Toxic epidermal necrolysis,Spironolactone,Torsemide,Dytor plus

 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

	Abstract
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.
Keywords Dytor plus tablet, TEN, toxic epidermal necrolysis, erythematous rash, Pharmacovigilance
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 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).

Hematinics,anemia,types of anemias ,treatment,iron supplements,folic acid ,vitamin B12 ,filgrastim

Hematinics

Hematinics are essential compounds or required for the formation of blood. These agents are employed in the treatment of anemias.

Anemia is a condition in which a low number of red blood cells carrying adequate oxygen to tissues.

Types of anemias

• Iron deficiency anemia-due to excessive loss of iron.
• Hemolytic anemia-In hemolytic anemia red blood cells are destroyed faster than normal.
• Megaloblastic anemia-It is caused by a deficiency or an impaired utilization of vitamin B12 and /or folate.
• Aplastic anemia-A rare condition in which the body stops producing enough new blood cells due to bone marrow damage.
• Pernicious anemia-It can occur due to the inability to absorb vitamin B12 in small intesine . It is a type of megaloblastic anemia.
• Sickle cell anemia /sickle cell disease (SCD)-It is a genetic disease of the red blood cells . The red blood cells are shaped like sickles.
• Thalassemia-It is an inherited disorder and producing less hemoglobin than normal.

Gentamicin -Uses ,dosage , side effects

GENTAMICIN is an antibiotic under the class of Aminoglycoside and it is an important drug for the treatment of many serious gram-negative bacillary infections and usually is the aminoglycoside of first choice because of its low cost and reliable activity against all but the most resistant gram-negative aerobes. Gentamicin is given parenterally, ophthalmically,and topically.
Availability of Gentamicin
 Eye drops 0.3% w/v, cream 15g (0.1%w/w); INJECTION 2 ml ampoule (40 mg/ml),2 and 10 ml vials (40 mg/ml).

Amikacin-Uses and Side effects

AMIKACIN is an antibiotic under the class of aminoglycosides with amino sugars in glycosidic linkages. Amikacin is a semisynthetic product and used to treat conditions such as Bacterial infections, uncomplicated urinary tract infections, severe gram-negative infections resistant to gentamicin and tobramycin, and short term treatment of serious infections caused by Pseudomonas species, Escherichia coli, species of indole-positive and indole negative, Proteus, Klebsiella, Enterobacter, Serratia, Salmonella, Shigella and Acinetobacter. Get to know how Amikacin works, its side effects, precautions, interactions, and contraindications.

How does Amikacin work?

Amikacin has the capacity to kill the bacteria by binding to 30S ribosomes and inhibit bacterial protein synthesis. The drug penetrates the bacterial cell membrane through pores.

Amikacin has concentration-dependent bactericidal activity against Gram-negative aerobic bacteria, anaerobic bacteria are universally resistant because aminoglycoside transport into cells is oxygen-dependent.

NIPAH VIRUS INFECTION

NIPAH VIRUS INFECTION 

According to the World Health Organisation ,Nipah virus or NiV infection is a newly emerging zoonosis that cause severe disease in both animals and human beings .The natural host of the virus are fruit bats of the Pteropodidae Family ,Pteropus genus.
Niv first identified in 1998 during an outbreak in Malaysia.There is no vaccine for either humans or animals.The primary treatment for human cases is intensive medical care.

Zidovudine-uses, dosage and adverse effects

Zidovudine (ZDV)

Brands-Retrovir,Zidovir

Zidovudine (ZDV), also known as azidothymidine (AZT), is an antiretroviral medication used to prevent and treat HIV/AIDS.ZDV is of the nucleoside analog reverse-transcriptase inhibitor (NRTI) class.It works by inhibiting the enzyme reverse transcriptase that HIV uses to make DNA and therefore decreases replication of the virus.

Antiretroviral drugs do not cure HIV (human immunodeficiency virus) infection; they only temporarily suppress viral replication and improve symptoms. Patients receiving these drugs

require careful monitoring by appropriately trained health professionals in an adequately resourced setting. Rigorous promotion of measures to prevent new infections remains

essential and its need is not diminished by the availability of antiretroviral drugs. Effective therapy requires the simultaneous use of 3 or 4 drugs; alternative regimens are necessary

to meet specific requirements at start-up, to substitute for first-line regimens in cases of intolerance, or to replace failing regimens. The use of a 3- or 4-drug combination as specified in the WHO treatment guidelines is recommended. The use of fixed-dose preparations for these combinations is also recommended if the pharmaceutical quality is assured and interchangeability with the single products is demonstrated as specified by the relevant drug regulatory authority.

Pharmacovigilance Programme of India(PVPI)

Pharmacovigilance has been defined by the World Health Organization (WHO) as the science and activities relating to the detention ,assessment ,understanding and prevention of adverse effects or any other medicine related issues.
WHO established its programme for international drug monitoring in response to the Thalidomide tragedy happened in the year of 1961.Latter WHO decided to start pharmacovigilance programme at the country level .

Pharmacovigilance programme in India
The central drugs standard control organisation (CDSCO) New Delhi,under aegis of Ministry of Health and Family Welfare ,Government of India initiated a national wide pharmacovigilance programme in July 2010 with AIIMS New Delhi as National coordination Centre (NCC)for monitoring ADRs in the country for safe -guarding public health by ensuring the safety of medical products.The NCC was shifted from AIIMS ,New Delhi to Indian Pharmacopoeia Commision (IPC) Ghaziabad on 15th April 2011.