Posology and method of administration Xeloda

Xeloda should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products. Careful monitoring during the first cycle of treatment is recommended for all patients
Teva Pharmaceuticals USA has obtained FDA approval to market generic capecitabine at 150 and 500 mg strengths.
"Generic drugs are important options that allow greater access to health care for all Americans," said Kathleen Uhl, MD, acting director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research. "This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options."
According to the National Cancer Institute, an estimated 1.6 million people in the United States will be diagnosed with cancer and 580,000 will die in 2013. An estimated 142,820 people will be diagnosed with and 50,830 will die from colon and rectum cancer 2013 it is estimated that 232,340 women will be diagnosed with and 39,620 women will die from breast cancer in 2013.
In clinical trials for treatment with Xeloda, the most commonly observed adverse reactions were diarrhea; vomiting; nausea; pain, redness, swelling or sores in the mouth; Hand-foot syndrome (pain, swelling or redness of the hands or feet that prevents normal activity); and fever or infection.
It is important that the doctor knows if the patient is also taking a drug that is used to thin the blood, such as warfarin. Capecitabine may increase the effect of this drug, which can lead to serious side effects. Capecitabine has a boxed warning to alert healthcare professionals and patients about this risk.
Generic drugs approved by FDA have the same high quality and strength as brand-name drugs. Sites and generic drug manufacturing packaging must pass the same quality standards as those of brand name drugs.
Information about the availability of generic capecitabine can be obtained from Teva.
For more information:

      FDA: Understanding Generic Drugs
      National Cancer Institute: Comprehensive Cancer Information
      Information about specific drug products, Drugs @ FDA

The FDA, an agency within the Department of Health and Human Services United States, protects the public health by assuring the safety, efficacy and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply of our nation, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating snuff products ....
Chemotherapy drugs xeloda - chemotherapy pill for colon cancer
*Xeloda® is a registered trademark of Genentech USA, Inc.

FDA approves first generic XELODA (capecitabine) to treat colorectal and breast cancers

The U.S. Food and Drug Administration today approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer.
U.S. Department of Health and Human Services
Xeloda Contraindications

• History of severe and unexpected reactions to fluoropyrimidine therapy,

• Hypersensitivity to capecitabine or to any of the excipients listed in section 6.1 or fluorouracil,

• In patients with known dihydropyrimidine dehydrogenase (DPD) deficiency (see section 4.4),

• During pregnancy and lactation,

• In patients with severe leukopenia, neutropenia, or thrombocytopenia,

• In patients with severe hepatic impairment,

• In patients with severe renal impairment (creatinine clearance below 30 ml/min),

• Treatment with sorivudine or its chemically related analogues, such as brivudine (see section 4.5),

• If contraindications exist to any of the medicinal products in the combination regimen, that medicinal product should not be used.

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Xeloda FDA Prescribing Information

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