Zyceva 100mg (Erlotinib)

Erlotinib
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Zydus

Zyceva 100mg (Erlotinib)

ManufacturerZydusBrand nameZycevaActive substanceErlotinibStrength100mgCategoryAnti CancerManufacturerZydus

Description  of  Zyceva 100mg (Erlotinib 100mg)

Zyceva 100mg (Erlotinib 100mg) tablets consist of active ingredients known as Erlotinib (Generic Tarceva), that is considered as quinazoline derivative and anti-cancer agents that responses as a protein kinase prohibitors for EGFR related to tyrosine kinase. Zyceva 100mg (Erlotinib 100mg) is majorly used in the treatment of non-small cell lung cancer and pancreatic carcinoma and also involved to treat various cancers. Zyceva 100mg (Erlotinib 100mg) is especially aimed the epidermal growth factor receptor tyrosine kinase.

INDICATIONS of  Zyceva 100mg (Erlotinib 100mg)

Non small cell lung cancer:
Zyceva 100mg (Erlotinib 100mg) is indicated as continuance therapy, in patients with long lasting or metastasis non small cell lung carcinoma, whose disease has not get advance after four cycles with platinum based first line therapy. Zyceva 100mg (Erlotinib 100mg) is used in this condition only after the failure of one prior chemotherapy regimen. No clinical advantages occur while using Zyceva 100mg (Erlotinib 100mg) with platinum based compounds like Carboplatin, gemcitabine or cisplatin.
Pancreatic cancer:
Zyceva 100mg (Erlotinib 100mg) (Erlotinib Hydrochloride) tablet is indicated for the treatment concurrently with gemcitabine, gemcitabine is a chemotherapy drug used to treat the cancer of ovary, breast, pancreas, bladder and non small cell lung cancer. Cisplatin is also a chemotherapic drug used for the treatment of various types of cancer.

MECHANISM OF ACTION  of  Zyceva 100mg (Erlotinib 100mg)

Zyceva 100mg (Erlotinib 100mg) has pharmacological effects like anti-neoplastic activity, which exhibits its action by inhibiting the intracellular phosphorylation of tyrosine kinase related with epidermal growth factor receptor. This EGFR is present on the surface of the tumor cells. Thus results as inhibition causes interfere with signal transduction and lead to cell lyses.

ADME of  Zyceva 100mg (Erlotinib 100mg)

The peak plasma concentration time reaches at 4 hours after drug intake After an oral administration of Zyceva 100mg (Erlotinib 100mg), causes 60% of oral bioavailability. Increased by meals to 100%. The solubility of Erlotinib is depends upon pH level. If solubility decreases then leads to increasing pH levels. Smoking should be avoided during the treatment with Zyceva 100mg (Erlotinib 100mg), causes decreasing the exposure of Erlotinib. The apparent volume of distribution of Erlotinib is 232L Human protein binding to Erlotinib is occurs as 93%. The metabolism of Erlotinib is occurs by CYP3A4 The route of elimination of Erlotinib metabolites occurs via; Feces: 83%; urine: 8% half life period of Erlotinib is 36.2 hours.

 SIDE EFFECTS  of  Zyceva 100mg (Erlotinib 100mg)

During the therapy, some undesirable effects like; Paronychia, Bullous, blistering and expoliative skin conditions like Stevens Johnson’s syndrome. Gastrointestinal perforation Hepatic failure occurs during monotherapy or combination with other chemotherapy agents Some common side effects: Diarrhea, Fatigue, Anorexia, Pruritus, Acne, Dermatitis, Dry skin, Loss of weight, Paronychia, Cough, Vomiting, Conjunctivitis, Keratoconjuctivities sicca, Abdominal pain, Stomatits, Infection, nausea, Bone pain, Alopecia, Anxiety, Neuropathy, Renal disorders, hepatic disorders, ocular disorders, skin, hair and nail disorders.          

 

PRECAUTIONS  of  Zyceva 100mg (Erlotinib 100mg)

 

Pulmonary toxicity: Interstitial lung disease and other pulmonary toxicity conditions, Avoid the treatment with Zyceva 100mg (Erlotinib 100mg) Renal failure: Frequent monitoring of renal function or serum electrolytes occurs or avoids the treatment. Bullous & exfoliative skin disorders Myocardial infarction or Ischemia Cerebrovascular accident Ocular disorder Elevation of bleeding while concurrent use with warfarin Hemolytic anemia or thrombocytopenia In pregnancy condition In all these condition, treatment using with Zyceva 100mg (Erlotinib 100mg) should be avoided. Hepatic failure: Hepatic function should be periodically monitored, or otherwise discontinue the therapy with Zyceva 100mg (Erlotinib 100mg). Gastro intestinal perforation: In this condition, discontinue the Zyceva 100mg (Erlotinib 100mg) therapy permanently. This condition is occurs due to concurrent use of Zyceva 100mg (Erlotinib 100mg) with NSAIDS, anti-angiogenic drugs, corticosteroids, taxane based chemotherapy or other drugs etc.

