Search

Background: Treatment inertia, non-adherence and non-persistence to medical treatment contribute to poor blood pressure (BP) control worldwide. Fixed dose combination (FDC) antihypertensive medicines simplify prescribing patterns and improve adherence. The aim of this study was to identify factors associated with prescribing FDC antihypertensive medicines and to understand if these factors differ among doctors worldwide. Methods: A cross-sectional survey was conducted online from June 2023 to January 2024 to recruit doctors. We collaborated with an international network of researchers and clinicians identified through institutional connections. A passive snowballing recruitment strategy was employed, where network members forwarded the survey link to their clinical colleagues. The survey instrument, developed through a literature review, interviews with academic and clinical researchers, and pilot testing, assessed participants perspectives on prescribing FDC antihypertensive medicines for hypertension. Participants rated their level of agreement (5-point Likert scale) with statements representing six barriers and four facilitators to FDC use. Findings: Data from 191 surveys were available for analysis. 25% (n = 47) of participants worked in high-income countries, 38% (n = 73) in upper-middle income, 25% (n = 48) in lower-middle income, 6% (n = 10) in low-income countries. Forty percent (n = 70) of participants were between 36–45 years of age; two thirds were male. Cost was reported as a barrier to prescribing FDC antihypertensive medicines [51% (n = 87) agreeing or strongly agreeing], followed by doctors’ confidence in BP measured in clinic [40%, (n = 70)], access [37%, (n = 67)], appointment duration [35%, (n = 61)], concerns about side-effects [(21%, n = 37)], and non-adherence [12%, (n = 21)]. Facilitators to FDC antihypertensive polypills prescribing were clinician facing, such as access to educational supports [79%, (n = 143)], more BP measurement data [67%, (n = 120)], a clinical nudge in health records [61%, (n = 109)] and patient-facing including improved patient health literacy [49%, (n = 88)]. The levels of agreement and strong agreement across all barriers and facilitators were similar for participants working in higher or lower income countries. Across all countries, participants rated FDC antihypertensive medications highly valuable for managing patients with non-adherence, (82% reported high or very high value), for patients with high pill burden (80%). Interpretation: Cost and access were the most common barriers to prescribing FDCs across high- and low-income countries. While greater educational support for clinicians was perceived as the leading potential facilitator of FDC use, this seems unlikely to be effective without addressing access.

The goal of this work is development & validation of dissolution method for Amlodipine and Hydrochlorothiazide in different conditions, such as dissolution medium type, volume, rotation speed, apparatus, and filter appropriateness. Apparatus II (paddle) and 1000 mL of phosphate buffer pH 6.8 & 0.1N HCL as the dissolution medium were used to achieve the most discriminative release profile for Amlodipine and Hydrochlorothiazide which was kept at 37 0.5°C with a rotation speed of 75 rpm. UV/Vis spectrophotometry at 239 & 271nm was used to quantify the emitted active ingredient. The dissolution method was validated using the following parameters: specificity, accuracy, precision, linearity, robustness, and stability of the solutions, which were found to match the preset acceptance requirements. A developed dissolution method has the ability to distinguish any changes related to quantitative formulation and can be used for routine batch testing. [ABSTRACT FROM AUTHOR]

Cardiovascular diseases (CVD), in particular arterial hypertension (AH), are the main causes of morbidity and mortality, Ukraine is on the 1st place in Europe for mortality from these diseases. Modern clinical guidelines emphasize the use of combined antihypertensive drugs, and improving the accessibility of these medicines for Ukrainian patients with hypertension is relevant. In Ukraine, at the end of 2022, there were no combined antihypertensive drugs in the List of reimbursed drugs. Therefore, there is a need to develop scientific and practical approaches to improve the «Affordable Medicines» reimbursement program in accordance with modern trends in the treatment of hypertension. The aim of the study is to formulate scientific and practical proposals for the inclusion of combined antihypertensive drugs in the state reimbursement program «Affordable Medicines» and to improve external reference pricing. Оbjects of the study were Orders of the Ministry of Health of Ukraine, national and international clinical guidelines, WHO ATC/DDD methodology guidelines. The study used content analysis, methods of comparative and logical analysis. At the 1st stage of the study, it was found that the current legislation of Ukraine does not prohibit the inclusion of combined antihypertensive drugs in the National List of Essential Medicines, and it is not limited solely to WHO recommendations. In the second stage of the study, it is proposed to use the data of pharmacoepidemiological studies and data of studies of actual consumption of combinated antihypertensive drugs in Ukraine, for further state HTA assessment and inclusion in the National List of Essential Medicines and «Affordable Medicines» program. The third and fourth stages of the study showed that the mechanism of external reference pricing needs to be improved and an algorithm for conducting external reference pricing for combined antihypertensive drugs, consisting of five consecutive stages, was developed and proposed. The current regulatory framework of Ukraine provides the possibility of including combined antihypertensive drugs in the state program «Affordable Medicines», and the initiation of the inclusion of medicines is within the competence of the Ministry of Health and the NHSU. A scientific and practical approach to the use of pharmaco-epidemiological research data to identify the most used doses of combined antihypertensive drugs as potential candidates for inclusion in the «Affordable Medicines» program is proposed. A scientific and practical algorithm for external reference pricing for combinated antihypertensive drugs was developed, considering current regulatory and methodological aspects.

IntroductionThe emergence of MDR-TB is a global threat and an obstacle to the effective control of TB in Pakistan. A lack of proper TB knowledge among the staff in private pharmacies and the sale of compromised quality anti-TB drugs are the main instigators of multidrug-resistant tuberculosis (MDR-TB). Thus, this study was aimed at investigating the quality and storage conditions of fixed-dose combination (FDC) anti-TB drugs along with the awareness of staff working in private pharmacies regarding the identification of potential patients with TB and dispensing the inappropriate treatment regimens contributing to MDR-TB.MethodsThe study is completed in two phases. In phase I a cross-sectional study is performed using two quantitative research designs, i.e., exploratory and descriptive, to evaluate the knowledge of private pharmacy staff. The sample of 218 pharmacies was selected. While in phase II cross sectional survey is conducted in 10 facilities from where FDC anti TB drugs were sampled for analyzing their quality.ResultResults revealed the presence of pharmacists only at 11.5% of pharmacies. Approximately 81% of staff at pharmacies had no awareness of MDR-TB, while 89% of pharmacies had no TB-related informative materials. The staff identified that most of the patients with TB (70%) were of poor socio-economic class, which restricted their purchase of four FDCs only up to 2–3 months. Only 23% were acquainted with the Pakistan National TB Program (NTP). Except for MDR-TB, the results showed a significant correlation between the experiences of staff with TB awareness. Findings from the quality evaluation of four FDC-TB drugs indicated that the dissolution and content assay of rifampicin were not according to the specifications, and overall, 30% of samples failed to comply with specifications. However, the other quality attributes were within the limits.ConclusionIn light of the data, it can be concluded that private pharmacies could be crucial to the effective management of NTP through the timely identification of patients with TB, appropriate disease and therapy-related education and counseling, and proper storage and stock maintenance.

