Abstract

Objectives: This study aimed to evaluate the safety and efficacy of TumsUP drops in the treatment of infantile colic in infants and toddlers.

Setting and Design: An active post-marketing surveillance study was conducted in the department of pediatrics of 4 hospitals from August 2020 to February 2021.

Material and Methods: A total of 200 patients aged two weeks to two years, with symptoms of infantile colic for >3 hours/day, occurring >3 days/week were enrolled. TumsUP (A fixed-dose combination of simethicone 40 mg, dill oil 0.005 mL, and fennel oil 0.0007 mL) oral drops were administered for 7 days. The safety of the study drug and its efficacy in infantile colic symptoms were assessed after the end of the treatment.

Results: Among 200 patients, 4 (2%) adverse events (AEs) were reported. They were mild, not related to the study drug, and resolved without sequelae. The mean crying time was reduced from 3.35±1.68 hours/day at baseline to 0.37±0.67 hours/day on day 7 (mean reduction: -2.98; 95%CI: -3.24 to -2.72, p<0.001). The mean number of daily episodes of colic reduced from 3.09±1.90 at baseline to 0.47±0.88 on day 7 (mean difference: -2.61; 95%CI: -2.90 to -2.33; p<0.001). A statistically significant (p<0.001) reduction was observed in excessive crying, fussing, sleep disturbances, clenching of fists, bending of arms and legs towards the belly, bloated tummy, redness of the face, flatulence and milk regurgitation on Day 7 as compared to the baseline. Complete remission of infantile colic was reported in 67.84% of patients after 7 days of treatment.

Conclusion: TumsUP reduced the duration and severity of infantile colic and showed good safety, efficacy and tolerability.

ABSTRACT

Background: Lactic acid bacillus spores (Bacillus coagulans) has excellent stability and shows therapeutic effects on intestinal diseases, such as acute diarrhoea, irritable bowel syndrome, antibiotic-related diarrhoea, constipation and colitis. Spores of Lactic acid bacillus resist gastric acid to reach the small intestine, where they can germinate and propagate. There is an existing misconception that antibiotics degrade the probiotics when given in conjunction.

Aim: To study the survival, germination and proliferation of Lactic acid bacillus spores in presence of Amoxicillin/Clavulanate antibiotic.

Method: ‘Augpen LB® -625’ tablet (FDC tablet of Amoxicillin 500 mg, Potassium Clavulanate 125 mg with Lactic acid bacillus 60 million spores) is dissolved in 0.1N HCl and pH 6.8 phosphate buffer. It was diluted and incubated in MRS broth and mixed with PNY agar media, followed by solidification and repeated incubation. The resulted number of colonies in each plate was counted.

Results: It was observed that 60 million spores of lactic acid bacillus present in the ‘Augpen LB® -625’ tablet produced 7.3 billion CFU at 24 hours and 51 billion CFU at 72 hours under suitable conditions mimicking human intestinal pH, which helps in intestinal colonization with the probiotics.

Conclusion: This study provides the evidence for survivability of the probiotic Lactic acid bacillus in acidic pH and its germination in presence of Amoxicillin and Clavulanate.

ABSTRACT

Acute Respiratory Distress Syndrome (ARDS) is a severe medical condition caused due to direct or indirect lung injuries with the highest rate of mortality. Aviptadil is a synthetic form of human vasoactive intestinal peptide and has been used to treat various lung inflammatory conditions, including ARDS. Aviptadil exerts an anti-cytokine effect and increases surfactant production which helps to improve the oxygenation index in ARDS patients. Our case series highlights the role of Aviptadil in the reduction of oxygen requirement and increase in PaO2:FiO2 ratio in moderate to severe ARDS patients.

Abstract

Aim: This is a post marketing surveillance carried out to assess the clinical safety and efficacy of S(-) Amlodipine in patients with hypertension.

Materials & Methods: 81 practicing physicians throughout India collaborated in the recruitment of 235 hypertensive patients over a period of 6 months. Hypertensive patients were administered S(-) Amlodipine (2.5 or 5 mg). The fall in Blood pressure was observed at the end of 30 days. Serious adverse events were also reviewed.

