Download What is the first choice antidepressant for patients with renal

Medicines Q&As
Q&A 369.2
What is the first choice antidepressant for patients with renal
impairment?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date prepared: Oct 2014
Background
Depression is a common psychiatric disorder which can be caused and exacerbated by chronic
physical health problems [1-2]. Patients with chronic kidney disease, especially severe renal
impairment (RI) have been shown to be at higher risk of depression [2]. It has been shown that
antidepressant prescribing rates are lower in patients on dialysis despite the increased prevalence of
depression [3]. There is a lack of controlled trial data for the treatment of depression in RI and this
together with concern over antidepressant side effects may contribute to reduced prescribing of
antidepressants in RI [3]. The use of antidepressants in renal replacement therapies is not discussed
here.
Answer
Most antidepressants can be used with caution in RI [3-9] since the majority are hepatically metabolised
and do not significantly accumulate, even in severe RI [3-9]. The main issues surrounding prescribing
antidepressants for patients with RI are therefore much the same as for those patients with normal renal
function, where the effects of age, comorbidities and the potential effects of other medications taken
concurrently need to be considered. In addition patients with renal impairment have specific increased
risks including gastrointestinal bleeding, cardiovascular disease and cerebral sensitivity to sedating
medications which also need to be considered.
In line with NICE guidance [1-2], the most appropriate antidepressant should be chosen based on:


Any anticipated adverse events, for example side effects and discontinuation symptoms and
potential interactions with concomitant medication or physical health problems
The patient’s perception of the efficacy and tolerability of any antidepressants they have
previously taken.
NICE guidelines state that there is no evidence as yet supporting the use of specific antidepressants
for patients with particular chronic physical health problems [1-2]. They recommend that when an
antidepressant is to be prescribed, a SSRI is usually chosen first line as they are equally effective as
other antidepressants but have a favourable side effect profile; citalopram and sertraline are particularly
recommended as they also have less propensity to interact compared with other SSRIs [1-2].This
advice is not specific to RI.
Table 1 contains a summary of the information from the manufacturer’s product information, Renal Drug
Handbook and The Maudsley Prescribing Guidelines for a range of antidepressants.
The Maudsley Prescribing Guidelines state that no agent is clearly preferred over another in RI
however citalopram and sertraline may be reasonable choices [5].
The Psychotropic Drug Directory assesses antidepressants in terms of risk in RI as follows [6]:



Lower risk – agomelatine, mianserin, moclobemide, TCA’s, trazodone, tryptophan
Moderate risk – duloxetine, MAOIs, mirtazapine, reboxetine, SSRIs (except sertraline)
Higher risk – venlafaxine, fluoxetine, sertraline
Available through NICE Evidence. Search at www.evidence.nhs.uk
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Medicines Q&As
Both The Psychotropic Drug Directory and The Maudsley Prescribing Guidelines provide information
on individual drugs where available [5,6]. The Psychotropic Drug Directory considers sertraline a higher
risk antidepressant, compared with the recommendation in The Maudsley Guidelines. This view is
based on a study of 12 patients with end stage renal disease who were on maintenance haemodialysis
and were taking 25mg/day sertraline. All 12 showed signs of serotonin syndrome and 11 discontinued
within 3 weeks. The Renal Drug Handbook [4] suggests no dose reduction is required with sertraline in
various stages of RI whereas Nagler et al [9] suggest dosage reduction of sertraline is required in
patients with severe RI (eGFR <30mL/min).
The majority of information regarding the use of antidepressants relates to pharmacokinetic studies or
to patients undergoing dialysis and there is limited data on clinical use in RI prior to dialysis. Reviews by
Hedayati et al [3] and Nagler et al [9] provide information on most antidepressants in RI, including
pharmacokinetic data, where available, and both reviews suggest that SSRIs be considered as a first
choice although specific agents are not mentioned. Raymond et al [8] and Nagler et al [9], highlight that
few studies have evaluated the clinical efficacy of antidepressants in RI but state that there is most
evidence for the use of SSRI’s. Raymond et al., apply the principles of prescribing antidepressants for
the general population to those with renal disease and suggest that newer drugs such as SSRIs,
venlafaxine and mirtazapine are generally favoured over TCA’s and MAOIs due to their safety profiles,
with choice of a particular agent based on adverse effects and interactions [8].
