An inventory of medicinal products causing skin rash: Clinical and regulatory lessons

Ancuceanu, Robert; Dinu, Mihaela; Furtunescu, Florentina; Boda, Daniel

doi:10.3892/etm.2019.7837

Cited by 9 publications

(10 citation statements)

References 48 publications

(50 reference statements)

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“…A study indicated that the rash was a very rare adverse reaction associated with torasemide. Only around 3 % of the 1,048 medicines analyzed developed rashes (Ancuceanu et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide

Philip¹,

P²,

Prakash³

2020

jpadr

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Introduction: 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. Methods: 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 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 since 2 days. Results: On examination, her vital signs were stable and lab results indicate 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. Conclusions: 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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“…A study indicated that the rash was a very rare adverse reaction associated with torasemide. Only around 3 % of the 1,048 medicines analyzed developed rashes (Ancuceanu et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide

Philip¹,

P²,

Prakash³

2020

jpadr

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“…A further consideration to this route of administration is the requirement of significantly higher doses to achieve the proposed 15-30 mg/L therapeutic levels. If it is feasible to develop transdermal patches to achieve such levels, the risk of local skin reactions, which is a known side-effect of transdermal melatonin may become a concern [145]. There are some limitations of current animal models for NE in the LMIC setting.…”

Section: Melatonin As a Single Agent For The Low Resource Settingmentioning

confidence: 99%

Melatonin for Neonatal Encephalopathy: From Bench to Bedside

Pang

Advic-Belltheus

Meehan

et al. 2021

IJMS

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Neonatal encephalopathy is a leading cause of morbidity and mortality worldwide. Although therapeutic hypothermia (HT) is now standard practice in most neonatal intensive care units in high resource settings, some infants still develop long-term adverse neurological sequelae. In low resource settings, HT may not be safe or efficacious. Therefore, additional neuroprotective interventions are urgently needed. Melatonin’s diverse neuroprotective properties include antioxidant, anti-inflammatory, and anti-apoptotic effects. Its strong safety profile and compelling preclinical data suggests that melatonin is a promising agent to improve the outcomes of infants with NE. Over the past decade, the safety and efficacy of melatonin to augment HT has been studied in the neonatal piglet model of perinatal asphyxia. From this model, we have observed that the neuroprotective effects of melatonin are time-critical and dose dependent. Therapeutic melatonin levels are likely to be 15–30 mg/L and for optimal effect, these need to be achieved within the first 2–3 h after birth. This review summarises the neuroprotective properties of melatonin, the key findings from the piglet and other animal studies to date, and the challenges we face to translate melatonin from bench to bedside.

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“…Some other rare reactions to antibiotics are rashes, but patients with low urinary tract symptoms, especially the stocking symptoms, often receive overactive bladder syndrome diagnosis and treatment. Anticholinergic treatment can also cause rashes in up to 3.06% [16] and by the time the patients receive antibiotic treatment for the correct diagnosis adverse effects of antibiotics might overlap with the previous medication. For this reason, we decided not to follow rare adverse effects in our study.…”

Section: Escherichia Coli Resistancementioning

confidence: 99%

Levofloxacin Versus Cefixime as an Empiric Treatment in Acute Bacterial Prostatitis

Pricop¹

2021

FARMACIA

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Acute bacterial prostatitis (ABP) is a clinical condition frequently encountered in clinical practice, but there is a lack of consensus for the diagnosis, investigations, and treatment for this pathology. We have enrolled patients diagnosed with acute prostatitis in three academic urological centres between 2019 -2020 and followed-up prospectively their evolution under two different frequently used antibiotics-fluoroquinolones and cephalosporins, both combined or not with alpha-blockers. All patients received standard start-up treatment. A total of 154 patients were included. Both groups had similar side effects rates ranging from 8.97% to 11.84%. Both groups had similar positive urine culture 15.38% for group A, respectively 14.47% for group B. Although it is an ongoing study, we can confirm that fluoroquinolones and cephalosporins, with or without alpha-blocker, are as effective and tolerated in enhancing empirical treatment initiated at admission for patients with acute bacterial prostatitis. RezumatProstatita bacteriană acută (ABP) este o afecțiune clinică întâlnită frecvent în practică, dar există o lipsă de consens pentru standardizarea diagnosticului, a investigațiilor și pentru stabilirea tratamentului. În acest studiu prospectiv au fost înrolați pacienți diagnosticați cu prostatită acută din trei centre urologice academice în perioada 2019 -2020 și s-a urmărit evoluția sub tratamentul cu două antibiotice utilizate frecventfluorochinolone (grupul A) și cefalosporine (grupul B), ambele combinate sau nu cu alfa-blocante. Toți pacienții au primit tratament standard la internare. Au fost incluși un total de 154 de pacienți. Ambele grupuri au avut rate de efecte secundare similare, variind între 8,97% și 11,84%. Ambele grupuri au avut frecvența uroculturilor pozitive similară: 15,38% pentru grupul A, respectiv 14,47% pentru grupul B. Deși studiul este încă în desfășurare, putem confirma că fluorochinolonele și cefalosporinele, cu sau fără alfa-blocant, sunt la fel de eficiente și tolerate în îmbunătățirea tratamentului empiric inițiat la internare la pacienții cu prostatită acută bacteriană.

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An inventory of medicinal products causing skin rash: Clinical and regulatory lessons

Cited by 9 publications

References 48 publications

Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide

Toxic epidermal necrolysis associated with combination therapy of spironolactone and torsemide

Melatonin for Neonatal Encephalopathy: From Bench to Bedside

Levofloxacin Versus Cefixime as an Empiric Treatment in Acute Bacterial Prostatitis

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