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Aim: The study was conducted to assess the prescribing behaviour for antimicrobials and various groups of drugs in tertiary care hospital in Puducherry. Prescription audit was done. Total 500 presc Method: riptions were analysed for sex wise distribution, no of patients for specific age group, antimicrobials prescribed in generic name, percentage of antibiotics, antacids, NSAIDs and multivitamins, among the prescribed drugs, groups of antibiotics, drugs prescribed from National List of Essential Medicines (2022), use of fixed drug combinations, injectable preparations if any. Results: Demographic analysis showed that out of 500 patients in OPD, most were female (53%) and in the age group between 41 to 60 years. In 500 number of prescriptions,9.96% of antibiotics were prescribed; fluoroquinolones (5.42%) were prescribed more from antibiotics followed by extended spectrum penicillin (1.64%).14.78%of antacids were prescribed; PPIs (11.28%) were prescribed more from antacids.21.63% of NSAIDs were prescribed.11.66% were prescribed in generic names,65.44% drugs were prescribed from National List of Essential Medicines (2022),15.88% of FDCs were prescribed,6.13% of injectable preparations were prescribed. The rational use of antimicrobial agents is one of the main contribut Conclusion: ors to control worldwide emergence of bacterial resistance, side effects and reduced cost of the treatment.
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Background : 20-30% of the Indian population suffers from at least one allergic disease that can have an adverse impact on the quality of life of the patients. Aim : To develop expert opinion-related guidance for the diagnosis and management of allergic disorders. Methodology : An advisory board meeting (hybrid mode) was conducted with 11panel members of the Indian Medical Association (IMA). The panel members discussed issues related to the management of allergic disorders based on the Delphi method. Result : Spirometry is helpful in selected patients of allergic rhinitis where the coexistence of asthma is suspected. In patients with urticaria second-generation antihistamines are preferred for both adults and children due to their low side effects, less drug-drug interaction, anticholinergic effects, longer duration of action, and higher safety. Diagnosis of allergic contact dermatitis can be made based on occupational and exposure history. In atopic dermatitis, patient education about lifestyle changes can prevent flare-ups. In patients with asthma, patients must be educated about the use of the peak flow meter. The diagnosis of food allergy can be made by correlating the food intake timing withthe patient history and the results of allergy testing. Allergic drug reactions can be treated with oral antihistaminic drugs, emollients, and if needed topical corticosteroids. Conclusion : The diagnosis of allergic disorders requires the clinician to consider the clinical presentation, patient history, presence of triggers, and comorbid conditions. Patient education and the new generation of antihistaminic drugs can improve the quality of life of patients with allergic disorders
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Aim: The aim of this study was to evaluate the anti-hypertensive efficacy of a fixed-dose combination (FDC) of Efonidipine 40 mg and Telmisartan 40 mg in Stage II hypertensive patients. Study Design: Multicentric, randomized, double-blind, parallel, comparative Phase III clinical trial. Methodology: This clinical trial was conducted at six geographically distributed sites across India and enrolled 240 Stage II hypertensive patients. They were randomized into two groups in a ratio of 1:1 using computer-generated block randomization to receive E+T (FDC of Efonidipine 40 mg + Telmisartan 40mg) or C+T (FDC of Cilnidipine 10 mg + Telmisartan 40 mg) group intervention once daily for a period of 90 days. The study site staff, investigator and patients were blinded to the treatment allocation. The primary endpoint of the study evaluated the mean reduction in sitting systolic BP (SBP) and diastolic BP (DBP) from baseline to day 90 whereas the secondary endpoints assessed were mean reduction in BP from baseline to day 30 & 60, patients achieving target BP (<140/90 mmHg) and the safety and tolerability of the investigational products based on the incidences of adverse events (AEs) reported. Results: A total of 118 subjects were randomized to the E+T group wherein the mean (±SD) SBP and DBP at baseline was 167.25 ± 4.68/107.26 ± 5.19 mmHg. After 30 days of treatment with the E+T group, the mean reduction in SBP/DBP of 29.37/18.06 mmHg was observed whereas at Day 60 reduction of 38.55/22.69 mmHg was seen from the baseline. At Day 90, SBP/DBP decreased to 119.41±14.99/81.67±4.29 mmHg with a mean reduction of 47.94/25.89 mmHg in the E+T group. During the study period, the difference in systolic blood pressure between the treatments with E+T and C+T was -0.48 mmHg, with the two-sided 95% confidence interval (CI) ranging from -4.54 to 3.58?mmHg. The corresponding difference in diastolic blood pressure was -0.77 (95% CI: -2.60 to 1.06) mm?Hg. The upper boundary of the 95% CI was below the margin of 10?mmHg, confirming the non-inferiority of E+T to C+T. A total of 92% of patients who had been assigned to E+T treatment achieved their target BP goal. Only one patient reported an adverse event with E+T treatment. No unexpected AEs were reported in the E+T group suggesting its good safety and tolerability. Overall, the E+T treatment was effective, safe and well-tolerated by the patients for 90 days. Conclusion: It was concluded that the FDC of Efonidipine 40 mg and Telmisartan 40 mg was efficacious in the management of Stage II hypertension.
