Xifaxan – composition, indications, contraindications, action, price

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Xifaxan is an antibacterial drug that is used in the treatment of irritable bowel syndrome, but it is not the only indication for taking the drug. How does Xifaxan work? Are there any contraindications to its use? We check what Xifaxan contains, as well as how much it costs.

Xifaxan – general characteristics of the drug

Xifaxan is an oral antibiotic with antibacterial activity. It contains rifaximin, an antibiotic of a class of drugs called rifamycins, but unlike other rifamycins, it is only slightly absorbed from the gut into the bloodstream, so it only acts on microbes in the gut. Xifaxan is active against most bacteria responsible for intestinal infections.

Xifaxan is available in pharmacies only with a prescription.

Xifaxan is a medicine in the form of pink, round, biconvex, film-coated tablets. Xifaxan tablets are packed in foil blisters and placed in a cardboard box. The package may contain 9, 12, 14, 28 or 42 tablets.

The entity responsible for the production and distribution of the drug is Alfasigma SpA. Alfasigma is one of the 5 largest pharmaceutical companies in Italy, with a turnover in 2020 of approximately EUR 1 billion. It is a private company, over 75% owned by the family of its founder. The origins of the activity date back to 1948, and its success and development was possible thanks to Marino Golinelli, an entrepreneur and philanthropist who recently died at the age of 101. Alfasigma in its present shape and structure was established in 2015 from the merger of two large companies – Alfa Wassermann and Sigma-Tau – both with over 60 years of history.

What should you know about bacteria and bacterial diseases? Check: Bacteria – role, research, pathogenic bacteria

Xifaxan – action

The antibacterial drug Xifaxan contains the active substance rifaximin. It is an antibiotic belonging to the rifamycin class of drugs that are absorbed into the bloodstream only to a small extent. Xifaxan is most often used for infections that are bacterial in nature.

1. What should you eat while taking an antibiotic and after finishing the treatment?

Xifaxan – forms and composition of the drug

Xifaxan is available in two forms:

1. Xifaxan film-coated tablets – the active substance is rifaximin. The excipients are: sodium starch glycolate, glycerol distearate, colloidal silica, talc, microcrystalline cellulose, hydroxypropyl methylcellulose, titanium dioxide E171, sodium edetate, propylene glycol, red iron oxide E172; 
2. Xifaxan granules for oral suspension – the active substance is rifaximin. The excipients are: microcrystalline cellulose, sodium carboxymethyl cellulose, pectin, kaolin, sodium saccharin, sodium benzoate, sucrose, black cherry flavor. 

Rifaximin is an antibiotic, a semi-synthetic derivative of SV rifamycin. This substance is bactericidal and is practically not absorbed from the gastrointestinal tract.

The active substance of Xifaxan works by inhibiting the synthesis of bacterial RNA and proteins. Rifaximin exhibits a broad spectrum of antimicrobial activity, its activity affects gram-positive and gram-negative, aerobic and anaerobic bacteria, including ammonia-producing species.

Rifaximin can inhibit the proliferation of urea deamination bacteria, thereby reducing the production of ammonia and other substances thought to be important in the pathogenesis of hepatic encephalopathy.

Xifaxan – indications for use

The main indication for the use of Xifaxan is infections with bacteria sensitive to rifaximin. However, in the case of diarrhea with blood in the stool or accompanying fever, Xifaxan should not be administered to adults and children over 12 years of age. In addition, the drug can be taken with travelers’ diarrhea.

Additionally, Xifaxan can be administered to adults during treatment with:

1. irritable bowel syndrome; 
2. hepatic encephalopathy. 

Patients who follow a low-residue diet because of symptomatic uncomplicated diverticular disease of the colon can also take Xifaxan.

Xifaxan – how to take coated tablets?

The method of administration of the antibacterial drug should be determined by the physician. The package leaflet also provides details on the dosage:

1. infection with bacteria sensitive to rifaximin – 1-2 tablets every 8-12 hours; 
2. travelers’ diarrhea – 1 tablet every 8 hours for (maximum) three days; 
3. hepatic encelophabia – 2 tablets every 8 hours for (maximum) seven days; 
4. symptomatic uncomplicated diverticular disease of the large intestine – 2 tablets every 8 hours for seven days. 

Xifaxan – dosage of granules for oral suspension

As with film-coated tablets, the method of administering granules for oral suspension should be determined by the physician. The package leaflet also provides detailed information on its dosage:

1. Infection with bacteria sensitive to rifaximin – 10 ml of suspension every 8 hours or 400 ml of suspension every 8-12 hours; 
2. Travelers’ diarrhea – 10 ml of suspension every 8 hours for (maximum) three days; 
3. Irritable bowel syndrome – 27,5 ml of suspension every 8 hours for 14 days; 
4. Hepatic encelophabia – 20 ml of suspension every 8 hours for (maximum) seven days; 
5. Symptomatic uncomplicated diverticular disease of the large intestine – 20 ml of suspension every 12 hours for seven days. 

