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   2014| April-June  | Volume 5 | Issue 2  
    Online since April 7, 2014

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Switch over from intravenous to oral therapy: A concise overview
Jissa Maria Cyriac, Emmanuel James
April-June 2014, 5(2):83-87
DOI:10.4103/0976-500X.130042  PMID:24799810
Majority of the patients admitted to a hospital with severe infections are initially started with intravenous medications. Short intravenous course of therapy for 2-3 days followed by oral medications for the remainder of the course is found to be beneficial to many patients. This switch over from intravenous to oral therapy is widely practiced in the case of antibiotics in many developed countries. Even though intravenous to oral therapy conversion is inappropriate for a patient who is critically ill or who has inability to absorb oral medications, every hospital will have a certain number of patients who are eligible for switch over from intravenous to oral therapy. Among the various routes of administration of medications, oral administration is considered to be the most acceptable and economical method of administration. The main obstacle limiting intravenous to oral conversion is the belief that oral medications do not achieve the same bioavailability as that of intravenous medications and that the same agent must be used both intravenously and orally. The advent of newer, more potent or broad spectrum oral agents that achieve higher and more consistent serum and tissue concentration has paved the way for the popularity of intravenous to oral medication conversion. In this review, the advantages of intravenous to oral switch over therapy, the various methods of intravenous to oral conversion, bioavailability of various oral medications for the switch over program, the patient selection criteria for conversion from parenteral to oral route and application of intravenous to oral switch over through case studies are exemplified.
  25,452 3,870 63
Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities
Sandeep Kumar Gupta, Roopa Prasad Nayak
April-June 2014, 5(2):88-92
DOI:10.4103/0976-500X.130046  PMID:24799811
Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical practice, but unfortunately, usually this is done without adequate scientific data. Often, when the best available therapeutic option fails, patients demand new approach or new treatment which ultimately leads to off-label uses. Major concerns about efficacy and safety have been raised by inappropriate use of off-label drugs because it leads to drug being used without risk-benefit analysis by the regulatory agency. Although the regulatory approval process requires ample proof of efficacy and safety for granting approval for specific indications of prescription drugs but unfortunately, more clarity is required about regulations governing off-label use of medicine. Above all because of the financial aspects involved it is highly impractical to expect that pharmaceutical companies will restrict or stop off-label promotion. Off-label use might be compared to double-edged sword which might be very useful for some patients while it can also expose them to unrestricted experimentation, unknown health risks, or ineffective medicine. Hence, there is an urgent need for guidance to encourage proper off-label use of medicine by the distribution of scientifically valid and authentic information from the pharmaceutical companies. In fact, few countries such as the USA and France have taken an initiative and have come up with the regulations about off-label use of medicine.
  6,716 1,311 21
Lorcaserin: A novel antiobesity drug
Dick B. S. Brashier, AK Sharma, Navdeep Dahiya, SK Singh, Anjan Khadka
April-June 2014, 5(2):175-178
DOI:10.4103/0976-500X.130158  PMID:24799830
Obesity is a major co-morbidity with hypertension and diabetes mellitus. There are few drugs for treatment of obesity like orlistat and recentlty approved drug lorcaserin. Lorcaserin has serotonergic properties and acts as an anorectic. It may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. Although, mainstay and first line of approach of treatment will always remain in having low calorie diet and increase in physical activity. Lorcaserin has come as a new hope to achieve success in treating obese patients but still a long road with further extensive research to be undertaken in the treatment of obesity.