Aim: The aim of this study was to evaluate the use of fixed dose combinations (FDC) in the outpatient clinics of Slovak general practitioners (GPs), cardiologists and internists and to explore the determinants of FDC prescriptions. Methods: At the level of contact (prescription by one doctor to one patient on one day), we evaluated whether therapeutic groups could be, and were, prescribed in the form of FDC. The total number of evaluated contacts was 5,463,492. Results: In 2021, 66.6% of contacts, in which FDC could have been prescribed, ended with its prescription. This is an increase of 2.7% compared to 2019 (p<0.001). FDC are most often used by internists (69.9%), followed by GPs (66.4%) and cardiologists (63.0%). Increasing age of the patient negatively affected the odds of a fixed combination prescription, as did a higher number of medications regularly used by the patient. Bronchial asthma and diabetes mellitus were the only comorbidities associated with more frequent FDC prescription (by 12% and 21%, respectively). Other comorbidities reduced the chance of FDC prescription: heart failure by 26%, coronary heart disease by 26%, atrial fibrillation by 33%, and chronic kidney disease by 28%. Conclusion: Despite the positive trend, there is room for improvement in the prescription of FDC in Slovakia, especially its prescription for elderly and polymorbid patients, in whom it can be difficult to overcome resistance to the treatment change. [ABSTRACT FROM AUTHOR]

Purpose of Review: Hypertension represents the most important cardiovascular risk factor, affecting over 4.06 billion adults worldwide. In this review, we will discuss potential barriers and their solutions to improve prevention, detection, and management of hypertension. Recent Findings: The prevalence of hypertension has been increasing in low- and middle-income countries, requiring new strategies to improve its recognition and proper management. The World Heart Federation (WHF) developed a roadmap for hypertension, advising health system policies and clinical practices as part of its commitment to improving global cardiovascular health. The World Health Organization (WHO) has published in 2021 practical guidelines for the pharmacological treatment of hypertension in adults. Summary: Identifying potential roadblocks and solutions deserves high priority to improve the detection, management, and control of hypertension. [ABSTRACT FROM AUTHOR]

Allergic rhinitis (AR) is one the most common allergic diseases affecting from 10 to 40% of the population in different countries, including Russia. AR is a risk factor of bronchial asthma, other upper airway disease and may decrease patient quality of life, their productivity, increase probability of occupational traumatism, depression and anxiety. AR also presents a substantial economic burden. The rationale to use fixed dose combination of intranasal steroids and topical H1 antihistamines includes suboptimal control of symptoms by monotherapy, its complementary pharmacologic activity and the results of clinical trials. This review focused on fixed dose combination of intranasal mometasone furoate and olopataine. Double blind placebo-controlled and open clinical trials have confirmed that this combination decreased severity of nasal and ocular symptoms of seasonal and perennial AR, improved patient quality of life and had a good tolerability. Its efficacy was higher than those of monotherapy. Fast onset of action and sustainable effect on symptoms (during 1 yr) may improve adherence patients to the treatment and control of symptoms of AR.

Aim. To assess the efficacy and safety of Vamloset (amlodipine/valsartan 5/80, 5/160, 10/160 mg) and Co-Vamloset (amlodipine/valsartan/hydrochlorothiazide 10/160/12.5, 10/160/25 mg) in achieving the target levels of blood pressure (BP) in patients with stage 23 arterial hypertension (AH). The article discusses indicators affecting adherence to antihypertensive therapy (AHT). Material and methods. The VICTORY II Russian study in 8 clinical centers of the Russian Federation included 103 patients over 18 years of age with stage 23 essential AH (who havent been previously treated and have office systolic BP160 mm Hg and/or diastolic BP100 mm Hg or who havent reached the target office blood pressure with mono- or double AHT). The Full Analysis Set (FAS) for efficacy analysis included 99 patients, a FAS population with the restoration of data missed using Last Observation Carried Forward. The SF-36 questionnaire for assessing the quality of life, the effect on erectile function in men, the convenience of current therapy from the point of view of patients were analyzed after 16 weeks of treatment. The Per Protocol (PP) population included 80 patients completing the study without major protocol deviations to assess the primary parameters of efficacy. All patients with stage 2 hypertension were prescribed Vamloset (amlodipine/valsartan 5/80 mg), with stage 3 hypertension amlodipine/valsartan 5/160 mg. Dose titration of Vamloset and Co-Vamloset (LLC Krka-RUS) was carried out every 4 weeks according to the AHT schemes. Results. The studys active phase included 100 patients aged 59.510.9 years (women 59%) with AH duration of 83.48.4 months; 83% of patients received AHT prior inclusion in the study. In the PP population, 16 week- AHT with Vamloset or Co-Vamloset allowed reaching the target BP in 90.0% of patients (95% confidence interval [CI] 81.295.6). Overall clinical efficacy was achieved in 98.8% of patients (95% CI 93.2100.0). All treatment regimens were characterized by high patient compliance. In the total group, 50% of patients rated their AHT as more convenient than they had previously used; of them, in the stage 2 AH group 47.8%, in the stage 3 AH group 53.3%. Metabolic neutrality with regard to at least one indicator was observed in 100% of patients, with regard to 6 indicators in 43.9% [33.9; 54.9]. For all 98 patients included in the analysis, changes in all SF-36 scales, except for physical functioning (p=0.339), were statistically significant (p0.05). The effect of AHT on erectile function was rated as positive in 51.3% of men. Good tolerance data are consistent with the established drug safety profile. Conclusion. In the VICTORY II study, high antihypertensive efficacy and an improvement in a set of indicators of optimal adherence to AHT by Vamloset and Co-Vamloset within 16 weeks were proved in patients with stage 23 AH. Patients high rating for quality improvement in the quality of life, safety of therapy and ease of use ensured optimal compliance of Vamloset and Co-Vamloset therapy throughout the study.

