NORMIX Rifaximin 200mg Film-Coated Tablet 1's

For the treatment of traveler's diarrhea, hepatic encephalopathy, small intestine bacterial overgrowth, irritable bowel syndrome, diverticular disease and inflammatory bowel disease.

For oral use.
Adults and children over 12 years of age: Gastrointestinal diseases caused by pathogenic bacteria: Traveler's diarrhea: from 600 mg/day (one 200 mg tablet every 8 hours) to 800 mg/day (two 200 mg tablets every 12 hours) for 3 days.
Gastrointestinal diseases sustained by intestinal bacteria: Hepatic encephalopathy: 1,200 mg/day (two 200 mg tablets every 8 hours) for 7-10 days.
Doses maybe modified in quantity and frequency, according to physician's advice.
Diverticular Disease of the colon: 800 mg/day (two 200 mg tablets every 12 hours) for 7-10 days. Repeated monthly treatment is recommended (7-10 days/month).
Small Intestine Bacterial Overgrowth, Irritable Bowel Syndrome and Inflammatory Bowel Disease: 800 mg/day (two 200 mg tablets every 12 hours) to 1200 mg/day (two 200 mg tablets every 8 hours) for 7-14 days.
Doses may be modified in quantity and frequency, according to physician's advice. In cases where repeated courses of treatment are required, cyclic treatments of one week per month are recommended.
The total duration of the intermittent therapy should be determined by the adequacy of the clinical response of the patients.
NORMIX can be administered with or without food.
No dosage adjustment is necessary in patients with hepatic or renal insufficiency.
Pediatric Population: The safety and efficacy of Rifaximin in children younger than 12 years of age have not been established.

May be taken with or without food.

Patients with known hypersensitivity to rifaximin, to similar types of antibiotics (such as rifampicin or rifabutin), Rifaximin must not be used in the case of infectious diarrhea or traveler's diarrhea complicated with fever and/or presence of blood in stools. It is not recommended for children below 12 years old, pregnant women or nursing mothers.

If the patient is taking estrogens for birth control there is a possibility that contraception methods should be increased therefore consult the doctor before use. In the case of infectious or traveler's diarrhea, if symptoms persist or reappear shortly after 3 days of treatment the doctor should be consulted.

It is not recommended for pregnant women or nursing mothers.

The majority of the reaction listed in particular for gastrointestinal disorders may also be attributed to the symptoms of the diseases being treated.
Common adverse effects: Dizziness, headache, wind abdominal bloating, abdominal pain, constipation, diarrhea, urgency to evacuate feces, nausea, involuntary and painful or ineffective straining, vomiting, fever.
Uncommon adverse effects: Thrush, cold sore, swollen throat, inflammation or infection of the nose and throat; Abnormal blood test results (increased lymphocytes, increased monocytes, reduced neutrophils); Loss of appetite, loss of body fluid (dehydration); Abnormal dreams, depressed mood, sleeplessness, drowsiness; Double vision, earache, sensation of the room going round (vertigo), heart racing; Increase blood pressure, hot flushes, cough, dry throat, shortness of breath, blocked nose, sore throat, runny nose; Upper abdominal pain, indigestion, intestinal movement disorder, dry lips, hard stools, blood in the stools, mucus in stools, taste disorders; Increased liver enzymes values (aspartate-aminotransferase); Back pain, muscle cramps, muscle weakness, muscle pain, neck pain, blood in urine, sugar in urine (glycosuria), frequent urination, excessive urination (polyuria), protein in urine, frequent periods (polymenorrhea); Loss of strength, chills, cold sweat, increased perspiration, flu-like illness, swollen arm, pain.
Occasionally reported adverse effects: Bacterial infections (Clostridial infections); Abnormal blood test (reduced platelets, liver function test out of normal range, international normalized ratio abnormalities); Severe acute reactions to the drug, allergic reactions to the drugs; Near fainting or fainting; Giant hives; Skin roughness, skin rashes, itching, wheals.

Pharmacotherapeutic group: Gastrointestinal Antibacterial.
Pharmacology: Rifaximin is a non-systemic antibiotic with a broad spectrum of antibacterial action due mainly to the inhibition of RNA-synthesis by binding to the β-subunit of the DNA-dependent RNA polymerase enzyme of both Gram-positive and Gram-negative bacteria. The characteristics of rifampin, in its polymorphic form α (alpha) is negligible adsorption (less than 1%) from the gastrointestinal tract; therefore, it is an agent with local antimicrobial activity at intestinal level against both pathogens and in clinical conditions where it is useful in reducing the endogenous intestinal bacterial load.
Bioavailability and Pharmacokinetics: Rifaximin absorption after oral administration is virtually nil (less than 1%), according to pharmacokinetic studies carried out on rats, dogs and in man.
Plasma levels are negligible (less than 10 ng/mL in almost all cases) following the administration of therapeutic doses of rifaximin in both healthy volunteers and Inflammatory Bowel Disease patients with damaged intestinal mucosa.
The urinary recovery of rifaximin does not exceed 0.4% of administered dose.
Virtually all orally administered rifaximin is available in the intestinal tract where it reaches very high concentrations (fecal concentrations of 4,000-8,000 µg/g are reached after 3 days of therapy with daily doses of 800 mg).
Systemic absorption of rifaximin was low in both the fasting state and when administered within 30 minutes of high-fat breakfast.
Comparative pharmacokinetic studies have shown that polymorphic forms of Rifaximin different from polymorphic form α were significantly absorbed.
Special Populations: No clinical data are available on the use of Rifaximin in patients with impaired renal function. However since the urinary recovery of Rifaximin does not exceed 0.4% of the administered dose in healthy volunteers, no dosage adjustment is necessary in patients with renal insufficiency.
In patients with hepatic encephalopathy Rifaximin mean peak rifaximin plasma concentrations of 13.5 ng/mL were detected in hepatic encephalopathy patients administered rifaximin 800 mg three times daily for 7 days/less than 0.1% the administered dose was recovered after 7 days. Because of the limited systemic absorption of rifaximin, no specific dosing adjustments are recommended for patients with hepatic insufficiency.