Evaluation of Effectiveness of Doxycycline as Empirical Therapy for Treatment in Acute Undifferentiated Febrile Illnesses in Routine Clinical Practice: A Retrospective, EMR-based, Real-world Study

Background: Tetracyclines, in particular doxycycline, are recommended for the treatment of patients with acute undifferentiated febrile illness (AUFI); however, real-world studies are scarce. Methods: This retrospective, multicenter, observational study reviewed electronic medical records (April 2018 to March 2021) of adult patients (outpatient and inpatient departments [OPD and IPD]) with AUFI, treated with doxycycline monotherapy (doxycycline group) or doxycycline in combination with other antimicrobials (combination therapy group), from 7 tertiary hospitals and clinics in India. Results: Overall, 473 patients were included; 73.8% and 26.2% patients were prescribed doxycycline alone or in combination with other antimicrobials, respectively. Defervescence was achieved in 65.6% and 57.3% patients, respectively at the second (8-14 days) follow-up visit. Clinical cure rate for symptomatic resolution varied between 89.6% and 100% in OPD settings. Time taken from treatment initiation to defervescence was 3.51 ± 3.16 days for the doxycycline group and 3.46 ± 3.07 days for the combination therapy group. Both groups showed improvements in body temperature in OPD settings (84.2% and 84.5%) as well as IPD settings (97.4% and 94.1%). Adverse events in OPD patients in both groups were nausea (7.8% and 8.7%), anorexia (1.6% and 33.0%) and dyspepsia (1.6% and 67.9%). Conclusion: Doxycycline appears to be a promising candidate for treating patients with AUFI due to its demonstrated real-world effectiveness and safety profile

Narrative Review of Nimesulide in Adults: Current Scenario

Nimesulide, a nonsteroidal anti-inflammatory drug (NSAID), has been used as an effective treatment regimen for patients aged >12 years for fever, acute pain, acute tendinitis, osteoarthritis and dysmenorrhea. It is reported to be a superior antipyretic and anti-inflammatory drug than paracetamol and aspirin, respectively, and is equal to any of the NSAIDs alone in terms of analgesia. This paper reviews the current scenario of nimesulide in adult patients, concerning clinical evidence, use in special population and expert opinion. Overall, in comparison to other NSAIDs, including coxibs, nimesulide has a promising overall efficacy, safety and tolerability profile, as well as a satisfactory benefit/risk evaluation

In-Vitro Comparative Study of Levocetirizine Dihydrochloride and Montelukast Sodium Release Profiles in Xyzal M Suspension and Other Marketed Syrup Formulations

Objectives: In-vitro comparative analysis of the release profile of levocetirizine dihydrochloride and montelukast sodium in Xyzal M Suspension and three commercially available syrup formulations. Method: The active components and their impurities were initially assayed in all formulations using a validated HPLC method. The enantiomeric impurities of montelukast sodium in different pH media were determined using the HPLC method specified in the United State Pharmacopoeia (USP) monograph. Additionally, dissolution studies and the soluble fractions of the components were evaluated in pH media that mimic the conditions of the gastrointestinal tract. The particle size was also analyzed using microscopic analysis. All parameters were examined in fresh, stressed, and aged samples of each formulation.   Results: The assay results indicate the claimed potency of formulations. The total and enantiomeric impurities meet the limits set by the Indian Pharmacopoeia (<2%) and USP monograph (<0.2%), respectively. The particle size analysis demonstrated that montelukast remained suspended throughout the Xyzal M suspension. Levocetirizine in all formulations exhibited a soluble fraction of >70% after 1 and 24 hours in various pH media. For montelukast, the soluble fraction exceeded 50% in all syrup formulations. However, in Xyzal M suspension, montelukast was found to be 100% insoluble in all pH media after 1 and 24 hours, except in simulated intestinal fluid (~40-45%) after 24 hours. The absence of S-enantiomer, even in simulated intestinal fluid, indicates its presence in the pharmacologically active form.   Conclusion: Xyzal M suspension is a promising dosage formulation for achieving desired pharmacological action, outperforming the syrup formulations. Keywords: Levocetirizine dihydrochloride, Montelukast sodium, Release profile, Suspension, Syrup, S-enantiome

Effectiveness of levocetirizine in treating allergic rhinitis while retaining work efficiency

The manifestation and severity of Allergic rhinitis symptoms show diurnal variation which negatively impacts the patient’s quality of life, day-to-day activities, and productivity at the workplace. The symptoms worsen at night or early morning and therefore administration of levocetirizine towards evening may be more acceptable. Consequently, the present study evaluated the effectiveness of evening Levocetirizine administration on 24-hour symptom control, Physical and mental health, and daytime somnolence in patients with allergic rhinitis the study was a prospective, open-labeled, single-arm, two-center, observational study among patients with allergic rhinitis. Levocetirizine was prescribed as 5 mg or 10 mg once a day evening oral dose for at least 7 days before sleep. The 24-hour total nasal symptom scores (TNSS) for self-reported signs and symptoms of allergic rhinitis were recorded. Additionally, study evaluations included the SF-12 scale (Quality of Life), Stanford Sleepiness Scale (degree of sleepiness), and work productivity and activity impairment (WPAI) questionnaires. These evaluations were performed at baseline (Day 0) and at scheduled intervals of Day 1 (24-hour), Day 3, and Day 7. Results demonstrated that evening administration of Levocetirizine facilitates 24-hour symptom control while having no significant effect on daytime somnolence, daily activities, and the work productivity of patients

Role of <i>Lactobacillus reuteri</i> <i>DSM 17938</i> on Crying Time Reduction in Infantile Colic and Its Impact on Maternal Depression: A Real-Life Clinic-Based Study

Background: Infantile colic is characterized by prolonged periods of inconsolable, incessant crying and persistent fussing in an otherwise healthy infant. It is a self-limiting condition, but causes significant stress to mothers. AIM: To observe the role of Lactobacillus reuteriDSM 17938 in reducing crying time in colicky infants in routine clinical practice. Methods: This was a prospective observational multicentric clinic-based study. Each practitioner included approximately 30 infants L. reuteri DSM 17938 for a period of 21 days. There were four physical consultations and two telephonic consultations. The parents were given a daily diary to record the duration of crying and fussing episodes and a questionnaire was administered during the consultations. Results: A total of 120 infants with a mean age of 56.9 ± 34.2 days were included in this 28-day study. The mean crying time as reported by the parents in the subject diary reduced from 248.2 ± 101.2 min, 95% CI: 229.45, 266.94 at baseline to 45.6 ± 79.1 min 95% CI: 31.02, 60.31 at study end (P L. reuteri DSM 17938 was associated with a significant reduction in crying time in colicky infants, and showed improvement in maternal depression