Interactions between Omesec and Pirfenidone
1 drug interaction and 8 additional warnings found for the following 2 drugs:
- Omesec (omeprazole)
- pirfenidone
Drug interactions
Moderate drug interactions
Moderate:
omeprazole pirfenidone
Applies to: Omesec (omeprazole) and pirfenidone
Monitor
Coadministration with moderate or potent inhibitors of CYP450 2C9, 2C19, 2D6, and/or 2E1 may increase the plasma concentrations of pirfenidone, especially when used in addition to a moderate or potent CYP450 1A2 inhibitor. Pirfenidone is primarily (70% to 80%) metabolized by CYP450 1A2, with minor contribution from CYP450 2C9, 2C19, 2D6, and 2E1. In 25 healthy nonsmokers and 25 smokers who were administered a single dose of pirfenidone with the potent CYP450 1A2 inhibitor fluvoxamine (50 mg at bedtime for 3 days; 50 mg twice a day for 3 days; then 50 mg in the morning and 100 mg at bedtime for 4 days), pirfenidone systemic exposure (AUC) increased approximately 4-fold in nonsmoking subjects and 7-fold in smoking subjects. Fluvoxamine also inhibits CYP450 2C9, 2C19 and 2D6, although the extent to which these effects contribute to the interaction has not been established. The interaction has not been studied with specific inhibitors of other isoenzymes involved in the metabolism of pirfenidone.
Management
Concomitant use of pirfenidone with moderate or potent inhibitors of CYP450 2C9, 2C19, 2D6, and/or 2E1 in addition to a moderate or potent inhibitor of CYP450 1A2 (e.g., certain fluoroquinolones, oral contraceptives, deferasirox, methoxsalen, mexiletine, thiabendazole, ticlopidine, zileuton) should be avoided. No particular precaution is necessary if pirfenidone and CYP450 2C9, 2C19, 2D6, and/or 2E1 inhibitors are coadministered without a moderate or potent CYP450 1A2 inhibitor. However, a prolonged duration of monitoring for adverse effects may be required depending on the elimination half-life of the concomitant drug. For example, it should be noted that rolapitant, a moderate CYP450 2D6 inhibitor, may increase plasma concentrations and the risk of adverse effects of pirfenidone for at least 28 days after administration of rolapitant.
References (3)
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2013) "Product Information. Esbriet (pirfenidone)." Intermune Inc
- (2015) "Product Information. Varubi (rolapitant)." Tesaro Inc.
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
pirfenidone Food/Lifestyle
Applies to: pirfenidone
Adjust dosing interval
Food significantly slows the rate but only modestly reduces the extent of absorption of pirfenidone. In healthy, older adult volunteers aged 50 to 66 years, administration of a single 801 mg oral dose of pirfenidone in the fed state resulted in an approximately 50% reduction in peak plasma concentration (Cmax) and a 15% to 20% reduction in systemic exposure (AUC) compared to administration in the fasted state. Median time to reach peak concentration (Tmax) increased from 0.5 hours to 3 hours with food. Less nausea and dizziness were observed in fed subjects compared to fasted subjects.
Generally avoid
Consumption of grapefruit juice is associated with inhibition of CYP450 1A2 and may increase the plasma concentrations of pirfenidone, which is primarily metabolized by the isoenzyme.
Generally avoid
Cigarette smoking may reduce pirfenidone exposure due to induction of CYP450 1A2, the isoenzyme primarily responsible for the metabolic clearance of pirfenidone. Following a single 801 mg oral dose of pirfenidone in 25 smokers and 25 healthy nonsmokers, the Cmax and AUC of pirfenidone in smokers were 68% and 46% of those in nonsmokers, respectively.
Management
Pirfenidone should be administered with food to reduce the likelihood of dizziness and gastrointestinal side effects such as nausea, diarrhea, dyspepsia, and vomiting. Patients who experience intolerance to therapy due to these adverse events should be reminded to take pirfenidone with food. If symptoms do not improve, or they worsen in severity, a dosage reduction or discontinuation of therapy may be warranted. Patients should be advised to avoid consumption of grapefruit and grapefruit juice during treatment with pirfenidone. Cigarette smoking should also be avoided during therapy to prevent reduced exposure to pirfenidone.
References (2)
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2013) "Product Information. Esbriet (pirfenidone)." Intermune Inc
Disease interactions
7 potential interactions Applies to: 7 conditions, including Osteoporosis, Diarrhea, Liver Disease, Smoking, and Renal Dysfunction.
Diarrhea
Major:
Omesec
The omeprazole in Omesec has a major potential interaction with Diarrhea.
Published observational studies suggest that proton pump inhibitor (PPI) use may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. It is recommended that patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Close monitoring is recommended in patients with diarrhea and in those taking antibacterial agents as CDAD has been reported with the use of nearly all these agents. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Liver Disease
Moderate:
pirfenidone
Pirfenidone has a moderate potential interaction with Liver Disease.
Increases in ALT and AST (>3 x ULN) with or without concomitant elevations in bilirubin, have been reported in patients treated with pirfenidone. These findings were reversible with dose modification or treatment discontinuation. Conduct liver tests prior to therapy initiation in all patients, then monthly for the first 6 months and every 3 months thereafter. Dose modification or interruption may be necessary for liver enzyme elevations. Pirfenidone should be used with caution in patients with mild to moderate hepatic impairment, monitoring adverse reactions. The safety and efficacy of pirfenidone has not been studied in patients with severe hepatic impairment, and is not recommended for use in these patients.
Magnesium Imbalance
Moderate:
Omesec
The omeprazole in Omesec has a moderate potential interaction with Magnesium Imbalance.
Symptomatic and asymptomatic hypomagnesemia has been reported rarely in patients treated with PPIs for at least 3 months, in most cases after a year of therapy. Serious adverse events can include tetany, seizures, and arrhythmias. Caution should be used in patients prone to magnesium imbalances such as patients taking other medications that can cause hypomagnesemia (e.g., diuretics). Regular monitoring is recommended.
Osteoporosis
Moderate:
Omesec
The omeprazole in Omesec has a moderate potential interaction with Osteoporosis.
Various published observational studies have reported that PPI therapy may be associated with an increased risk for osteoporosis related fractures of the hip, wrist or spine. The risk was increased in patients who received high doses (multiple daily doses), and long term treatment (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Caution should be used in patients at risk for osteoporosis related fractures and should be managed according to established treatment guidelines.
Pseudomembranous Colitis
Major:
Omesec
The omeprazole in Omesec has a major potential interaction with Pseudomembranous Colitis.
Published observational studies suggest that proton pump inhibitor (PPI) use may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. It is recommended that patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Close monitoring is recommended in patients with diarrhea and in those taking antibacterial agents as CDAD has been reported with the use of nearly all these agents. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Renal Dysfunction
Moderate:
pirfenidone
Pirfenidone has a moderate potential interaction with Renal Dysfunction.
Pirfenidone should be used with caution in patients with mild, moderate, or severe renal impairment, monitoring for adverse reactions and considering dosage modifications or discontinuation as needed. The safety and efficacy of pirfenidone has not been studied in patients with end-stage renal disease requiring dialysis, so its use is not recommended in these patients.
Smoking
Moderate:
pirfenidone
Pirfenidone has a moderate potential interaction with Smoking.
Smoking causes decreased exposure to pirfenidone, which may alter its efficacy. Patients should be instructed to stop smoking prior to treatment, and to avoid smoking while taking pirfenidone.
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More resources
Omesec
A total of 269 drugs are known to interact with Omesec.
- Omesec is in the drug class proton pump inhibitors.
- Omesec is used to treat the following conditions:
pirfenidone
A total of 171 drugs are known to interact with pirfenidone.
- Pirfenidone is in the drug class miscellaneous uncategorized agents.
- Pirfenidone is used to treat Idiopathic Pulmonary Fibrosis.
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
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