India is among the largest consumers of antibiotics. Easy availability and growing sales of Fixed Dose Combinations (FDCs) of antibiotics can worsen Antimicrobial Resistance (AMR). There is lack of comprehensive data on available antibiotic FDC formulations, their dose strengths and adequacy of scientific evidence regarding their efficacy, safety and suitability for human use. In the present work, we aimed at addressing this knowledge gap. Availability of FDCs was ascertained from the Current Index of Medical Specialties (CIMS) [Issue Jan-April 2020]. Customized data abstraction form was used to capture pertinent information for these FDCs. Assessment of rationality was done based on standard parameters. More than 90% of the existing FDCs were found to be irrational; with two third of them being unapproved and or banned from use in the country. Although the regulatory agency has already taken cognizance of the seriousness of the matter; there is an urgent need to revisit these FDCs to promote prudent antibiotic use. High antibiotic use is associated with antimicrobial resistance; it is imperative that all factors which lead to high antibiotic use are adequately addressed. Easy availability of fixed dose combinations (FDCs) has begun to catch the attention of regulators in developing economies like India leading to a ban of 330 FDCs of which 19% were antibiotic combinations. The continuing presence and increasing sales of these irrational FDCs is a concern for effective antimicrobial stewardship. [ABSTRACT FROM AUTHOR]

Abstract Background Antibiotic resistance is an emerging problem caused due to antibiotic use. In countries with high rates of infectious diseases, antibiotic resistance is a frequent cause of mortality. The aim was to analyse antibiotic prescribing practices between 2008 and 2017 in a teaching (TH) and a non-teaching (NTH) hospital, as typical hospitals of low- and middle-income countries, and to compare antibiotic prescribing for severe infectious indications for which empiric antibiotic treatment is recommended. Methods Data from adult patients registered at two Indian private-sector hospitals with one of the following indications: epiglottitis, pneumonia, peritonitis, pyelonephritis, cellulitis, erysipelas, septic arthritis, endocarditis, meningitis or sepsis; were included and analysed. Antibiotic prescription data was analyzed using the World Health Organization’s (WHO) Anatomical Therapeutic Chemical classification system and the Defined Daily Doses. Chi-square and linear regression were used to compare the data between groups. Time series analyses were conducted using linear regression. P-values

OBJECTIVES AND METHODS: In September 2018, the government of India banned 328 fixed dose combinations (FDCs), 24 of which are combinations containing topical steroids. To assess what impact can be expected from this regulatory action, we analyzed reports of adverse drug events due to topical corticosteroids at a hospital-based pharmacovigilance center between January 2017 and August 2018. RESULTS: Among 34 different steroid-containing FDCs responsible for 485 reports of ADEs with topical steroids, only three preparations, accounting for 50.10% of ADEs, come under the umbrella of the recent ban. Clobetasone propionate (68.87%) and betamethasone (28.45%) were the corticosteroids most frequently associated with adverse events. Most of the steroid preparations (87.84%) had been bought without a prescription for the treatment of dermatophytoses (76.70%). Males (77.73%) were predominantly affected, and nearly half (47.43%) of the patients were between 21 and 30 years of age. Skin atrophy (50.10%), striae (25.54%), and hypopigmentation (19.79%) were the major ADEs. CONCLUSION: Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter. [ABSTRACT FROM AUTHOR]

Allergic rhinitis in childhood has been often missed, mistreated and misunderstood. It has significant comorbidities, adverse effects upon quality of life and educational performance and can progress to asthma or worsen control of existing asthma. Accurate diagnosis and effective treatment are important. The new EUFOREA algorithm provides a succinct but wide- ranging guide to management at all levels, based on previous guidelines with updated evidence and has been adjusted and approved by experts worldwide.

Introduction: Gastric problems are the most common diseases seen in many countries for which majority of the population prefer Proton Pump Inhibitors (PPI) and Histamine (H2) Blockers. They are prescribed most commonly for Gastroesophageal Reflux Disease (GERD), Dyspepsia, Peptic Ulcer Disease, alongwith medications like Non-Steroidal Antiinflammatory Drugs (NSAIDs) and other drugs. Concerns have been raised about the increasing costs associated with prescription of these drugs as they are often prescribed for minor symptoms and without clear indications. Prescribing pattern should be evaluated periodically to promote rational use of medicines. Aim: To assess the prescribing pattern of PPIs and H2 Blockers in Surgery and Medicine Department of a Tertiary Care Hospital. Materials and Methods: An observational study was conducted in a Tertiary Care Hospital, Karamsad over a period of one year from November, 2018 to October, 2019, among patients visiting to Out Patient Department (OPD) and In Patient Department (IPD) of Medicine and Surgery Department that were prescribed PPI and H2 Blockers. Total 1100 prescriptions and 1265 PPI, H2 Blockers were analysed. The data were analysed for sociodemographic variables along with details of PPI and H2 Blockers. co-prescribing drugs, Fixed Dose Combinations (FDCs) and drug interactions of each prescription was analysed. Results: In the study, PPI and H2 Blockers were prescribed more in males (54.36%). The predominant age group was 18-40 years (42%). Among studied drugs, most commonly prescribed single drug was Pantoprazole and FDC was Ranitidine + Domperidone. The drugs were most commonly prescribed through oral route (90.9%). They were most commonly prescribed along with an NSAID for gastroprotection (28.9%). Pharmacokinetic drug interactions were observed more in the study. Conclusion: This study showed that physicians prescribe PPI and H2 Blockers as a co-medication for gastroprotection. There is a need to increase documentation for prescribing PPI and H2 Blockers.

Background: Antibiotic resistance is an emerging problem caused due to antibiotic use. In countries with high rates of infectious diseases, antibiotic resistance is a frequent cause of mortality. The aim was to analyse antibiotic prescribing practices between 2008 and 2017 in a teaching (TH) and a non-teaching (NTH) hospital, as typical hospitals of low- and middle-income countries, and to compare antibiotic prescribing for severe infectious indications for which empiric antibiotic treatment is recommended.Methods: Data from adult patients registered at two Indian private-sector hospitals with one of the following indications: epiglottitis, pneumonia, peritonitis, pyelonephritis, cellulitis, erysipelas, septic arthritis, endocarditis, meningitis or sepsis; were included and analysed. Antibiotic prescription data was analyzed using the World Health Organization's (WHO) Anatomical Therapeutic Chemical classification system and the Defined Daily Doses. Chi-square and linear regression were used to compare the data between groups. Time series analyses were conducted using linear regression. P-values < 0.05 were considered significant.Results: In total, 3766 patients were included, 2504 inpatients in the NTH and 1262 in the TH, of which 92 and 89% patients, respectively, were prescribed antibiotics. Sixty-one percent of total prescriptions in the TH and 40% in the NTH comprised the access category of antibiotics (i.e. the first-choice of treatment according to the WHO). The WHO's second-choice of treatment, the watch category, comprised 29 and 40% of total prescriptions in the TH and NTH, respectively. Prescribing of fixed-dose combinations (FDCs) of antibiotics was significantly higher in the NTH (18%) than in the TH (8%, P < 0.05). Prescribing of watch antibiotics and FDCs increased significantly in both hospitals between 2008 and 2017 among patients with pneumonia, cellulitis and peritonitis (P < 0.05).Conclusions: Prescribing of watch antibiotics and FDCs of antibiotics increased over time at both hospitals, indicating under prescribing of access antibiotics and more prescribing of second-choice antibiotics. The results can be used to highlight the areas of improvement in similar settings. Implementing diagnostic routines and local prescribing guidelines could improve the prescribing practices. [ABSTRACT FROM AUTHOR]

