Safety Pharmacological studies of Kalyanaka ghrita

2021 ◽  
Vol 12 (3) ◽  
pp. 2155-2163
Author(s):  
Diddi Sneha Latha ◽  
Arulmozhi S
Keyword(s):  
Side Effects ◽  
Safety Profile ◽  
Wistar Rats ◽  
Vehicle Control ◽  
Basic Component ◽  
Nasal Administration ◽  
Promising Candidate ◽  
Nasal Turbinate ◽  
Safety Pharmacology ◽  
Pharmacological Studies

Safety pharmacology is a study of unfavorable, pharmacodynamic effects of a drug on physiological functions with therapeutic range by using International Conference on Harmonization (ICH) S7A guidelines. The cardiovascular, central nervous, and respiratory systems are most affected by pharmacological side effects, resulting withdrawal of multiple medications from the market. Kalyanaka ghrita (KG) is an Ayurvedic formulation with ghee as a major basic component, though a promising candidate in treatment of AD, KG has not been documented for its safety profile, which prompted the study. In this study we evaluated safety pharmacology of KG oral (4, 2, 1g/kg), and nasal (100, 50, 25 µl/rat), in Wistar rats for 28 days subjected to CNS, CVS and the respiratory safety profile was evaluated on day 0, 14 and 28. At the end of the study the nasal turbinate was evaluated histopathologically. In the present study KG did not cause any significant change in CNS profile. However KG treatment had increased the grooming and rearing behaviors, which were not significant compared to vehicle control and did not cause change in CVS and respiratory profile upon treatment with KG for 28 days. The epithelium of nasal turbinate of animals was found intact after 28 days of nasal administration. After sustained dosing, the KG oral and intranasal treated groups showed no harmful events, which illustrates the CNS, CVS and respiratory safety profile of Kalyanaka ghrita.

Safety and Tolerability of Fluconazole in Children

1999 ◽  
Vol 43 (8) ◽  
pp. 1955-1960 ◽  
Author(s):  
Vas Novelli ◽  
Helen Holzel
Keyword(s):  
Side Effects ◽  
Safety Profile ◽  
Antifungal Agents ◽  
Fungal Infections ◽  
Pediatric Population ◽  
Gastrointestinal Symptoms ◽  
Underlying Disease ◽  
Severe Underlying Disease ◽  
Excellent Safety Profile ◽  
Concomitant Medications

ABSTRACT The safety profile of fluconazole was assessed for 562 children (ages, 0 to 17 years) comprising 323 males and 239 females. The data are derived from 12 clinical studies of fluconazole as prophylaxis or treatment for a variety of fungal infections in predominantly immunocompromised patients. Most children received multiple doses of fluconazole in the range of 1 to 12 mg/kg of body weight; a few received single doses. Administration was mainly by oral suspension or intravenous injection. Overall, 58 (10.3%) children reported 80 treatment-related side effects. The most common side effects were associated with the gastrointestinal tract (7.7%) or skin (1.2%). Self-limiting, treatment-related side effects affecting the liver and biliary system were reported in three patients (0.5%). Overall, 18 patients (3.2%) discontinued treatment due to side effects, mainly gastrointestinal symptoms. Dose and age did not appear to influence the incidence and pattern of side effects. Treatment-related laboratory abnormalities were uncommon, the most frequent being transient elevated alanine aminotransferase (4.9%), aspartate aminotransferase (2.7%), and alkaline phosphatase (2.3%) levels. Although 98.6% of patients were taking concomitant medications, no clinical or laboratory interactions were observed. The safety profile of fluconazole was compared with those of other antifungal agents, mostly oral polyenes, by using a subset of data from five controlled studies. Side effects were reported by more patients treated with fluconazole (45 of 382; 11.8%) than by those patients treated with comparable agents (25 of 381; 6.6%); vomiting and diarrhea were the most common events in both groups. The incidence and type of treatment-related laboratory abnormalities were similar for the two groups. In conclusion, fluconazole was well tolerated by the pediatric population, many of whom were suffering from severe underlying disease and were taking a variety of concurrent medications. The safety profile of fluconazole in children mirrors the excellent safety profile seen in adults.

scholarly journals Dual orexin receptor antagonist in treatment of insomnia

Engrami ◽  
2020 ◽  
Vol 42 (2) ◽  
pp. 57-68
Author(s):  
Nikola Trajanović
Keyword(s):  
Circadian Rhythm ◽  
Side Effects ◽  
Receptor Antagonist ◽  
Safety Profile ◽  
The Elderly ◽  
First Line ◽  
Future Studies ◽  
Good Safety Profile ◽  
Circadian Rhythm Disorders