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Aim: To evaluate the antihypertensive efficacy and safety of the fixed-dose combination (FDC) of Efonidipine and S (-) Metoprolol in adult patients with hypertension. Study Design: Multicentric, double-blind, randomized, parallel, comparative Phase III trial. Methodology: This clinical trial was conducted at five geographically distributed sites across India and enrolled 240 hypertensive patients. They were randomized (1:1) to receive either FDC of Efonidipine 40 mg + S (-) Metoprolol 25 mg tablet (E+S(-)M group) or FDC of Cilnidipine 10 mg + Metoprolol 50 mg tablet (C+M group) once daily for 90 days. Patients were evaluated for changes in their blood pressure (BP) from baseline to Day 30, 60 and 90. The study site staff, investigator and patients were blinded to the treatment allocation. Blood pressure was recorded as the mean of 3 consecutive measurements taken in a sitting position. Patients achieving target BP (<140/90 mmHg) were evaluated and the safety and tolerability were assessed based on the incidences of adverse events (AEs). Results: This study focused on evaluating the mean Systolic BP (SBP) and Diastolic BP (DBP) reduction from baseline to Day 30, 60 and 90. At baseline, patients had a mean (±SD) SBP and DBP of 154.60 (±11.33) mmHg and 98.68 (±8.18) mmHg respectively. After 30 days of the E+S(-)M treatment, the mean SBP/DBP was 136.06±10.55/ 86.68±5.51 mmHg (p<0.0001) and on Day 60 it was 129.48±10.51/ 84.17±5.51mmHg (P <0.0001), corresponding to mean reductions in SBP/DBP of 18.09/11.66 and 24.78/14.17 mmHg, respectively. There was a statistically significant (p <0.0001) reduction to 123.59 ± 15.21 mmHg in SBP and 82.38 ± 5.05 mmHg in DBP observed on Day 90 as compared to baseline. Post-treatment with E+S(-)M group, SBP/DBP reduction of 31.01/16.29 mmHg in hypertensive patients was observed. A total of 95% of the patients achieved a pre-defined target BP <140/90 mmHg on the administration of E+S(-)M. Furthermore, it was observed that 93% of Stage I and 96% of Stage II hypertensive patients achieved the target BP goal. A total of 5.78% of patients experienced adverse events (AEs) in the E+S(-)M group which was similar to that of C+M group. All AEs were mild in severity and resolved without any sequelae at the end of the study. No unexpected adverse events were reported, and the E+S(-)M dosage regimen was well tolerated by the patients. Both the treatment groups were non-inferior to each other. Conclusion: The study results demonstrated clinically meaningful reductions in blood pressure after administration of FDC of Efonidipine 40 mg + S(-) Metoprolol 25 mg over a period of 90 days. The treatment was efficacious, safe, and well?tolerated in the study population.
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Type 2 Diabetes Mellitus (T2DM) is a highly prevalent cardiometabolic disorder in India and is further projected to rise (10.4% by 2030). In newly diagnosed patients, maintaining HbA1c 6.5-7.0% and minimizing glycaemic exposure, particularly during the first year following diagnosis, may be crucial for preventing complications. Early treatment initiation with a synergistic combination of vildagliptin and metformin is one of the many possible combinations to manage type 2 diabetes mellitus. In view of emerging clinical evidence on early initiation of combination therapy than monotherapy with metformin, there is a need for expert consensus on the use of the current approved Fixed Dose Combination (FDC) of Metformin SR + Vildagliptin IR in newly diagnosed diabetic patients. Experts framed final consensus statements based on available scientiûc evidence, experience and collective clinical judgment from practical experience this FDC.
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Dry eye syndrome (DES) is a common disorder with rising incidence due to increased use of digital devices. While multiple treatment options are available, some are not efficacious or sometimes even safe for use in DES. This is particularly true for Fixed Dose Combinations (FDCs) that may contain ingredients having no rational for their use or may actually be harmful. Various committees appointed by the Government have reviewed several FDCs marketed in India and found some of them to be irrational and recommended for their removal. This paper discusses the contents of some of these FDCs marketed for DES with an aim to ensure that prescribers are mindful of their ingredients and whether there is adequate data about their efficacy and safety and prescribe them only if they consider them necessary for managing the patient.
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Background: We assessed utilization patterns, profile of diagnoses, and fixed dose combination (FDC) with pregabalin in patients with various indications. Aims and Objectives: The aim of the study was to estimate the prevalence of pregabalin prescribing pattern among the patients attending the various outpatient departments (OPDs) of a tertiary care hospital at Trichy in South India. Materials and Methods: A hospital-based prospective observational study was planned and conducted over a period of 12 months. Patients who attended the various OPDs were included in the study. Prescriptions were collected from the respective consulting departments and pharmacy. Results: A total of 2490 patients prescription were analyzed. There was female preponderance (54.22%). Majority (45.74%) were in the age group of 51� years. General medicine was the highest (41.36%) visited patients. Neuropathic pain was the most prevalent disease condition among the various age group (57.67%), and predominant between 40 and 65 years (55.86%). Total of 12,220 drugs were prescribed, most frequently prescribed drugs belong to category of plain pregabalin 75 mg (53.37%) with female predominance, with maximum prescription from the medicine department (40%). Among the FDC, pregabalin 75 mg with nortriptyline 10 mg was the highest prescribed drug by the orthopedic department (41%). Extended release pregabalin 75 mg (13.04%) and low dose pregabalin 50 mg (2.19%) were also prescribed in our study. Conclusion: The prevalence of pregabalin prescription was maximum to neuropathic pain followed by radicular pain, trigeminal neuralgia, claudication, and herpetic neuralgia. Plain pregabalin 75 mg is preferred by most of the departments, few preferred extended release of 75 mg. Among the various FDC, pregabalin 75 mg with nortriptyline 10 mg and with methylcobalamine 750 mcg were prescribed by many departments.
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Purpose: To describe the increase in prevalence of ethambutol-induced optic neuropathy (EON) in patients presenting to a single tertiary referral eye care center in India after introduction of weight-based fixed dose combinations and an increase in duration of ethambutol use from 2016 in the Revised National Tuberculosis Control Program. Methods: This was a retrospective, observational, referral hospital-based study of 156 patients with a diagnosis of EON presenting to a single tertiary referral eye care center between January 2016 and December 2019. The main outcome measure was to assess the increase in prevalence of EON cases presenting to our tertiary care institute. Results: During the 4-year study period, 156 new patients were diagnosed with EON. A total of 101 patients (64.7%) were males and 55 (35.3%) were females. The most common age group affected was 41–60 years. The significant complaint at presentation was decreased vision in all the patients. A rising trend in the number of patients diagnosed as EON was seen, with the prevalence increasing from 16 cases in 2016, 13 cases in 2017, and 31 cases in 2018 to 96 cases in 2019. Conclusion: The results of this study indicated an alarming increase in the trend of EON cases presenting to our tertiary care institute.
