Imatib 400mg (Imatinib)
Imatib 100mg tablet belongs to class of anti cancer medicine which is useful for treating; Advanced myelogenous leukemia (CML), and gastrointestinal stromal tumors (GISTs) and a number of malignancies.
DESCRIPTION
Imatib 400mg tablet belongs to class of anti cancer medicine which is useful for treating; Advanced myelogenous leukemia (CML), and gastrointestinal stromal tumors (GISTs) and a number of malignancies. Imatib 400mg is a class of tyrosine kinase inhibitor which inhibits BCR-ABL kinase produced by chromosomal rearrangement in chronic myeloid leukemia and acute lymphoblastic leukemia.
The PDG-derived tyrosine kinase which are expressed in gastrointestinal stromal tumor. Imatib 400mg is used as alone treatment, or combine with some other medicine in the conditions of certain types of cancer or bone marrow disorders.
INDICATION
The drug Imatib 400mg is mostly indicated for the treatment of patient having following disease Aggressive systemic mastocytosis Chronic esinophillic leukemia Dermatofibrosarcoma protuberans Gastrointestinal stromal tumors Hyperesinophillic syndrome Myelodysplastic syndrome Myeloproliferative disease Philadelphia chromosome positive acute lymphoblastic leukemia Philadelphia chromosome positive chronic myeloid leukemia
ADME
ABSORPTION
It is highly absorbed peak plasma concentration of 2-4 hours. The bioavailability is 98%.
DISTRIBUTION
Imatib 400mg is highly bound to the human plasma protein is 95%.
METABOLISM
Primary enzyme that is specific for metabolism of Imatib 400mg tablet is CYP3A4. The Imatib 400mg Active metabolite is N-demethylated piperizine derivative
ELIMINATION
The excretion of Imatib 400mg is broadly occurred in feces. Nearly drug eliminated within 7 days via feces 81% and of drug through urine 13%. The half life time of Imatinib around 18 and 40 hours respectively
DOSAGE MANAGEMENT
DOSAGE AND ADMINISTRATION
The usual dose of tablet Imatib 400mg or 600mg as a single dose. Whereas 800mg which is administered as 400mg twice daily. Imatib 400mg tablets should be taken with food The recommended dose for following conditions;
ACUTE LYMPHOBLASTIC LEUKEMIA
In adults, the prescribed dose is 600mg should be taken orally as a single dose.
MYELODYSPLASTIC / MYELOPROLIFERATIVE DISEASES
The usual dose is 400mg PO qDay
HYPERESINOPHILLIC SYNDROME
In this condition, recommended dose is 400mg PO qDay
CHRONIC MYELOID LEUKEMIA
Chronic phase: In newly diagnosed patients, the dose of Imatib 400mg tablet is 400mg should be orally taken as a single dose. If the failure of chronic phase of the treatment with interferon alpha therapy; dose is raised to 600mg per day. Quick phase: 600mg PO qDay; dose variation to 400mg PO as twice in a day if there is no serious adverse drug reaction or non leukemia associated neutropenia or thrombocytopenia.
DERMATOFIBROSARCOMA PROTUBERANS
Recommended dose is 400mg PO q12hr
GASTROINTESTINAL STROMAL TUMORS
The prescribed dose of the tablet Imatib 400mg is 400mg should be taken orally as a twice daily
IN PEDIATRIC
CHRONIC MYELOID LEUKEMIA
<1 year: the safety and efficacy of the drug has not been established ≥1 year: 340mg/m2/day PO; should not be exceed 600mg/day
ACUTE LYMPHOBLASTIC LEUKEMIA
<1 year: the safety and efficacy of the drug has not been established ≥1 year: 340mg/m2/day PO; should not be exceed 600mg/day
PRECAUTIONS
in hepatic impairment patients use with caution Avoid concomitant use with strong CYP3A4 inducers Risk of serious ventricular dysfunction (CHF) Bleeding occurs In children Growth retardation occurs
SIDE EFFECTS
GENERAL DISORDERS
Weakness, anasarca, chills, malaise
VASCULAR DISORDERS
Flushing, hemorrhage, hypertension, peripheral coldness, Reynaud’s phenomenon, elevated LDH levels
SKIN DISORDERS
Dry skin, alopecia, face edema, Erythema, photosensitivity reactions, nail disorder, purpura, psoriasis, rashes, vascular rash, Stevens Johnson syndrome, acute febrile neutrophillic dermatosis.