This investigation aimed to review the prescribing trends of fixed dose combinations, to assess their rationality and inclusion in essential medicines list and national list of essential medicines. Medication charts of 1000 in-patients from general medicine department were reviewed for 12 months excluding casualty and ICUs. The data on morbidities and drugs prescribed were documented and assessed for fixed dose combinations prescribed, their inclusion in WHO essential medicines list and national list of essential medicines and approval by regulatory bodies such as US FDA and DCGI. Rationality of the prescribed fixed dose combinations were determined based on WHO guidelines. The drug-drug interactions with fixed dose combinations were analysed. Descriptive statistics was used to express results in numbers and percentages. Out of 1000 case sheets studied a total of 435 fixed dose combinations were prescribed, all by their brand names during hospitalization. Fixed dose combinations given for infectious diseases were 29.57 % and for respiratory disorders 20.82 %. Those included in WHO essential medicines list 2017 were 11.72 %, while 10.57 % were in the national list of essential medicines 2015 and 17.7% were approved by the US FDA, 56.78 % by DCGI. Rational fixed dose combinations were 38.62 % and 61.37 % were irrational. In the discharge medication chart, miscellaneous agents (19.72 %) and drugs for infectious disorders (15.80 %) were the commonly prescribed fixed dose combinations. Among these 8.25 % were listed in WHO essential medicines list 2017, 6.78 % in the national list of essential medicines 2015 and 15.04 % fixed dose combinations were approved by the US FDA, 53.98 % by the DCGI. Rational combinations were 36.87 % and 63.12% were irrational. Rationality in combining drugs as fixed dose combinations and their appropriate use can reduce pill burden, cost and improve patient adherence. [ABSTRACT FROM AUTHOR]

Background: Fixed-dose combinations (FDCs) are being widely prescribed for the treatment of various disorders in India. However, not all FDCs are rational. To know the awareness of physicians in prescribing rational FDCs was the need of the hour in order to assess the prescribing trends and rationality of FDCs. Eventually, this will help to formulate the guideline for rational use of FDCs. Methods: This was a prospective observational study conducted in All India Institute of Medical Sciences Bhopal, MP, India. Prescriptions were collected over a period of 2 months by the convenience sampling method from hospital pharmacy. The data were subjected to descriptive analysis using Microsoft Excel and Graph Pad Prism. Results were expressed in mean ± standard deviation (SD), percentages and 95% confidence interval. Results: A total of 2496 drugs were prescribed in 1008 prescriptions, of which 945 (37.82%) were FDCs with an average of 0.93 ± 0.94 (mean ± SD) per prescription. Of 945, 67 (7.09%) were included in National List of Essential Medicine 2015 considered as rational. The number of prescriptions containing one or more FDCs was 629 (62.40%). FDCs were more frequently prescribed to male patients (54.92%) and in the age group of 18–30 years (33.44%). FDCs containing a proton pump inhibitor were prescribed most frequently (16.29%) followed by nonsteroidal anti-inflammatory drugs (13.96%) and multivitamins (7.83%). Conclusions: Prescribing irrational FDCs was very common, and hence there is an obvious need to update our prescribers about the irrationality of FDC and motivate them to develop a habit of rational prescribing. [ABSTRACT FROM AUTHOR]

Introduction: There are positive aspects regarding the prescribing of fixed dose combinations (FDCs) versus prescribing the medicines separately. However, these have to be balanced against concerns including increased costs and their irrationality in some cases. Consequently, there is a need to review their value among lower- and middle-income countries (LMICs) which have the greatest prevalence of both infectious and noninfectious diseases and issues of affordability.Areas covered: Review of potential advantages, disadvantages, cost-effectiveness, and availability of FDCs in high priority disease areas in LMICs and possible initiatives to enhance the prescribing of valued FDCs and limit their use where there are concerns with their value.Expert commentary: FDCs are valued across LMICs. Advantages include potentially improved response rates, reduced adverse reactions, increased adherence rates, and reduced costs. Concerns include increased chances of drug:drug interactions, reduced effectiveness, potential for imprecise diagnoses and higher unjustified prices. Overall certain FDCs including those for malaria, tuberculosis, and hypertension are valued and listed in the country's essential medicine lists, with initiatives needed to enhance their prescribing where currently low prescribing rates. Proposed initiatives include robust clinical and economic data to address the current paucity of pharmacoeconomic data. Irrational FDCs persists in some countries which are being addressed. [ABSTRACT FROM AUTHOR]

Type 2 diabetes brought about by Insulin resistance which bit by bit prompts to loss of beta cells activity. There will be no sufficient reaction from given portion of insulin. Expanded abdominal adipocyte triglyceride store in obese patient advance insulin resistance. Interferance of tissue insulin flagging course by the delivered fiery cytokines from adipocytes prompts to insulin resistance. Lessening in adiponectin (adipose specific) focus in type2 diabetes mellitus likewise causes insulin resistance. Hyperglycemia gets poisonous to beta cells. Because normal beta cells secrete more insulin in response to insulin resistance, insulin secretory deformity of beta cells created after a timeframe. In the event that diabetes is not dealt with appropriately, it can prompt renal, retinal, cardiovascular, neurological intricacies, wellbeing weakness, diabetic extreme lethargies and passing. Comprehension of own malady, diet control, work out, look at blood glucose level as often as possible and severe adherence to medicate treatment are more significant if there should be an occurrence of patient side consideration. On the off chance that diabetes is not constrained by diet and exercise, start monotherapy with oral hypoglycemic drug like metformin. On the off chance that patient is indicative, haemoglobin A1C (HbA1c) value esteem equvalent or more than 10 %, if patient tolerant not ready to accomplish target blood sugar level or target HbA1c after three months think about insulin therapy. While choosing pharmacological therapy consider the medications cardiovascular advantages, persistent age, other co dismal conditions, quiet inclinations, drug viability, safety and cost. Currently we are centering the older established drugs and the novel ant diabetic drugs which have scope in future in the treatment of type2 diabetes in different patient factors. [ABSTRACT FROM AUTHOR]