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Background: Fixed dose combinations (FDCs) are combinations of two or more active drugs in a single pharmaceutical formulation. The rationality of FDC is a controversial and challenging issue in today’s practice of medicine. Aims and Objectives: The aim of the study was to assess the prescription pattern and rationality of FDCs in a tertiary care hospital. Materials and Methods: This is a record-based cross-sectional study conducted in the Department of Pharmacology, Government Medical College, Thrissur. The data were collected from the case records of 183 patients admitted under various departments during the month of January 2019. The FDCs prescribed were listed and the prescription pattern was assessed. All the FDCs were evaluated for rationality with the help of a comprehensive seven-point criteria by Panda et al. The data were analyzed using Epi info 7. Descriptive statistics were used to analyze the data. Results: Out of 183 case records, 39.3% contained at least one FDC, 13.1% contained two FDCs, and 4.4% contained three FDCs. The different drug classes prescribed as FDCs include anti-infective drugs 45%, vitamins and minerals 33%, analgesics 9%, and miscellaneous drug combinations 13%. The most prescribed anti-infective drug FDC is amoxicillin with clavulanic acid combination (56%). In our study, 92.5% of the antibacterial FDCs prescribed were rational and 7.5% irrational. According to the World Health Organization rationality criteria, 62% of the FDCs prescribed were rational and 38% were irrational. Conclusion: The present study showed the increased use of FDCs in tertiary care teaching hospital and most of the FDCs prescribed were rational (62%).
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Background :The common cold and flu syndrome primarily affects the upper respiratory tract, along with a low fever and some systemic symptoms such as sore throat, cough, nasal decongestion, headache, and so on. Several clinical studies have shown that combining analgesics, antihistaminics, and decongestants provides better symptom relief in the common cold. The current post-marketing surveillance study was designed to look into the safety and efficacy of commercially available Flucold Drops in the Indian population. Methodology :A current prospective, single arm, multicenter, post-marketing clinical study included 224 subjects, 220 of whom completed the study. All patients were given Flucold Drops for three days and then monitored for the next six days. During the study, the incidence of adverse events (AE) and serious adverse events (SAE) was assessed. The efficacy of the Flucold Drops was evaluated using VAS score changes from the beginning to the end of the treatment. The product’s safety was also evaluated using blood biomarkers such as haemoglobin, platelet count, SGOT, SGPT, and creatinine level. Results : Results show the reduction in symptomatic score of common cold and flu syndrome observed after 2rd follow-up visit (0.202+0.325 to 0.139+0.231). During the study, no intervention-related adverse events were observed. Furthermore, no Serious Adverse Events (SAE) were observed in the study or follow-up period. The study found no changes in the levels of blood biomarkers (haemoglobin, platelets, SGOT, SGPT, and creatinine). Conclusions : Flucold Drops are safe and effective in the treatment of common cold and flu syndrome in Children and infants.
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Background: Drug utilization studies (DUS) provide insight into recent trend of drug usage and facilitate rationality of prescribed drugs. Few DUS have been conducted in ophthalmology. Aim and Objective: To analyse the prescription pattern in outpatients of the ophthalmology department at a tertiary care teaching hospital. Materials and Methods: A prospective, observational and cross-sectional study was conducted at GCS Medical College Hospital and Research Centre, Ahmedabad. All patients who visited ophthalmic outpatient department were enrolled and necessary data were recorded regarding drugs prescribed in pre-defined case record form. Data analysis was carried out using Microsoft Excel. Results: A total of 388 prescriptions were analysed. Average number of drugs and fixed-dose combinations (FDCs) per prescription were 2.47 (95% CI, 2.29–2.64) and 0.44 (95% CI, 0.36–0.51), respectively. Drugs were prescribed in different dosage forms with eye drops being the most common (95.1%) followed by tablet (12.3%), ointments (8.5%), capsules (2.8%), syrup (1.1%), and injections (0.3%). One or more dosage forms were seen per prescription. Total 957 drugs were prescribed, out of which drugs with brands name and generic name were 88.4% and 11.6%, respectively. Total FDCs prescribed were 17.5%. Overall, 43.5% of prescriptions had antibiotics ranging from 1 to 5 per prescription and 25% of antibiotics were seen out of total drugs. Conclusion: Most of the drugs prescribed were in the form of drops. FDCs and antimicrobial use have been increasing in the management of ophthalmic diseases. Less numbers of drugs were prescribed by generic names.
