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Rx Item-Xifaxan 550Mg Tab 60 By Valeant Pharma

NDC 65649-0303-03 UPC/GTIN No.3-65649-30303-6 Mfg.Part No.30303BRAND: XIFAXAN NDC: 65649-0303-03,65649030303 UPC: 3-65649-30303-6,365649303036 Valeant PharmaOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Xifaxan 550Mg Tab 60 By Valeant Pharma

$3570.38$3199.00

Item No.: RX081529 NDC No.65649030303 UPC No.:365649303036 NDC No.65649-0303-03 UPC/GTIN No.3-65649-30303-6 MPN 30303 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx081529 Xifaxan 550mg Tab 60 by Valeant Pharma Item No.3081529 NDC No.65649030303 UPC No.365649303036 Other Name Xifaxan Therapeuti

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XIFAXAN � rifaximin tablet
Physicians Total Care, Inc.


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 infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1.1 Travelers� Diarrhea
XIFAXAN 200 mg is indicated for the treatment of patients (? 12 years of age) with travelers� diarrhea caused by noninvasive strains of Escherichia coli [ see Warnings and Precautions (5) , Clinical Pharmacology (12.4) and Clinical Studies (14.1)].
Limitations of Use
XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.
1.2 Hepatic Encephalopathy
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ? 18 years of age.
In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. Differences in the treatment effect of those patients not using lactulose concomitantly could not be assessed.
XIFAXAN has not been studied in patients with MELD (Model for End-Stage Liver Disease) scores > 25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction [see Warnings and Precautions (5.4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
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. XIFAXAN can be administered orally, with or without food [see Clinical Pharmacology (12.3)].
2.2 Dosage for Hepatic Encephalopathy
The recommended dose of XIFAXAN is one 550 mg tablet taken orally two times a day, with or without food[see Clinical Pharmacology (12.3)].
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.
550 mg � an oval tablet debossed with �rfx" on one side.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
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 dermatitis, angioneurotic edema, and anaphylaxis [see Adverse Reactions ( 6.2)].
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 than Escherichia coli.
Discontinue XIFAXAN if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered.
XIFAXAN is not effective in cases of travelers� diarrhea due to Campylobacter jejuni. The effectiveness of XIFAXAN in travelers� diarrhea caused by Shigella spp. and Salmonella spp. has not been proven. XIFAXAN should not be used in patients where Campylobacter jejuni , Shigella spp., or Salmonella spp. may be suspected as causative pathogens.
5.2 Clostridium difficile -Associated Diarrhea
Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, 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. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.3 Development of Drug Resistant Bacteria
Prescribing XIFAXAN for travelers� diarrhea in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
5.4 Severe (Child-Pugh C) Hepatic Impairment
There is increased systemic exposure in patients with severe hepatic impairment. Animal toxicity studies did not achieve systemic exposures that were seen in patients with severe hepatic impairment. The clinical trials were limited to patients with MELD scores <25. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C)
[see Use in Specific Populations (8.7), Nonclinical Toxicology (13.2) and Clinical Studies (14.2)].
6 ADVERSE REACTIONS
6.1 Clinical Studies 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 drug and may not reflect the rates observed in practice.
Travelers� Diarrhea
The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers� diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ? 65 years old, 53% were male and 84% were White, 11% were Hispanic.
Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation.
All adverse reactions for XIFAXAN 200 mg three times daily that occurred at a frequency ? 2% in the two placebo-controlled trials combined are provided in Table 1. (These include adverse reactions that may be attributable to the underlying disease.)
OVERDOSAGE
No specific information is available on the treatment of overdosage with XIFAXAN. In clinical studies at doses higher than the recommended dose (> 600 mg/day for travelers� diarrhea or > 1100 mg/day for hepatic encephalopathy), adverse reactions were similar in subjects who received doses higher than the recommended dose and placebo. In the case of overdosage, discontinue XIFAXAN, treat symptomatically, and institute supportive measures as required.
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 (2S ,16Z ,18E ,20S ,21S ,22R ,23R ,24R ,25S ,26S ,27S ,28E)-5,6,21,23,25-pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca-[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-�]-benzimidazole-1,15(2H)-dione,25-acetate. The empirical formula is C43 H51 N3 O11 and its molecular weight is 785.9.
XIFAXAN Tablets for oral administration are film-coated and contain 200 mg or 550 mg of rifaximin.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Rifaximin is an antibacterial drug
Microbiology
Mechanism of Action
Rifaximin is a non-aminoglycoside semi-synthetic antibacterial derived from rifamycin SV. Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase resulting in inhibition of bacterial RNA synthesis.
Escherichia coli has been shown to develop resistance to rifaximin in vitro. However, the clinical significance of such an effect has not been studied.
Rifaximin is a structural analog of rifampin. Organisms with high rifaximin minimum inhibitory concentration (MIC) values also have elevated MIC values against rifampin. Cross-resistance between rifaximin and other classes of antimicrobials has not been studied.
Rifaximin has been shown to be active against the following pathogen in clinical studies of infectious diarrhea as described in the Indications and Usage (1) section: Escherichia coli (enterotoxigenic and enteroaggregative strains).
For HE, rifaximin is thought to have an effect on the gastrointestinal flora.
Susceptibility Tests
In vitro susceptibility testing was performed according to the National Committee for Clinical Laboratory Standards (NCCLS) agar dilution method M7-A6 [see References (15)]. However, the correlation between susceptibility testing and clinical outcome has not been determined.


NDC 65649-0303-03 UPC/GTIN No.3-65649-30303-6 Mfg.Part No.30303
RX ITEM-Xifaxan 550Mg Tab 60 By Valeant
NDC 65649-0303-03 UPC/GTIN No.3-65649-30303-6 Mfg.Part No.30303

BRAND: XIFAXAN NDC: 65649-0303-03,65649030303 UPC: 3-65649-30303-6,365649303036 Valeant Pharma
Xifaxan 550Mg Tab 60 By Valeant Pharma
BRAND: XIFAXAN NDC: 65649-0303-03,65649030303 UPC: 3-65649-30303-6,365649303036 Valeant Pharma

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
RIFAXIMIN ORAL TABLET 550
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.