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nilotinib-200mg

PRODUCT DETAILS

Active ingredient : Nilotinib hydrochloride monohydrate
Strength of the content : 200MG
Category : Anti-neoplastic drug

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Tasigna is cancer drugs, the main ingredient which is used as lapatinib, which prohibits growth of the tumor cells. Nilotinib is sold under the brand name Tasigna< which is a targeted cancer medication Tasigna tablet belongs to the class of kinase inhibitors. The medicine Tasigna in children younger than 1 year has no safety and efficacy not been established The drug Tasigna is a prescription drugs, which is used under the knowledge of medical oncologist.

DOSAGE

The usual dose of Tasigna Tablet should be given as twice daily at 12 hours time intervals Tasigna must be administer on an empty stomach Taking of food should not be at least 1 hour after the dose is taken or 2 hours before the dose is taken Who are unable to taken the Tasigna capsules, the patients can be dispersed the tablet in one teaspoon of applesauce. This tablet should be administer immediately within 15 minutes Tasigna should be combination with hematopoietic growth factors such as erythropoietin or G-CSF Also concomitant use with hydroxyurea or anagrelide

Dosage in adult patients with Philadelphia positive CML-CP:

The regular dose of the Tasigna tablet in this condition given is 300mg should be given orally as twice daily.

With resistant or intolerant Philadelphia positive CML-CP and CML-AP:

The normal dose is 400mg should be administered as orally twice in a day.

In pediatrics:

The normal dose 230mg/m2 should be administer orally twice daily The maximum dose of Tablet Tasigna is 400mg.

PHARMACOKINETICS

Absorption:
The Tasigna has bioavailability about 50% The time of peak plasma concentration is occurred within 3 hours after administration.
Distribution:
The Tasigna has serum protein binding is approximately 98% The Nilotinib blood to serum ratio is 0.68
Metabolism:
Tasigna is metabolized via CYP3A4 mediated oxidation. The prime flowing component in the blood stream is Nilotinib.
Elimination:
The half life period of Tasigna Tablet is approximately 17 hours. The mean apparent clearance value is 29L/hr.
Effect of food:
The effect of drug is increased to 82% when the dose was given 30 minutes after a high fat meal when compared to fasted patient.

MECHANISM OF ACTION

CML: chronic myelogenous leukemia is caused by BCR-ABL oncogene.Tasigna (nilotinib) is a kinase inhibitor, which prohibits BCR-ABL kinase activity. Binding of Tasigna to the ATP-binding site of BCR-ABL protein. The drug Tasigna prevents the proliferation of murine leukemic cell lines and human cell lines derived from patients with Philadelphia positive CML

PRECAUTION

Tasigna may cause thrombocytopenia, neutropenia and anemia, so check blood counts periodically to reduce these complications

Embryo fetal damage

While using this in pregnancy then the drug Tasigna causes fetal damage Examine the patients properly who are stop the Tasigna therapy, the range of Bcr-Abl transcripts level. Use the drug with caution while using Tasigna in patient who are suffered with Hypokalemia Hypomagnesemia Hepatotoxicity Electrolyte abnormalities

Long QT syndrome

Monitor ECG frequently Avoid concomitant use of Tasigna with anti-arrhythmia agents Provide supportive measures

Pancreatitis and elevated lipase

Patient suffering with pancreatitis may have serum lipase levels increase, this may results in abdominal symptoms and to decrease the problems, treatment should be postponed & undergone with appropriate diagnostics. Test serum lipase value periodically.

Tumor lysis syndrome

Maintain with sufficient hydration Balance the level of uric acid before starting the treatment.

DRUG INTERACTION

While interaction of strong CYP3A inhibitors with Tasigna drug interactions leads to increase nilotinib concentrations compared to while using Tasigna alone Concomitant use with strong CYP3A inducer leads to reduce nilotinib concentration Tasigna interaction With proton pump inhibitors: decrease the Tasigna efficacy Avoid combination of Tasigna with drugs that may prolong the QT interval like anti-arrhythmic drugs.

CONTRAINDICATION

Tasigna tablet is contraindicated in the patients who are having; Hypokalemia Hypomagnesemia Long QT syndrome

MISSED DOSE

If patients missed to have the dose , then administer the dose of Tasigna should be take within the time, or the missed dose should be swapped and continue the next dosing schedule. Consult with your doctor for more clarification

STORAGE

Stored at between 68℉ to 77℉ (20℃ to 25℃) room temperature keep away from heat, moisture and light.

SIDE EFFECTS

Tasigna side effects, General: Fatigue, pyrexia, asthenia, peripheral edema, face edema
Pulmonary: Dyspnae , Cough, oropharyngeal pain,
Skin: Rash, Pruritus, alopecia, dry skin
GIT: Nausea, constipation, diarrhea, vomiting, upper abdominal pain, dyspepsia
Nerve system: Dizziness , Headache,
Vascular: Hypertension
Muscle: Myalgia, arthralgia, muscle spasm, pain in extremity, back pain
Infections & infestations: Nasopharyngitis, upper respiratory tract infection, influenza, gastroenteritis
Eye: Eyelid edema, periorbital edema
Psychiatric: Insomnia, this are the tasigna side effects.

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