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capecitabine
Overview
What is Capecitabine?
Capecitabine tablets, USP are a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5’-deoxy-5-fluorouridine (5’-DFUR) which is converted to 5-fluorouracil.
The chemical name for capecitabine is Pentyl 1-(5-deoxy-
-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate and has a molecular weight of 359.35. Capecitabine has the following structural formula:
Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC.
Capecitabine is supplied as film-coated tablets for oral administration. Each round, white tablet contains 150 mg capecitabine and each oval, white tablet contains 500 mg capecitabine. The inactive ingredients in capecitabine tablets include: anhydrous lactose, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
What does Capecitabine look like?
What are the available doses of Capecitabine?
Capecitabine Tablets, USP are available containing 150 mg or 500 mg of capecitabine, USP.
What should I talk to my health care provider before I take Capecitabine?
How should I use Capecitabine?
Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures.1 If capecitabine tablets must be cut or crushed, this should be done by a professional trained in safe handling of cytotoxic drugs using appropriate equipment and safety procedures. Capecitabine tablets dose is calculated according to body surface area.
What interacts with Capecitabine?
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What are the warnings of Capecitabine?
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What are the precautions of Capecitabine?
Sorry No Records found
What are the side effects of Capecitabine?
Sorry No records found
What should I look out for while using Capecitabine?
Severe Renal Impairment (
)
Hypersensitivity (
)
Capecitabine Tablets-Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important capcitabine tablets-warfarin drug interaction was demonstrated in a clinical pharmacology trial
. Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine tablets concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time capecitabine tablets were introduced. These events occurred within several days and up to several months after initiating capecitabine tablets therapy and, in a few cases, within 1 month after stopping capecitabine tablets. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
What might happen if I take too much Capecitabine?
The manifestations of acute overdose would include nausea, vomiting, diarrhea, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary supportive medical interventions aimed at correcting the presenting clinical manifestations. Although no clinical experience using dialysis as a treatment for capecitabine tablets overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5’-DFUR, a low–molecular-weight metabolite of the parent compound.
Single doses of capecitabine tablets were not lethal to mice, rats, and monkeys at doses up to 2000 mg/kg (2.4, 4.8, and 9.6 times the recommended human daily dose on a mg/m
basis).
How should I store and handle Capecitabine?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs. Capecitabine Tablets, USP are available containing 500 mg of capecitabine, USP.The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-510-05 – Unit dose blister packages of 20 (2 cards of 10 tablets each).Storage and Handling: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]Capecitabine tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. Any unused product should be disposed of in accordance with local requirements, or drug take back programs.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Enzymes convert capecitabine to 5-fluorouracil (5-FU)
. Both normal and tumor cells metabolize 5-FU to 5-fluoro-2’-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N
-methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2’-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division. Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.
Non-Clinical Toxicology
Severe Renal Impairment ( )Hypersensitivity ( )
Capecitabine Tablets-Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important capcitabine tablets-warfarin drug interaction was demonstrated in a clinical pharmacology trial . Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine tablets concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon. Postmarketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time capecitabine tablets were introduced. These events occurred within several days and up to several months after initiating capecitabine tablets therapy and, in a few cases, within 1 month after stopping capecitabine tablets. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.
Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with UNASYN may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with UNASYN and allopurinol administered concurrently. UNASYN and aminoglycosides should not be reconstituted together due to the inactivation of aminoglycosides by the ampicillin component of UNASYN.
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely with great frequency and the anticoagulant dose should be adjusted accordingly
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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