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Manufacturer
MERCK SHARP & D
SKU
0006008061

brand janumet xr 50-1,000 mg tablet

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Uses

Diabetes Mellitus

Sitagliptin is used as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. Sitagliptin is used as initial therapy in combination with metformin hydrochloride (given separately or as the fixed combination) as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. Sitagliptin also is used in combination with other oral antidiabetic agents (e.g., metformin, a sulfonylurea, a thiazolidinedione [peroxisome proliferator-activated receptorγ agonist]) or insulin as an adjunct to diet and exercise in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control with one or more oral antidiabetic agents and/or insulin.

While metformin generally is the preferred antidiabetic agent for initial therapy in patients with type 2 diabetes mellitus, the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) suggests a dipeptidyl peptidase-4 (DPP-4) inhibitor as one of several alternative antidiabetic agents for initial monotherapy in patients with a contraindication to metformin (e.g., renal disease, hepatic disease, GI intolerance, risk of lactic acidosis). DPP-4 inhibitors also are recommended by AACE/ACE as part of combination therapy, particularly when both postprandial and fasting plasma glucose concentrations are elevated.

Sitagliptin should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Sitagliptin Monotherapy

Efficacy of sitagliptin as monotherapy for the management of type 2 diabetes mellitus is supported by results of 2 controlled trials of 18 or 24 weeks' duration. Sitagliptin (100 or 200 mg once daily) improved glycemic control, as evidenced by reductions in glycosylated hemoglobin (hemoglobin A1c [HbA1c]) as well as fasting and 2-hour postprandial plasma glucose concentrations, compared with placebo. HbA1c was reduced by 0.5-0.6% (from an average baseline value of about 8%) in patients receiving sitagliptin 100 mg daily, compared with an increase of 0.1-0.2% in those receiving placebo. Overall, use of a higher than recommended dosage of sitagliptin (200 mg daily) did not provide greater glycemic control than did the recommended dosage of 100 mg daily.

Combination Therapy

Efficacy of the combination of sitagliptin and metformin as initial therapy in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise is supported by results of a 24-week randomized, placebo-controlled trial. In this trial, patients receiving initial therapy with sitagliptin (50 mg twice daily) in combination with metformin hydrochloride (500 mg or 1 g twice daily) had greater improvements in HbA1c, fasting plasma glucose, and 2-hour postprandial glucose concentrations than those receiving placebo, metformin monotherapy, or sitagliptin monotherapy. Mean reductions in HbA1c from baseline in patients not receiving an antihyperglycemic agent at trial entry were 1.1% with sitagliptin 100 mg once daily, 1.1% with metformin hydrochloride 500 mg twice daily, 1.2% with metformin hydrochloride 1 g twice daily, 1.6% with sitagliptin 50 mg twice daily in combination with metformin hydrochloride 500 mg twice daily, 1.9% with sitagliptin 50 mg twice daily in combination with metformin hydrochloride 1 g twice daily, and 0.2% with placebo. In the same study, patients with more severe hyperglycemia (HbA1c exceeding 11% or blood glucose exceeding 280 mg/dL) who received sitagliptin (50 mg twice daily) in combination with metformin hydrochloride (1 g twice daily) on an open-label basis achieved mean reductions from baseline of 2.9% in HbA1c, 127 mg/dL in fasting plasma glucose, and 208 mg/dL in 2-hour postprandial glucose by the end of the trial (at 24 weeks).

In another 24-week, randomized trial in patients who had inadequate glycemic control with diet and exercise, initial therapy with the combination of sitagliptin (100 mg once daily) and pioglitazone (30 mg once daily) produced greater improvements in HbA1c, fasting plasma glucose, and 2-hour postprandial glucose concentrations than pioglitazone monotherapy (30 mg once daily). In this trial, patients receiving the sitagliptin/pioglitazone combination achieved a 0.9% mean reduction in HbA1c compared with those receiving pioglitazone monotherapy, and 60% of patients receiving sitagliptin/pioglitazone achieved a mean HbA1c less than 7%, compared with 28% of those receiving pioglitazone monotherapy.

