International Journal of Basic & Clinical Pharmacology

Journal Information
ISSN / EISSN : 2319-2003 / 2279-0780
Published by: Medip Academy (10.18203)
Total articles ≅ 3,293
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Mahesh Eddula, Vasant P. Patil
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20221810

Abstract:
Background: Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgery for extracting renal and urinary stones, and a choice modality in large, multiple, and stag-horn stones. Anaesthesia for PCNL can be general or regional. Despite good results of PNCL with general anaesthesia, it may cause atelectasis, drug reactions, nausea, and vomiting. General anaesthesia (GA) has its limitations in the form of poor postoperative pain control, greater incidence of nausea and vomiting, prolonged recovery stays and prolonged hospitalizations. Methods: The study was performed in a tertiary care centre. A prospective, randomised study including 60 patients divided into 2 groups. Data collection tools included study proforma, numerical rating scale (NRS) scores and visual analog scale (VAS) scores. Data analysed using science and statistical packaged (SPSS) version 21, independent t tests and z-test for proportion. Results: The demographic data when statistically analysed showed no statistically significant differences between the groups. Haemoglobin percentage (Hb%) was significantly lower in GA group. Spinal anaesthesia (SA) group showed lower VAS and NRS scores hence lower requirement of pain relief and antiemetics. The post-operative complications were insignificant. Conclusions: We concluded that SA is safe and effective method as an alternative method for PCNL surgeries.
Swati A. Biswas, Anadya Prakash Tripathi, Dyotona Sen-Roy
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20221817

Abstract:
Background: Few studies have assessed the pharmacokinetics of various marketed formulations of levothyroxine available in the Indian market. Here, we assessed the pharmacokinetics and safety of Thyronorm® 100 in healthy Indian volunteers. Methods: The primary and secondary objectives were to determine the pharmacokinetic profile and to monitor safety and tolerability of 600 µg of levothyroxine, respectively. Eligible subjects received a single oral dose of 6×100 µg of levothyroxine, and pharmacokinetic profiles were monitored up to 432 hours post-dose. Safety assessments included exposure of study drug and incidence of adverse events (AEs) and serious AEs. The mean plasma concentration of LT4 versus time profile was presented on both untransformed and log-transformed scales. Results: Of 20 enrolled subjects, 1 was discontinued due to an AE of pain, unrelated to study drug. The mean [standard deviation (SD)] age and body mass index of subjects were 35.7 (6.33) years and 25.0 (3.0) kg/m2, respectively. Following baseline correction, the mean maximum observed drug concentration (Cmax) and area under the plasma concentration-time curve measured to the last quantifiable concentration (AUC0-t) of free thyroxine were found to be 68.4 (12.09) ng/ml and 6760.0 (2065.05) ng×hr/ml, respectively, with an elimination half-life (t1/2) of 205.6 (180.26) hrs and a residual area of 24.6%. The median time to first observed maximum drug concentration (Tmax) was 2.5 (1.5-2.5) hrs. Conclusions: These parameters were in accordance with those of other marketed formulations and confirmed the pharmacokinetics and safety of Thyronorm® 100 in healthy volunteers from India.
Diego Mendoza Contreras, Jose Maria Zepeda Torres, Grecia Jazmín García Gutiérrez, Félix Osuna Gutiérrez, Larissa Michelle Navarro Soberanes
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20222064

Abstract:
Kaposi's sarcoma (KS) is a malignant vascular neoplasm that typically appears opportunistically in patients with acquired immunodeficiency syndrome (AIDS); it can also arise in organ transplanted subjects and exceptionally in carriers of autoimmune diseases, such as Behçet's disease. A 23-year-old man with Behçet's disease who debuts with clinically and histologically compatible dermatosis with KS. Conclusions. KS is not exclusive to HIV-AIDS, it also prevails in situations of primary or secondary immunocompromision that favor its appearance, as is the case of Behçet's Disease and its immunomodulatory therapy.
Diego Mendoza Contreras, José Maria Zepeda Torres, Grecia Jazmín García Gutiérrez, Félix Osuna Gutiérrez, Larissa Michelle Navarro Soberanes
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20222051

