Safety, Tolerance and Bio-equivalence of Imatinib (Gleevec) Tablets over Capsules

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Safety, Tolerance and Bio-equivalence of
Imatinib (Gleevec) Tablets over Capsules
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• Generic Imatinib
• Brand Gleevec
• Imatinib Mesylate is a medication used for the
  treatment of certain kinds of cancers such as
• chronic myeloid leukemia
• gastrointestinal stomach tumours
• acute lymphoblastic leukemia
• myelodysplastic / myeloproliferative diseases
• Imatinib / Gleevec is a chemotherapeutic
  medication which is used to slow down or stop
  tumour growth.
• Imatinib / Gleevec cost information

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Imatinib (Gleevec) is proven to be highly
effective in treating chronic myeloid leukemia
and gastrointestinal tumors. However, the
recommended daily dose of 400-600 mg requires
taking several capsules of 100 mg dosage or a
combination of 100 mg and 400 mg capsules.
Swallowing multiple capsules at the same time
may have negative impact on treatment
adherence. In response to this problem, imatinib
100 mg and 400 mg film-coated tablets were
developed. Additionally, a research test was
conducted to study their effectiveness.
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• Research Overview
• A group of 33 candidates were on random assigned
  to 1 of the 6 treatment combination of imatinib
  capsules / tablets.
• The candidates were given either of the
  following
• Four 100 mg capsules as a reference point
• Four 100 mg scored tablets for testing
• One 400 mg tablet for testing

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After 96 hours of taking the doses, blood
sampling tests were performed. This was
followed by a 10 day period of washout before the
next sequence can start. After receiving the 3rd
dose, the candidates were observed for adverse
events due to the medication.
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Results 95 of the confidence intervals were
within the pre-determined intervals. 1 moderate
and 8 mild adverse events were reported that
could have been related to the medication. Howeve
r, these events were of no clinical significance
as no clustering by type of the dosage form was
observed.
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Conclusion The 100 mg film coated tablets
(scored) and the 400 mg tablets were deemed to be
as safe and tolerated as the commercial 100 mg
hard gelatin capsules.
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Imatinib Mesylate Usage Imatinib (Gleevec)
tablets are generally taken once or twice in a
day with a meal and a glass of water (240 ml or 8
ounces) or as directed by a doctor. Do not
crush, chew or break the tablet.
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If you are facing difficulty in swallowing the
tablet. You can dissolve it in a glass of water
or apple juice, stir it thoroughly and drink it
immediately. The amount of liquid to be
consumed depends on the dosage required. Several
factors such as your response to treatment, other
medications that you may take and your medical
condition are considered by your doctor when
determining the dosage to be taken.
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Inform your doctor about all the medications that
you are taking such as prescription medications,
non-prescription medications, vitamins and/or
herbal products. Imatinib / Gleevec side effects
and interactions
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• Some common Imatinib side effects include
• Low levels of white and/or red blood cells
• Vomiting and/or nausea
• Skin rashes
• Pain in bone and/or muscles cramps
• Bleeding problems (haemorrhage)
• Fever
• Diarrhea

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Avoid the use of grapefruit or grapefruit
products as they can interact with Imatinib to
cause unwanted side effects. Do not increase or
decrease the dosage taken of this medication as
they cause other side effects to occur and reduce
the medications effectiveness.
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Imatinib can be absorbed through the skin and
lungs. Therefore, pregnant women should avoid
handling this medication to prevent harm to the
unborn baby. Imatinib Cost Information The
information provided on the page is meant for the
purpose of being helpful and educational. It
should not be considered as medical advice.
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