  5,053 968 15
Treatment outcome of standardized regimen in patients with multidrug resistant tuberculosis
Kalpesh Jain, Mira Desai, Rajesh Solanki, Ram Kumar Dikshit
April-June 2014, 5(2):145-149
DOI:10.4103/0976-500X.130062  PMID:24799815
Objective: To evaluate the treatment outcome of second line drugs used in directly observed treatment, short-course (DOTS)-Plus regimen under Revised National Tuberculosis Control Program (RNTCP). Materials and Methods: A prospective, observational study was carried out on multidrug resistant tuberculosis (MDR-TB) patients enrolled for DOTS-Plus regimen at TB and Chest Disease Department from January to December 2009. Demographic details, symptoms, sputum examination and adverse drug reactions were recorded in a case record form. Patients were followed up for 24 months. The data were analysed by Fisher's exact test and paired student's 't' test. Results: Out of 130 patients, 51 (39%) were cured, 7 (5%) completed the treatment, 25 (19%) died, 30 (23%) defaulted and 17 (13%) failure. A significant increase in body weight (P < 0.0001) was observed at the end of the 24 months. Out of 89 patients with sputum culture conversion, majority (73) turned negative within first 3 months. Female gender (P < 0.05), conversion of sputum culture from positive to negative (P < 0.0001), and radiological improvement (P < 0.0001) were found to be positive predictors of a successful treatment outcome. While smoking habit (P < 0.05) and alcohol consumption (P < 0.05) were negative predictors of successful treatment outcome. Thirty five (26%) patients developed ADRs that required withdrawal of causal drug. The most common ADR was joint pain due to pyrazinamide (11) followed by neurological and psychiatric disturbances due to cycloserine (9). Conclusion: The treatment outcome of standardized regimen in MDR-TB patients was low. The long duration of treatment and defaulters are major challenges for a successful outcome.
  4,481 955 16
Identification of risk factors for carbamazepine-induced serious mucocutaneous adverse reactions: A case-control study using data from spontaneous adverse drug reaction reports
Ilma Bertulyte, Sofie Schwan, Pär Hallberg
April-June 2014, 5(2):100-138
DOI:10.4103/0976-500X.130051  PMID:24799813
Objectives: To identify risk factors other than genetic for severe carbamazepine-induced mucocutaneous reactions, that is, SJS, TEN, and exfoliative dermatitis (ED). Materials and Methods: We did a case-control study using data from the Swedish national database of spontaneously reported adverse drug reactions (ADRs). We selected all patients who had been reported from January 1, 1965 to March 31, 2010 as having experienced SJS (n = 78), TEN (n = 6), or ED (n = 8), and assessed as at least possibly related to carbamazepine. We also included diagnoses possibly representative of early signs of these serious conditions, that is, erythema multiforme (EM, n = 34) and scaly rash (n = 13). We compared data on demographics, drug treatment, and clinical features for these patients (cases, n = 139) with those from patients who had experienced any other type of ADR from carbamazepine during the same time period (controls, n = 887). Results: After adjustment for multiple comparisons, alcohol abuse was statistically significantly more common among cases than controls (34.5% vs 8.7%, odds ratio 5.5 [95% confidence interval 3.6-8.4], P = 3.14 × 10 -14 ). The same was seen for SJS and EM individually. Conclusion: Alcohol abuse is a possible risk factor for serious carbamazepine-induced mucocutaneous reactions.
  3,640 594 2
Folic acid supplementation on homocysteine levels in children taking antiepileptic drugs: A randomized controlled trial
Mathummal Cherumanalil Jeeja, Thayyil Jayakrishnan, Puthiya Veettil Narayanan, Mathur Sreedharan Vinod Kumar, Thayyil Thejus, Vadakay Purayil Anilakumari
April-June 2014, 5(2):93-99
DOI:10.4103/0976-500X.130048  PMID:24799812
Objectives: To assess the level of homocysteine (tHcy) in children taking AEDs and to study whether daily oral supplementation of folic acid for 1 month will reduce the tHcy level. Materials and Methods: This was a double-blinded, randomized control trial conducted in Institute of Maternal and Child Health, Kozhikode, India. Totally 60 children were recruited and of them, 48 were enrolled. Of these children, 32 were assigned to the experimental group and 16 to the control group. Baseline data collection and tHcy estimation were done. One mg folic acid tablets were given to the experimental group and placebo tablets to the control group for 30 days. tHcy levels were re-estimated after 1 month follow-up. Statistical significance was tested by χ2 test, and paired and unpaired t-tests, as appropriate. Correlation was tested by Pearson correlation test and P value less than 0.05 was taken as the cut-off for statistical significance. Results: Baseline plasma tHcy concentrations in both groups were comparable [11.90 (6.3) and 13.02 (2.4) μmol/l, respectively]. During the follow-up period, no increase in seizure episodes or no serious adverse reactions were noticed in either group. The reduction of tHcy in the experimental group was 1.92 μmol/l (P = 0.04) and in the control group, there was an increase of 1.05 μmol/l (P = 0.16). Conclusions: In children on AED treatment, folic acid supplementation may reduce tHcy level and thus reduce CVD risk.