Results: Significant reduction was observed in the systolic and diastolic blood pressure after treatment with S(-) Amlodipine for a period of 30 days. More than 80% of the patients on S(-) Amlodipine monotherapy achieved the JNC 7 goal in standing, sitting and supine positions.

Conclusion: These results are reassuring and provide further evidence of the safety and efficacy of S(-) Amlodipine in the management of hypertension. 

ABSTRACT

Aim: To determine the Indian Practitioner's Perspective on the clinical efficacy and safety of Netilmicin (NETROMAX)

Materials & Methods: 105 practitioners, including surgeons, chest specialists, pediatricians and internal medicine specialists, throughout India collaborated in the recruitment of 202 patients over a period of 6 months. Patients with bacterial infections were administered Netilmicin (NETROMAX) as determined by the practitioner, and the practitioner's opinion on the clinical efficacy and safety were observed at the end of treatment duration.

Results: 161 patients were evaluable for efficacy of Netilmicin (NETROMAX). The most commonly employed regimen by the practitioners was administrating 300 mg Netilmicin (NETROMAX) I.V. once daily for up to 14 days. Favorable clinical response, as correlated with the practitioner's opinion, was observed in 94.4% of the patients. The opinion that Netilmicin (NETROMAX) provided excellent therapeutic, rather than only prophylactic, benefits to the infected patients was given by 57.55% of the practitioners. Netilmicin (NETROMAX) was well tolerated in the evaluable patients with only two patients (1%) complaining of adverse events.

Conclusion: Netilmicin (NETROMAX) was found to be a safe, well tolerated and useful aminoglycoside to treat a number of bacterial infections in current Indian scenario.

Abstract

Aim : The purpose of the present study was to assess the efficacy of an empiric peri-operative prophylactic regimen in prevention of surgical site infections (SSI), using cefoperazone & sulbactam combination to be followed by oral switch over therapy with cefditoren.

Material and Methods: It was an open, non comparative, multicentric, post-marketing surveillance study of 190 patients from 95 surgical centers, spread across India, undergoing various types of emergency and elective surgeries. Patients were categorized according to the type of operative wound as "clean", "clean contaminated", "contaminated" and "dirty". They were evaluated according to the Southampton scoring system.

Result: The rate of SSI in general was 7.36%. The observed rate of SSI for patients with dirty wounds was 3.92% whereas it was 3.07%, 6.38% and 25.9% for clean, clean contaminated and contaminated wounds respectively. The global wound score got reduced from 12.89 on day 1 to 2.75 on day 8 (p<0.01).

Conclusion: This is the first study clearly providing the efficacy data to reduce the incidence of SSI with the peri-operative antibiotic regimen of `Zostum', consisting of cefoperazone & Sulbactam for an average duration of 5 days followed by switch over to oral antibiotic prophylaxis with `Zostum 0', containing cefditoren. The result of the present study shows a superior outcome as compared to earlier studies in peri-operative prophylaxis conducted with single cephalosporins. In conclusion, this regimen is highly effective and can be adapted for wide varieties of surgeries.

Abstract

Objective: A post-marketing study of Netilmicin (NetromaxTM) in Indian pediatric patients to assess the safety and efficacy of the drug in various susceptible infections.

Method: The study was carried out by 129 pediatricians from across India in 10 states (Maharashtra, Delhi, Uttar Pradesh,Andhra Pradesh, Odisha, Chhattisgarh, Kamataka, MadhyaPradesh, West Bengal, and Bihar) from November 2011 to February 2012. A total number of 542 case report forms were collected and considered eligible for further analysis based upon the completeness of data. The disease profileof patients included bacteremia, septicemia (including neonatalsepsis), severe respiratory tract infections (RTI), intra-abdominalinfections (including peritonitis), kidney and genitourinarytract infections, skin and soft tissue infections, bums, bone and joint infections, wounds and perioperative infections.

Result: Demographic analysis showed the medianage of patients to be 13 months and median duration of therapy was 5 days. Intravenous route (IV) (n= 340) was preferred over intramuscular route (1M) (n=202) by the physicians. Netilmicin was administered in the therapeutic dose range depending upon the age and severity of the condition. The results revealed a favorable clinical efficacy and safety profile of Netilmicin. Clinical Improvement was observed in 98% (n=532) of patients among whom, clinical resolution (Defined as the absence of the infection) was achieved in 63% (n=343) patients. