- AGGRENOX® (aspirin/extended-release dipyridamole) Capsules
Comments: Avoid use in patients with severe hepatic or renal insufficiency
- Alendronate Sodium Tablets:
Renal Impairment: Alendronate sodium tablets are not recommended in patients with renal impairment (creatinine clearance less than 35 mL/min).
- Azathioprine:
Use in Renal Dysfunction: Relatively oliguric patients, especially those with tubular necrosis in the immediate postcadaveric transplant period, may have delayed clearance of azathioprine tablets or its metabolites, may be particularly sensitive to this drug, and are usually given lower doses.
- Benazepril hydrochloride tablets:
For Hypertensive Patients with Renal Impairment: For patients with a creatinine clearance <30 mL/min/1.73 m2 (serum creatinine >3 mg/dL), the recommended initial dose is 5 mg benazepril hydrochloride tablet once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 40 mg.
Normal renal function: The recommended initial dose for patients not receiving a diuretic is 10 mg once a day. The usual maintenance dosage range is 20-40 mg per day administered as a single dose or in two equally divided doses. A dose of 80 mg gives an increased response, but experience with this dose is limited.
- Canagliflozin -INVOKANA™: Recommended Dosage for Patients with Renal Impairment: Assess renal function before initiating INVOKAMET and periodically thereafter. Do not initiate or continue INVOKAMET in patients with serum creatinine levels greater than or equal to 1.5 mg/dL for males or 1.4 mg/dL for females. In patients who meet these serum creatinine levels, do not initiate or continue INVOKAMET if eGFR is persistently less than 45 mL/min/1.73 m2. No dose adjustment of INVOKAMET is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater). Limit the dose of INVOKAMET to canagliflozin 50 mg twice daily in patients with moderate renal impairment with an eGFR of 45 to less than 60 mL/min/1.73 m2.
- Dapagliflozin -FARXIGA™: The recommended starting dose of FARXIGA is 5 mg once daily, taken in the morning, with or without food. In patients tolerating FARXIGA 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily.
Patients with Renal Impairment: Assessment of renal function is recommended prior to initiation of FARXIGA therapy and periodically thereafter. FARXIGA should not be initiated in patients with an eGFR less than 60 mL/min/1.73 m2. No dose adjustment is needed in patients with mild renal impairment (eGFR of 60 mL/min/1.73 m2 or greater). FARXIGA should be discontinued when eGFR is persistently less than 60 mL/min/1.73 m2
- Diflunisal tablet:
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of diflunisal tablets in patients with advanced renal disease. Therefore, treatment with diflunisal tablets is not recommended in these patients with advanced renal disease. If diflunisal tablet therapy must be initiated, close monitoring of the patient's renal function is advisable.
- Empagliflozin -JARDIANCE®: The recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. In patients tolerating JARDIANCE, the dose may be increased to 25 mg. Patients with Renal Impairment: Assessment of renal function is recommended prior to initiation of JARDIANCE and periodically thereafter. JARDIANCE should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2. JARDIANCE should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2
- Fluvastatin capsules:
Renal Impairment: Dose adjustments for mild to moderate renal impairment are not necessary. Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore caution should be exercised when treating such patients at higher doses.
- Fondaparinux sodium -ARIXTRA:
Renal Impairment: Patients with impaired renal function are at increased risk of bleeding due to reduced clearance of ARIXTRA. Assess renal function periodically in patients receiving ARIXTRA. Discontinue ARIXTRA immediately in patients who develop severe renal impairment while on therapy. After discontinuation of ARIXTRA, its anticoagulant effects may persist for 2 to 4 days in patients with normal renal function (i.e., at least 3 to 5 half-lives). The anticoagulant effects of ARIXTRA may persist even longer in patients with renal impairment. Contraindications: ARIXTRA is contraindicated in patients with Severe renal impairment (creatinine clearance [CrCl] <30 mL/min).
- Lithium carbonate capsules/tablets:
CONTRAINDICATIONS: Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients.
Warnings: When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.
- Meloxicam tablets:
Renal Insufficiency: Meloxicam pharmacokinetics have been investigated in subjects with different degrees of renal insufficiency. Total drug plasma concentrations decreased with the degree of renal impairment while free AUC values were similar. Total clearance of meloxicam increased in these patients probably due to the increase in free fraction leading to an increased metabolic clearance. There is no need for dose adjustment in patients with mild to moderate renal failure (CrCL >15 mL/min). Patients with severe renal insufficiency have not been adequately studied. The use of meloxicam in subjects with severe renal impairment is not recommended.
- Methotrexate (tablets/injection):
Warnings: Methotrexate elimination is reduced in patients with impaired renal function, ascities, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration.
- Midodrine hydrochloride tablet:
CONTRAINDICATIONS: Midodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride should not be used in patients with persistent and excessive supine hypertension.
Dosing: Because desglymidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5 mg doses.
- Mirabegron - MYRBETRIQ: Dosing Information: The recommended starting dose of Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily. Myrbetriq should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
Dose Adjustments in Specific Populations: The daily dose of Myrbetriq should not exceed 25 mg once daily in the following populations: •Patients with severe renal impairment (CLcr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m2). •Patients with moderate hepatic impairment (Child-Pugh Class B).
Myrbetriq is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C).
- Mirtazapine tablets:
Renal Insufficiency: The disposition of mirtazapine was studied in patients with varying degrees of renal function. Elimination of mirtazapine is correlated with creatinine clearance. Total body clearance of mirtazapine was reduced approximately 30% in patients with moderate (Clcr = 11 to 39 mL/min/1.73 m2) and approximately 50% in patients with severe (Clcr ≤10 mL/min/1.73 m2) renal impairment when compared to normal subjects. Caution is indicated in administering mirtazapine to patients with compromised renal function.
Dosing: Elderly and Patients with Renal or Hepatic Impairment: The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment.
- Oxacillin sodium powder, for solution:
If any impairment of renal function is suspected or known to exist, a reduction in the total dosage should be considered and blood levels monitored to avoid possible neurotoxic reactions.
Geriatric use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
- Oxcarbazepine tablet:
Patients with Renal Impairment: In patients with impaired renal function (creatinine clearance <30 mL/min) Oxcarbazepine therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response.
- Penicillamine capsule/tablets:
Contraindication: Because of its potential for causing renal damage, penicillamine should not be administered to rheumatoid arthritis patients with a history or other evidence of renal insufficiency.
Geriatric use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and careful monitoring of renal function is recommended.
- Perindopril erbumine- ACEON:
Dose Adjustment in Renal Impairment and Dialysis: Perindoprilat elimination is decreased in renally impaired patients. ACEON is not recommended in patients with creatinine clearance <30 mL/min. For patients with lesser degrees of impairment, the initial dosage should be 2 mg/day and dosage should not exceed 8 mg/day. During dialysis, perindopril is removed with the same clearance as in patients with normal renal function.
- Potassium chloride tablets/capsules:
Warnings: The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.
Geriatric use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
- Quinapril hydrochloride tablet:
In using ACCUPRIL, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease.
Geriatric use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. The recommended initial dosage of ACCUPRIL in elderly patients is 10 mg given once daily followed by titration to the optimal response.
Dosing in Renal Impairment: Kinetic data indicate that the apparent elimination half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses, based on clinical and pharmacokinetic data from patients with renal impairment, are as follows:
Creatinine
Clearance |
Maximum Recommended
Initial Dose |
| >60 mL/min |
10 mg |
| 30-60 mL/min |
5 mg |
| 10-30 mL/min |
2.5 mg |
| <10 mL/min |
Insufficient data for dosage recommendation |
- Quinine sulfate capsules:
Renal Impairment: Clearance of quinine is decreased in patients with severe chronic renal failure. The dosage and dosing frequency should be reduced. In patients with acute uncomplicated malaria and severe chronic renal impairment, the following dosage regimen is recommended: one loading dose of 648 mg QUALAQUIN followed 12 hours later by maintenance doses of 324 mg every 12 hours.
The effects of mild and moderate renal impairment on the safety and pharmacokinetics of quinine sulfate are not known
- Ranolazine (RANEXA) tablet:
Renal Failure: Acute renal failure has been observed in some patients with severe renal impairment (creatinine clearance [CrCL] < 30 mL/min) while taking RANEXA. If acute renal failure develops (e.g., marked increase in serum creatinine associated with an increase in blood urea nitrogen [BUN]), discontinue RANEXA and treat appropriately. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL < 60 mL/min) for increases in serum creatinine accompanied by an increase in BUN.
Geriatric use: In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease, or other drug therapy.
- Repaglinide (PRANDIN®) tablet:
Renal Insufficiency: Initial dose adjustment does not appear to be necessary for patients with mild to moderate renal dysfunction. However, patients with type 2 diabetes who have severe renal function impairment should initiate PRANDIN therapy with the 0.5 mg dose - subsequently, patients should be carefully titrated. Studies were not conducted in patients with creatinine clearances below 20 mL/min or patients with renal failure requiring hemodialysis.
- Rifabutin (MYCOBUTIN) capsule:
Renal Insufficiency: The disposition of rifabutin (300 mg) was studied in 18 patients with varying degrees of renal function. Area under plasma concentration time curve (AUC) increased by about 71% in patients with severe renal insufficiency (creatinine clearance below 30 mL/min) compared to patients with creatinine clearance (Crcl) between 61-74 mL/min. In patients with mild to moderate renal insufficiency (Crcl between 30-61 mL/min), the AUC increased by about 41%. A reduction in the dosage of rifabutin is recommended for patients with Crcl< 30 mL/min.
Warnings: Severe renal impairment (creatinine clearance below 30 mL/min) requires a dosage reduction of 50%. Mild to moderate renal impairment does not require any dosage adjustment.
DOSAGE AND ADMINISTRATION: It is recommended that MYCOBUTIN Capsules be administered at a dose of 300 mg once daily. For those patients with propensity to nausea, vomiting, or other gastrointestinal upset, administration of MYCOBUTIN at doses of 150 mg twice daily taken with food may be useful. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of MYCOBUTIN should be reduced by 50%. No dosage adjustment is required for patients with mild to moderate renal impairment.
- Solifenacin (Vesicare ® ): Dosing Information: The recommended dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.
Dose Adjustment in Patients with Renal Impairment: For patients with severe renal impairment (CLcr <30 mL/min), a daily dose of VESIcare greater than 5 mg is not recommended
- Tiludronate disodium (SKELID) tablet :
Renal Insufficiency: SKELID is not recommended for patients with severe renal failure (creatinine clearance <30 mL/min) due to lack of clinical experience. After a single oral dose equivalent to 400 mg tiludronic acid, subjects with creatinine clearance between 11 and 18 mL/min had Cmax values (approximately 3 mg/L) in the range of healthy volunteers. However, the plasma elimination half-life was approximately 205 hours, which is longer than that observed in pagetic patients after repeated doses (150 hours) and healthy subjects after single doses (50 hours).
- Tolterodine (Detrol ® ): The initial recommended dose of DETROL Tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of DETROL is 1 mg twice daily
- Topiramate (TOPAMAX) capsule/tablet:
Renal impairment: In renally impaired patients (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the adult dose is recommended.
Geriatric use: Dosage adjustment may be necessary for elderly with impaired renal function.
- Trospium (Sanctura ® ): The recommended dose is 20 mg twice daily. SANCTURA® should be dosed at least one hour before meals or given on an empty stomach. Renal: For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime.
- Venlafaxine hydrochloride tablet:
In patients with renal impairment (GFR=10 to 70 mL/min) or cirrhosis of the liver, the clearances of venlafaxine and its active metabolite were decreased, thus prolonging the elimination half-lives of these substances. A lower dose may be necessary.
Geratric use: No dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction.
Dosing: Given the decrease in clearance for venlafaxine and the increase in elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 10 to 70 mL/min) compared to normals, it is recommended that the total daily dose be reduced by 25% in patients with mild to moderate renal impairment. It is recommended that the total daily dose be reduced by 50% in patients undergoing hemodialysis. Since there was much individual variability in clearance between patients with renal impairment, individualization of dosing may be desirable in some patients.
- Vytorin® (ezetimibe/simvastatin) Tablets:
Patients with Renal Impairment/Chronic Kidney Disease: In patients with mild renal impairment (estimated GFR greater than or equal to 60 mL/min/1.73 m2), no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate less than 60 mL/min/1.73 m2, the dose of VYTORIN is 10/20 mg/day in the evening. In such patients, higher doses should be used with caution and close monitoring.
- Zonisamide capsule:
Dosing -Patients with Renal or Hepatic Disease: Because zonisamide is metabolized in the liver and excreted by the kidneys, patients with renal or hepatic disease should be treated with caution, and might require slower titration and more frequent monitoring.
Renal Insufficiency: Single 300 mg zonisamide doses were administered to three groups of volunteers. Group 1 was a healthy group with a creatinine clearance ranging from 70 to 152 mL/min. Group 2 and Group 3 had creatinine clearances ranging from 14.5 to 59 mL/min and 10 to 20 mL/min, respectively. Zonisamide renal clearance decreased with decreasing renal function (3.42, 2.50, 2.23 mL/min, respectively). Marked renal impairment (creatinine clearance < 20 mL/min) was associated with an increase in zonisamide AUC of 35%.
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