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Imatinib Mesylate (Imatinib Mesylate)

Trade Name : Imatinib Mesylate

West-Ward Pharmaceuticals Corp

TABLET, FILM COATED

Strength 100 mg/1

IMATINIB MESYLATE Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

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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 Imatinib Mesylate (Imatinib Mesylate) which is also known as Imatinib Mesylate and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 100 mg/1 per ml. Read more

Imatinib Mesylate (Imatinib Mesylate) 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.

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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.

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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.

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  • No data
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  • u00a0
  • 5.14
  • Imatinib mesylate is a kinase inhibitor indicated for the treatment of:
  • All doses of imatinib mesylate tablets should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Imatinib mesylate tablets can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400 mg tablet to reduce exposure to iron.
  • Imatinib Mesylate Tablets
  • 100 mg film-coated tablets: coated beige, round convex, tablet with the product identification u201c54 [above] 441u201d on one side and a score on the other side.
  • 400 mg film-coated tablets: coated beige, modified oval, tablet with the product identification u201c54 [score] 724u201d and a score on the other side.
  • Tablets (scored): 100 mg and 400 mg ()
  • None.
  • None. ()
  • No data
  • 5.1n- 6.1
  • 5.10n- 8.1
  • 5.11n- 6.2
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The most frequently reported adverse reactions (greater than or equal to 30%) were edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue and abdominal pain. ()
  • No data
  • 2.12n- 7.1n- 12.3
  • 7.2n- 12.3
  • 7.3n- 7.4n- 12.3
  • No data
  • Experience with doses greater than 800 mg is limited. Isolated cases of imatinib mesylate overdose have been reported. In the event of overdosage, observe the patient and give appropriate supportive treatment.
  • Adult Overdose
  • 1,200 to 1,600 mg (Duration Varying Between 1 to 10 Days):
  • 1,800 to 3,200 mg (as High as 3,200 mg Daily for 6 Days)
  • 6,400 mg (Single Dose)
  • 8 to 10 g (Single Dose)
  • A patient with myeloid blast crisis experienced Grade 1 elevations of serum creatinine, Grade 2 ascites and elevated liver transaminase levels, and Grade 3 elevations of bilirubin after inadvertently taking 1,200 mg of imatinib mesylate daily for 6 days. Therapy was temporarily interrupted and complete reversal of all abnormalities occurred within 1 week. Treatment was resumed at a dose of 400 mg daily without recurrence of adverse reactions. Another patient developed severe muscle cramps after taking 1,600 mg of imatinib mesylate daily for 6 days. Complete resolution of muscle cramps occurred following interruption of therapy and treatment was subsequently resumed. Another patient that was prescribed 400 mg daily, took 800 mg of imatinib mesylate on Day 1 and 1,200 mg on Day 2. Therapy was interrupted, no adverse reactions occurred and the patient resumed therapy.
  • Pediatric Overdose
  • One 3-year-old male exposed to a single dose of 400 mg experienced vomiting, diarrhea and anorexia and another 3-year-old male exposed to a single dose of 980 mg experienced decreased white blood cell count and diarrhea.
  • Imatinib is a small molecule kinase inhibitor. Each film-coated tablet contains imatinib mesylate equivalent to 100 mg or 400 mg of imatinib free base. Imatinib mesylate is designated chemically as 4-[(4-Methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]aminophenyl]benzamide methanesulfonate salt and its structural formula is:
  • Imatinib mesylate is a white to slightly yellowish powder. Its molecular formula is CHNO u2022 CHSO and its molecular weight is 589.7. Imatinib mesylate is soluble in methanol and slightly soluble in ethanol.
  • Imatinib Mesylate Tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. The tablet coating contains: iron oxide yellow, iron oxide red, macrogol, polyvinyl alcohol, talc, and titanium dioxide.
  • No data
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  • Imatinib Mesylate Tablets
  • 100 mg Tablet: Film-coated beige, round convex, tablet with the product identification u201c54 [above] 441u201d on one side and a score on the other side.
  • NDC 0054-0248-22: Bottle of 90 Tablets
  • NDC 0054-0248-12: 30 Unit-Dose Blisters
  • 400 mg Tablet: Film-coated beige, modified oval, tablet with product identification u201c54 [score] 724u201d and a score on the other side.
  • NDC 0054-0249-13: Bottle of 30 Tablets
  • NDC 0054-0249-22: Bottle of 90 Tablets
  • NDC 0054-0249-12: 30 Unit-Dose Blisters
  • Store at 20u00ba to 25u00baC (68u00baF to 77u00baF). [See USP Controlled Room Temperature.]
  • Protect from moisture. Dispense in a tight container, USP.
  • Do not crush imatinib mesylate tablets. Avoid direct contact of crushed tablets with the skin or mucous membranes. If such contact occurs, wash thoroughly as outlined in the references. Avoid exposure to crushed tablets.
  • Dosing and Administration
  • Advise patients to take imatinib mesylate tablets exactly as prescribed, not to change their dose or to stop taking imatinib mesylate tablets unless they are told to do so by their doctor. If the patient missed a dose of imatinib mesylate tablets, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time. Advise patients to take imatinib mesylate tablets with a meal and a large glass of water.
  • Fluid Retention and Edema
  • Inform patients of the possibility of developing edema and fluid retention. Advise patients to contact their health care provider if unexpected rapid weight gain occurs n
  • Hepatotoxicity
  • Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including jaundice, anorexia, bleeding or bruising n
  • Pregnancy and Breastfeeding
  • Advise patients to inform their doctor if they are or think they may be pregnant. Advise women of reproductive potential to avoid becoming pregnant while taking imatinib mesylate tablets. Female patients of reproductive potential taking imatinib mesylate tablets should use highly effective contraception during treatment and for fourteen days after stopping treatment with imatinib mesylate tablets Avoid breastfeeding during treatment and for 1 month after the last dose n
  • Drug Interactions
  • Imatinib mesylate and certain other medicines such as warfarin, erythromycin, and phenytoin, including over-the-counter medications such as herbal products, can interact with each other. Advise patients to tell their doctor if they are taking or plan to take iron supplements. Avoid grapefruit juice and other foods known to inhibit CYP3A4 while taking imatinib mesylate n
  • Pediatric
  • Advise patients that growth retardation has been reported in children and pre-adolescents receiving imatinib mesylate. The long term effects of prolonged treatment with imatinib mesylate on growth in children are unknown. Therefore, closely monitor growth in children under imatinib mesylate treatment n
  • Driving and Using Machines
  • Advise patients that they may experience side effects such as dizziness, blurred vision or somnolence during treatment with imatinib mesylate. Therefore, caution patients about driving a car or operating machinery.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • Revised November 2018
  • 10006715/05
  • No data
  • No data
  • No data

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

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Name Patient Supply

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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Pharmaceutical Contract Manufacturing

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