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Background: Studies comparing the efficacy and tolerability of the three fixed combinations of timolol with its monotherapy are not readily available. In this background, the current prospective observational study was planned. Aim and Objective: To evaluate and compare the intraocular pressure (IOP) reduction, change in visual field, and cup-disc ratio in glaucoma patients receiving timolol monotherapy vis-a-vis timolol based dual therapies among timolol sub-optimal responders. Materials and Methods: After obtaining written informed consent and fulfilling the inclusion-exclusion criteria, fifty consecutive newly diagnosed cases of glaucoma or ocular hypertension with risk factors were recruited in the study. They received timolol eye drop up to 4th week. Participants not responding to timolol monotherapy optimally received either timolol plus brimonidine or timolol plus dorzolamide or timolol plus latanoprost for another 12 weeks. Participants responding optimally (at least 30% reduction of baseline) were continued with timolol monotherapy. Besides IOP changes, effects on visual field, visual acuity, cup disc ratio, safety, tolerability, and rate of persistency to therapy were studied. Results: Fifteen participants (30%) achieved target IOP reduction at 4 weeks of timolol monotherapy. All four treatment groups achieved significant IOP reduction (P < 0.001) from baseline to 16th week. Participants receiving timolol followed by timolol plus latanoprost had shown the highest IOP reduction at 16th week both from baseline and 4th week value (ANOVA test, P = 0.027, P = 0.000 respectively). No change in visual field or visual acuity or cup disc ratio was noticed. Adverse drug reactions observed were mild and mostly self limiting. Conclusion: Timolol and latanoprost combination might be a better choice in sub-optimal responders to timolol whereas it is wise to continue timolol monotherapy in optimally responders.
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Background: Evaluation of the pattern of fixed dose combinations (FDCs) prescribing among the practitioners in India. Aims and Objectives: Aims and objectives of the study was to find out prevalence, prescribing pattern and rationality of FDCs in Jhalawar district of Rajasthan. Materials and Methods: Photocopies of one thousand prescriptions of general practitioners, containing 800 FDCs were randomly collected from few big pharmacies of Jhalawar district of Rajasthan and analyzed for the different pattern of prescribing and rationalism. Results were expressed as percentages. After excluding the repetitions, the numbers of FDCs were 218, which were considered for final analysis. Results: Out of 218 FDCs, the most commonly prescribed FDCs were of anti-microbial agents followed by anti-inflammatory drugs and anti-hypertensive drugs. The FDCs were maximum from the department of medicine (30.2%), followed by surgery (20.2%) and Obstetrics (16.9%). Out of 218 FDCs, only 13.3% were rational, and rest of the FDCs was irrational. 94% of all FDCs prescribed with brand names. Conclusions: In our study, most of the prescriptions contains irrational FDCs. Physicians have no knowledge about the essential drugs and FDCs. Therefore, physicians and regulators should be educated regularly by seminars and conferences. Government laws should be made mandatory. Implementation of central drug standard control organizations guidelines on industries for manufacture of FDCs must be made compulsory.
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Background: The global incidence and prevalence of analgesic nephropathy is 28% in 1981 and 12% in 1990. Intake of 6–8 tablets per day for 6–8 years attributes to development of analgesic nephropathy. This article serves caution and reminder about unnoticed renal threat posed by long-term use of analgesics. Aim and Objectives: The study objective is to assess the drug utilization pattern in patients of analgesic nephropathy. Materials and Methods: It is a cross-sectional observational study, carried out across multicenter under the tertiary care hospital, after obtaining permission from respective institutes. Data were collected on demographic features such as age, gender, duration, and type of analgesics used by patients from various monitoring centers through CDSCO forms. To analyze the drug utilization pattern, the World Health Organization prescribing indicator scales were applied. Results: A total of 32 patient case sheets were analyzed, showing more of females (65.6%) being affected compared to men. Involving more patients aged above 31–50 years (50%). 51–70 years (37.5%) being affected with cyclooxygenase (COX-2) inhibitors along with nonselective COX inhibitors. The most common prescribed are COX-2 inhibitors such as Diclofenac and Aceclofenac along with combination of Paracetamol. 40.4% patients were affected with fixed drug combinations and usage of drugs between 2 and 6 months were 34.4%. 56% landed with acute renal failure and 44% were progressed to end stage renal disease. Conclusions: Usage and prescribing of analgesics were more of irrational combinations and patients taking self-medication for long duration were against the WHO standards.