Hyponatraemia has been associated with all antidepressants, although it has been reported more
frequently with SSRIs; reduced renal function is a risk factor for developing hyponatraemia [10-11].
Particular caution may be required when switching between antidepressants as half lives of individual
agents may be increased in RI [4,6,7]. Wash out periods, where advised, may need to be extended to
take this into account.
The Maudsley Guidelines specifically recommend vigilance in monitoring for serotonin syndrome in
patients with RI prescribed antidepressants [5].
Selective Serotonin Reuptake Inhibitors (SSRIs)
SSRIs are often recommended as the agents of choice in RI [3, 5, 9] although there is a lack of robust
evidence to support this recommendation and therefore it is mainly based on pharmacokinetic data and
clinical experience [3, 7, 9]. Reviews by Nagler et al [9] and the Cochrane Collaboration [12] have
demonstrated the paucity of information available on the use of antidepressants, including SSRIS, in RI
and renal replacement therapies.
SSRIs are predominantly hepatically metabolised and some SSRIs alter the kinetics of CYP450
enzymes [13-19]. In general SSRIs do not require a dose adjustment in RI, however as some
metabolites are renally excreted, caution is required [4,13-18]. The half life and plasma concentration
of paroxetine have been shown to increase as renal function declines and lower starting doses are
recommended by most sources [4,5,7,8,16] Drug interactions may be a problem with the SSRIs that
affect CYP450 enzymes. Fluoxetine, fluvoxamine and paroxetine in particular may interact with other
medicines via this mechanism [1, 8]. Fluoxetine has been shown to be efficacious and well tolerated in
in dialysis patients [7]; however it may not be the most appropriate first-line agent due to its extended
half-life and interaction potential [1, 5, 7-8].(See notes above regarding citalopram and sertraline).
SSRIs are associated with an increased bleeding risk which may be a concern in RI [3, 8,11].
Tricyclic Antidepressants (TCAs)
Historically TCAs were the agents of choice in RI due to more experience of their use, but they have
been superseded by the SSRIs due to safety concerns and adverse effects with TCAs [3, 8].
Amitriptyline and dosulepin are effective but they are particularly dangerous in overdose and NICE [1dosulepin only] and the BNF do not recommend their use in the treatment of depression [11]. Although
most TCAs can be used cautiously in RI, as in patients with normal renal function, they are generally
not recommended as first-line antidepressants.
Available through NICE Evidence. Search at www.evidence.nhs.uk
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Medicines Q&As
The majority of TCAs are hepatically metabolised and most do not alter the kinetics of enzymes in the
CYP450 pathway [18-19, 20-26]. Interactions with other medicines metabolised via the CYP450
pathway are therefore less likely than with the SSRIs, but numerous other interactions occur [11, 18-19,
20-26]. Lofepramine, of which approximately 50% is renally excreted, is contraindicated by its
manufacturer in severe RI [6, 24].
TCAs’ antimuscarinic adverse effects may be more pronounced in RI, and all patients given TCAs
should be monitored for urinary retention, confusion, sedation and postural hypotension [5]. Cardiac
adverse effects, e.g. hypotension and arrhythmias, may also be a problem in patients with RI and coexisting cardiovascular disease [3, 8].
Miscellaneous Antidepressants
As Duloxetine is a relatively new antidepressant there is only limited experience of its use in RI.
Duloxetine is contra-indicated in patients with creatinine clearance (CrCl) of less than 30mL/min [5,27].
Duloxetine is extensively metabolised by the CYP450 pathway to mainly inactive metabolites and it has
been shown to accumulate in dialysis patients [7, 27]. Duloxetine has also been associated with
increases in blood pressure, and patients with known hypertension or other cardiac disease or whose
condition may be affected by an increase in blood pressure should have their blood pressure monitored
[10].
Mirtazapine is extensively metabolised via the CYP450 pathway to active and inactive metabolites
which are mainly excreted in the urine [18, 28]. Clearance of mirtazapine is reduced in moderate to
severe RI (CrCl <40mL/min) and the manufacturers advise that this should be taken into account when
prescribing mirtazapine [28]. Mirtazapine exhibits weak antimuscarinic effects [11, 28].
Moclobemide is extensively metabolised by the liver, in part by CYP450 enzymes, to mainly inactive
metabolites, which are renally excreted [18, 29]. No dose alteration is required in RI as RI has not been
shown to alter the elimination of moclobemide [29]. Moclobemide is claimed to have a reduced risk of
interactions and to cause less potentiation of the pressor effect of tyramine than other MAOIs, but
patients should still be advised to avoid consumption of large amounts of tyramine rich foods and to
avoid taking sympathomimetics [11].
Reboxetine has been shown to be metabolised predominately by the CYP450 pathway in in vitro
studies, to inactive metabolites, which are renally excreted [18,30]. Reboxetine is not thought to have
any clinically significant effects on CYP450 enzymes [18,30]. Systemic exposure and half life are
approximately doubled in patients with renal insufficiency and therefore the manufacturer recommends
a 50% reduction in starting dose for patients with RI [30]. The manufacturers of reboxetine do not
recommend its use in the elderly due to limited evidence of its use in this patient group [30].
Venlafaxine is extensively metabolised via the CYP450 pathway to active metabolites which are mainly
excreted in the urine [18, 31]. The half lives of venlafaxine and its metabolites have been shown to
increase in RI [7, 18]. The manufacturer recommends reducing the dose by 50% in severe RI [31].
Venlafaxine has been shown to cause hypertension and monitoring of blood pressure is indicated for all
patients taking venlafaxine but is especially important for those with pre-existing hypertension [10-11,
31]. Venlafaxine also has an increased bleeding risk and it should be used cautiously in patients with
cardiovascular disease [11, 31]. Avoid using the XL preparations if the GFR is <30ml/min [5]
Agomelatine is one of the newer antidepressants and there is very little information available regarding
its use in RI. Agomelatine is metabolised via the CYP450 pathway to inactive metabolites which are
renally excreted [32]. No dosage modification in severe RI is recommended by the manufacturers but
caution should be used due to the lack of clinical experience in this patient group [32].
Trazodone is a tricyclic related drug and therefore has cautions similar to the TCAs [11]. Trazodone is
extensively metabolised by the CYP450 pathway to active metabolites which are renally excreted [18,
33]. In general doses do not need to be reduced in RI but it is advisable to start with a low dose and
increase the dose cautiously [4-5, 33].
Available through NICE Evidence. Search at www.evidence.nhs.uk
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Medicines Q&As
Due to the complexity of using lithium in RI, seek specialist advice before lithium is prescribed.
Summary








Data on the use of antidepressants in renal impairment are limited.
The majority of antidepressants can be used in renal impairment with caution.
The choice of the initial antidepressant is based on the same general principles as in normal
renal function.
Specific increased risks due to renal disease need to be considered.
Start with a low dose, titrate slowly and monitor patients closely.
Side effects may be enhanced in renal impairment.
Extra caution may be needed when switching between antidepressants as half lives may be
extended.
Lofepramine and duloxetine are contraindicated by their manufacturers in severe renal
impairment.
Limitations
This Medicines Q&A is not designed to be a standalone resource on choice or dosing of
antidepressants in renal impairment. Readers are advised to use standard drug dosing in renal disease
resources to support decision making. This Q&A is intended for use in adult patients only. The use of
antidepressants for indications other than depression is outside the scope of this Q&A. The use of
antidepressants in renal replacement therapies is not discussed here.
Available through NICE Evidence. Search at www.evidence.nhs.uk
4
Medicines Q&As
Table 1: Summary of information on the use of antidepressants in renal impairment from the manufacturer’s product information, Renal Drug
Handbook and the Maudsley Prescribing Guidelines. (Details based on current editions and correct at the time of writing).
Manufacturers' Information
Renal Drug Handbook [4]
The Maudsley Prescribing Guidelines [5]
 Monitor all patients given TCAs for urinary retention,
confusion, sedation and postural hypotension.
TCAs
Amitriptyline
 No information on dose adjustment available from
the manufacturer [20]
Clomipramine
 The effects of RI on the pharmacokinetics of
clomipramine have not been determined. [21]
Doxepin
 Use with caution in patients with RI. [22]
Imipramine
 Caution in severe RI. [23]
 In patients with severe RI, no change occurs in
renal excretion of imipramine and its biologically
active metabolites. However concentrations of the
biologically inactive metabolites are elevated. The
clinical significance of this finding is not known. [23]
 Lofepramine is contraindicated in severe RI. [24]
 Lofepramine should be used with caution in RI.