Objectives: To analyze the rationality of central nervous system fixed dose combinations used in a tertiary care hospital. Methodology: The study was an hospital based observational study. The data was collected from an annual drug compendium entitled “Hospital Drug List”. Fixed dose combinations (FDCs) enlisted in central nervous system (CNS) sections were selected for the study purpose. The active pharmacological ingredients (APIs) in FDC was checked for approval by Drug Control General of India (DCGI), World Health Organization (WHO) and essential medicine (EML)/national essential medicine list (NEML), both or none and all the ingredients (molecule, excipients) present in the FDC was checked whether banned or under any controversies in India as well as worldwide. Efficacy and safety of the individual active pharmacological ingredients (APIs) and their combination were searched. Details of each drug were collected [Generic name, Pharmacokinetics, Interaction affected, Pharmacodynamics, and Advantages of FDCs]. The data collected was analyzed by a tool to assess the rationality of fixed dose combinations which is pre-tested and validated by Shah et al., based on WHO guidelines. Result and Discussion: A total of 25 CNS FDCs were taken, on assessment of CNS FDCs 21 (84%) were found to be rational and 4 (16%) were found to be irrational with the mean rationality score of 7.2. By winding up, state of nonbeing, absenteeism of legality and effectiveness of the formulations appeared in to a peculiar combinations and inadequate practice. The approval process of these combinations by various committees should be robust. [ABSTRACT FROM AUTHOR]

Nils von Hentig HIV Center, Medical Department II, Hospital of the JW Goethe-University, Frankfurt, BAG Darab-Kaboly/von Hentig, General Medicine and HIV Care, Frankfurt am Main, Germany Abstract: The pharmacoenhancement of plasma concentrations of protease inhibitors by coadministration of so-called boosters has been an integral part of antiretroviral therapy for human immunodeficiency virus (HIV) for 1.5 decades. Nearly all HIV protease inhibitors are combined with low-dose ritonavir or cobicistat, which are able to effectively inhibit the cytochrome-mediated metabolism of HIV protease inhibitors in the liver and thus enhance the plasma concentration and prolong the dosing interval of the antiretrovirally active combination partners. Therapies created in this way are clinically effective regimens, being convenient for patients and showing a high genetic barrier to viral resistance. In addition to ritonavir, which has been in use since 1996, cobicistat, a new pharmacoenhancer, has been approved and is widely used now. The outstanding property of cobicistat is its cytochrome P450 3A-selective inhibition of hepatic metabolism of antiretroviral drugs, in contrast with ritonavir, which not only inhibits but also induces a number of cytochrome P450 enzymes, UDP-glucuronosyltransferase, P-glycoprotein, and other cellular transporters. This article reviews the current literature, and compares the pharmacokinetics, pharmacodynamics, and safety of both pharmacoenhancers and discusses the clinical utility of cobicistat in up-to-date and future HIV therapy. Keywords: human immunodeficiency virus, fixed-dose combinations, pharmacoenhancers, drug safety

Insufficient control of blood pressure levels of the essential hypertension in Russia (less than 30% for women, less than 20% for men) was proven by epidemiology trials. This article is a review of the present opportunities to increase efficacy of treating hypertension by application of combined anti-hypertensive therapy and the advantages of fixed dose combinations (FDC). The authors scientifically prove the importance of using the combination, including angiotensin I-converting enzyme perindopril arginine and the long-half time dihydropyridine calcium channel blocker amlodipine in various clinical cases. Also the article summarizes the research of real clinical practice proving the high efficiency and safety of perindopril arginine /amlodipine FDC.

Objective: To assess the proportion and sales of unapproved Fixed Dose Combinations (FDCs) of anti-tubercular, antimalarial and antiretroviral medicines available on the Indian market.Methods: Available FDCs of anti-tubercular, antimalarial and antiretrovirals were screened against the Central Drugs Standard Control Organization (CDSCO) database of approved FDCs. The FDC sales information in the given categories was obtained from AIOCD AWACS PharmaTrac, a market database. FDCs available in India were also screened against the National List of Essential Medicines India 2015 and the Orange Book Database of products approved by USFDA.Results: Of 110 available first- to fourth-line anti-tubercular FDCs, only 32 were approved. Of 20 antimalarial FDCs available, eight were approved. However, almost 95% of available antiretroviral FDCs and branded products were approved. The sales volume of all anti-tubercular drugs was 730 million units of which 71% were unapproved, amounting to 14.30 billion rupees in sales value (58%). Almost half of the sales value and volume of antimalarials was generated by unapproved products. About 1% of sales volume of antiretroviral FDCs came from unapproved formulations, accounting for 5% of sales value.Conclusion: A large proportion of FDC formulations available in India has never been approved by CDSCO, hence raising the doubts about their safety and efficacy. An opaque regulatory framework and ambiguity over licensing powers have contributed to the problem. The rationality of unapproved FDCs should be reviewed and irrational formulations should be banned. [ABSTRACT FROM AUTHOR]

Graphical abstract Abstract Increasing numbers of elderly people require multi-drug therapies. One route to improve adherence rates is to prepare fixed dose combinations (FDCs), in which multiple active ingredients are loaded into a single formulation. Here, we report the use of electrospinning to prepare fast-dissolving oral FDCs containing amlodipine besylate and valsartan, two drugs prescribed as FDCs for the treatment of hypertension. Electrospun fibers were prepared loaded with one or both drugs, using polyvinylpyrrolidone as the polymer matrix. The fibers were largely cylindrical in morphology and comprise amorphous solid dispersions except with the highest loadings of amlodipine besylate. HPLC demonstrated drug entrapment efficiencies of >85% of the theoretical dose. The mats have folding endurances and thicknesses suitable for use as oral films. The amlodipine besylate-loaded systems are fast-dissolving, with >90% release obtained within 120 s. In contrast, valsartan release from its single-drug formulations took longer, ranging from 360 s to 24 min. With the FDC formulations, rapid release within 360 s was achieved when the loading was 5% w/w of each drug, but again the release time increased with drug loading. Electrospun fibers therefore have significant promise as FDCs, but the target drug and its loading need to be carefully considered. [ABSTRACT FROM AUTHOR]

The purpose of this work was to investigate the application of different advanced continuous processing techniques (hot melt extrusion and spray drying) to the production of fixed-dose combination (FDC) monolithic systems comprising of hydrochlorothiazide and ramipril for the treatment of hypertension. Identical FDC formulations were manufactured by the two different methods and were characterised using powder X-ray diffraction (PXRD) and modulated differential scanning calorimetry (mDSC). Drug dissolution rates were investigated using a Wood’s apparatus, while physical stability was assessed on storage under controlled temperature and humidity conditions. Interestingly both drugs were transformed into their amorphous forms when spray dried, however, hydrochlorothiazide was determined, by PXRD, to be partially crystalline when hot melt extruded with either polymer carrier (Kollidon® VA 64 or Soluplus®). Hot melt extrusion was found to result in significant degradation of ramipril, however, this could be mitigated by the inclusion of the plasticizer, polyethylene glycol 3350, in the formulation and appropriate adjustment of processing temperature. The results of intrinsic dissolution rate studies showed that hot-melt extruded samples were found to release both drugs faster than identical formulations produced via spray drying. However, the differences were attributable to the surface roughness of the compressed discs in the Wood’s apparatus, rather than solid state differences between samples. After a 60-day stability study spray dried samples exhibited a greater physical stability than the equivalent hot melt extruded samples. [ABSTRACT FROM AUTHOR]

