Capecitabine (Capecitabine)

Trade Name : Capecitabine

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 150 mg/1

CAPECITABINE Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Capecitabine (Capecitabine) which is also known as Capecitabine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 150 mg/1 per ml. Read more

Capecitabine (Capecitabine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

Capecitabine-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 Capecitabine-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 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 was introduced. These events occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. 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.
WARNING: CAPECITABINE-WARFARIN INTERACTION
See full prescribing information for complete boxed warning.
Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulants such as warfarin and phenprocoumon should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. Altered coagulation parameters and/or bleeding, including death, have been reported during concomitant use.

Occurrence: Within several days and up to several months after initiating capecitabine therapy; may also be seen within 1 month after stopping capecitabine
Predisposing factors: age> 60 and diagnosis of cancer

Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for:

Adjuvant Colon Cancer
Metastatic Colorectal Cancer
Metastatic Breast Cancer

No data

Take capecitabine tablets with water within 30 min after a meal ()
Monotherapy: 1250 mg/m twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles ()
Adjuvant treatment is recommended for a total of 6 months (8 cycles) ()
In combination with docetaxel, the recommended dose of capecitabine tablets is 1250 mg/m twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m as a 1-hour IV infusion every 3 weeks ()
Capecitabine tablets dosage may need to be individualized to optimize patient management ()
Reduce the dose of capecitabine tablets by 25% in patients with moderate renal impairment ()

150 mg: Peach to light peach, oblong, film-coated, biconvex, unscored tablets, debossed with 190 on one side and 77 on the other side.
500 mg: Peach to light peach, oblong, film-coated, biconvex, unscored tablets debossed with 191 on one side and 77 on the other side.

Tablets: 150 mg and 500 mg ()

No data

Severe Renal Impairment ()
Hypersensitivity ()

No data

Coagulopathy
Diarrhea
Cardiotoxicity
Increased Risk of Severe or Fatal Adverse Reactions in Patients with Low or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity:
Dehydration and Renal Failure
Embryo-Fetal Toxicity
Mucocutaneous and Dermatologic Toxicity
Hyperbilirubinemia
Hematologic

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.
Most common adverse reactions (u2265 30%) were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

Anticoagulants: Monitor anticoagulant response (INR or prothrombin time) frequently in order to adjust the anticoagulant dose as needed. (5.2, )
Phenytoin: Monitor phenytoin levels in patients taking capecitabine concomitantly with phenytoin. The phenytoin dose may need to be reduced. ()
Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin. ()u00a0u00a0
Allopurinol: Avoid the use of allopurinol during treatment with capecitabine.
CYP2C9 substrates: Care should be exercised when capecitabine is coadministered with CYP2C9 substrates. ()
Food reduced both the rate and extent of absorption of capecitabine. (, , )

No data

Lactation
Females and Males of Reproductive Potential
Geriatric
Hepatic Impairment
Renal Impairment

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 overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5'-DFUR, a lowu2013molecular-weight metabolite of the parent compound.
Single doses of capecitabine 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).

Capecitabine Tablets USP are a fluoropyrimidine carbamate with antineoplastic activity. They are an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5-fluorouracil.
The chemical name for capecitabine, USP is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has the following structural formula:
CHFNO M.W. 359.35
Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20u00b0C.
Capecitabine Tablets USP are supplied as oblong, film-coated, biconvex, unscored tablets for oral administration. Each peach to light peach-colored tablet contains 150 mg or 500 mg capecitabine, USP. The inactive ingredients are as follows: anhydrous lactose, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, talc, titanium dioxide, and yellow iron oxide.

No data

Adequate studies investigating the carcinogenic potential of capecitabine have not been conducted. Capecitabine was not mutagenic to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay). Capecitabine was clastogenic in vitro to human peripheral blood lymphocytes but not clastogenic to mouse bone marrow (micronucleus test). Fluorouracil causes mutations in bacteria and yeast. Fluorouracil also causes chromosomal abnormalities in the mouse micronucleus test .
In studies of fertility and general reproductive performance in female mice, oral capecitabine doses of 760 mg/kg/day (about 2300 mg/m/day) disturbed estrus and consequently caused a decrease in fertility. In mice that became pregnant, no fetuses survived this dose. The disturbance in estrus was reversible. In males, this dose caused degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids. In separate pharmacokinetic studies, this dose in mice produced 5'-DFUR AUC values about 0.7 times the corresponding values in patients administered the recommended daily dose.