Xifaxan – Recommended Precautions

If the symptoms mentioned by the patient do not improve within 24-48 hours of receiving Xifaxan, see your doctor in order to have your treatment changed. Children under the age of 12 should not take the medicine. In addition, it should be taken into account that the drug contains 5,8 mg of sucrose. The patient should be informed that the stools may become red after ingestion.

1. What does the altered stool report?

Xifaxan – contraindications

The main contraindication to taking Xifaxan is hypersensitivity to any of the substances contained in the drug.

Intestinal obstruction, including ulcerative colitis, are also among the factors that prevent you from taking Xifaxan.

As already mentioned, the drug should not be administered to patients who have blood in their stools, have a fever or have high stool frequency (> 8 times a day).

Xifaxan – interactions with other drugs

Before starting treatment with Xifaxan, please inform your doctor or pharmacist about all the medicines you are taking or have recently taken. You should also inform what medications the patient plans to take in the near future.

Please tell your doctor if you are taking:

1. warfarin; 
2. antiepileptic drugs; 
3. antiarrhythmic drugs; 
4. cyclosporine; 
5. P-glycoprotein inhibitors (e.g. cyclosporine). 

Which drugs should never be combined with each other? Check: Dangerous interactions

Xifaxan – side effects

Xifaxan, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

Side effects resulting from taking Xifaxan include:

1. gastrointestinal disorders – abdominal pain, constipation, diarrhea; 
2. blood and lymphatic system disorders – neutropenia; 
3. circulatory system disorders – palpitations; 
4. ear and labyrinth disorders – dizziness; 
5. visual disturbances – visual disturbances (double vision); 
6. general disorders – fever. 

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Common (affects 1 to 10 patients in 100):

1. pain in the upper abdomen;
2. constipation;
3. a sudden need to defecate;
4. diarrhea;
5. flatulence with the passing of winds;
6. increased tension of the abdominal wall;
7. nausea;
8. painful pressure on the stool;
9. vomiting;
10. fever;
11. Headache;
12. dizziness.

Uncommon (affects 1 to 10 users in 1000):

1. abdominal pain, ascites, indigestion;
2. dry mouth, disturbances in the speed of food transport in the intestines;
3. blood in the stools, hard stools, stools with some mucus;
4. taste disturbance;
5. abnormal blood test results;
6. palpitations, dizziness, earache, double vision;
7. weakness, pain and discomfort, chills, cold sweat, excessive sweating, flu-like illness;
8. swelling of the legs and arms;
9. thrush, vaginal yeast infection, H. simplex, nasopharyngitis, upper respiratory tract infection;
10. decreased appetite, dehydration, back pain, muscle spasm, muscle weakness, muscle pain, neck pain, hypoaesthesia;
11. migraine, tingling in extremities, sinus pain, drowsiness, sleep disturbances, depressed mood, insomnia, nervousness;
12. blood in the urine, protein in the urine, sugar in the urine, frequent urination, excessive urination, excessive menstruation;
13. cough, dry throat, shortness of breath, stuffy nose, sore throat and larynx, runny nose
14. rashes, skin eruption, rash, photoallergic reactions, flushing, increase in blood pressure.

Not known:

1. abnormal blood test results;
2. infections with bacteria of the genus Clostridum;
3. anaphylactic reactions;
4. hypersensitivity;
5. pre-syncope;
6. angioedema, dermatitis, exfoliative dermatitis, eczema, skin redness;
7. itching, petechiae, hives.

What causes an antibiotic rash? Read on: Antibiotic rash – is it an allergy symptom?

Xifaxan – how to store the drug?

Both Xifaxan film-coated tablets and granules for oral suspension should be kept out of the reach of children in the original packaging. Do not take this medicine after the expiry date, so always check the date on the package.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Xifaxan – can it be used during pregnancy and breastfeeding?

As with other medications, the dosage of Xifaxan during pregnancy and breastfeeding should be discussed with your doctor. This is because women who are expecting a baby cannot take the medicine. Its effect on the fertility of both women and men has not been confirmed.

Animal studies have shown no direct or indirect harmful effects on male and female fertility.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Xifaxan – price and availability

Xifaxan is a prescription-only medicine. It can be purchased at a pharmacy or through the website. The regular price for 28 200 ml coated tablets is around PLN 80. On the other hand, the cost of granules for the preparation of an oral suspension 60 ml is about PLN 60.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor