XIFAXAN Tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Salix Pharmaceuticals, Inc.
Λέξεις κλειδιά
65649-301 65649-303
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Indications and Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection should be used only to treat or prevent ...
2. Dosage and Administration
2.1 Dosage for Travelers' Diarrhea The recommended dose of XIFAXAN is one 200 mg tablet taken orally three times a day for 3 days. 2.2 Dosage for Hepatic Encephalopathy The recommended dose of XIFAXAN ...
3. Dosage Forms and Strengths
XIFAXAN is a pink-colored biconvex tablet and is available in the following strengths: 200 mg – a round tablet debossed with Sx on one side and plain on the other. 550 mg – an oval tablet debossed with ...
4. Contraindications
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative ...
5. Warnings and Precautions
5.1 Travelers' Diarrhea Not Caused by Escherichia coli XIFAXAN was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in labeling: <em>Clostridium difficile</em>-associated diarrhea <em>[see Warnings and Precautions (5.2)]</em>
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of XIFAXAN. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot ...
7. Drug Interactions
7.1 P-glycoprotein Inhibitors Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, ...
8.1. Pregnancy
Risk Summary There are no available data on XIFAXAN use in pregnant women to inform any drug-associated risks. Teratogenic effects were observed in animal reproduction studies following administration ...
8.2. Lactation
Risk Summary There is no information regarding the presence of rifaximin in human milk, the effects of rifaximin on the breastfed infant, or the effects of rifaximin on milk production. The development ...
8.4. Pediatric Use
The safety and effectiveness of XIFAXAN has not been established in pediatric patients less than 12 years of age with TD or in patients less than 18 years of age for HE and IBS-D.
8.5. Geriatric Use
Of the total number of patients in the clinical study of XIFAXAN for HE, 19% of patients were 65 and over, while 2% were 75 and over. In the clinical studies of IBS-D, 11% of patients were 65 and over, ...
8.6. Renal Impairment
The pharmacokinetics of rifaximin in patients with impaired renal function has not been studied.
8.7. Hepatic Impairment
Following administration of XIFAXAN 550 mg twice daily to patients with a history of hepatic encephalopathy, the systemic exposure (i.e., AUC<sub>τ</sub>) of rifaximin was about 10-, 14-, and 21-fold higher ...
10. Overdosage
No specific information is available on the treatment of overdosage with XIFAXAN. In clinical studies at doses higher than the recommended dose (greater than 600 mg per day for TD, greater than 1,100 mg ...
11. Description
XIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is ...
12.1. Mechanism of Action
Rifaximin is an antibacterial drug <em>[see Clinical Pharmacology (12.4)]</em>.
12.3. Pharmacokinetics
Absorption In healthy subjects, the mean time to reach peak rifaximin plasma concentrations was about an hour and the mean C<sub>max</sub> ranged 2.4 to 4 ng/mL after a single dose and multiple doses of ...
12.4. Microbiology
Mechanism of Action Rifaximin is a semi-synthetic derivative of rifampin and acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase blocking one of the steps in transcription. This ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Malignant schwannomas in the heart were significantly increased in male Crl:CD (SD) rats that received rifaximin by oral gavage for two years at 150 to 250 mg/kg per day (doses equivalent to 2.4 to 4 times ...
14. Clinical Studies
14.1 Travelers' Diarrhea The efficacy of XIFAXAN given as 200 mg orally taken three times a day for 3 days was evaluated in 2 randomized, multi‑center, double-blind, placebo-controlled studies in adult ...
16.1. How Supplied
The 200 mg tablet is a pink-colored, round, biconvex tablet with Sx debossed on one side and plain on the other. It is available in the following presentation: NDC 65649-301-03, bottles of 30 tablets ...
16.2. Storage and Handling
Store XIFAXAN Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
17. Patient Counseling Information
Persistent Diarrhea For those patients being treated for travelers' diarrhea, discontinue XIFAXAN if diarrhea persists more than 24-48 hours or worsens. Advise the patient to seek medical care for fever ...