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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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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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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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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.
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Ethambutol is one of the first line chemotherapeutic agents used in the treatment of tuberculosis used both in the intensive and continuation phase according to the new Revised National Tuberculosis Control Program guidelines. Patient acceptability is rather good with this drug as it produces comparatively lesser adverse effects. The most important and serious side effect reported is optic neuritis, resulting in loss of visual acuity, color vision and field defects. The incidence of optic neuritis is generally directly proportional to the dose and duration of ethambutol therapy. Here we report four cases of ethambutol induced optic neuritis in patients on fixed dose combinations (FDC) of ethambutol, isoniazid, pyrazinamide and rifampicin who presented in Ophthalmology OPD in a span of 2 months, between June and July 2019. Contradictory to the rare occurrence of ethambutol induced optic neuritis this comparatively higher incidence of optic neuritis is alarming. We observed that the presentation of ethambutol induced optic neuritis can vary and dose of ethambutol along with other factors can also contribute to it. So proper pre-treatment evaluation, dosage adjustment, periodic monitoring and early detection have a significant role in prevention and treatment of ethambutol induced optic neuritis.
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Background: P-drug is a personal or preferred or priority choice drug of a clinician. The aim of the study is to evaluate knowledge, awareness, practice of p-drug which helps the clinician to prescribe drugs rationally.Methods: The study was a prospective cross-sectional pre-validated questionnaire-based study conducted in Government General Hospital, Rangaraya Medical College, Kakinada. During the study period a total of 300 members were enrolled and instructed to fill the questionnaire forms. These filled forms were collected and data were analyzed.Results: Out of 300 members, 240 filled the questionnaire, and these forms were evaluated. Among them 16.6% were aware of p-drug, 27.5% were aware of P treatment, 32.5% were not including FDC抯 in their p drug list, 28.33% were aware of advantages of prescribing P drug and 82% felt that teaching programs were needed for preparing p drug list.Conclusions: For promoting and achieving rational use of medicine, P drug concept is one of the milestones. As few were aware of p-drug concept, institutional teaching review board should conduct teaching programs regarding p drug concept.
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South Africa has the world’s largest antiretroviral (ARV) program and despite having stringent upstream medicine’sregulatory oversight, the post-market reassessment of ARV quality is prohibitively resource intensive. The aim of thisstudy was to evaluate and compare the post-market quality of four fixed-dose combination (FDC) generics containingefavirenz (EFV) 600 mg, emtricitabine 200 mg, and tenofovir 300 mg against the innovator, Atripla® and accordingto the International Pharmacopoeia (IP). Generic tablet samples, sourced from a South African provincial depot, weresubjected to the identification, content assay, dissolution, uniformity of weight and disintegration tests. An in-housereversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated in lieuof the RP-HPLC IP method which proved to be unsuitable. All samples passed the identification, assay, uniformityof weight and disintegration tests and one generic FDC failed the dissolution test (at both stage 1 and 2), releasing62.23% (standard deviation 20.43) of EFV in 30 minutes. One generic first-line ARV combination that is currentlysupplied to the South African public health sector was found to be substandard and this reinforces the need for routineARV post-market surveillance, as well as reliable compendial methods to facilitate this undertaking
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Combination therapies of antihypertensive drugs are recommended in cases where hypertension is not controlled by monotherapy. This study aimed to compare the pharmacokinetics (PKs) between fixed-dose combination (FDC) of fimasartan/amlodipine 60/10 mg and the corresponding loose combination. Because of the high intra-subject variability for maximum plasma concentration (C(max)) of fimasartan, a randomized, open-label, 3×3 partial replicated crossover design was adopted. Subjects received a single dose of FDC of fimasartan/amlodipine 60/10 mg or the corresponding loose combination in each period. Blood samples for PK analysis were collected up to 48 hours for fimasartan and 144 hours for amlodipine, respectively. Geometric mean ratios (GMRs) and its 90% confidence intervals (CIs) of the FDC to the loose combination for C(max) and area under the concentration-time curve from time 0 to the last quantifiable time point (AUC(last)) were calculated. Sixty healthy subjects were randomized, and 57 subjects completed the study. The concentration-time profiles of fimasartan and amlodipine were similar between the FDC and loose combination. The GMRs (90% CIs) of the FDC to the loose combination for C(max) and AUC(last) were 1.0440 (0.9202–1.1844) and 1.0412 (0.9775–1.1090) for fimasartan, and 1.0430 (1.0156–1.0711) and 1.0339 (1.0055–1.0631) for amlodipine, respectively. The GMRs and its 90% CIs for C(max) and AUC(last) of fimasartan and amlodipine were included not only in the scaled bioequivalence criteria but also in the conventional bioequivalence criteria. In conclusion, FDC of fimasartan/amlodipine 60/10 mg showed comparable PK profiles with the corresponding loose combination, which suggests their bioequivalence.