DRUG INTERACTION  of  Zyceva 100mg (Erlotinib 100mg)

Co administration of Zyceva 100mg (Erlotinib 100mg) with midazolam causes decreasing the AUC of CYP3A4 substrate. Drugs involved in alteration of pH levels causes variation in solubility of Erlotinib. Avoid concomitant use of gastric regulators with Zyceva 100mg (Erlotinib 100mg). Avoid concomitant use of warfarin with Zyceva 100mg (Erlotinib 100mg), causes increasing the bleeding condition. Co administration of Zyceva 100mg (Erlotinib 100mg) with CYP3A4 strong inhibitors like ketaconazole causes increasing Erlotinib exposure. Zyceva 100mg (Erlotinib 100mg) concomitant with statins drugs (lipid lowering drug), causes increasing the concentration of these drugs (rosuvastatin, simvastatin or atorvastatin). Zyceva 100mg (Erlotinib 100mg) concurrently used with ciprofloxacin, CYP3A4 & CYP1A2 inhibitor causes elevation of exposure of Erlotinib tablets. CYP3A4 strong inhibitors like itraconazole, grape fruit juice, rotonavir, indinavir etc CYP3A4 inducers concurrently used with Zyceva 100mg (Erlotinib 100mg) tablets causes decreasing the exposure of Erlotinib. CYP3A4inducers like, rifampin, rifampicin, carbamazepine, phenytoin etc Cigarette smoking is decreasing the AUC of Erlotinib.

OVERDOSAGE  of  Zyceva 100mg (Erlotinib 100mg)

In case of over dosage, Zyceva 100mg (Erlotinib 100mg) therapy should be postponed and symptomatic treatment should be recommended.

PREGNANCY  of Zyceva 100mg (Erlotinib 100mg)

 

Pregnancy category: D

Zyceva 100mg (Erlotinib 100mg) should not be used in pregnancy condition

LACTATION  of Zyceva 100mg (Erlotinib 100mg)

Breast feeding should not be suggested

DOSAGE of  Zyceva 100mg (Erlotinib 100mg)

The usual recommended dosage of Zyceva 100mg (Erlotinib 100mg) is 150mg should be administered as a single dose by taking in an empty stomach for at least one hour earlier or two hours after intake of food. Therapy with Zyceva 100mg (Erlotinib 100mg) should be continued until the disease advanced or undesirable toxicity occurs. It is not confirmed that the advancement after the therapy is beneficial or not.
In pancreatic cancer:
The daily usual recommended dosage of Zyceva 100mg (Erlotinib 100mg) in pancreatic carcinoma is 100mg should be taken on an empty stomach as a single dose. In this condition Zyceva 100mg (Erlotinib 100mg) is combined with gemcitabine.
Dosage adjustment:
In case of patients suffered with pulmonary symptoms like dyspnea, fever, cough, or any other conditions, Zyceva 100mg (Erlotinib 100mg) treatment should be discontinued. In interstitial lung disease: To avoid the Zyceva 100mg (Erlotinib 100mg) therapy. In case of gastrointestinal perforation or hepatic failure: Post pone or discontinue the Zyceva 100mg (Erlotinib 100mg) treatment. If diarrhea occurs during the therapy, substitute with loperamide for managing this condition. If dosage reduction is necessary then the dose of Zyceva 100mg (Erlotinib 100mg) reduced into 50mg. Dose reduction is essential in the condition, while concomitant of Zyceva 100mg (Erlotinib 100mg) with strong CYP3A4 inhibitors like atazanavir, clarithromycin, indinavir, itraconazole, ketaconazole, voriconazole, grape fruit juice etc. Dosage elevation occurs in case of concurrent use of Zyceva 100mg (Erlotinib 100mg) with strong CYP3A4 inducers like rifampin, rifampicin, anti-convulsants etc. The dosage should be increased by 50mg. In chain smoking conditions, increase the dose of Erlotinib into 50mg at two intervals to higher dose of 300mg. Then the dose is suddenly reduced to 100mg or 150mg in discontinuation of smoking. Zyceva 100mg (Erlotinib 100mg) should not be administered with gastric regulators drug, like proton pump inhibitors or H2 receptor antagonist. In H2 receptors antagonist: Administer Zyceva 100mg (Erlotinib 100mg) at least 10 hours after or 2 hours before H2 receptors antagonist. In proton pump inhibitors: Do not use concurrently if possible.


STORAGE  of  Zyceva 100mg (Erlotinib 100mg)

Zyceva 100mg (Erlotinib 100mg) tablets should be stored at 25℃ (77℉). Protect from light, heat & moisture


MISSED DOSE of  Zyceva 100mg (Erlotinib 100mg)

In case of missed dose, patients must consult with medical oncologist and follow the regular dosing schedule.

Brand name:
Zyceva
Active substance:
Erlotinib
Strength:
100mg
Category:
Anti Cancer
Manufacturer:
Zydus
Packaging:
30 Tablet
Product form:
Tablet

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