Medication adherence is a growing concern for public health and poor adherence to therapy has been associated with poor health outcomes and higher costs for patients. Interventions for improving adherence need to consider the characteristics of the individual therapeutic regimens according to the needs of the patients. In particular, geriatric and paediatric populations as well as dermatological patients have special needs/preferences that should be considered when designing drug products. Patient Centric Drug Product Pharmaceutical Design (PCDPD) offers the opportunity to meet the needs and preferences of patients. Packaging, orodispersible formulations, fixed dose combinations products, multiparticulate formulations, topical formulations and 3D printing are of particular relevance in a PCDPD process. These will be addressed in this review as well as their impact on medication adherence.

Fixed-dose combinations of an angiotensin II receptor antagonist (telmisartan) and a thiazide diuretic (hydrochlorothiazide) provide an effective antihypertensive therapy while promoting patient compliance with the convenience of once-daily single dose administration. The current study investigated two capillary electrophoretic methods: a capillary zone electrophoresis (CZE) and micellar electrokinetic capillary chromatography one (MEKC) for the simultaneous determination of hydrochlorothiazide and telmisartan. In order to optimize the analytical conditions, efforts were focused on establishing the influence of several experimental parameters on the separation: buffer composition, concentration and pH, applied voltage, temperature, injection pressure and time. The separation of the two analytes can be achieved by CZE using a 25 mM phosphate buffer at pH 2.50 and by MEKC using a 50 mM borate buffer at pH 9.50 containing 25 mM sodium dodecyl sulfate as surfactant. The analytical performance of the two methods was verified in terms of their linearity, precision, accuracy and robustness, and the methods were applied for the determination of the analytes from fixed-dose combinations. [ABSTRACT FROM AUTHOR]

Background: Fixed Dose Combinations (FDCs) improve patient compliance and decrease pill burden. However, irrational prescribing of FDCs is a major health concern. As resident doctors are primarily involved in patient management at tertiary care hospitals, knowledge about prescribing FDCs is of paramount importance. Objective: To evaluate knowledge, attitude and practice, regarding use of FDCs by resident doctors at a tertiary care teaching hospital. Materials and Methods: The study was carried out among resident doctors working at Civil Hospital, Ahmedabad, a tertiary care teaching hospital. One hundred resident doctors from the departments of medicine, obstetrics and gynaecology, surgery, paediatrics, skin and psychiatry, who gave their informed consent, were enrolled. A prevalidated questionnaire regarding knowledge, attitude and prescribing practice of fixed dose combinations was filled up. Data was analyzed with suitable statistical tests. Results: Out of the 100 residents recruited for the study, 34, 33 and 33 residents were selected from the 1 st , 2 nd and 3 rd year respectively. The resident doctors were not aware about all of the advantages and disadvantages of FDCs. On an average, only 31% of the residents (lowest 16% among 1 st year residents) had knowledge about the Essential Medicine List (EML). Knowledge about rationality of given FDCs was lacking in 81% of the residents. Only 47% could name a single banned FDC in India. Common sources of information about FDCs were medical representatives, colleagues/peers, the Monthly Index of Medical Specialities (MIMS) and Continuous Medical Education (CMEs). A majority of residents (96%) agreed that FDCs should be allowed to be marketed. The residents opined that most commonly prescribed FDCs were of antimicrobial drugs, amongst which amoxicillin + clavulanic acid was the most frequent. Conclusion: There is need to improve knowledge about rationality, EML, usage and banned FDCs in post graduate medical students to promote the rational use of drugs.

Introduction: Fixed Dose Combinations (FDCs) are being increasingly used to improve compliance and achieve greater benefits of the two or more active ingredients given together than the corresponding individual drug components given separately. Aim: To analyse the rationality of Cardiovascular (CV) and Central Nervous System (CNS) FDCs available in Indian market. Materials and Methods: CVS and CNS FDCs, enlisted in Indian Drug Review, 2014, were analysed by a pretested validated eight point criteria tool. Each FDC was assessed for number of active pharmacological ingredients, approval by regulatory authority, listing in WHO Essential Medicine List. While efficacy, safety, pharmacokinetic, pharmacodynamic interactions and advantages of each FDC were analysed by literature search. The total score of the tool was 12 and score ≥7 was considered rational. FDCs were divided in four groups as per rationality and DCGI approval. ANOVA was used for statistical analysis and p

The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all of the actives contribute to the overall therapeutic effect. Such combinations of drugs are particularly useful in the management of chronic diseases. In addition, there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution and reduced development of resistance in the case of antimicrobials. Above all, FDC therapy reduces pill burden and improves medication compliance. Although, FDCs seem to be ideal under certain pre-defined circumstances, if a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient and if an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945, India) states the requirements for marketing approval of various types of FDCs. The same is further elaborated in this article to provide a detailed guidance including the clinical trial requirements. However, the heterogeneity of the therapeutic field makes it difficult to develop a standard guidance document.

Background : Non-steroidal antiinflammatory drugs (NSAIDs) are one of the most commonly prescribed drugs in clinical practice. Presently, several varieties of fixed dose combinations (FDCs) of NSAIDs are available over the counter and are being prescribed too. There is paucity of literature regarding comparative efficacy of these combinations against their individual component. Various clinical studies have documented increased incidence of gastric ulcerations with usage of more than one NSAID simultaneously. Objectives : To study gastric tolerability, antinociceptive and antiinflammatory activity of combination NSAIDs in rats. Materials and Methods : Gastric tolerability of different NSAIDs was observed after administration of drugs for 7 days orally. On 7 th day, 4 h after drug administration, rats were sacrificed and stomach mucosa was examined for ulcerations. Analgesic or antinociceptive activity of single and combination NSAIDs was evaluated using Writhing test model. For induction of writhing, 4% normal saline (hypertonic saline) was injected (0.1 ml/10 gm) intraperitoneally. Evaluation of antiinflammatory activity for FDCs of NSAIDs was done by using rat paw edema model with the aid of plethysmometer. Paw edema was induced by injecting 0.1 ml of 1% formalin in sub-planter region of hind paw. Results : Analgesic activity was found to be enhanced or significant only in the group pretreated with combination of nimesulide with ibuprofen as compared to ibuprofen-alone group (P = 0.01). Decrease in mean paw edema (antiinflammatory activity) was not significant in rats pretreated with combination NSAIDs as compared to NSAID-alone group. Mean gastric ulcer index was significant in groups pretreated with diclofenac alone (P = 0.03) and in combination groups of nimesulide with diclofenac and ibuprofen with paracetamol as compared to control (P = 0.03, P = 0.007). Conclusion : Addition of ibuprofen to paracetamol and combining diclofenac to nimesulide, significantly increased severity of gastric ulcerations. Fixed dose combination does not possess additional analgesic activity over their individual components, only exception being combination of nimesulide with ibuprofen, which has additional analgesic activity over ibuprofen alone, and this combination was not found to be ulcerogenic. Antiinflammatory activity of ibuprofen, paracetamol and nimesulide was significantly enhanced after addition of diclofenac.