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We developed a novel portable and automated dissolution test analyzer for rapid and high precision in vitro dissolution testing of drugs.The analyzer consists of a flow-through-cell drug dissolution system,an automated sequential sampling system,a high-speed capillary electrophoresis (HSCE) system,and a data acquisition system.Combining the high-temporal resolution flow-gating sampling approach with HSCE,which has outstanding advantages of efficient separation and resolution,the analyzer can achieve rapid analysis and exhibits the ability in miniaturization for on-site assessment of different active pharmaceutical ingredients.To integrate the flow-through-cell dissolution system with HSCE,a specially designed flow-gating-injection (FGI) interface was employed.The performance of the analyzer was investigated by analyzing the dissolution of immediate-release drugs including single dose (amoxicillin dispersible tablets) and fixed dose combination (amoxicillin and clavulanate potassium) drug tablets with the high-temporal resolutions of 12 s and 20 s,respectively.The dissolution profiles of different active pharmaceutical ingredients could be simultaneously and automatically monitored with high repeatability and accuracy.The analyzer was successfully utilized for the pharmaceutical quality control and bio-relevant dissolution testing,as well as in vivo-in vitro correlation analysis.Our portable analyzer is miniaturized,convenient and of low-cost,and will provide a valuable tool for dissolution testing in pharmaceutical research and development.
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Objective:Aim of this study is to assess the drug utilization pattern of cardiovascular drugs in cardiology outpatient department (OPD). Methodology:This prospective, multicenter, cross-sectional observational study was conducted at three selected tertiary care hospitals from different regions in South India. A total of 1026 prescriptions of the patients attending cardiology OPD of these selected hospitals 342 each over a period of 12 months was randomly identified and included in this study then critically analysed for WHO/INRUD core prescribing indicators. Results:Medicines prescribed from NLEM were 89.27%, average drugs prescribed was 5, medicinesprescribed by its generic name were 2.33% and encounters with an injection prescribed were 14.52%. Commonly prescribed different class of drugs for CVDs patients were Anti-platelets (67.73%) followed by Statins (62.57%), Beta blockers (49.51%), ACE-inhibitors (40.93%), Angiotensin receptor blockers (30.40%), Calcium channel blockers (30.11%), Nitrates (25.34%), Diuretics (20.56%), Anticoagulants (20.27%), Vasodilators (9.94%) rest of the cardiovascular drugs were prescribed within 0.5-5% only, other class of drugs also prescribed for patients with different comorbidities are Anti-ulcers (69.10%), Opioid analgesics (4.09%), Antacids (3.80%), Anti-emetics and Pro-kinetics (1.85%), a pattern of poly-pharmacy was clearly evident, majority of drugs were prescribed as single drug (86.78%) whereas 13.21% as FDCs. The most commonly prescribed single drug was Aspirin (59.93%) and FDCs were Aspirin + Clopidogrel (40.24%). Anti-thrombotic agents’ particularly antiplatelet drugs expected to overtake anti-cholesterol drugs as the sales leader in the market. Maximum drugs were prescribed from the recent NLEM of India by most of practitioners its shows its acceptance and implementation by the prescribers.Conclusion: Deprescribing PPIs for the non-required patients is suggested to lower the risk of adverse drug interactions and economic burden to patients, also pharmacists needs to encourage the prescriptions with drugs in generic name if it’s deviated from the standards recommended by WHO/INRUD
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Background: Study of prescription patterns is an important to determine rationality of drug therapy and to maximize the utilization of resources. Objective: This prospective, multicenter, cross-sectional observational study was conducted at three selected tertiary care hospitals in South India to assess the drug utilization pattern (DUP) of cardiovascular drugs in outpatient department (OPD). Materials and Methods: A total of 1026 prescriptions of the patients attending cardiology OPD over a period of 1 year were randomly identified then critically analyzed for World Health Organization (WHO) core prescribing indicators. Results: The average number of drugs prescribed was five and medicines prescribed by its generic name were 2.33%, encounters with an injection prescribed (14.52%), medicines prescribed from National List of Essential Medicine (NLEM) were 89.27%, apart from above some other class of drugs also prescribed for patients with different comorbidities. Majority of drugs were prescribed as single drugs (86.78%) whereas 13.21% as fixed-dose combinations (FDCs). The most commonly prescribed single drug was aspirin (59.93%) and FDC were Aspirin + Clopidogrel (40.24%). Most of drugs were prescribed from the recent NLEM of India which indicates the implementation and adoption of national drug policy by the hospitals and cardiologists. Conclusion: Antiplatelets dominated the prescribing pattern in the cardiology OPD and expected to overtake anti-cholesterol agents as the sales leader. Updated knowledge about the banned drugs, irrational FDCs, deleted drugs, and recent NLEM are very important to both practitioners and pharmacists, also pharmacists have to encourage the prescribers to prescribe the cardiovascular drugs by its generic name.
