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ZAXINE is a brand name for Rifaximin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ZAXINE is indicated for: • the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. • the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. In the trials of ZAXINE for HE, 91% of the patients were treated with lactulose concomitantly or were on lactulose…
Verbatim from this product's HC label. Tap a section to expand.
). 4. 1 Dosing Considerations Due to the limited systemic absorption of ZAXINE (rifaximin), no specific dosing adjustment is recommended for patients with mild to moderate hepatic insufficiency. Although no dosage adjustment is recommended at this time, caution should be exercised when ZAXINE is administered to patients with severe (Child-Pugh C) hepatic impairment and in patients with MELD score ≥25 (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics).
While taking ZAXINE with food has resulted in small increases in systemic exposure in healthy subjects, the effects of food on ZAXINE exposure in hepatic impairment patients have not been studied. However, since the absolute systemic bioavailability of rifaximin is still relatively low and the drug works locally in the gastrointestinal tract, rifaximin can be given with or without food.
Treatment duration beyond 6 months should take into consideration the individual balance between benefits and risks, including those associated with the progression of hepatic dysfunction and increasing systemic exposure to rifaximin.
2 Recommended Dose and Dosage Adjustment Hepatic Encephalopathy The recommended dose of ZAXINE is one 550 mg tablet taken orally two times a day. No more than two doses of ZAXINE (1 tablet twice a day) should be taken in a 24-hour period.
Irritable Bowel Syndrome with Diarrhea The recommended dose of ZAXINE is one 550 mg tablet taken orally three times a day for 14 days. In the trials of ZAXINE for IBS-D, patients who experienced a recurrence of symptoms and who responded to a first treatment were safely and effectively retreated for up to 2 times.
Current clinical trials have not evaluated the safety and efficacy of three or more repeat treatments for IBS-D. No more than three doses of ZAXINE (1 tablet three times a day) should be taken in a 24-hour period. 4 Administration ZAXINE can be taken with or without food (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Table 7).
Tablets should be swallowed whole. 5 Missed Dose If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, no additional dose should be taken and the regular dosing schedule should be Product Monograph ZAXINE, Rifaximin Tablets Page 6 of 36 resumed.
5. OVERDOSAGE No specific information is available on the treatment of overdosage with ZAXINE (rifaximin). , > 1100 mg/day for HE and 1650 mg/day for IBS-D [up to a daily maximum of 2400 mg rifaximin]), adverse reactions were similar in subjects receiving ZAXINE or placebo.
December 2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. TABLE OF CONTENTS................................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 4 1 INDICATIONS .........................................................................................................................
4 4 DOSAGE AND ADMINISTRATION ....................................................................................... 1 Dosing Considerations ....................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................... 4 Administration .................................................................................................................
5 5 OVERDOSAGE ..................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 6 7 WARNINGS AND PRECAUTIONS ........................................................................................
1 Special Populations ........................................................................................................ 1 Pregnant Women ......................................................................................................
2 Breast-feeding........................................................................................................... 3 Pediatrics ..................................................................................................................
4 Geriatrics................................................................................................................... 8 8 ADVERSE REACTIONS ........................................................................................................
4 4 DOSAGE AND ADMINISTRATION ....................................................................................... 1 Dosing Considerations ....................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................... 4 Administration .................................................................................................................
5 5 OVERDOSAGE ..................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 6 7 WARNINGS AND PRECAUTIONS ........................................................................................
1 Special Populations ........................................................................................................ 1 Pregnant Women ......................................................................................................
2 Breast-feeding........................................................................................................... 3 Pediatrics ..................................................................................................................
4 Geriatrics................................................................................................................... 8 8 ADVERSE REACTIONS ........................................................................................................
1 Adverse Reaction Overview ........................................................................................... 2 Clinical Trial Adverse Reactions .....................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Rifaximin in Canada.
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In the case of overdosage, discontinue ZAXINE, treat symptomatically, and institute supportive measures as required. 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging ZAXINE (rifaximin) 550 mg is a pink, oval, biconvex tablet with “rfx” debossed on one side.
It is available in bottles of 60 tablets. 7 WARNINGS AND PRECAUTIONS General Not for Systemic Infections ZAXINE (rifaximin) acts locally on the microflora of the gut and should not be used for the treatment of systemic bacterial infections.