Efficacy of sitagliptin in combination with metformin, a sulfonylurea, and/or a thiazolidinedione in the management of type 2 diabetes mellitus (in patients inadequately controlled with metformin or thiazolidinedione monotherapy) is supported by results from several long-term (24 weeks' duration), randomized, placebo-controlled trials. In these trials, the addition of sitagliptin (100 mg once daily) to existing metformin and/or glimepiride therapy or to pioglitazone or rosiglitazone/metformin therapy improved glycemic control, as evidenced by reductions in HbA1c as well as fasting and/or 2-hour postprandial plasma glucose concentrations, compared with placebo or existing therapy. In patients receiving metformin hydrochloride therapy (dosage of at least 1.5 g daily), the addition of sitagliptin resulted in a reduction of 0.7% in HbA1c, while the addition of placebo resulted in no appreciable change in HbA1c. In patients receiving glimepiride therapy (dosage of at least 4 mg daily), the addition of sitagliptin resulted in a reduction of 0.6% in HbA1c compared with addition of placebo. In patients receiving glimepiride (dosage of at least 4 mg daily) in combination with metformin hydrochloride (dosage of at least 1.5 g daily), the addition of sitagliptin resulted in a reduction of 0.9% in HbA1c compared with addition of placebo. In patients receiving pioglitazone therapy (30-45 mg daily), the addition of sitagliptin or placebo resulted in reductions of 0.9 or 0.2%, respectively, in HbA1c. In patients receiving metformin and rosiglitazone therapy in a 54-week trial, addition of sitagliptin 100 mg once daily or placebo resulted in mean reductions in HbA1c of 1 or 0.3%, respectively; sulfonylurea (e.g., glipizide) rescue therapy was used in 18 or 40% of patients receiving sitagliptin or placebo, respectively. In a 52-week noninferiority trial in patients receiving metformin hydrochloride (dosage of at least 1.5 g daily), add-on therapy with sitagliptin (100 mg once daily) or glipizide (5-20 mg once daily; mean 10 mg once daily) was associated with similar mean reductions from baseline in HbA1c (intent-to-treat analysis); results may be applicable principally to patients with baseline HbA1c values less than 8-9%, comparable to those of this study population.

Efficacy of sitagliptin in combination with insulin (with or without metformin) in the management of type 2 diabetes mellitus in patients who have inadequate glycemic control with insulin is supported by results of a 24-week, randomized, placebo-controlled trial. In this trial, addition of sitagliptin (100 mg once daily) to existing stable insulin (premixed insulin or intermediate- or long-acting insulin) therapy with or without metformin hydrochloride (dosage of at least 1.5 g daily) resulted in improvements in HbA1c, fasting plasma glucose, and 2-hour postprandial glucose concentrations compared with addition of placebo. In patients who received sitagliptin as add-on therapy to metformin and insulin, 14% had HbA1c reductions to less than 7% compared with 5% of those receiving add-on placebo with metformin and insulin. Among patients also receiving metformin, the median daily dosage of insulin at baseline for patients treated with sitagliptin or placebo was 40 or 42 units, respectively; the median daily insulin dosage for both groups at the end of the study was unchanged. Patients in both treatment groups gained a mean of 0.1 kg of body weight over the study period; hypoglycemia was more common in patients receiving add-on sitagliptin therapy.

Dosage and Administration

General

The dosage of sitagliptin/metformin hydrochloride in fixed combination should be individualized according to clinician judgment based on the patient's current antidiabetic regimen, clinical response, and tolerability. Any change in therapy should be undertaken with care and appropriate monitoring because changes in glycemic control can occur.

Administration

When sitagliptin is administered as monotherapy, the drug should be administered orally once daily with or without food. If a dose is missed, the missed dose should be taken as soon as it is remembered followed by resumption of the regular schedule. If the missed dose is remembered at the time of the next dose, the missed dose should be skipped and the regular schedule resumed. The dose should not be doubled to replace a missed dose.