  3,431 581 2
Alopecia caused by isoniazid
Ramakant Dixit, Danish Qureshi, Sunil Mathur
April-June 2014, 5(2):155-157
DOI:10.4103/0976-500X.130081  PMID:24799819
Drug-induced alopecia is a known clinical entity and mainly seen with anti-mitotic drug therapy. Alopecia during anti-tuberculosis therapy is very uncommon and previously observed with isoniazid, thiacetazone, and ethionamide. Present communication describes an additional case of isoniazid-induced alopecia in a 10-year-old male child, which was reversible after isoniazid withdrawal. Possible mechanisms of drug-induced alopecia are also briefly discussed.
  3,210 434 1
Assessment of demographics, treatment strategies, and evidence-based medicine use among diabetic and non-diabetic patients with acute coronary syndrome: A cohort study
Bhavik S Shah, Shrikalp S Deshpande
April-June 2014, 5(2):139-144
DOI:10.4103/0976-500X.130058  PMID:24799814
Objectives: To evaluate and compare clinical and epidemiological characteristics, treatment strategies, and utilization of evidence-based medicine (EBM) among coronary artery disease (CAD) patients with or without diabetes. Materials and Methods: Prospective observational cohort study from a tertiary care hospital in India among patients with CAD (myocardial infarction, unstable angina, or chronic stable angina). Data included demographic information, vital signs, personal particulars, risk factors for CAD, treatment strategies, and discharge medications. We evaluated epidemiologic characteristics and treatment strategies for diabetic and non-diabetic patients. Results: Of 1,073 patients who underwent angiography, 960 patients (30% diabetic) had CAD. Proportion of hypertensive patients was higher among diabetic patients (58 vs 35% non-diabetic, P < 0.001). Similar proportion of patients received medical management in diabetic vs non-diabetic CAD patients (35 vs 34%, P = 0.091); in diabetics the use of surgical procedure was higher (22 vs 17%, P = 0.0230) than interventional strategy (percutaneous transluminal coronary angioplasty, 43 vs 49%, P = 0.0445). Key medications (antiplatelet agents, angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB), beta-blockers, and ahtihyperlipidemic agents) were prescribed in 95, 53/12, 67, and 91% diabetic (n = 252) and 96, 51/8, 67, and 94% non-diabetic (n = 673) patients, respectively on discharge. Conclusions: Clustering of several risk factors at presentation, typically diabetes and hypertension, is common in CAD patients. Though diabetic patients are managed more conservatively, utilization of EBM for diabetic and non-diabetic patients is consistent with the recommendations.
  2,992 470 3
Tumor lysis syndrome in multiple myeloma treated with bortezomib
KM Dhanraj, Dubashi Biswajit
April-June 2014, 5(2):161-162
DOI:10.4103/0976-500X.130091  PMID:24799821
A 65 year old male diagnosed as multiple myeloma was started on bortezomib developed tumor lysis syndrome. Bortezomib induced tumor lysis is rare and suitable precautions should be considered in these patients.
  2,820 531 2
Skin rash during treatment with generic itraconazole
Antonio De Vuono, Caterina Palleria, Francesca Scicchitano, Aida Squillace, Giovambattista De Sarro, Luca Gallelli
April-June 2014, 5(2):158-160
DOI:10.4103/0976-500X.130086  PMID:24799820
Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.
