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205, Al Qaizi Building, Al Muteena Street, Deira 40192 AE
JollyRX
205, Al Qaizi Building, Al Muteena Street, Deira , AE
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61adb9ceef82a93ef21a3345 ESBRIET 267 MG 270 CAP. https://cdn1.storehippo.com/s/6052eead9e1cf8aa024c48c8/61adb937aef48f31eb8fb12c/webp/esbriet-267-mg-270-cap-.png

What is Esbriet and how is it used?

Esbriet is a prescription medicine used to treat the symptoms of Idiopathic Pulmonary Fibrosis. Esbriet may be used alone or with other medications.

Esbriet belongs to a class of drugs called Transforming Growth Factor Inhibitors.

It is not known if Esbriet is safe and effective in children.

What are the possible side effects of Esbriet?

Esbriet may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • persistent nausea,
  • vomiting,
  • loss of appetite,
  • stomach pain,
  • yellowing of the eyes and skin (jaundice),
  • dark urine,
  • rash, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Esbriet include:

  • tiredness,
  • lack of energy,
  • loss of appetite,
  • weight loss,
  • change in taste,
  • dizziness,
  • nausea,
  • upset stomach,
  • vomiting,
  • diarrhea, and
  • heartburn

DESCRIPTION

ESBRIET belongs to the chemical class of pyridone. ESBRIET is available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration, or, as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone.

Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone.

ESBRIET® (pirfenidone) Structural Formula - Illustration

Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C.

ESBRIET capsule contains pirfenidone and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate.

In addition, the capsule shell contains gelatin and titaniuum dioxide. The capsule brown printing ink includes shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide.

ESBRIET tablets contain pirfenidone and the following inactive ingredients: Microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.

INDICATIONS

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

DOSAGE AND ADMINISTRATION

Testing Prior To ESBRIET Administration

Conduct liver function tests prior to initiating treatment with ESBRIET [see WARNINGS AND PRECAUTIONS].

Recommended Dosage

The recommended daily maintenance dosage of ESBRIET is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day.

Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows:

Table 1. Dosage Titration for ESBRIET in Patients with IPF

Treatment daysDosage
Days 1 through 7267 mg three times daily (801 mg/day)
Days 8 through 14534 mg three times daily (1602 mg/day)
Days 15 onward801 mg three times daily (2403 mg/day)

Dosages above 2403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

Dosage Modifications Due To Adverse Reactions

Patients who miss 14 or more days of ESBRIET should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Recommended Dosage]. For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed.

If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms [see WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

CYP1A2 Inhibitors

Pirfenidone is metabolized primarily (70 to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1.

Strong CYP1A2 Inhibitors

The concomitant administration of ESBRIET and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to ESBRIET [see CLINICAL PHARMACOLOGY]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of ESBRIET and avoided during ESBRIET treatment. In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of ESBRIET as needed [see DOSAGE AND ADMINISTRATION].

Moderate CYP1A2 Inhibitors

Concomitant administration of ESBRIET and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to ESBRIET [see CLINICAL PHARMACOLOGY]. If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended [see DOSAGE AND ADMINISTRATION]. Monitor patients closely when ciprofloxacin is used at a dosage of 250 mg or 500 mg once daily.

Concomitant CYP1A2 And Other CYP Inhibitors

Agents or combinations of agents that are moderate or strong inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of ESBRIET (i.e., CYP2C9, 2C19, 2D6, and 2E1) should be discontinued prior to and avoided during ESBRIET treatment.

CYP1A2 Inducers

The concomitant use of ESBRIET and a CYP1A2 inducer may decrease the exposure of ESBRIET and this may lead to loss of efficacy. Therefore, discontinue use of strong CYP1A2 inducers prior to ESBRIET treatment and avoid the concomitant use of ESBRIET and a strong CYP1A2 inducer [see CLINICAL PHARMACOLOGY].

PRECAUTIONS

Elevated Liver Enzymes And Drug-Induced Liver Injury

Cases of drug-induced liver injury (DILI) have been observed with ESBRIET. In the postmarketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. Patients treated with Esbriet 2403 mg/day in three Phase 3 trials had a higher incidence of elevations in ALT or AST ≥3x ULN than placebo patients (3.7% vs 0.8%, respectively). Elevations ≥10xULN in ALT or AST occurred in 0.3% of patients in the Esbriet 2403 mg/day group and in 0.2% of patients in the placebo group. Increases in ALT and AST ≥3x ULN were reversible with dose modification or treatment discontinuation.

Conduct liver function tests (ALT, AST, and bilirubin) prior to the initiation of therapy with ESBRIET, monthly for the first 6 months, every 3 months thereafter, and as clinically indicated. Measure liver function tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Dosage modification or interruption may be necessary for liver enzyme elevations [see DOSAGE AND ADMINISTRATION].

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ESBRIET 267 MG 270 CAP.

ESBRIET 267 MG 270 CAP.