When sitagliptin is administered in fixed combination with metformin hydrochloride, the combination should be administered orally twice daily with meals, increasing dosage gradually to minimize the adverse GI effects of the metformin component. If a dose is missed, the missed dose should be taken with a meal as soon as it is remembered followed by resumption of the regular schedule. If a missed dose is remembered at the time of the next dose, the missed dose should be skipped and the regular schedule resumed. The dose should not be doubled to replace a missed dose.

Dosage

Sitagliptin phosphate is commercially available as the monohydrate; dosage is expressed in terms of sitagliptin.

Sitagliptin Monotherapy

The recommended dosage of sitagliptin for the management of type 2 diabetes mellitus in adults is 100 mg once daily. In clinical trials, higher dosages (200 mg daily) did not provide additional glycemic benefit.

Sitagliptin/Metformin Hydrochloride Fixed-combination Therapy

Dosage of sitagliptin in fixed combination with metformin hydrochloride should be individualized based on the patient's current antidiabetic regimen, effectiveness, and tolerability. In patients not currently receiving metformin hydrochloride, the recommended initial dosage is 50 mg of sitagliptin and 500 mg of metformin hydrochloride twice daily as the fixed combination, with gradual dosage escalation to reduce adverse GI effects associated with the metformin hydrochloride component.

When the fixed combination of sitagliptin and metformin hydrochloride is used in patients currently receiving metformin hydrochloride, the recommended initial dosage is 50 mg of sitagliptin and 500 mg of metformin hydrochloride or 50 mg of sitagliptin and 1 g of metformin hydrochloride twice daily, depending on the patient's existing dosage of metformin hydrochloride. In patients currently receiving metformin hydrochloride 850 mg twice daily, the recommended initial dosage is 50 mg of sitagliptin and 1 g of metformin hydrochloride twice daily as the fixed combination.

The efficacy and safety of switching therapy from oral antidiabetic agents other than sitagliptin or metformin hydrochloride specifically to the fixed combination of sitagliptin and metformin hydrochloride has not been established.

Combination Therapy with Sitagliptin and Other Oral Antidiabetic Agents or Insulin Given as Separate Components

When given in combination with metformin hydrochloride as separate tablets, a sitagliptin dosage of 100 mg once daily has been used.

When given as separate tablets in combination with a sulfonylurea with or without metformin hydrochloride, a sitagliptin dosage of 100 mg once daily has been used. Dosage of the concomitant sulfonylurea may need to be reduced to decrease risk of hypoglycemia. For additional details, see Uses: Diabetes Mellitus.

When given as separate tablets in combination with a thiazolidinedione antidiabetic agent (e.g., pioglitazone, rosiglitazone) with or without metformin hydrochloride, a sitagliptin dosage of 100 mg once daily has been used. For additional details, see Uses: Diabetes Mellitus.

When given in combination with insulin with or without metformin hydrochloride, a sitagliptin dosage of 100 mg once daily has been used. Dosage of concomitant insulin may need to be reduced to decrease risk of hypoglycemia.

Special Populations

Hepatic Impairment

No dosage adjustments are necessary in patients with mild to moderate hepatic impairment (Child-Pugh score 9 or less). Efficacy and safety are not established in patients with severe hepatic impairment (Child-Pugh score greater than 9).

Renal Impairment

Sitagliptin Monotherapy

Dosage adjustment is recommended for patients with moderate or severe renal impairment or end-stage renal disease requiring hemodialysis or peritoneal dialysis. Caution should be used to ensure that the correct dosage of sitagliptin is prescribed for patients with moderate or severe renal impairment.(See Worsening of Renal Function under Cautions: Warnings/Precautions.) In patients with moderate renal impairment (creatinine clearance of 30 to less than 50 mL/minute, corresponding to serum creatinine concentrations ranging from greater than 1.7 to 3 mg/dL in men or from greater than 1.5 to 2.5 mg/dL in women), the recommended dosage of sitagliptin is 50 mg once daily. In patients with severe renal impairment (creatinine clearance less than 30 mL/minute, corresponding to serum creatinine concentrations greater than 3 mg/dL in men or greater than 2.5 mg/dL in women), the recommended dosage is 25 mg once daily. Patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis should receive a dosage of 25 mg once daily. Sitagliptin may be administered without regard to the timing of dialysis.

Sitagliptin/Metformin Hydrochloride Fixed-combination Therapy

Patients with renal impairment receiving reduced dosages of sitagliptin should not be switched to the fixed combination of sitagliptin and metformin hydrochloride.(See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Geriatric Patients

Dosage should be selected with caution because of age-related decreases in renal function.(See Geriatric Use and also see Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.) Dosage should be titrated carefully to the minimum dosage necessary for adequate glycemic control.

Cautions

Contraindications

Sitagliptin is contraindicated in patients with known serious hypersensitivity (e.g., anaphylaxis, angioedema) to sitagliptin or to any ingredient in the formulation.

Warnings/Precautions

Pancreatitis and Pancreatic Precancerous Changes

Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been reported during postmarketing experience in patients receiving sitagliptin or sitagliptin/metformin. The most common manifestations associated with pancreatitis were abdominal pain, nausea, and vomiting. Hospitalization was required in 66% of 88 reported cases, including 2 cases of hemorrhagic or necrotizing pancreatitis that necessitated prolonged hospitalization and intensive-care unit (ICU) care. Pancreatitis occurred within 30 days of initiation of sitagliptin or sitagliptin/metformin therapy in 21% of cases; discontinuance of the drug led to resolution of pancreatitis in 53% of patients. At least one other risk factor (e.g., obesity, high cholesterol and/or triglyceride concentrations) was noted in 51% of cases.

FDA has been evaluating unpublished findings suggesting an increased risk of pancreatitis and precancerous pancreatic cell changes (pancreatic duct metaplasia) in patients with type 2 diabetes mellitus receiving incretin mimetics (exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin, or linagliptin). These findings are based on examination of a small number of pancreatic tissue specimens taken from patients who died from unspecified causes while receiving an incretin mimetic. FDA will notify healthcare professionals of its conclusions and recommendations when the review is complete or when the agency has additional information to report.

FDA has recommended that clinicians continue to follow the recommendations in the prescribing information for incretin mimetics. The manufacturer states that patients receiving sitagliptin-containing therapy should be monitored for manifestations of pancreatitis, such as nausea, vomiting, anorexia, and persistent severe abdominal pain, sometimes radiating to the back; persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. If pancreatitis is suspected, sitagliptin should be promptly discontinued and appropriate management instituted (e.g., including laboratory studies such as serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, and serum calcium, glucose, and lipase). Safety and efficacy of sitagliptin have not been established in patients with a history of pancreatitis and it is not known whether such patients are at increased risk for pancreatitis with sitagliptin therapy.

Worsening of Renal Function

Renal function should be assessed prior to initiation of sitagliptin and periodically thereafter. Worsening of renal function, including acute renal failure that sometimes required dialysis, has been reported in some patients during postmarketing experience. A subset of these patients had renal insufficiency, some of whom were prescribed inappropriate dosages of sitagliptin. A return to baseline levels of renal insufficiency has been observed with supportive treatment and discontinuance of potentially causative agents. Cautious reinitiation of sitagliptin can be considered if another etiology is deemed likely to have precipitated the acute worsening of renal function. The manufacturer states that sitagliptin has not been found to be nephrotoxic in clinical trials or in preclinical studies at clinically relevant dosages.

Severe Arthralgia

Severe, disabling joint pain has been reported during postmarketing experience in patients receiving DPP-4 inhibitors (e.g., alogliptin, linagliptin, saxagliptin, sitagliptin). Onset of such symptoms has ranged from 1 day to years following initiation of therapy. Fever, chills, rash, and swelling accompanied joint pain in some patients, suggesting an immunologic reaction; some patients have required hospitalization. Symptoms resolved upon discontinuance of the DPP-4 inhibitor, usually in less than a month. In some patients, symptoms recurred when the same or another DPP-4 inhibitor was restarted. DPP-4 inhibitors should be considered as a possible cause of severe joint pain and should be discontinued if appropriate.(See Advice to Patients.)

Concomitant Therapy with Hypoglycemic Agents

When sitagliptin was used in combination with a sulfonylurea or insulin, the incidence of hypoglycemia was greater than that in patients receiving placebo with a sulfonylurea or insulin. In a long-term (52-week) clinical noninferiority study, rates of hypoglycemia with sitagliptin/metformin combination therapy were lower than those observed with glipizide/metformin combination therapy. However, in a 24-week clinical study, rates of hypoglycemia in patients receiving sitagliptin and glimepiride with or without metformin were greater than those in patients receiving glimepiride and metformin. Patients receiving sitagliptin may require a lower dosage of a concomitant insulin secretagogue (e.g., sulfonylurea) or insulin to reduce the risk of hypoglycemia.

Sensitivity Reactions

There have been postmarketing reports of serious allergic and hypersensitivity reactions (e.g., anaphylaxis, angioedema, exfoliative skin conditions such as Stevens-Johnson syndrome); rash, urticaria, and cutaneous vasculitis also have been reported. The onset of such reactions usually was within the first 3 months following treatment initiation, but such reactions may occur after the first dose.(See Cautions: Contraindications.)

If hypersensitivity reactions occur, promptly discontinue the drug, assess for other potential causes of the event, institute appropriate monitoring and treatment, and initiate alternative antidiabetic therapy.(See Advice to Patients.) Use caution in patients with a history of angioedema with other dipeptidyl peptidase-4 (DPP-4) inhibitors because it is unknown whether such patients will be predisposed to angioedema with sitagliptin.

Loss of Glycemic Control

Loss of glycemic control may occur during periods of stress (e.g., fever, trauma, infection, surgery).(See Advice to Patients.)

Temporary discontinuance of sitagliptin and administration of insulin may be required. Sitagliptin therapy may be reinstituted after the acute episode of hyperglycemia has resolved.

Macrovascular Outcomes

Evidence of macrovascular risk reduction with sitagliptin or any other antidiabetic agent has not been conclusively demonstrated in controlled clinical trials.

Use of Fixed Combinations

When sitagliptin is used in fixed combination with metformin hydrochloride, the cautions, precautions, and contraindications associated with metformin hydrochloride should be considered.

Specific Populations

Pregnancy

Category B. Pregnancy registry may be contacted at 800-986-8999.

Lactation

Sitagliptin is distributed into milk in rats; it is not known whether the drug is distributed into human milk. Use caution.

Pediatric Use

Safety and efficacy of sitagliptin alone or in fixed combination with metformin has not been established in children younger than 18 years of age.

Geriatric Use

No substantial differences in safety and efficacy of sitagliptin relative to younger adults, but increased sensitivity cannot be ruled out.(See Renal Impairment under Warnings/Precautions: Specific Populations, in Cautions.)

Renal Impairment

Sitagliptin is substantially eliminated by the kidneys; renal function should be assessed prior to initiation of therapy and periodically thereafter. (See Worsening of Renal Function under Cautions: Warnings/Precautions and also see Renal Impairment under Dosage and Administration: Special Populations.)

Common Adverse Effects

Adverse effects reported in at least 5% of patients receiving sitagliptin as monotherapy or add-on therapy with metformin and/or a thiazolidinedione or glimepiride and more commonly than with placebo include nasopharyngitis, upper respiratory tract infection, peripheral edema, and headache.

Adverse effects reported in at least 5% of patients receiving the sitagliptin/metformin fixed combination and more commonly than with placebo include diarrhea, upper respiratory infection, and headache.

Adverse effects reported in at least 5% of patients receiving sitagliptin in combination with metformin and a sulfonylurea (glimepiride) and more commonly than with placebo include hypoglycemia and headache.

Adverse effects reported in at least 5% of patients receiving sitagliptin in combination with insulin and more commonly than with placebo include hypoglycemia.

Drug Interactions

Drugs Metabolized by Hepatic Microsomal Enzymes

Sitagliptin is metabolized to a limited extent by cytochrome P-450 (CYP) isoenzymes 3A4 and 2C8 to inactive metabolites. Sitagliptin does not inhibit CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4 in vitro or induce CYP3A4. Pharmacokinetic interactions with drugs metabolized by these isoenzymes are unlikely.

Drugs Secreted by Renal Tubular Cationic Transport

Sitagliptin is a substrate of the organic anion transport system; pharmacokinetic interactions are unlikely with substrates of the organic cationic transport system.

Inhibitors of P-glycoprotein Transport System

Sitagliptin is a substrate of the P-glycoprotein transport system. There is a potential pharmacokinetic interaction (increased absorption and renal clearance of sitagliptin) with P-glycoprotein inhibitors.

Clinically important pharmacokinetic interactions with P-glycoprotein inhibitors appear to be unlikely. Sitagliptin does not appear to inhibit the P-glycoprotein transport system.

Protein-bound Drugs

Pharmacokinetic interactions between sitagliptin and protein-bound drugs are unlikely.

Cyclosporine

Concomitant administration of cyclosporine and sitagliptin may increase absorption and plasma concentrations of sitagliptin. However, this interaction is not considered clinically important.

Digoxin

Concomitant administration of sitagliptin (100 mg daily for 10 days) with digoxin resulted in a slight increase in plasma concentrations and area under the concentration-time curve (AUC) of digoxin (18 and 11%, respectively). While these increases are not considered clinically important, patients receiving digoxin should be monitored appropriately; however, no digoxin or sitagliptin dosage adjustment is needed.

Hormonal Contraceptives, Oral

Sitagliptin has no clinically important effect on the pharmacokinetics of norethindrone or ethinyl estradiol.

Metformin

Sitagliptin and metformin have a potential additive effect on active glucagon-like peptide (GLP-1) concentrations. Pharmacokinetic interactions are unlikely.

The relevance of these effects to glycemic control in patients with type 2 diabetes mellitus is unclear.

Simvastatin

Pharmacokinetic interactions between sitagliptin and simvastatin are unlikely.

Sulfonylureas or Insulin

The incidence of hypoglycemia was increased compared with placebo when sitagliptin was added to therapy with an insulin secretagogue (e.g., sulfonylurea) or insulin.(See Concomitant Therapy with Hypoglycemic Agents under Cautions: Warnings/Precautions.) Clinically important pharmacokinetic interactions between sitagliptin and sulfonylureas (e.g., glimepiride, glipizide, glyburide, tolbutamide) are unlikely.

Thiazolidinediones

Pharmacokinetic interactions between sitagliptin and thiazolidinediones are unlikely.

Warfarin

Pharmacokinetic interactions between sitagliptin and warfarin are unlikely.

Pharmacokinetics

Absorption

Bioavailability

The absolute bioavailability of sitagliptin is approximately 87%. The drug is rapidly absorbed following oral administration; at steady state (within 3 days of therapy initiation), peak plasma concentrations generally are attained within 3 hours following administration of recommended doses.

Fixed-combination tablet containing sitagliptin 50 mg and metformin hydrochloride 500 mg or 1 g (Janumet) bioequivalent to one 50-mg tablet of sitagliptin and one 500-mg or 1-g tablet of metformin hydrochloride, respectively, given simultaneously.

Onset

Reduction in postprandial plasma glucose excursion: Approximately 60 minutes.

Duration

Approximately 80% inhibition of DPP-4 activity persists for 12 or 24 hours following administration of >=50 or >=100 mg, respectively, of sitagliptin.

Food

Food does not appear to affect absorption.

Special Populations

Renal impairment results in increased plasma AUC. Removed modestly by hemodialysis; time to peak plasma drug concentration increased in a limited number of patients with end-stage renal disease requiring hemodialysis.

Moderate hepatic impairment results in increased peak plasma concentrations and AUC; not considered clinically important.

In geriatric patients, modest increases in plasma concentrations compared with younger adults.

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.

Plasma Protein Binding

38%.

Elimination

Metabolism

Metabolized to a limited extent by CYP isoenzymes 3A4 and 2C8 to inactive metabolites.

Elimination Route

Eliminated principally by kidneys via active tubular secretion. Excreted in urine (87%) mainly as unchanged drug and in feces (13%).

Half-life

12.4 hours.

Special Populations

Renal impairment results in increased terminal elimination half-life.

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