce and be expelled more easily, relieving bloating and flatulence.
Alternate Names
- Entrogyl Tablet
- Enterozol Tablet
- Tinorid Plus Tablet
- Protorid Forte Tablet
How It Works
Pharmacodynamics: The combined effect of the four components provides comprehensive management of intestinal amoebiasis and associated symptoms. Tinidazole targets the infectious agent, while diloxanide furoate further aids in the eradication of intraluminal amoebae. Dicyclomine relieves abdominal cramps and spasms, and simethicone addresses gas and bloating.
Pharmacokinetics:
- Tinidazole: Well-absorbed orally, metabolized in the liver, and primarily excreted by the kidneys.
- Diloxanide furoate: Poorly absorbed, acting locally within the gut.
- Dicyclomine: Well-absorbed orally, metabolized in the liver.
- Simethicone: Not absorbed systemically; eliminated unchanged in the feces.
Mode of Action: As described above, each component has a specific mode of action contributing to the overall therapeutic effect. Tinidazole inhibits DNA synthesis, diloxanide furoate has an unknown luminal amoebicidal action, dicyclomine acts as an anticholinergic agent at muscarinic receptors, and simethicone alters the surface tension of gas bubbles.
Elimination Pathways: Tinidazole is primarily excreted renally, diloxanide furoate is eliminated in the feces, dicyclomine is metabolized in the liver, and simethicone is excreted unchanged in the feces.
Dosage
Standard Dosage
Adults:
- Entrogyl: One tablet three times a day.
- Enterozol, Tinorid Plus, Protorid Forte: Dosage specifications for these brands weren’t available in the provided sources.
The duration of treatment is generally 5-10 days, as determined by the physician.
Children:
Entrogyl is not recommended for children below 2 years of age. Pediatric dosages for other brands were not specified in the provided information.
Special Cases:
Dosage adjustments may be necessary for elderly patients, individuals with renal or hepatic impairment, and patients with comorbid conditions. Due to the scarcity of information in the provided sources regarding dosing for patients with liver or renal diseases, consult with a specialist and clinical resources for more specific guidelines.
Clinical Use Cases
The provided sources did not offer specific dosage recommendations for clinical use cases such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dosage adjustments may be necessary for patients with hepatic or renal dysfunction. These adjustments will depend on the severity of the impairment and the patient’s overall clinical picture. Always consult clinical guidelines and specialized resources for personalized advice.
Side Effects
Common Side Effects:
Nausea, metallic taste, diarrhea, dry mouth, vomiting, stomach pain, flatulence, weakness, nervousness, headache, blurred vision, dizziness, sleepiness.
Rare but Serious Side Effects:
Angioedema, apnea, confusion, skin rash, difficulty breathing, cough.
Long-Term Effects:
The provided sources did not include information about long-term effects of this combination medication.
Adverse Drug Reactions (ADR):
Severe allergic reactions such as skin rash, swelling, itching, and difficulty breathing require urgent medical attention.
Contraindications
Hypersensitivity to any component of the medication; liver disease; neurological disorders; blood dyscrasias. Entrogyl is contraindicated in children under 2 years of age. Additional contraindications may apply based on the specific components and the patient’s overall health status.
Drug Interactions
- Anticoagulants (e.g., warfarin): Tinidazole may enhance the anticoagulant effect.
- Alcohol: Disulfiram-like reaction with tinidazole.
- Lithium: Tinidazole may increase lithium levels.
- Interactions with other medications are possible. Consult a comprehensive drug interaction resource for a complete list.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding is not well established. Use cautiously. Consult with a physician.
Drug Profile Summary
- Mechanism of Action: See “How It Works” section.
- Side Effects: See “Side Effects” section.
- Contraindications: See “Contraindications” section.
- Drug Interactions: See “Drug Interactions” section.
- Pregnancy & Breastfeeding: Use with caution; potential risks exist. Consult a physician.
- Dosage: See “Dosage” section.
- Monitoring Parameters: Liver function tests, complete blood count, neurological examination.
Popular Combinations
The provided sources do not specify any popular drug combinations.
Precautions
- Screen patients for allergies and pre-existing medical conditions.
- Exercise caution in patients with liver or kidney disease.
- Avoid alcohol during treatment with tinidazole.
- This medication may impair the ability to drive or operate machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dicyclomine + Diloxanide + Simethicone + Tinidazole?
A: See “Dosage” section. Consult a specialist and clinical resources due to the limited information regarding this combination medication.
Q2: What are the common side effects?
A: Common side effects include nausea, metallic taste, diarrhea, dry mouth, vomiting, stomach pain, flatulence, weakness, nervousness, headache, blurred vision, dizziness, and sleepiness.
Q3: Are there any serious side effects I should be aware of?
A: Yes, rare but serious side effects include angioedema, apnea, confusion, skin rash, and difficulty breathing. Seek immediate medical attention if these occur.
Q4: Can I drink alcohol while taking this medication?
A: No, alcohol should be avoided as it can interact with tinidazole and worsen side effects like dizziness.
Q5: Is this medication safe during pregnancy or breastfeeding?
A: The safety during pregnancy and breastfeeding is not well established. It should only be used if the potential benefit outweighs the risk. Consult a physician.
Q6: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Don’t double the dose.
Q7: How should this medication be stored?
A: Store below 30°C.
Q8: Are there any drug interactions I should be aware of?
A: Yes, potential drug interactions exist with anticoagulants (e.g., warfarin), alcohol, and lithium. Consult a comprehensive drug interaction resource and/or a pharmacist for detailed information.
Q9: What should I tell my doctor before taking this medication?
A: Inform your doctor about any pre-existing medical conditions, allergies, and other medications you are taking, including over-the-counter drugs and supplements. Discuss any planned pregnancy or breastfeeding.
