Capecitabine (Capecitabine)

Trade Name : Capecitabine

West-Ward Pharmaceuticals Corp.

TABLET, FILM COATED

Strength 150 mg/1

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

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 West-Ward Pharmaceuticals Corp.. 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • 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 is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:
  • No data
  • 2n- 2
  • Capecitabine Tablets USP 150 mg and 500 mg are supplied as pink to speckled pink film-coated, modified oval, beveled edge tablets.
  • Tablets: 150 mg and 500 mg ()
  • No data
  • 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 (u226530%) were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported. ()
  • No data
  • 5.2n- 7.1
  • 2n- 7.2n- 12.3
  • 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 5u2019-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 2,000 mg/kg (2.4, 4.8, and 9.6 times the recommended human daily dose on a mg/m basis).
  • Capecitabine is a fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5u2019-deoxy-5-fluorouridine (5u2019-DFUR) which is converted to 5-fluorouracil.
  • The chemical name for capecitabine is 5u2019-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35. Capecitabine has the following structural formula:
  • Capecitabine USP is a white to off-white powder that is sparingly soluble in water.
  • Capecitabine Tablets USP are supplied as pink to speckled pink, film-coated, modified oval tablets for oral administration. Each tablet contains either 150 mg or 500 mg capecitabine USP. The inactive ingredients in Capecitabine Tablets USP include: croscarmellose sodium, magnesium stearate and silicified microcrystalline cellulose. In addition to the ingredients listed above, each tablet contains Opadry II (Pink). Opadry II (Pink) contains FD&C Blue #2 Indigo Carmine Aluminum Lake, FD&C Red #40 Allura Red AC Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, macrogol, polydextrose, titanium dioxide, and triacetin.
  • 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 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 2,300 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 5u2019-DFUR AUC values about 0.7 times the corresponding values in patients administered the recommended daily dose.
  • No data
  • http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • Capecitabine Tablets USP
  • 150 mg supplied as a pink to speckled pink film-coated, modified oval, beveled edge tablet with product identification u201c54 242u201d on one side and plain on the other.
  • NDC 0054-0271-21: Bottle of 60 Tablets
  • 500 mg supplied as pink to speckled pink film-coated, modified oval, beveled edge tablet with product identification u201c54 706u201d on one side and plain on the other.
  • NDC 0054-0272-23: Bottle of 120 Tablets
  • Storage and Handling
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] KEEP TIGHTLY CLOSED.
  • 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 [].
  • 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 [].
  • 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 your 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 [n ].
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006275/06
  • Revised December 2019
  • No data
  • Capecitabine Tablets USP
  • NDC 0054-0271-21: Bottle of 60 Tablets
  • Rx only
  • Capecitabine Tablets USP
  • NDC 0054-0272-23: Bottle of 120 Tablets
  • Rx only

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71247 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.