Introduction: Fixed Dose Combinations (FDCs) are being increasingly used to improve compliance and achieve greater benefits of the two or more active ingredients given together than the corresponding individual drug components given separately. Aim: To analyse the rationality of Cardiovascular (CV) and Central Nervous System (CNS) FDCs available in Indian market. Materials and Methods: CVS and CNS FDCs, enlisted in Indian Drug Review, 2014, were analysed by a pretested validated 8 point criteria tool. Each FDC was assessed for number of active pharmacological ingredients, approval by regulatory authority, listing in WHO Essential Medicine List. While efficacy, safety, pharmacokinetic, pharmacodynamic interactions and advantages of each FDC were analysed by literature search. The total score of the tool was 12 and score =7 was considered rational. FDCs were divided in four groups as per rationality and DCGI approval. ANOVA was used for statistical analysis and p<0.05 was considering statistically significant. Results: Out of 152 FDCs, 107 were CV and 45 belonged to CNS group and 40 had documented evidence of efficacy and safety. Majority of FDCs showed advantage of being convenient by reducing pill count and only 32 showed reducing adverse drug reactions. Out of 107 CV FDCs, 46 were rational and 61 were irrational with a mean rationality score of 6.72 ± 2.82 (CI- 95%, 3.90 - 9.54). While out of 45 CNS FDCs, 8 were rational and 37 were irrational with a mean rationality score of 6.22 ± 2.08 (CI - 95%, 4.14 - 8.30). A significant difference in mean rationality score of group A (DCGI approved + rational) was observed as compared to group B (DCGI approved + irrational) and group C (DCGI unapproved + rational) as compared to group D (DCGI unapproved + irrational) (p<0.05). Conclusion: The absence of watertight pre-requisite, critical analysis of the scientific validity of the formulations and 'convenience' category has resulted into proliferation of irrational FDCs. This calls for strict regulatory approval process to avoid miserable FDC scenario in the country. [ABSTRACT FROM AUTHOR]

Aim: To assess the knowledge, attitude, and practices of fixed dose combination drugs among postgraduate dental students. Materials and Methods: A cross-sectional study was carried out among postgraduate dental students of dental colleges in coastal Andhra Pradesh. Three colleges were randomly selected and students of all the three years were included. Data was collected from the specialities of oral medicine and radiology, oral surgery, endodontics, pedodontics, periodontics, and public health dentistry. The total sample was 90 postgraduate students; informed consent was obtained from the participants, and a pretested questionnaire was distributed to them. Data was analyzed using the Statistical Package for the Social Sciences version 20 software. Results: Out of 90 postgraduates, 33 were males and 57 were females. Thirty-five percent were aware of the essential medical list (EML), among them 11% were from oral medicine and radiology and 6.7% were from pedodontics. However, most of them were unaware of the number of fixed dose combination drugs present in the World Health Organization EML. None of them were able to name at least a single banned fixed dose combination drug. Most of them were unaware of the advantages and disadvantages of using fixed dose combination drugs. Amoxicillin with clavulanic acid was the most common drug prescribed by students (73.3%) followed by ofloxacin with ornidazole (54.4%), ibuprofen with paracetamol (53.3%), and sulfamethoxazole with trimethoprim (6%). Most of them were unaware of the rationality in using fixed dose combination drugs. Common sources of information were medical representatives 43 (47.8%), internet 39 (43.3%), and 12 (13.3%) reported using WHO EML. Conclusion: There is an urgent need to improve knowledge on the rationality for using fixed dose combination, EML, and banned fixed dose combination in India to the promote rational use of fixed dose combination. [ABSTRACT FROM AUTHOR]

Purpose: Aiming to improve the dissolution rate of ezetimibe (EZE) and lovastatin (LOV) in a fixed dose combination (FDC), co-amorphous systems and ternary solid dispersions were prepared by quench cooling and spray drying, respectively. Methods: Formulations were characterized through X-ray diffraction, modulated differential scanning calorimetry, infrared spectroscopy, scanning electron microscopy and laser diffraction, and evaluated by ' in vitro' dissolution. Stability studies were conducted at different conditions during 30 days with the ternary solid dispersion composed of 75% of Soluplus® (ELS 1:1 75%). Results: Single phase co-amorphous systems made up of the pure drugs were not able to increase the dissolution rate of EZE and LOV. However, ternary solid dispersions achieved high dissolution for both compounds, especially when Soluplus® was used as carrier. The dissolution efficiency increased up to 18 (EZE) and 6 (LOV) times in ternary solid dispersions, compared to the crystalline drugs. ELS 1:1 75% preserved its amorphous state during 30 days, in different stability conditions. Conclusions: A spray dried ternary solid dispersion able to enhance the dissolution rate of two poorly soluble, therapeutically complementary drugs, is reported for the first time. These promising results open new perspectives for the development of more advanced FDCs. [ABSTRACT FROM AUTHOR]

Background: analgesic use is common in adults but their use in children has not been extensively studied. This observational study was envisaged to study prevalence and pattern of analgesic use in hospitalized children in pediatric general ward. Methods: 120 patients were included in the study. Disease was classified as per ICD-10 and medicines used were classified according to ATC classification. WHO indicators for rationality was used. Descriptive statistics was used to present the data i.e. percentage; proportions, frequency, mean and standard deviation using Microsoft excel worksheet. Result: A total of 791 drugs from different classes were prescribed to 120 patients with a mean of 6.6 ± 2.68 drugs described per patient during their stay in the hospital. 81 analgesics were prescribed. 25 were prescribed as fixed dose combination. Paracetamol was the most commonly prescribed non steroidal anti-inflammatory agent. [ABSTRACT FROM AUTHOR]

The article discusses the drug prescription pattern in children. The study assesses the drug dosage in comparison with fixed dose combination (FDC) and prescribing indicator by the World Health Organization (WHO). The cross-sectional study was conducted on children aged between 0-18 years from June - October, 2014. The article talks about irrational drug being prescribed to children commonly.