No data

No data

Capecitabine Tablets USP are available as follows:
150 mg: Peach to light peach, oblong, film-coated, biconvex, unscored tablets, debossed with 190 on one side and 77 on the other side. Available in bottles of 60 tablets (NDC 0093-7473-06).
500 mg: Peach to light peach, oblong, film-coated, biconvex, unscored tablets debossed with 191 on one side and 77 on the other side. Available in bottles of 120 tablets (NDC 0093-7474-89).
Storage and Handling
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP TIGHTLY CLOSED.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Capecitabine is 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.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Diarrhea
Inform patients experiencing grade 2 diarrhea (an increase of 4 to 6 stools/day or nocturnal stools) or greater or experiencing severe bloody diarrhea with severe abdominal pain and fever to stop taking capecitabine. Advise patients on the use of antidiarrheal treatments (e.g., loperamide) to manage diarrhea n
Cardiotoxicity
Advise patients of the risk of cardiotoxicity and to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness n
Dihydropyrimidine Dehydrogenase Deficiency
Advise patients to notify their healthcare provider if they have a known DPD deficiency. Advise patients if they have complete or near complete absence of DPD activity they are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by capecitabine (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity) .
Dehydration and Renal Failure
Instruct patients experiencing grade 2 or higher dehydration (IV fluids indicated < 24 hours) to stop taking capecitabine immediately and to call their healthcare provider to correct the dehydration. Advise patients to not restart capecitabine until rehydrated and any precipitating causes have been corrected or controlled .
Important Administration Instructions
Advise patients to swallow capecitabine tablets whole with water within 30 minutes of a meal. Advise patients and caregivers not to crush or cut capecitabine tablets. Advise patients if they cannot swallow capecitabine tablets whole, to inform their healthcare provider .
Nausea
Instruct patients experiencing grade 2 nausea (food intake significantly decreased but able to eat intermittently) or greater to stop taking capecitabine immediately and to contact their healthcare provider for management of nausea n
Vomiting
Instruct patients experiencing grade 2 vomiting (2 to 5 episodes in a 24-hour period) or greater to stop taking capecitabine immediately and to contact their healthcare provider for management of vomiting .
Hand-and-Foot Syndrome
Instruct patients experiencing grade 2 hand-and-foot syndrome (painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patientsu2019 activities of daily living) or greater to stop taking capecitabine immediately and to contact their healthcare provider. Inform patients that initiation of symptomatic treatment is recommended and hand-and-foot syndrome can lead to loss of fingerprints which could impact personal identification .
Stomatitis
Inform patients experiencing grade 2 stomatitis (painful erythema, edema or ulcers of the mouth or tongue, but able to eat) or greater to stop taking capecitabine immediately and to contact their healthcare provider .
Fever and Neutropenia
Inform patients who develop a fever of 100.5u00b0F or greater or other evidence of potential infection to contact their healthcare provider .
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with capecitabine and for 6 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy .
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with capecitabine and for 3 months after the last dose .
Lactation
Advise females not to breastfeed during treatment with capecitabine and for 2 weeks after the last dose .
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Manufactured In Czech Republic By:n Opava-Komarov, Czech Republic
Manufactured For:n North Wales, PA 19454
Rev. H 3/2019

This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 Rev. F 3/2019

NDCn- 7473
CapecitabineTABLETS USP
150 mg
Cytotoxic Agent
PHARMACIST: Please dispense with accompanying Patient Information leaflet.
Rx only
60 TABLETS
TEVA

NDCn- 7474
CapecitabineTABLETS USP
500 mg
Cytotoxic Agent
PHARMACIST: Please dispense with accompanying Patient Information leaflet.
Rx only
120 TABLETS
TEVA

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Capecitabine (Capecitabine)

Trade Name : Capecitabine

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Capecitabine (Capecitabine)

Trade Name : Capecitabine

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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