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Background: The fixed dose drug combinations (FDCs) of drugs is defined as product of two or more active ingredients in a defined composition. There is a need to study the pattern of prescription from time to time to evaluate their rationality. In this context we undertook this study to know the prescription pattern of FDC in our setting. To study the rationality of different prescribed FDCs.Methods: This is a prospective study which is carried out in NIMRA Institute of medical sciences which is a tertiary care teaching private hospital. For this study we have collected one thousand prescriptions of patients for 3 months that is from 10th March 2017 to 25th of June 2017 including both in-patients as well as outpatients. Selection criteria of patients mainly basing on their willingness to give prescriptions. Institutional ethical committee permission was taken for the study. The prescribed FDCs were compared with the essential drug list of FDCs approved by Drugs Controller General of India, July 2018. we have used descriptive statistics to analyze data. The percentage of FDCs used in each class and their contribution to overall FDCs were calculated.Results: In a total of 2952 drugs were prescribed, of this 747 were FDCs and 2205 were non FDCs. In the prescribed FDCs 89.2% drugs were rational and 10.8% drugs were irrational.Conclusions: From this study, we can conclude that 10.8% of irrational prescription of fixed dose drug combinations are prescribed in Nimra Institute of Medical Sciences which is a tertiary care teaching private hospital.
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Objective: To study fixed-dose combinations (FDC) of antibacterial and antiprotozoal products (ofloxacin and azoles), prescribed for the treatment of diarrhea. Methods: Rationality of these FDC products was verified by assessing parameters such as drug content and release by assay and dissolution tests, respectively mentioned in the Indian Pharmacopoeia (IP). Amount of drug solubilized and permeated as per the Biopharmaceutics Classification System (BCS) was determined. Ex vivo permeation study was performed on the gut of goat using the everted gut sac technique. Antimicrobial efficacy in terms of minimum inhibitory concentration (MIC) was assessed using agar well diffusion method against Shigella boydii, the causative agent for diarrhea. Comparative studies were performed on an individual as well as combination doses of antibacterial and antiprotozoal products for the synergistic effects to assess the rationale of these FDC. Results: The BCS solubility of ciprofloxacin (CPX), norfloxacin (NFX) and tinidazole (TNZ) was high in acidic medium (pH 1-5) and decreased at pH above 5. The assay studies showed that the individual drug contents of FDC were within the IP limits. In vitro dissolution results for both, individual drugs and their combination illustrated 99 % drug release within 30 min in 0.01N HCl. Ex vivo permeation of TNZ was higher than CPX and NFX in individual drugs. No significant change in the permeation rate was observed for individual drugs and their FDC. CPX and NFX exhibited more antimicrobial activity in terms of inhibitory zones than their FDC with antiprotozoal TNZ, above 2.5 µg/ml MIC. The pharmaceutical, biopharmaceutical and antimicrobial evaluation study showed the similarity of FDC with the individual drugs. Conclusion: The study showed no significant data to justify the therapeutic advantage of FDC over individual drugs.
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Cefixime, a third generation cephalosporin and ornidazole, a nitroimidazole is used for a wide variety of conditions like urinary tract infections, otitis media, pharyngitis, uncomplicated gonorrhea and anaerobic infections. Fixed drug eruption (FDE) is commonly associated with anticonvulsants, antimicrobials and NSAIDs. Here we report a case of a rare cefixime and ornidazole combination induced fixed drug eruption. A 39 year old male developed hyper-pigmented patches over both forearms and left thigh after consuming fixed dose combination of cefixime and ornidazole tablet for the treatment of urinary tract infection.