Amicline Plus

Amicline Plus Uses, Dosage, Side Effects, Food Interaction and all others data.

Diloxanide (as Diloxanide furoate) is an anti-protozoal drug used in the treatment of Entamoeba histolytica and some other protozoal infections. Although it is not currently approved for use in the United States, it was approved by a CDC study in the treatment of 4,371 cases of Entamoeba histolytica from 1977 to 1990.

Diloxanide is a luminal amebicide, however the mechanism of action of diloxanide is unknown. Diloxanide destroys the trophozoites of E. histolytica that eventually form into cysts. The cysts are then excreted by persons infected with asymptomatic amebiasis. Diloxanide furoate is a prodrug, and is hydrolyzed in the gastrointestinal tract to produce diloxanide, the active ingredient.

Ornidazole is a 5-nitroimidazole derivative active against protozoa and anaerobic bacteria. It is converted to reduction products that interact with DNA to cause destruction of helical DNA structure and strand leading to a protein synthesis inhibition and cell death in susceptible organisms.

Trade Name Amicline Plus
Generic Ornidazole + Diloxanide
Weight 250mg
Type Tablet
Therapeutic Class
Manufacturer Franco Indian Pharmaceuticals Pvt Ltd
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Amicline Plus
Amicline Plus

Uses

Diloxanide is used alone as a primary agent in the treatment of asymptomatic (cyst passers) intestinal amebiasis caused by Entamoeba histolytica. Diloxanide may also be used concurrently, or sequentially, with other agents such as the nitroimidazoles (eg. metronidazole) in the treatment of invasive or extraintestinal forms of amebiasis.

Ornidazole is used for Amoebiasis (Intestinal and hepatic), Giardiasis, Trichomoniasis, Bacterial vaginosis, Treatment of susceptible anaerobic infections

Amicline Plus is also used to associated treatment for these conditions: Amebiasis, Anaerobic Bacterial Infection, Chlamydial Infections, Gastrointestinal Infections caused by entamoeba histolytica, Giardiasis, Mixed Vaginal Infections, Surgical Site Infections, Trichomonal Vaginitis, Trichomoniasis

How Amicline Plus works

Unknown. Diloxanide may inhibit protein synthesis.

Dosage

Amicline Plus dosage

Amoebiasis:

  • Adults: 500 mg twice a day for 5 days.
  • Children: 10-25 mg per kg body weight in two divided doses.

Amoebic dysentery:

  • Adults: 1.5 gm once a day for 3 days.
  • Children: 40 mg per kg body weight, once a day for 3 days.

Giardiasis:

  • Adults: 1.5 gm once daily for 1-2 days.
  • Children: 40 mg per kg body weight for 2 days.

Trichomoniasis: 1.5 gm once or 500 mg twice a day for 5 days. Sexual partner should also be treated at the same time.

Bacterial vaginosis: 3 tablets of 500 mg each as a single dose or one tablet of 500 mg once daily for 5-7 days.

Side Effects

Side effects of Ornidazole have been mainly limited to the gastrointestinal tract (nausea, vomiting, epigastric pain) and central nervous system (dizziness, headache, lassitude). Unlike other nitroimidazoles, Ornidazole does not interact with alcohol, although this requires further study.

Leukopenia has been described occasionally during therapy. Adverse central nervous system (CNS) effects of Ornidazole have mainly included headache, dizziness, lassitude or somnolence, fatigue and weakness. Adverse CNS effects of Ornidazole may be less than that happens with metronidazole. Seizures have not been reported with Ornidazole in studies available to date.

Precaution

In patient with ataxia, vertigo, and mental confusion, Ornidazole should be prescribed with caution. During prolonged treatment with Ornidazole, blood dyscrasia namely mild leukopenia have been reported rarely. In case leukopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.

Interaction

Like other imidazoles, Ornidazole has a mild potential to cause disulfiramlike reactions. Concomitant administration of oral anticoagulants may increase the risk of haemorrhage due to diminished hepatic metabolism. Ornidazole has been reported to decrease the clearance of 5-fluorouracil.

Elimination Route

Bioavailability is 90% (in diloxanide parental form), however diloxanide furoate is slowly absorbed from the gastrointestinal tract.

Half Life

3 hours

Elimination Route

Renal (90%, rapidly excreted as glucuronide metabolite). 10% is excreted in the feces as diloxanide.

Pregnancy & Breastfeeding use

Adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefit justifies the potential risk to fetus/neonate.

Contraindication

Previous hypersensitivity to Ornidazole and to other nitroimidazoles. Ornidazole is contraindicated in central nervous system disorders, particularly in epilepsy or in peripheral neuropathy.

Acute Overdose

Renal Impairment Haemodialysis patients: Give a supplemental dose (50% of the usual dose) before dialysis.

Hepatic Impairment Severe: Double the interval between doses.

Storage Condition

Store at room temperature and protect from light and moisture.

Innovators Monograph

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*** Taking medicines without doctor's advice can cause long-term problems.
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