Abstract:
Among the most feared toxico-dermas is drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome, a rare drug dermatitis that occurs after acute exposure to drugs whose clinical impact is based on multiple organs (skin, liver, kidneys, lungs, heart) and cell lines (eosinophils and lymphocytes). It is an entity with high mortality if it is not identified early, its treatment consists of the immediate suspension of the responsible drug and the administration of steroids, these being the therapeutic protagonists. A 64-year-old male patient with clinical, biochemical and histopathological criteria compatible with DRESS syndrome. It is essential to suspect the clinical course of DRESS syndrome before the appearance of dermatosis with multisystem involvement associated with the use of drugs, emphasis is placed on its early identification and the establishment of timely treatment to modify its prognosis.  
Mohit R. Shete, Sanjay V. Popere, James John
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20222046

Abstract:
Orally administered serine and cysteine proteolytic enzymes are used extensively in the therapy of various inflammatory conditions. However, due to their protein nature, there have been concerns about these enzymes undergoing digestion or biotransformation in the gut and the resultant amount of active enzyme reaching blood circulation and at the site of inflammation. Research has shown that orally administered serine and cysteine proteases are able to pass through the mucosal barrier of the gastrointestinal tract and reach the blood and lymph as intact, high molecular weight and physiologically active forms. These have been studied in in vitro, animal models and further confirmed in human studies. Despite high inter-individual variability, the maximum plasma levels of the free proteases follow dose linearity. They circulate bound to plasma anti-proteases and are detectable in clinically significant concentrations. Targeted studies also indicate that paracellular transport mechanism may play a significant role in the absorption of these molecules. We present a summary of the existing knowledge from these studies.
Reka Deva, Priyadharsini Rajendran
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20221826

Abstract:
Every 5 minutes, someone somewhere in the world is diagnosed with an inflammatory, demyelinating, neurodegenerative disorder known as multiple sclerosis (MS). MS was historically known as "La sclèrose en plaques" which involves the central nervous system (the brain and the spinal cord). It is always considered to be a disease of adulthood but nowadays pediatric MS is also gaining popularity. It is the most common non-traumatic chronic disabling disease of adults. MS is said to have etiology of multifactorial origin. of the myelin structure thereby producing a dysregulated immune system. MS is an ongoing disease with episodes of relapses and remissions whereas the basic pathophysiology remains increasing over time. Since the pathophysiology of MS is very complex, it makes the pharmacotherapy part bit difficult. MS therapy is disease subtype-specific. The drugs which were previously approved for MS lacks efficacy and sometimes possess serious adverse effects and thereby creating lacunae in treating MS patients include the need for a drug with better efficacy especially it should be evidence-based. There are several new drugs approved for the treatment of MS in recent times especially over the past 5-8 years and 'n' number of new molecules being tried in clinical trials. In this review, an effort was made to discuss MS epidemiology, potential etiological factors, pathophysiology, clinical aspects of MS before moving on to pharmacotherapy and other non-pharmacological management of MS. A special elaborative note on recently approved drugs and drugs under pipeline has been discussed in this review.
Iram Kahkashan, Majid Farooq, Semira Imran
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20222047

Abstract:
Background: A package insert (PI) is a document certified by the administering licensing authority, provided along the package of a drug. They are a valuable source of knowledge and can be of tremendous help to doctors as doctors are evidence based. The objective of this study was to assess the awareness about package inserts among residents in a teaching hospital in north India. Methods: The present study was a cross-sectional, observational study carried out on residents in SKIMS Medical College, Srinagar (Jammu and Kashmir) to assess the awareness of participants regarding PIs. The questionnaire was pre-validated and then was used to elicit responses from the residents about their knowledge and opinion regarding the PIs. Results: A total of 96 residents participated in the study. About 67.7% of the participants agreed that PIs augment drug information but only 47.9% of the residents referred PIs as a source of knowledge for indication/contraindication/ adverse effects. 57.29% asserted it is important to tell the patient to read the package insert. Unfortunately, only 8.3% of the study participants had the knowledge of DRUG ACTS governing the information to be provided on PIs in India. Conclusions: The present study revealed that the residents have good attitude and knowledge towards PIs. However, the information provided on Package Inserts was not optimally used by them. The results of this study strongly suggest that there is a need to create awareness among resident doctors about PIs.
Neerajkumar Sharma Manohar, Ngamba Akham, Oinam Joychandra Singh, Hidam Surjikumari, Anisha Kh
International Journal of Basic & Clinical Pharmacology; https://doi.org/10.18203/2319-2003.ijbcp20221830