  2,784 454 2
European Heart and Rhythm Association guidelines on new oral anticoagulants: A bold step forward
Vishal Sehgal, Sukhminder Jit Singh Bajwa
April-June 2014, 5(2):167-169
DOI:10.4103/0976-500X.130147  PMID:24799825
  2,766 457 1
A case of tinnitus induced by chlorpromazine in a pediatric patient
Carla Carnovale, Paolo Pellegrino, Silvia Beretta, Gian Vincenzo Zuccotti, Valentina Perrone, Stefania Antoniazzi, Marco Pozzi, Emilio Clementi, Sonia Radice
April-June 2014, 5(2):163-165
DOI:10.4103/0976-500X.130110  PMID:24799822
Chlorpromazine is a well-known antipsychotic agent that binds with a variety of receptors in the central nervous system. To date, chlorpromazine has never been associated with onset of hearing disorders and tinnitus. We report on an unexpected suspect adverse reaction to chlorpromazine that occurred in a 12-year-old boy, affected by severe generalized anxiety disorder. After treatment with chlorpromazine, the patient experienced an enhanced sensitivity to sounds accompanied by perception of noises of the buzzing or ringing type. This clinical case is of great clinical interest as chlorpromazine is not currently included among potentially ototoxic drugs.
  2,850 319 3
Why patients in pain cannot get "God's own medicine?"
Gitanjali Batmanabane
April-June 2014, 5(2):81-82
DOI:10.4103/0976-500X.130040  PMID:24799809
  2,508 479 1
Intrahepatic cholestasis in Bruton's agammaglobulinemia receiving mesalamine for co-morbid Crohn's disease
Giovanni Clemente Actis, Rinaldo Pellicano, Floriano Rosina
April-June 2014, 5(2):151-152
DOI:10.4103/0976-500X.130071  PMID:24799817
  2,364 337 2
Randomization and online databases for clinical trials
Jatinder Singh
April-June 2014, 5(2):173-174
DOI:10.4103/0976-500X.130155  PMID:24799829
  2,147 411 -
Amniotic fluid volume changes in response to frusemide induced maternal fluid shifts
K Manikandan, S Raghavan
April-June 2014, 5(2):153-154
DOI:10.4103/0976-500X.130075  PMID:24799818
Frusemide use in pregnancy is generally restricted to patients with cardiac decompensation. In the past, maternal administration of oral frusemide had been tried to identify non-functioning fetal kidneys by utilizing the diuretic effect of frusemide on the fetal kidneys. We report a case of primigravida with severe mitral stenosis presenting in pulmonary edema that received high dose of frusemide. This was associated with the development of transient oligohydramnios. We discuss the clinical significance of this observation and the possible explanations.
  2,133 295 2
Amikacin, bupivacaine, fentanyl and Kounis syndrome
Nicholas G Kounis, George N Kounis, George D Soufras
April-June 2014, 5(2):169-171
DOI:10.4103/0976-500X.130152  PMID:24799827
  1,945 338 2
Drug utilization pattern and pharmacoeconomic analysis in geriatric medical in-patients of a tertiary care hospital of India
Viral N Shah
April-June 2014, 5(2):166-166
DOI:10.4103/0976-500X.130116  PMID:24799823
  1,876 385 -
Informed Consent on Camera
Smita Sontakke, Parag Kinge
April-June 2014, 5(2):150-151
DOI:10.4103/0976-500X.130066  PMID:24799816
  1,881 309 1
Author reply
Sukhen Samanta, Sujay Samanta, Abhishek Jha
April-June 2014, 5(2):171-172
  1,510 180 -
Author reply
Manish J Barvaliya, Tejas K Patel, CB Tripathi
April-June 2014, 5(2):166-167
  1,387 221 -
Author reply
Sangeeta Bhanwra, Kaza Ahluwalia
April-June 2014, 5(2):169-169
  1,354 198 -