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Osicent 80mg (Osimertinib)

Product Name : Osicent
Generic Name : Osimertinib
Formulation : Tablet
Available Pack Size : 30’s
Available Strengths : 80 mg
Registrations : Export Only

Product Description

What is Osicent 80mg?

Osicent 80mg is a medicine prescribed by medical professionals to treat non-small cell lung cancer. Osicent 80mg drug is researched based on a target drug, Osimertinib, so it directly targets cancer cells, paralyzing and blocking their activity.

Basic information of the drug Osicent 80mg

  • Active ingredient: Osimertinib.
  • Classification of active ingredients: Anticancer drugs, protein kinase inhibitors.
  • Trade name: Osicent 80.
  • Dosage form: Film-coated tablets.
  • Product packaging: Box of 1 bottle of 30 tablets.
  • Origin: Incepta Pharmaceutical Company - Bangladesh.

Ingredients of Osicent 80mg

  • Osicent 80mg tablet contains:
  • Osimertinib - 80 mg.
  • Mixed excipients just enough 1 tablet.

Pharmacodynamic properties

  • Osimertinib is a tyrosine kinase inhibitor, which irreversibly inhibits epidermal growth factor receptors (EGFRs) containing susceptible mutations (EGFRm) and TKI resistance mutations T790M resulting in inhibition of the growth of cell.

Pharmacokinetic properties

  • Absorption: The bioavailability and rate of oral absorption of osimertinib are increased following administration of the crushed tablet in relation to the administration of the whole tablet. After oral administration, maximum concentrations are obtained on average 6 (3-24) hours.
  • Distribution: The estimated median volume of distribution in the study population for osimertinib at steady state (Vss/F) is 997 L indicating extensive tissue distribution.
  • Metabolism: In vitro studies have shown that osimertinib is metabolised primarily by CYP3A4 and CYP3A5. Metabolism via CYP3A4 may be a secondary route of metabolism. Alternative metabolic pathways may exist but have not been fully described.
  • Elimination: Following a single oral dose of 20 mg, 67.8% of the dose was detected in the feces (1.2% unchanged), while 14.2% of the dose (0.8% as unchanged drug) was detected. unchanged) was found in the urine 84 days after sample collection. Unchanged osimertinib accounts for approximately 2% of elimination with 0.8% in the urine and 1.2% in the faeces.

Effects - indications of Osicent 80mg

Osicent medicine 80mg with the main ingredient is Osimertinib with the corresponding strength is indicated for:

  • Treatment of advanced or metastatic non-small cell lung cancer that has the EGFR T790M mutation.
  • Treatment of non-small cell lung cancer when other treatments have failed.

Contraindications of Osicent 80mg

The use of Osicent 80mg is contraindicated in the following cases:

  • Patients with known hypersensitivity to osimertinib or any of the excipients.
  • Pregnant women, lactating women.
  • Children, the elderly.

How to take Osicent 80mg

  • Osicent 80mg is taken orally. Can be taken before or after meals.
  • The medication is usually taken once a day in cycles to ensure steady absorption into the body.
  • Note: Do not crush, split or chew. however, it can be dissolved in water if the patient cannot swallow.

Dosage of Osicent 80mg

  • Dosage of Osicent depends on the weight, health and age of the patient.
  • However, the recommended dose depends on the use of monotherapy or a combination of anticancer drugs.
  • Dosage is used on cancers and malignant tumors as prescribed by the doctor.
  • Recommended dosage: Maximum 2 tablets, 1 time per day.
  • Adjust the next dose (increase/decrease) in increments of 80 mg depending on tolerability. Only the initial dose should be reduced from 160mg to 80mg per day.

Caution when using Osicent 80mg

  • Treatment with this medicine must be through a qualified and experienced physician.
  • Do not change the dose on your own without consulting your doctor.
  • When Osicent 80mg is required, patients should be carefully monitored for unusual or potent side effects.
  • Adjust dose in patients with hepatic impairment.
  • Talk to your doctor about your medical condition such as high blood pressure, cardiovascular dysfunction, etc.
  • Before treatment, patients should be informed about the side effects of the drug, as well as drug interactions, if any.

Use Osicent 80mg in pregnant or lactating women

  • Pregnant women: Do not use osimertinib if you are pregnant. If you are pregnant you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 weeks after your last dose.
  • Lactation: Women who are breast-feeding should not use Osicent 80mg or if using Osicent 80mg should not breast-feed while taking this medicine and for at least 2 weeks after the last dose. .

Use Osicent 80mg with drivers and machine operators

  • The drug Osicent 80mg can cause users to have fever, fatigue, and headache.
  • So do not use machines, drive a car, or do anything that requires alertness or clear vision until you are sure you can do it safely.

What are the side effects of Osicent 80mg?

Some unwanted effects that may occur when taking Osicent 80mg include:

  • Common side effects can be:
  • Mouth sores, loss of appetite.
  • Diarrhea.
  • Feeling tired.
  • Dry skin, rash.
  • Pain, discoloration, infection, or other problems with your fingernails or toenails.
  • Other less common side effects were not mentioned. Not all side effects are listed here.

Tell your doctor if you experience any unwanted effects.

Interactions of Osicent 80mg with other products

Some drugs and Osicent 80mg may interact with each other, increasing/decreasing plasma drug concentrations including:

  • Phenytoin, carbamazepine or phenobarbital.
  • Rifabutin or rifampicin
  • Modafinil.
  • Aliskiren.
  • Rosuvastatin.
  • Hormonal oral contraceptives are used to prevent pregnancy.

Be sure to tell your doctor the list of medications you are taking so that the most appropriate treatment can be given.

Forgotten dose of Osicent 80mg and how to handle it

  • If the patient forgets to take a dose, it should be taken as soon as the patient remembers.
  • If you miss a dose of Osicent 80mg for too long and it is almost time for your next dose, skip the missed dose.
  • Do not take 2 doses of Osicent 80mg at the same time to make up for a missed dose.

Overdose of the drug Osicent 80mg and how to handle it

  • There is no specific treatment for an overdose of Osicent 80mg.
  • In case of a suspected overdose, the drug should be stopped immediately and treated symptomatically.
  • In an emergency situation, go to the nearest local Health station.

How to store Osicent 80mg

  • Store Osicent 80mg in a cool, dry place.
  • The temperature should not exceed 30°C.
  • Avoid direct sun exposure.
  • Keep out of reach of children and pets.

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