A novel group of medications, dual orexin receptor antagonists, emerged as a competent group that challenges current first-line hypnotics. They have relatively infrequent and mostly well-tolerated side effects, primarily in the form of residual somnolence, fatigue and nightmares/disturbing dreams. The advantage over conventional hypnotics stems from the specifics of their target receptors, which translates into lack of tolerance after long term use and good safety profile. They are particularly favoured in some specific populations, including the elderly. Ongoing and future studies are set to explore their effect on selected conditions, such as addiction and psychiatric disorders, dementias, perimenopausal condition and circadian rhythm disorders, to name a few.

scholarly journals Current Approaches to the Treatment of Gastrointestinal Infections: Focus on Nitazoxanide

2009 ◽  
Vol 1 ◽  
pp. CMT.S2297 ◽  
Author(s):  
Jennifer L. Halsey
Keyword(s):  
Side Effects ◽  
Drug Interactions ◽  
Broad Spectrum ◽  
Safety Profile ◽  
Taenia Saginata ◽  
Gastrointestinal Infections ◽  
Oral Tablet ◽  
Acceptable Safety Profile ◽  
H Pylori ◽  
Immunocompetent Patients

Nitazoxanide is a broad-spectrum agent active against several protozoa, helminths, and bacteria, including C. difficile and H. pylori. It is available as an oral tablet and suspension, both with adequate bioavailability. Nitazoxanide is associated with minimal side effects, has an acceptable safety profile, and has been classified as a pregnancy category B agent. It is 99% protein bound, which could result in drug interactions. It is the preferred agent for the treatment of Cryptospordiosis and Giardiasis in immunocompetent patients and has shown promise for the treatment of rotavirus, mild to moderate initial C. difficile infection, refractory C. difficile infection, Amoebiasis, Blastocystosis, and Taenia saginata.

Mikania laevigata syrup does not induce side effects on reproductive system of male Wistar rats

2007 ◽  
Vol 111 (1) ◽  
pp. 29-32 ◽  
Author(s):  
Carlos Graça ◽  
Cristina Setim Freitas ◽  
Cristiane Hatsuko Baggio ◽  
Paulo Roberto Dalsenter ◽  
Maria Consuelo Andrade Marques
Keyword(s):  
Side Effects ◽  
Reproductive System ◽  
Wistar Rats ◽  
Male Wistar Rats ◽  
Mikania Laevigata

Chitosan-coated rosmarinic acid nanoemulsion nasal administration protects against LPS-induced memory deficit, neuroinflammation, and oxidative stress in Wistar rats

2020 ◽  
Vol 141 ◽  
pp. 104875
Author(s):  
Flávia Nathiely Silveira Fachel ◽  
Luana Roberta Michels ◽  
Juliana Hofstätter Azambuja ◽  
Gabriela Spies Lenz ◽  
Nicolly Espindola Gelsleichter ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Rosmarinic Acid ◽  
Wistar Rats ◽  
Memory Deficit ◽  
Nasal Administration ◽  
And Oxidative Stress

scholarly journals Efficacy of topical hydrogel Epigallocatechin-3-gallate against neutrophil cells in perforated dental pulp

2020 ◽  
Vol 53 (2) ◽  
pp. 88
Author(s):  
Kun Ismiyatin ◽  
Ari Subiyanto ◽  
Michelle Suhartono ◽  
Paramita Tanjung Sari ◽  
Olivia Vivian Widjaja ◽  
...  
Keyword(s):  
Side Effects ◽  
Dental Pulp ◽  
Wistar Rats ◽  
Radical Scavenging ◽  
Recovery Process ◽  
Mechanical Trauma ◽  
High Concentration ◽  
Group Data ◽  
Molar Teeth ◽  
Radical Scavenging Ability

Background: One cause of pulpitis is mechanical trauma such as pulp perforation. The emergency treatment of pulpitis in a clinic uses eugenol. Eugenol in a high concentration causes cytotoxicity, which causes local necrosis and inhibits the recovery process, while in lower doses it can cause oral mucosal hypersensitivity. Due to these side effects, it is worth considering other biocompatible materials with minimal side effects, such as epigallocatechin-3-gallate (EGCG) which is found in green tea. As a polyphenol, EGCG has a radical scavenging ability, which has an effect on reducing the number of neutrophils. The application of EGCG is expected to reduce neutrophils on the second day after injury so the rehabilitation process is completed more quickly and ongoing inflammation and pulp necrosis is prevented. Purpose: To analyse the efficacy of topical hydrogel EGCG in reducing the number of neutrophils after 48 hours in the perforated dental pulp of Wistar rats. Method: 20 Wistar rats were divided equally into four groups, which were designated control (C) and treatment groups (T1, T2, T3). The upper first molar teeth of each rat were perforated and then T1, T2, and T3 were given 60 ppm, 90 ppm and 120 ppm hydrogel EGCG respectively. On the second day, the rats were sacrificed. HPA preparations were made to calculate the number of neutrophils in each group. Data was analysed using Kolmogorov–Smirnov, Levene’s, one-way ANOVA and Tukey HSD test (p<0.05). Results: There were significant differences between T2 and T3 compared with C and T1 (p<0.05), but no significant differences in the comparison of T1 with C and of T2 with T3 (p>0.05). Conclusion: 90 ppm hydrogel EGCG is effective in reducing the number of neutrophils in the perforated dental pulp of Wistar rats.