₹100


Sold By: jollyrx
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Description of product

What is Esbriet and how is it used?

Esbriet is a prescription medicine used to treat the symptoms of Idiopathic Pulmonary Fibrosis. Esbriet may be used alone or with other medications.

Esbriet belongs to a class of drugs called Transforming Growth Factor Inhibitors.

It is not known if Esbriet is safe and effective in children.

What are the possible side effects of Esbriet?

Esbriet may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • persistent nausea,
  • vomiting,
  • loss of appetite,
  • stomach pain,
  • yellowing of the eyes and skin (jaundice),
  • dark urine,
  • rash, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Esbriet include:

  • tiredness,
  • lack of energy,
  • loss of appetite,
  • weight loss,
  • change in taste,
  • dizziness,
  • nausea,
  • upset stomach,
  • vomiting,
  • diarrhea, and
  • heartburn

DESCRIPTION

ESBRIET belongs to the chemical class of pyridone. ESBRIET is available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration, or, as film-coated tablets containing 267 mg (yellow) and 801 mg (brown) pirfenidone.

Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone.

ESBRIET® (pirfenidone) Structural Formula - Illustration

Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C.

ESBRIET capsule contains pirfenidone and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate.

In addition, the capsule shell contains gelatin and titaniuum dioxide. The capsule brown printing ink includes shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide.

ESBRIET tablets contain pirfenidone and the following inactive ingredients: Microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, and iron oxide.

INDICATIONS

ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

DOSAGE AND ADMINISTRATION

Testing Prior To ESBRIET Administration

Conduct liver function tests prior to initiating treatment with ESBRIET [see WARNINGS AND PRECAUTIONS].

Recommended Dosage

The recommended daily maintenance dosage of ESBRIET is 801 mg three times daily for a total of 2403 mg/day. Doses should be taken with food at the same time each day.

Upon initiation of treatment, titrate to the full dosage of 2403 mg/day over a 14-day period as follows:

Table 1. Dosage Titration for ESBRIET in Patients with IPF

Treatment daysDosage
Days 1 through 7267 mg three times daily (801 mg/day)
Days 8 through 14534 mg three times daily (1602 mg/day)
Days 15 onward801 mg three times daily (2403 mg/day)

Dosages above 2403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day.

Dosage Modifications Due To Adverse Reactions

Patients who miss 14 or more days of ESBRIET should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Recommended Dosage]. For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed.

If patients experience significant adverse reactions (i.e., gastrointestinal, photosensitivity reaction or rash), consider temporary dosage reductions or interruptions of ESBRIET to allow for resolution of symptoms [see WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

CYP1A2 Inhibitors

Pirfenidone is metabolized primarily (70 to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1.

Strong CYP1A2 Inhibitors

The concomitant administration of ESBRIET and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to ESBRIET [see CLINICAL PHARMACOLOGY]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of ESBRIET and avoided during ESBRIET treatment. In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of ESBRIET as needed [see DOSAGE AND ADMINISTRATION].

Moderate CYP1A2 Inhibitors

Concomitant administration of ESBRIET and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to ESBRIET [see CLINICAL PHARMACOLOGY]. If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended [see DOSAGE AND ADMINISTRATION]. Monitor patients closely when ciprofloxacin is used at a dosage of 250 mg or 500 mg once daily.

Concomitant CYP1A2 And Other CYP Inhibitors

Agents or combinations of agents that are moderate or strong inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of ESBRIET (i.e., CYP2C9, 2C19, 2D6, and 2E1) should be discontinued prior to and avoided during ESBRIET treatment.

CYP1A2 Inducers

The concomitant use of ESBRIET and a CYP1A2 inducer may decrease the exposure of ESBRIET and this may lead to loss of efficacy. Therefore, discontinue use of strong CYP1A2 inducers prior to ESBRIET treatment and avoid the concomitant use of ESBRIET and a strong CYP1A2 inducer [see CLINICAL PHARMACOLOGY].

PRECAUTIONS

Elevated Liver Enzymes And Drug-Induced Liver Injury

Cases of drug-induced liver injury (DILI) have been observed with ESBRIET. In the postmarketing period, non-serious and serious cases of DILI, including severe liver injury with fatal outcome, have been reported. Patients treated with Esbriet 2403 mg/day in three Phase 3 trials had a higher incidence of elevations in ALT or AST ≥3x ULN than placebo patients (3.7% vs 0.8%, respectively). Elevations ≥10xULN in ALT or AST occurred in 0.3% of patients in the Esbriet 2403 mg/day group and in 0.2% of patients in the placebo group. Increases in ALT and AST ≥3x ULN were reversible with dose modification or treatment discontinuation.

Conduct liver function tests (ALT, AST, and bilirubin) prior to the initiation of therapy with ESBRIET, monthly for the first 6 months, every 3 months thereafter, and as clinically indicated. Measure liver function tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Dosage modification or interruption may be necessary for liver enzyme elevations [see DOSAGE AND ADMINISTRATION].

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