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Amlodipine , Antihypertensive Agents , Cross-Over Studies , Healthy Volunteers , Hypertension , Pharmacokinetics , Plasma , Therapeutic EquivalencyABSTRACT
Background: The study was conducted with an aim to evaluate the pattern of occurrence of adverse drug reactions (ADRs) of Non-steroidal anti-inflammatory drugs (NSAIDs) in orthopedic patients in a tertiary care teaching hospital of North India.Methods: An observational study was carried out in the orthopedic outpatient department at the tertiary care hospital for the period of six months. All patients diagnosed with acute pain and receiving NSAIDs were included. The documented ADRs were assessed for causality, severity and preventability using Naranjo’s algorithm and WHO-UMC scale, modified Hartwig and Seigel Scale and modified Schumock and Thornton scale, respectively.Results: A total of 84 ADRs were reported from 51 patients. The most common ADRs observed were from gastrointestinal (38%) followed by skin (18%) and autonomic nervous system (12%). Maximum number of ADRs were reported in patients on diclofenac (47%) followed by piroxicam (44%). Upon causality assessment, majority of the reactions were possible (61.5% with WHO-UMC scale, and 57.1% with Naranjo’s algorithm). The association of results between the two scales was statistically significant (p<0.001). Majority of ADRs (73.4%) were assessed as mild and 66.7% of the ADRs were probably preventable.Conclusions: Authors conclude that incidence of ADRs can be decreased and compliance can be improved by early detection and management.
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Background: Musculoskeletal disorders like osteoarthritis, rheumatoid arthritis, bursitis, backache, tendinitis, cervical spondylitis etc. are very commonly encountered in orthopaedic practice and are generally treated with various analgesic drugs. There are number of non-steroidal anti-inflammatory drugs (NSAIDs), opiod analgesics and also fixed dose combination (FDC) of analgesics available for the treatment of such disorders with some advantages and disadvantages of these drugs. Since few studies are there on utilization of analgesic drugs in the orthopaedic practice, this study was undertaken to determine the current prescribing trends for these disorders.Methods: It was record based observational study carried out at NKP salve institute of medical sciences, Nagpur. A total of 200 prescriptions of patients reported to orthopaedic outpatient department, with presenting complaints of musculoskeletal disorder and rheumatological conditions like osteoarthritis, rheumatoid arthritis, bursitis, backache, tendinitis, cervical spondylitis etc. were noted for the various analgesic drugs prescribed for these disorders.Results: The common age groups encountered for musculoskeletal disorders were between 41-50 years (26%) and 31-40 years (20%) followed by other age groups. The common conditions for which patient attended orthopaedic outpatient department were low backpain in 42 (21%) and osteoarthritis in 41(20.5%) patients followed by others. Aceclofenac and diclofenac were the most commonly prescribed analgesics in 25 (12.5%) and18 (9%) patients followed by other analgesics. Fixed dose combinations of NSAIDS with other NSAIDS or opoid analgesic were also commonly prescribed. Diclofenac + Paracetamol and Tramadol + Paracetamol were most commonly prescribed combinations in 30 (15%) and 19 (9.5%) patients respectively.Conclusions: As monotherapy aceclofenac and diclofenac were the most commonly prescribed NSAIDS for various musculoskeletal disorders. Also, fixed dose combinations of NSAIDS with other NSAIDS or opoid analgesic were also commonly prescribed. Diclofenac + Paracetamol and Tramadol + Paracetamol were the most commonly prescribed FDCs in our study.
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Fixed drug eruptions (FDEs) may account for 16-21% of all cutaneous drug eruptions. Recent research suggests a cell-mediated process that initiates both the active and quiescent lesions. The major categories of causative agents of fixed drug eruption include antibiotics, antiepileptics, nonsteroidal anti-inflammatory agents, sildenafil, and phenothiazines, although numerous other agents and certain foods such as cashews and licorice have also been reported as causative agents. A 38 year old male presented to the dermatology OPD with hyperpigmented and erythematous macular eruptions on the neck, chest, right arm, left scapular region, left wrist and left knee. The eruptions were associated with burning sensation and itching. He informed having taken medications for gastroenteritis the night before. The medications were Ofloxacin and Ornidazole (FDC), Omeprazole and Domperidone (FDC) and Paracetamol. He gave a history of a similar event, a year ago, with the same antimicrobial combination (Ofloxacin and Ornidazole), although the macular eruptions were restricted to the neck, arm and knee with bleb formation and severe burning sensation. Since the macular eruptions reoccurred, although with extra regions being affected, a diagnosis of FDEs was made. The most probable cause for these FDEs seems to be FDC of Ofloxacin and Ornidazole, because the patient gives history of taking Omeprazole and Paracetamol before without any FDEs. According to Naranjo’s Adverse Drug Reaction Probability Scale, the FDC of Ofloxacin and Ornidazole is a definite cause for the FDEs. (Score = 9).