 <10-50 mL/min dose as in normal renal function
 10-50 mL/min dose as in normal renal function
 <10 mL/min start at a low dose
 10-50 mL/min dose as in normal renal function
 <10 mL/min start with a small dose and titrate slowly
Nortriptyline
 No information available from the manufacturer [25]
 10-50 mL/min dose as in normal renal function
 <10 mL/min start with small doses
Trimipramine
 No information available from the manufacturer [26]
 <10-50 mL/min normal






 Dosage adjustment is not necessary in mild or
moderate RI. [13]
 No information available for severe RI (CrCl <20
mL / min). [13]
 Dosage adjustment is not necessary in mild or
moderate RI. [14]
 Caution is advised in patients with severe RI (CrCl
 <10-50 mL/min dose as in normal renal function
 Caution <10ml/min, reduced clearance in
severe renal failure
 Dose as for normal renal function.
 Caution if GFR <10ml/min.
 30-50 mL/min dose as in normal renal function
 <10-30ml/min start with a low dose and titrate
slowly
 Dose as per manufacturer
 Start with a low dose and increase slowly.
 Renal failure and reversible renal tubular defects have been
Lofepramine
 <10-50 mL/min dose as in normal renal function
 Introduce gradually due to dizziness and
postural hypotension
 Withdraw treatment gradually
 20-50 mL/min dose as in normal renal function
 <10-20 mL/min start low and titrate according to
response
 Not included
 Dose as in normal renal function, but start with a low dose and
increase slowly
 Plasma monitoring may be useful
 Has been used to treat pain in renal disease
 20-50 mL/min dose as in normal renal function
 <10-20 mL/min, effects unknown, start at a low dose and monitor




Dose as in normal renal function
Haemolytic anaemia with renal failure has been reported.
No specific dose adjustment necessary in RI.
Renal impairment and renal damage have been reported rarely.
10-50 mL/min dose as in normal renal function
<10 mL/min start at a low dose.
Plasma level monitoring recommended at doses >100mg/day.
Worsening of GFR in elderly patients has been reported.
Dose as for normal renal function.
Elevated urea, acute renal failure and interstitial nephritis have
been reported.
SSRIs
Citalopram
Escitalopram
Available through NICE Evidence. Search at www.evidence.nhs.uk
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Medicines Q&As
Fluoxetine
Paroxetine
Sertraline
<30 mL / min). [14]
 Dialysis patients given fluoxetine 20mg/day for 2
months, showed no difference in levels of fluoxetine
or norfluoxetine compared to controls with no RI.
[15]
 Increased plasma concentrations of paroxetine
occur in severe RI (CrCl < 30 mL/min) Therefore,
dosage should be restricted to the lower end of the
dosage range [16]
 No dosage adjustment is necessary in patients with
RI [17]
 10-50ml/min dose as in normal renal function
 <10 mL/min decrease dose or give alternate
days,
 Metabolites excreted renally, accumulation may
occur in severe renal failure
 30-50 mL/min dose as in normal renal function
 <10-30 mL/min start with 20mg, titrate slowly
 <10-50 mL/min dose as in normal renal function
 Used in RF at normal doses with caution
reported
 20-50 mL/min dose as in normal renal function
 <20 mL/min use a low dose or on alternate days and increase
according to response
 30-50 mL/min dose as in normal renal function
 <10-30 mL/min start with 10mg (other sources say start at 20mg)
and increase according to response
 Rarely associated with Fanconi syndrome and acute renal failure.
 Dosing as for normal renal function
 Sertraline has been used to treat dialysis-associated hypotension;
however acute renal failure has been reported so use with
caution.
Others
Duloxetine
 No dosage adjustment is necessary for patients
with mild or moderate renal dysfunction (CrCl 30 to
80 mL/min). [27]
 Contraindicated in severe RI (CrCl <30 mL/min).
[27]
Mirtazapine
 Clearance of mirtazapine may be decreased in
patients with moderate to severe RI (CrCl <40
mL/min). This should be taken into account when
prescribing mirtazapine in this category of patients
[28]
 Patients with RI do not require a special dose
adjustment of moclobemide [29]
Moclobemide
Reboxetine
Venlafaxine
 The starting dose with renal insufficiency should be
2mg BD which can be increased based on patients’
tolerance. [30]
 No change in dosage is necessary for patients with
GFR between 30-70 mL/minute, Caution is advised.
[31]
 For patients with severe RI (GFR < 30 mL/min), the
dose should be reduced by 50%. [31]
 Because of inter-individual variability in clearance in
these patients, individualisation of dosage may be
desirable. [31]
 30-50 mL/min dose as in normal renal function,
start with a low dose
 10-30 mL/min start at a low dose and increase
according to response
 <10 mL/min start at a very low dose and
increase according to response
 10-50 mL/min dose as in normal renal function
 <10 mL/min start low, monitor closely
 As per manufacturer information
 >30ml/min advise to start at a low dose and increase slowly.
 <30ml/min contraindicated.
 <10-50 mL/min dose as in normal renal function
 <10 -50 mL/min dose as in normal renal function
 An active metabolite was found to be raised in RI but was not
thought to affect dosing.
 GFR <20ml/min 2mg BD adjust according to response
 Approximately 10 % is excreted unchanged in the urine
 Half life is prolonged as renal function decreases
 Dosing advice differs.
 30-50 mL/min dose as in normal renal function or reduce by 50%
 <10-30 mL/min decrease dose by 50% and give once daily.
 Avoid using the XL preparations if GFR <30ml/min.
 Rhabdomyolysis and renal failure have been reported rarely with
venlafaxine.
 Venlafaxine is used to treat neuropathy in dialysis patients.
 20-50 mL/min dose as in normal renal function
 <10-20 mL/min start with 2mg BD and adjust
according to response
 30-50 mL/min dose as in normal renal function,
 <10-30 mL/min decrease dose by 50% and
administer daily
 10-50 mL/min dose as in normal renal function
 <10 mL/min start low, monitor closely
 Mirtazapine has been used to treat pruritus caused by renal
failure but is associated with kidney calculus formation.
Available through NICE Evidence. Search at www.evidence.nhs.uk
6
Medicines Q&As
Acknowledgements
Highly Specialist Renal Pharmacist, North Bristol NHS Trust
Renal Pharmacist, Royal Devon and Exeter NHS Foundation Trust
Locality Pharmacists, Avon and Wiltshire Mental Health Partnership NHS Foundation Trust
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11/14. Accessed via: http://emc.medicines.org.uk. Date accessed: 25/9/14.
Summary of Product Characteristics. Molipaxin 150mg Tablets. Sanofi-Aventis. Date of revision
of text: 22/8/13. Accessed via: http://emc.medicines.org.uk. Date accessed: 25/9/14.
Quality Assurance
Prepared by
Tiffany Barrett, based on earlier work by Nicola Greenhalgh, South West Medicines Information,
University Hospitals Bristol NHS Foundation Trust
Date Prepared
October 2014
Available through NICE Evidence. Search at www.evidence.nhs.uk
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Medicines Q&As
Checked by
Julia Kuczynska, South West Medicines Information, University Hospitals Bristol NHS Foundation
Trust
Date of check
December 2014
Search strategy
Embase (via NHS Evidence) - Search terms used:
exp ANTIDEPRESSANT AGENT and (exp KIDNEY DYSFUNCTION OR exp KIDNEY DISEASE or
KIDNEY FAILURE)
Limit to: Human and English Language and Publication Year 2011-Current and (Human Age Groups
Adult 18 to 64 years or Aged 65+ years
Medline (via NHS Evidence) – Search terms used:
(exp ANTIDEPRESSIVE AGENTS or exp DEPRESSIVE DISORDER) and (exp RENAL
INSUFFICIENCY or exp KIDNEY DISEASES or exp ACUTE KIDNEY INJURY)
[Limit to: English Language and Humans and Publication Year 2011-Current and (Age Groups
Adult 19 to 44 years or Middle Age 45 to 64 years or Middle Aged 45 plus years or All Aged 65 and
Over or Aged 80 and Over)];.
In-house database/ resources
The Renal Association: http://www.renal.org/home.aspx
The Royal College of Psychiatrists: http://www.rcpsych.ac.uk/
Available through NICE Evidence. Search at www.evidence.nhs.uk
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