Low systemic absorption of rifaximin has been noted in healthy individuals, but absorption is increased in subjects with impaired hepatic function. (See 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). There is the potential for increased systemic exposure to rifaximin in disease states in which intestinal barrier function or gut motility is altered.
7-fold increases in Cmax and AUC, respectively) than in healthy subjects receiving the same doses. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets: 550 mg colloidal silicon dioxide, glyceryl distearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, gluten-free sodium starch glycolate, talc, and titanium dioxide.
If you think you, or a person you are caring for, have taken too much ZAXINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. Product Monograph ZAXINE, Rifaximin Tablets Page 7 of 36 The effect on the gut flora following long-term use of rifaximin is not known.
Carcinogenesis and Mutagenesis A possible relationship between Zaxine treatment and carcinogenicity cannot be ruled out. 2 times the recommended human dose, based on relative body surface area comparisons) showed an increased trend in malignant schwannomas of the heart in male rats, but not female rats.
Gastrointestinal Clostridium difficile-Associated Disease Clostridium difficile-associated disease (CDAD) has been reported with use of nearly all antibacterial agents, including ZAXINE (see 8 ADVERSE REACTIONS), and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.
difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
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1 Adverse Reaction Overview ........................................................................................... 2 Clinical Trial Adverse Reactions .....................................................................................
3 Less Common Clinical Trial Adverse Reactions ........................................................... 5 Post-Market Adverse Reactions ................................................................................... 17 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview. ......................................................................................... 4 Drug-Drug Interactions .................................................................................................
5 Drug-Food Interactions ................................................................................................. 6 Drug-Herb Interactions .................................................................................................
7 Drug- Laboratory Test Interactions ............................................................................... 19 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action .................................................................................................... 2 Pharmacodynamics ......................................................................................................
3 Pharmacokinetics ......................................................................................................... 20 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
23 PART II: SCIENTIFIC INFORMATION ....................................................................................... 24 13 PHARMACEUTICAL INFORMATION ................................................................................
24 14 CLINICAL TRIALS ............................................................................................................. 1 Trial Design and Study Demographics ........................................................................
2 Study Results ............................................................................................................. 27 15 MICROBIOLOGY ...............................................................................................................
31 16 NON-CLINICAL TOXICOLOGY ......................................................................................... ………33 Product Monograph ZAXINE, Rifaximin Tablets Page 4 of 36 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ZAXINE is indicated for: • the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
• the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. In the trials of ZAXINE for HE, 91% of the patients were treated with lactulose concomitantly or were on lactulose treatment concomitantly.
Differences in the treatment effect on those patients not using lactulose concomitantly could not be assessed. 6% of patients in the controlled trial had MELD scores over 19. There is increased […]
3 Less Common Clinical Trial Adverse Reactions ........................................................... 5 Post-Market Adverse Reactions ................................................................................... 17 9 DRUG INTERACTIONS .......................................................................................................
2 Drug Interactions Overview. ......................................................................................... 4 Drug-Drug Interactions .................................................................................................
5 Drug-Food Interactions ................................................................................................. 6 Drug-Herb Interactions .................................................................................................
7 Drug- Laboratory Test Interactions ............................................................................... 19 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action .................................................................................................... 2 Pharmacodynamics ......................................................................................................
3 Pharmacokinetics ......................................................................................................... 20 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
23 PART II: SCIENTIFIC INFORMATION ....................................................................................... 24 13 PHARMACEUTICAL INFORMATION ................................................................................
24 14 CLINICAL TRIALS ............................................................................................................. 1 Trial Design and Study Demographics ........................................................................
2 Study Results ............................................................................................................. 27 15 MICROBIOLOGY ...............................................................................................................
31 16 NON-CLINICAL TOXICOLOGY ......................................................................................... ………33 Product Monograph ZAXINE, Rifaximin Tablets Page 4 of 36 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ZAXINE is indicated for: • the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
• the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. In the trials of ZAXINE for HE, 91% of the patients were treated with lactulose concomitantly or were on lactulose treatment concomitantly.
Differences in the treatment effect on those patients not using lactulose concomitantly could not be assessed. 6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure to rifaximin in patients with hepatic dysfunction.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of rifaximin, ZAXINE should only be used for the authorized indication and clinical use. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. In the trials of ZAXINE for IBS-D, patients who experienced a recurrence of symptoms and […]