Imacent 100 mg (Tablet)

Unit Price: ৳ 100.00 (3 x 10: ৳ 3,000.00)
Strip Price: ৳ 1,000.00

Medicine Details

Category Details
Generic Imatinib mesylate
Company Incepta pharmaceuticals ltd
Also available as
Imacent 400 mg tablet

Title

  • Imacent Tablets 100mg, 400mg, 600mg, and 800mg

Categories

  • Medicine
  • Oncology
  • Hematology
  • Pharmacology

Description

  • Imatinib is a small molecule protein-tyrosine kinase inhibitor
  • First-line treatment for adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase
  • Treatment for patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
  • Treatment for adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
  • Adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST)
  • Treatment for patients with hypereosinophilic syndrome, chronic eosinophilic leukemia, aggressive systemic mastocytosis, dermatofibrosarcoma protuberans, and myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements
  • Information on absorption, distribution, metabolism, and excretion of Imatinib
  • Dosage and administration guidelines for different conditions
  • Interactions with other drugs and substances
  • List of potential side effects and precautions
  • Guidance on usage during pregnancy, lactation, and fertility
  • Storage conditions for Imatinib tablets

Strengths

  • 100mg
  • 400mg
  • 600mg
  • 800mg

Packaging

  • Tablets

Manufacturer

  • Name of manufacturer

Mode of Action

  • Protein-tyrosine kinase inhibition
  • Inhibition of Bcr-Abl tyrosine kinase and various receptor tyrosine kinases including Kit, discoidin domain receptors, colony stimulating factor receptor, and platelet-derived growth factor receptors

Absorption and Distribution

  • Well absorbed after oral administration
  • Cmax achieved within 2-4 hours post-dose
  • Mean absolute bioavailability is 98%
  • Mean Imatinib AUC increases proportionally with increasing doses
  • Plasma protein binding approximately 95%

Metabolism

  • CYP3A4 is the major enzyme responsible for metabolism
  • N-demethylated piperazine derivative is the main circulating active metabolite
  • Approximately 81% of the dose eliminated within 7 days, in feces (68% of dose) and urine (13% of dose)

Excretion

  • Elimination is predominately in the feces, mostly as metabolites
  • Approximately 25% of the dose excreted unchanged
  • Elimination half-lives of Imatinib and N-demethyl derivative are approximately 18 and 40 hours, respectively

Dosage and Administration

  • 400 mg/day for adults with Ph+ CML CP
  • 600 mg/day for adults with Ph+ CML AP or BC
  • 340 mg/m2/day for pediatrics with Ph+ CML CP
  • 600 mg/day for adults with Ph+ ALL
  • 340 mg/m2/day for pediatrics with Ph+ ALL
  • 400 mg/day for adults with MDS/MPD
  • 100 mg/day or 400 mg/day for adults with ASM
  • 100 mg/day or 400 mg/day for adults with HES/CEL
  • 800 mg/day for adults with DFSP
  • 400 mg/day for adults with metastatic and/or unresectable GIST
  • 400 mg/day for adjuvant treatment of adults with GIST
  • 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
  • Can be dissolved in water or apple juice for patients having difficulty swallowing
  • Guidance for patients with hepatic impairment

Drug Interactions

  • Agents Inducing CYP3A4 Metabolism
  • Agents Inhibiting CYP3A4 Metabolism
  • Interactions with drugs metabolized by CYP3A4
  • Interactions with drugs metabolized by CYP2D6

Side Effects

  • Fluid Retention and Edema
  • Hematologic Toxicity
  • Congestive Heart Failure and Left Ventricular Dysfunction
  • Hepatotoxicity
  • Hemorrhage
  • Gastrointestinal Disorders
  • Hypereosinophilic Cardiac Toxicity
  • Dermatologic Toxicities
  • Hypothyroidism
  • Growth Retardation in Children and Adolescents
  • Tumor Lysis Syndrome
  • Impairments Related to Driving and Using Machinery
  • Renal Toxicity

Pregnancy and Lactation

  • Use of effective contraception during treatment and for at least 15 days after stopping treatment
  • Limited data on use in pregnant women
  • Distribution into human milk
  • Effects on fertility and gametogenesis

Precautions and Warnings

  • Edema and severe fluid retention
  • Cytopenias, particularly anemia, neutropenia, and thrombocytopenia
  • Severe congestive heart failure and left ventricular dysfunction
  • Severe hepatotoxicity
  • Grade 3/4 hemorrhage
  • Cardiogenic shock/left ventricular dysfunction
  • Bullous dermatologic reactions
  • Hypothyroidism
  • Fetal harm
  • Growth retardation
  • Tumor Lysis Syndrome
  • Motor vehicle accidents
  • Renal Toxicity

Overdose Effects

  • Limited experience with doses higher than the recommended therapeutic dose
  • Reported outcomes and events at different dose ranges for adults and pediatric populations

Therapeutic Class

  • Targeted Cancer Therapy
  • Tyrosine Kinase Inhibitor

Storage Conditions

  • Store below 30°C
  • Cool and dry place
  • Keep away from light
  • Keep out of the reach of children

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