CARDIAC DISORDERS
Palpitations, pericardial effusion, congestive cardiac failure, tachycardia, pulmonary edema, arrhythmia, atrial fibrillation, cardiac arrest, myocardial infarction, angina pectoris
GASTROINTESTINAL DISORDERS
Abdominal distension, gastro esophageal reflux, dry mouth, gastritis, gastric ulcer, stomatitis, mouth ulcer, eructation, esophagitis, dysphasia, and pancreatitis
BLOOD AND LYMPHATIC SYSTEM
Pancytopenia, febrile neutropenia, Lymphopenia, esinophillia, thrombocythemia, bone marrow depression, lymphadenopathy, hemolytic anemia, Aplastic anemia
HEPATOBILIARY
Hepatitis, jaundice, hepatic failure, hepatic necrosis
IMMUNE SYSTEM
Angioedema
INFECTION AND INFESTATION
Sepsis, herpes simplex, herpes zoster, cellulitis, urinary tract infection, gastroenteritis
METABOLISM AND NUTRITION
Weight decreased, loss of appetite, dehydration, gout, hyperuricemia, hypocalcaemia, hyperglycemia, hyponatremia, hyperkelamia, hypomagnesemia
MUSCULOSKELETAL
Joint swelling, muscle stiffness, muscular weakness, arthritis
NERVE SYSTEM
Paresthesia, hypesthesia, syncope, peripheral neuropathy, somnolence, tremor
RENAL AND URINARY DISORDERS
Renal failure, frequency of urine will increased, Hematuria, renal pain
REPRODUCTIVE SYSTEM
Breast enlargement, menorrhagia, sexual dysfunction, gynecomastia, erectile dysfunction, menstruation irregular, nipple pain, scrotal edema
RESPIRATORY
Epistaxis, pleural effusion, interstitial pneumonitis, pulmonary fibrosis, pulmonary hypertension, pulmonary hemorrhage
EYE, EAR AND LABYRINTH DISORDERS
Conjunctivitis, vision blurred, orbital edema, conjuctival hemorrhage, dry eye, vertigo, tinnitus, eye irritation, eye pain, scleral hemorrhage, retinal hemorrhage, papilla edema, glaucoma
DRUG INTERACTION
Imatib 400mg tablet is contraindicated to some medicines like; Interaction with these drugs Cobimetinib, conivaptan, dihydroergotamine, eliglustat, aspirin, vitamin D, rosuvastatin, duloxetine, dasatinib, grapefruit, ibuprofen, Atorvastatin, pregabalin will reduce effectiveness of the drug.
CONTRAINDICATION
The Imatib 400mg tablet is contraindicated to the hypersensitivity reaction and the products of its expicients
PREGNANCY & LACTATION
Pregnancy category: D Imatib 400mg should not administrated for pregnant women and breast feeding mothers, it will cause fetal malformations and cause harm to the fetus. The metabolites excreted into human milk
STORAGE
Stored in cool and dry place The drug should keep away from moisture, heat and light.
MISSED DOSE
If the patient missed to take the drug, he/ she should administered within a time. Or the ,tablet should be discontinued and follow the next drug schedule. Please consult the doctor.
Brand name
|
Imatib |
Active substance
|
Imatinib 400mg |
Packaging
|
10 Tablets |
Product form
|
Tablet |
Strength
|
400mg |
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