Presentation and Status in Health Basket
Film Coated Tablets
12 X 200 mg
Adults and young people from the age of 12:
Travelers’ Diarrhea: 400-1200mg per day (1 – 2 tab two or three times per day).
Non-complicated diverticular diseases, Hepatic encephalopathy: 2 – 3 times per day 2 film-coated tablets Lormyx (corresponding to 800 – 1200 mg Rifaximin (polymorphic form α)) per treatment cycle.
The safety and effectiveness of Rifaximin (polymorphic form α) for children under the age of 12 has not been examined. No recommendation can be made regarding the dosage.
Type of Application: The film-coated tablets have to be taken with sufficient liquid and must not be chewed. Taking the tablets does not depend on meals.
Duration of Application:
Travellers’ Diarrhoea: If not otherwise specified by the doctor, the duration of the treatment for Travellers’ Diarrhoea must not exceed 3 days.
Non-complicated diverticular diseases, Hepatic encephalopathy: The duration of a treatment cycle should not exceed 7 – 10 days. For acute treatment, a single treatment cycle is sufficient. As maintenance treatment, one cycle per month is carried out.
Patients with liver and/or kidney malfunction: Adjusting the dosage for patients with liver or kidney malfunction is not necessary.
Casual treatment of diseases of grown-up and youngsters from 12 caused by bacteria in gastro intestinal tract sensitive to rifaximine:
– Non-complicated diverticular diseases
– Hepatic encephalopathy
– Travellers’ Diarrhoea caused by non-invasive enteropathogenic bacteria
Hypersensitivity to the active substance or its excipients.
In longer periods of treatment, in high doses, slight reddening of the urine can occur due to active component. Due to low absorption the drug is not suitable for treatments of systemic infections or invasive infections, not recommended in patient with complicated diarrhea and blood in the stool. If symptoms persist longer than 24-48 hours the drug should be discontinued and change of therapy should be considered. Use of infections such as: Campylobacter Jejuni, Shigella Spp., Salmonella Spp. has not been investigated, therefore it’s not recommend to use this drug in such infections.
Common: Exanthema, urticaria (due to hypersensitivity), headache, dizziness, urge to defecate, nausea.
See prescribing information for full details.
As the absorption via the gastro-intestinal tract of Rifaximin (polymorphic form α) taken orally is negligible (< 0.4 %), no systemic interaction with other pharmaceutical products is assumed. Studies for clinical interaction with healthy test subjects with Rifaximin (polymorphic form α) and pharmaceutical products which are metabolised via human cytochrome P450 isoenzymes (e. g. CYP3A), showed that Rifaximin (polymorphic form α) (600 mg daily) does not
significantly affect the pharmacokinetics of Midazolam and oral contraceptives (with the active ingredients ethinylestradiol and norgestimate). Therefore, interaction with pharmaceutical products which are metabolised via these
isoenzymes is not expected.
Interaction studies for concurrent use of Lormyx with other pharmaceutical products which may be used for Travellers’ Diarrhoea (e. g. Loperamide or activated carbon) do not exist. At the earliest, Lormyx may be taken 2 hours after application of activated carbon.
Note: The underlying condition itself can affect the enterohepatic cycle of oestrogen through the modification of the intestinal flora. As a result, its plasma concentration can decrease and the contraceptive protection may be compromised.
Considering additional alternative contraceptive measures is therefore advisable.
Pregnancy and Lactation
There is insufficient data for humans about the safety of taking Rifaximin (polymorphic form α) during pregnancy and whilst breastfeeding. Studies with experiments on animals have not shown indications of direct or indirect effects detrimental to health with regards to reproduction toxicity. It is advisable nevertheless not to take this drug during pregnancy or whilst breastfeeding.
Up to now, no cases of clinically relevant overdoses of Rifaximin (polymorphic form α) have become known. In clinical studies, doses of a maximum of 2400 mg/d (12 tablets/day) over 5 days have been applied without significant risk. When taking higher doses, it is recommended carrying out gastric lavage and suitable supporting measures.
Before/ after meal: The drug does not depend on meals, have to be taken with sufficient liquid and must not be chewed.