Abstract:
Background: The aim of the present study is to find out the ways to improve the status of adverse drug effect (ADE) reporting to the pharmacovigilance centres. Methods: The present study is a cross-sectional study with purposive sampling. Descriptive statistics is used for analysing the data from the questionnaire using frequencies and percentages. Results: The response on the questionnaire was 77.7%. The 90 participants knew the definition of ADE. The 91 participants want to report the ADEs of newly marketed drugs. Only 70 participants know about the existence of PvPI. The 80 participants did not consider all OTC drugs to be safe. 95 participants opined that all Herbal and non-allopathic drugs are not safe. The 69 participants replied that no ADE monitoring centre was available in SHIJA hospitals and research institute Pvt. Ltd. Though 90 participants knew the definition of ADE, only 85.1% of them considered to report it as a professional obligation. Maximum ADEs are seen with skin, paediatric and elderly patients as opined by 57.4% of the participants. Varied opinions of occurrence of ADEs according to the participants with polypharmacy was 70.3% and with foods and drinks was 40.6%. Although 85.1% participants have the attitude of reporting ADE, only 63.4% participants have good clarity when reporting and filling the ADE forms with careful observation of the risks and behaviour of the patients. Conclusions: To promote ADE reporting, a regular awareness cum sensitization programme coupled with CME program is necessary at various levels of health-care providers.
Moumita Hazra
International Journal of Basic & Clinical Pharmacology, Volume 11, pp 302-307; https://doi.org/10.18203/2319-2003.ijbcp20221595

Abstract:
Background: Pefloxacin is a newer broad-spectrum bactericidal fluoroquinolone antibiotic, with superior antibacterial activity in vivo against pathogenic ocular gram-negative and anaerobic microorganisms and better pharmacokinetic properties. The objective of this clinical research study was the rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals. Methods: The 43 bacterial conjunctivitis patients were prescribed topical pefloxacin 0.3% ophthalmological drops, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days. The pharmacovigilance safety appraisal was performed by monitoring the occurrence of adverse drug reactions, like, transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness, and recording in Adverse Event Case Report Forms, on days 0, 3, 5, 7, 10, 15, 30, and on further follow-ups. Results: In this study, the safety assessment showed that only 1 patient had ocular discomfort in the eye. The occurrence of adverse effects was statistically non-significant. Thus, 0.3% pefloxacin ophthalmological drops treatment was safe and tolerable, among all 43 patients. Conclusions: Therefore, pefloxacin is a safe ocular antibiotic for treating bacterial conjunctivitis, with adequate drug tolerability exhibited by the patients.
Anusha R., Geetha A.
International Journal of Basic & Clinical Pharmacology, Volume 11, pp 308-314; https://doi.org/10.18203/2319-2003.ijbcp20221596

Abstract:
Background: The aim was to analyze the percentage cost variations among different brands of the commonly prescribed anti-retroviral agents in the treatment of human immunodeficiency virus. Methods: The cost of different brands of commonly used Anti-Retroviral agents was sorted out by referring latest Indian drug index online, drug today, current index of medical specialties, Indian drug review. Results: The percentage variation in the cost was above 100% with most of the commonly used anti-retroviral agents. Overall sequinafir 500 mg shows maximum cost variation of 1490.3%, while nelfinavir (625 mg) shows minimum cost variation of 6.1% in single drug therapy. Lamivudine 300 mg and tenofovir 300 mg combination shows maximum cost variation of 14055% whereas, lamivudine 150 mg, zidovudine 300 mg and efavirenz 600 mg shows minimum cost variation of 10% in combination drug therapy. Conclusions: HIV is the most common infectious, life-threatening disease and drugs are to be prescribed for life-long period. If a costly brand is prescribed, the patients cannot afford to pay more money for their treatment. This also leads to poor patient compliance, dissatisfaction and failure of the treatment. Ideally, therefore, the drugs should be prescribed in such a way, to save the patient's economic burden and enhance the compliance of the treatment.
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