Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide
Melcy Mary Philip 1*, Kala Kesavan P 1,
Jai Prakash 2
1*Patient safety pharmacovigilance Associate, Govt.
TD Medical College, Vandanam, Alappuzha, Kerala, 688005, India
1HOD, Department of pharmacology, Govt Medical College, Vandanam, Alappuzha,Kerala , India
2Senior Principal
Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad, U.P.
Web of
Science Researcher ID: NA
ORCID
ID: NA
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Abstract |
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Date Received: 05/08/2020 Date Revised: 20/08/2020 Date Accepted: 24/08/2020 |
Dytor plus tablet is a fixed-dose combination of Torsemide and
Spironolactone used for generalized edema. TEN is a serious, potentially life-threatening dermatological disorder. Here we present a case report of a
47-year-old female who was on Dytor Plus (5/50 mg)therapy once daily for
generalized edema; presented to dermatology outpatient department with a chief
complaints of multiple erosions over oral cavity, swelling of lips with
scaling, redness, and burning sensation in both eyes, multiple well defined
mostly erythematous rashes over the entire body for 2 days .on examination,
her vital signs were stable and lab result indicates she had elevated SGOT(140
IU/L), SGPT (228 IU/L), ALP (162IU/L) and blood urea(47 mg/ml) values. The patient was diagnosed to have developed Dytor plus induced toxic epidermal
necrolysis. Discontinued the medicine and prescribed with Dexamethasone
injection, IgG Injection, Cefotaxime injection, Cloxacilline capsule,
Cetirizine tablet, Hydroxypropyl methylcellulose eye drop, and candid mouth
paint. The patient had a hospital stay of 25 days. The patient improved
symptomatically. Causality was assessed as per the WHO-UMC causality scale
and this case was put in the probable category. This case was uploaded via
vigiflow under the pharmacovigilance programme of India having report Id
2019-30695.
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Keywords Dytor
plus tablet, TEN, toxic epidermal necrolysis, erythematous rash,
Pharmacovigilance
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COPYRIGHT © 2020 JPADR |
Introduction
Toxic epidermal necrolysis (TEN) is a rare, more severe dermatological drug reaction as compared to a stevens-johnson syndrome which is less severe. The main symptoms are severe skin peeling and blistering that progresses quickly, resulting in large raw areas that may ooze or weep (Goodmann et al., 2008). Dytor Plus 5mg Tablet is a combination of two medicines Spironolactone (50mg) + Torsemide (5mg) used to treat edema (fluid overload) and reduce excess fluid levels in the body while maintaining the potassium balance. Dehydration is a very common side effect as well as it lowers down the level of calcium, sodium, and magnesium in the blood. Sometimes it causes dizziness or tiredness
Generally, Oedema associated with nephrotic syndrome was
treated with torsemide 100 mg co-administered with an aldosterone antagonist.
No pharmacokinetic interactions have been reported following coadministration
of torsemide with digoxin, spironolactone, carvedilol, or cimetidine (Joseph et al., 2003). Short-term studies have shown that orally administered torsemide 5 to 20 mg/day decreases the severity of edema and mean bodyweight to a greater extent than
placebo or furosemide 40 mg in patients with chronic CHF. Torsemide 20 mg/day
also achieved a greater reduction in pre-existing edema than furosemide 40
mg/day in patients with chronic CHF. Efficacy appeared to be maintained for 11
months in a longer-term dose-ranging study using torsemide 5 to 20 mg/day. Both
torsemide 10 to 200 mg/day as monotherapy, and torsemide 5 to 20 mg/day plus
spironolactone 50 to 200 mg/day, significantly reduced body weight and
peripheral edema after up to 13 weeks of treatment in
patients with nephrotic syndrome.
Torsemide 10 to 20 mg/day coadministered with spironolactone 100 to 200 mg/day
effectively reduced edema, ascites, and body weight in these patients. Torsemide
10 to 20 mg/day plus potassium canrenoate 200 mg/day decreased ascites and
edema in cirrhotic patients to a greater extent than either monotherapy with
potassium canrenoate 400 mg/day for up to 7 days, or furosemide 25 to 50 mg/day
plus potassium canrenoate 200 mg/day for 3 to 4 days. Addition of torsemide 10
to 40 mg/day to pre-existing therapy with spironolactone 50 to 400 mg/day
improved ascites and edema in 73 % and 67 % of patients, respectively, after 6
months of treatment (Dunn
et al., 1995).
