Erlonat

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BRAND :  ERLONAT  PRICE :  250$ STRENGTH : 150 MG ACTIVE :  ERLONAT-ERLOTINIB-150MG COMPANY NAME :  NATCO TABLETS :  30 TABLETS read more

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Drug profile 

Erlonat  is a Natco pharma item which is containing a functioning substance known as Erlotinib, a first line medication of decision in metastatic phase of non little cell lung tumor.

Erlonat  is normally endorsed for the patients who are not counters to less than one chemotherapy regimen.

Erlonat  is synthetically described as quinazoline subordinate, with hostile to neoplastic impact against tumor cells.

Erlonat  is pharmacologically arranged as tyrosine kinase inhibitor.

Erlonat  is altogether raising the serum aminotransferase levels amid the treatment and this may causes liver wounds.

Erlonat  tablets are containing 150mg of Erlotinib as a hostile to tumor specialist.

 

Brand name: Erlonat  

Active constituent: Erlotinib

Strength: 150MG

Mfg: Natco pharma

Pack: 30 tablets per container

Category: Anti-neoplastic agent

                       

Prescribing information of Erlonat ;

Before starting therapy with Erlonat , determination of mutation status is necessary for the patients to prevent the conditions like false positive or negative assessment.

 

Non small cell lung cancer:

Erlonat  tablets are indicated primarily for the treatment of advanced NSCLC, in patients who are containing exon 19 deletions or 21substitution mutations.

Erlonat  tablets are also considered as monotherapy for the advanced NSCLC patients who are progressive after 4 weeks of therapy with platinum based compounds.

Erlonat  is mainly indicated for the patients who are not responding for one chemotherapy drugs.

But the potency of Erlonat  has not been evaluated, for first line treatment in advanced NSCLC exon 19 deletions or mutations.

Erlotinib is also considered as a first line therapy while combining with gemcitabine which is eligible to treat advanced pancreatic carcinoma.

 

Mechanism of Erlonat

Erlonat  has Erlotinib dynamic substance comprising hostile to neoplastic action with tyrosine kinase denying impact.

Erlotinib is depicts as epidermal development factor receptor write I tyrosine kinase inhibitor.

Erlonat  displays hostile to tumor action by following up on cell surface in which the EGFR presents.

Erlonat  mediates with EGFR phosphorylation which is brings about cell lyses.

Erlonat  is likewise engaged with blockage of EFGR related flag exchange which is contributed for cell development.

Because of barricade of following motioning of EFGR, cell expansion is ceased and incited cell demise.

 

Absorption

Nearly 60% of Erlotinib get absorbed after oral administration of Erlonat  tablets.

The oral bioavailability reaches nearly 100%

The maximum plasma concentration time reaches at 4 hours after drug intake.

Erlotinib solubility is depends upon pH value, if pH increases leads to decrease the Erlotinib solubility.

In case of co administration of Erlonat  tablets with gastric regulators like proton pump inhibitors causes depletion of Erlotinib exposure and leads to increase its concentration.

 

Distribution

Approximately 93% of Erlotinib get binds to human plasma protein.

The apparent volume of distribution is 232L

 

Metabolism

The metabolism of Erlotinib is induced by CYP3A4 and lesser extent with CYP1A2.

There are three major metabolic pathway involves in Erlotinib metabolism;

Oxidation of carboxylic acids leads to O-demethylation of side chains.

The hydrolysis of aryl carboxylic acid causes oxidation of acetylene moiety.

Phenyl acetylene moiety undergo aromatic hydroxylation

 

Excretion

The mean creatinine clearance value 4.47L/hr

The terminal half life period of Erlotinib is 36.2 hours

The steady state plasma concentration occurs within 7 to 8 days.

 

When to take the Erlonat  tablets

Erlonat  tablets should be administered on an empty stomach; it should be taken at least 1 hour earlier or 2 hours after food intake.

 

Dosage regimens of Erlonat

In NSCLC:

The prescribed dose of Erlonat  in this condition is 150mg of tablet should be taken as once a day.

This therapy should be followed until disease progression and toxicity occurs.

In pancreatic:

The prescribed dose is 100mg of Erlotinib tablet should be combined with gemcitabine.

If patients not getting severe rashes, then therapy with Erlonat  should be continue.

In combinational therapy of Erlonat  with CYP3A4 substrates or modulators, dosage alteration is necessary for up to 50mg.

 

Dose modification;

In pulmonary symptoms like cough, dyspnea, fever conditions; Erlonat  tablets treatment should be postpones.

In interstitial lung disease: Discontinue the therapy.

In Bullous or exfoliative skin conditions or renal disorders; postpone or discontinue the treatment.

Severe diarrhea: Provide with supportive measures like loperamide tablets, or discontinue the treatment.

In case of dose reduction is required for the patients, Erlonat  dose may reduced to 50mg

Cigarette smoking should be avoided it may causes reduction in exposure of Erlotinib.

During elevation of bilirubin, an AST or ALT level causes liver injuries; Erlotinib undergoes hepatic metabolism & biliary elimination. Treatment should be interrupt or discontinue and investigate LFT frequently.

 

Erlonat  caused side effects

The most common adverse effects occurred in this therapy such as;

Severe diarrhea

Rashes

Interstitial lung disease

In NSCLC:

Anorexia

Fatigue

Dry skin

Conjunctivitis

Keratoconjuctivitis

Abdominal pain

Cough

Dyspnea

Nausea

Diarrhea

Rash

Infection

Vomiting

Stomatitis

Pruritus

Hepatic function abnormalities like;

Elevation of;

Bilirubin

AST

ALT

In pancreatic cancer;

Similar to NSCLC but some exceptional like;

Edema

Pyrexia

Constipation

Loss of weight

Dizziness

Insomnia

Alopecia

Anxiety

Neuropathy

Flatulence

Rigors

Deep venous thrombosis

Hemolytic anemia with thrombocytopenia

Cardiac disorders

Hemorrhage

Renal damage

Bone pain

Myalgia

Depression

In both NSCLS & pancreatic;

Peptic ulcer bleeding

Melena

Hematochezia

Hematemesis

Hypokalemia

Post marketing effects;

Skin & subcutaneous effects like hirsutism, eyelash or eyebrows altered, nail disorders,

GI perforations

Hepatic failure

 

Drug -drug interaction

Erlotinib should not be combined with platinum based compounds; it may increases the effect of concentration of platinum based compounds.

Erlonat  should not be concomitant with Capecitabine; it may causes elevation of effect of concentration of Erlotinib.

Proteasome prohibitor like Bortezomib may be conventionally significant the effect of EFGR inhibitors including Erlonat  

Erlonat  tablets are strong inhibitor of CYP1A1, moderate inhibitor of CYP3A4 & CYP2C8 and also potent inhibitor of Glucuronidation by UGT1A1.

Erlonat  tablets combined with CYP3A4 inhibitors causes increasing the exposure of Erlonat .

CYP3A4 inhibitors like ketaconazole, ciprofloxacin, ritonavir, clarithromycin, voriconazole.

Erlonat  tablet co administered with CYP3A4 inducers like rifampicin causes decreasing the exposure of Erlonat . Some CYP3A4 inducers like rifabutin, rifapentine, anti-convulsants.

Cigarette smoking is occurs during the therapy with Erlonat , leads to decreasing the exposure to Erlonat .

Erlonat  solubility is occurs by pH values, once pH decreases solubility of Erlotinib get increases and causes loss of effects.

Erlonat  should not be co administered with gastric regulators at a time; some time intervals like around 2 hours should be taken before or after ingestion of food.

 

Food drug interaction

Erlonat  tablets should be taken on an empty stomach; because pH regulates the solubility of Erlotinib.

Avoid intake of grape fruit or juice during therapy with Erlotinib.

This may results as elevating the Erlotinib levels in the body leads to causes adverse effects.

 

Possible contraindications

Any anaphylactic reactions like rashes, Stevens Johnson syndrome may occur during the therapy due to the patients are contraindicated to the component of Erlonat .

 

Safety measures

1.Pulmonary toxicities:

Interstitial lung disease may occur to overcome this effect by interrupt or discontinue the treatment with Erlonat .

Patient may frequently examine by undergone ILD analysis; this may occur in combinational therapy with gemcitabine.

2.Renal damage:

Some renal disorders may occur, to avoid this problem postpone or discontinue the theory with Erlonat  tablets and follow the regular renal function test.

3.Hepatic failure:

Due to increasing levels of bilirubin, AST & ALT causes liver toxicity, to prevent this effect monitor the patients with frequent hepatic function test.

In severe condition, treatment should be stopped.

4.Diarrhea:

Providing rehydration due to loss of fluids and also give loperamide as a alternative drug.

 In severity, discontinue the therapy with Erlonat

5.GI perforations:

This may occur due to concurrent use of Erlonat  with NSAIDS, corticosteroids, anti-angiogenic agents, or taxane based compounds causes GI perforation by increasing the acid levels in stomach.

This may overcome by discontinuing the treatment.

6.Bullous & exfoliative skin disorders:

Interrupt or stop the treatment

7.Cardiac disorders:

Myocardial infarction may occur due to combination of Erlonat  with gemcitabine, to avoid this problem stop the combinational therapy.

8.Cerebrovascular disorders:

Hemorrhage may occurs, stop the therapy

9.Hemolytic anemia related to thrombocytopenia:

Frequently counts the blood cells before & after the therapy for avoiding this problem.

10.Ocular disorders: In serious condition, stop the treatment

11.Bleeding:

Patient receiving coumarin derivatives or warfarin with Erlonat , must monitor with prothrombin time or INR values periodically to prevent bleeding disorders.

 

Pregnancy and lactation

Pregnancy category D

Erlotinib causes fetal harm; it should not be suggested in pregnancy condition.

Breast feeding should not be allowed.

The potency of Erlotinib has not been evaluated in pediatric patients.

 

Storage and handling

Erlonat  tablet container should be stored at 25oC.

The container should be keep away from heat, light & moisture.

 

Missed dose

Missed dose should not be followed, if it may occur patient must be consult with medical oncologist and follow the instructions

Follow the correct dosing schedule to avoid the missed dose condition; this may results as increasing the adverse effects of Erlotinib.

 

Over dosage

Missed dose is the one of the reason for obtaining over dosage condition.

Once over dosage of Erlonat  occurs in patients, must provided with supportive measures and follow the preventive measures

The over dosage of Erlotinib causes severe diarrhea & rashes, elevating AST, ALT leads to liver damage.

Discontinue the therapy.

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