scholarly journals Effectiveness, Safety and Obedience of Dienogest and Leuprolide Acetate in Postlaparoscopic Endometriosis Patients

2020 ◽  
pp. 44-51
Author(s):  
Joko P. Purwanto ◽  
Yusuf Effendi ◽  
Heriyadi Manan ◽  
Theodorus
Keyword(s):  
Blood Pressure ◽  
Side Effects ◽  
Safety Profile ◽  
Pulse Frequency ◽  
Leuprolide Acetate ◽  
Therapeutic Effectiveness ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Vas Scores

Abstract Objective: Comparing therapeutic effectiveness, safety profile, and adherence between Dienogest and postoperative Leuprolide Acetate in women with endometriosis who underwent laparoscopy. Methods: This study was a randomized clinical trial comparing the open label study to compare the effectiveness of therapy, safety profile, and obedience between postoperative dienogest and leuprolide acetate in women with endometriosis who underwent laparoscopy. Result: From the statistical test it was found that there was effectiveness of dienogest after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.004). In the leuprolide acetate group it was also found that there was effectiveness of administration after 4 weeks of therapy (p = 0.004), after 8 weeks of therapy (p = 0.004) and after 12 weeks of therapy (p = 0.003). There was no difference in systolic blood pressure (p = 0.481), diastolic blood pressure (p = 1,000) and pulse frequency (p = 0.125) breath frequency (p = 1,000) and temperature (p = 0.236) between patients who received dienogest and leuprolide acetate. From the statistical analysis it was found that there were no differences in side effects in patients who received dienogest and leuprolide acetate (p = 0.238). Conclusion: There was no difference in therapeutic effectiveness, and the safety profile assessed by side effects as well as obedience of postoperative Dienogest and Leuprolide Acetate in endometriosis women undergoing Laparoscopy because in both groups there was a decrease in VAS scores from week to week. Key Word: Dienogest, Leuprolide Acetate, Endometriosis, Post-Laparoscopy, Therapy   Abstrak Tujuan: Membandingkan efektivitas terapi, profil keamanan, dan kepatuhan antara Dienogest dengan Leuprolid Asetat pascaoperatif pada wanita endometriosis yang menjalani Lapararoskopi. Metode: Penelitian ini merupakan uji klinik acak berpembanding dengan open label study untuk membandingkan efektivitas terapi, profil keamanan, dan kepatuhan antara dienogest dan leuprolid asetat pascaoperatif pada wanita endometriosis yang menjalani lapararoskopi. Hasil: Dari uji statistik didapatkan hasil terdapat efektivitas pemberian dienogest setelah 4 minggu terapi (p = 0,004), setelah 8 minggu terapi (p = 0,004) dan setelah 12 minggu terapi (p = 0,004). Pada kelompok leuprolid asetat juga didapatkan hasil terdapat efektivitas pemberian setelah 4 minggu terapi (p = 0,004), setelah 8 minggu terapi (p = 0,004) dan setelah 12 minggu terapi (p = 0,003).  Tidak terdapat perbedaan tekanan darah sistolik (p = 0,481), tekanan darah diastolik (p = 1,000) dan frekuensi nadi (p = 0,125) frekuensi napas (p = 1,000) dan suhu (p = 0,236) antara pasien yang mendapatkan dienogest dan leuprolid asetat. Dari analisa statistik didapatkan hasil tidak terdapat perbedaan efek samping pada pasien yang mendapatkan dienogest dan leuprolid asetat (p = 0,238). Kesimpulan: Tidak terdapat perbedaan efektivitas terapi, dan profil keamanan yang dinilai dari efek samping serta kepatuhan Dienogest dan Leuprolid Asetat pascaoperatif pada wanita endometriosis yang menjalani Lapararoskopi karena pada kedua kelompok terdapat penurunan VAS skor dari minggu ke minggu.  

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