Background: Counterfeit and substandard medicines are a threat to health and the risks they pose have been largely underestimated to date. Almost all areas of the world are affected by the availability of substandard and counterfeit medicines, but mounting evidence shows that the problem is disproportionately severe in developing and emerging market countries, which also have a high burden of infectious diseases. In poor countries, essential and life-saving drugs used to treat infectious diseases such as tuberculosis and malaria are often the drugs under threat. Methodology: This was a cross sectional study whose objective was to determine the quality of 3 types of fixed dose combination (FDC) anti TB drugs namely 4FDC, 3FDC and 2FDC tablets available in Lusaka District by assessing the presence of active ingredients and the percentage content of these active ingredients according to the British pharmacopoeia 2008 using Spectrophotometric method. The drug samples analyzed had a shelf life of at least one year. Results: For presence of active ingredient, all the seventeen samples that were tested gave a positive result indicating that each sample had the correct active ingredients as indicated by the label claim. However, 20% (1/5) of the 4FDC samples and 14% (1/7) of the 2FDC samples were none compliant to the BP 2008 specification for percentage content. One sample of 4FDC had a percentage content of 106.3% for Isoniazid that was above the BP 2008 specification of 95% to 105% and one sample of 2FDC had a percentage content of 105.6% for Isoniazid that was also above the BP. 2008 specification of 95% to 105%. All the 3FDC samples were compliant to the BP 2008 specification for percentage content of 95% to 105%. Conclusion: The results from this study have established that substandard fixed dose combinations anti-TB drugs are present in Lusaka District. These results confirm the urgent need to have a national quality control laboratory that is supported by satellite mini laboratories at the points of entry for drugs and also to strengthen post marketing surveillance of all Pharmaceutical products that are imported into the country or manufactured locally. This will ensure safety and efficacy of the drugs that are used in the country. [ABSTRACT FROM AUTHOR]

Fixed dose combination ( FDC) dual bronchodilators that co-administer a long acting β2-adrenoceptor agonist ( LABA) and a long acting muscarinic antagonist ( LAMA) are a new class of inhaled treatment for chronic obstructive pulmonary disease ( COPD). This review focuses on the clinical evidence for the benefit of LABA/ LAMA FDCs compared with monocomponent treatments, and also compared with active comparators that are widely used for the treatment of COPD, namely tiotropium and salmeterol-fluticasone. Novel FDC dual bronchodilators include QVA149 and umeclidinium/vilanterol ( UMEC/ VI). Long term clinical trials show that QVA149 and UMEC/ VI are superior to monocomponent therapy in terms of trough forced expiratory volume in 1 s ( FEV1), although the FEV1 improvement was limited to approximately 80-90% of the added monocomponent values. This suggests that the effect of combining a LABA and a LAMA is not fully additive. LABA/ LAMA FDC were associated with the largest mean changes in symptoms and health status that were above the minimal clinically important difference, in contrast to the monocomponents. Furthermore, these LABA/ LAMA FDCs demonstrated superiority over the active comparators tiotropium and salmeterol-fluticasone in terms of trough FEV1 and patient-reported outcomes. LABA/ LAMA FDCs offer a simplified means of maximizing bronchodilation for COPD patients, with the improvements in lung function being mirrored by benefits in terms of symptoms and exacerbations. The use of LABA/ LAMA FDCs in clinical practice is set to grow and further studies are needed to define their optimal place in treatment guidelines. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the pattern of fixed dose combinations (FDCs) in Ahmedabad, a city in western part of India. Materials and Methods: Over a period of 24 months, prescriptions were collected from 24 pharmacy stores across 6 zones of Ahmedabad city. The information was recorded in pre-formed Data Record Form after written consent from the patients (or relative (s) of the patients). The pattern of use of FDC, rationality and seasonal variation in their use were analyzed. At the end of study, results were analyzed using Chi-square test. Results: Out of the total 1170 prescriptions, 941 (80.3%) contained 1647 FDC formulations. The average number of FDCs prescribed was 1.41 ± 1.04 (mean ± SD). The FDCs were more frequently prescribed in the age group of 31 to 40 years (23.7%) and in males (54.4%). FDCs were most commonly prescribed by oral route (92.7%). As per drug category analysis, a higher number of FDCs containing nutritional supplements (20.2%), and those for CNS (18.1%) complaints were prescribed. A seasonal analysis showed that FDCs were commonly prescribed for respiratory complaints (23.4%), central nervous system (CNS) complaints (20.3%) and as nutritional supplements (22.4%) in winter, monsoon and summer months, respectively. Only 5.8%, 9.8% and 10.9% FDCs prescribed were included in WHO (2010), National (2011) and Gujarat State (2011) Essential Medicines Lists (EML), respectively (P < 0.0001). Irrational FDCs that are banned or FDCs containing irrational active ingredients were 1343 (81.5%) and 203 (12.3%), respectively. Conclusion: FDCs are widely prescribed with seasonal influence in their use. FDCs containing banned or controversial ingredients are prescribed widely. [ABSTRACT FROM AUTHOR]

Background: The fixed dose combinations (FDCs) of muscle relaxants, non-steroidal anti-inflammatory drugs and paracetamol are commonly prescribed in the treatment of acute lower backache. Aim: The present study was undertaken with the aim of comparing the efficacy and safety of FDCs of thiocolchicoside and aceclofenac versus chlorzoxazone, aceclofenac and paracetamol in patients with acute lower backache associated with muscle spasm. Materials and Methods: A total of 100 patients between ages range from 18 and 55 years having low back pain of ≤7 days duration were randomly divided into two groups. Group A was prescribed thiocolchicoside (4 mg) + aceclofenac (100 mg) while Group B was prescribed chlorzoxazone (500 mg) + aceclofenac (100 mg) + paracetamol (325 mg) orally twice daily for 7 days. Severity of pain at rest and on movement was recorded using visual analogue scale. Muscle spasm was evaluated by hand-to-floor distance and Lasegue's maneuver. Readings were noted on day 1 (baseline), day 3 and day 7. Results: There was statistically significant reduction in severity of pain and muscle spasm on day 3 and day 7 in both groups. There was no statistically significant difference in pain relief and muscle spasm among the treatment groups but clinically showed better improvement in the Group A. The adverse drug reactions occurring during study showed a statistically significant better safety profile in the Group A than Group B. Conclusion: These findings confirm that FDC of thiocolchicoside and aceclofenac is a preferred option for patients with lower backache pain associated with muscle spasm. [ABSTRACT FROM AUTHOR]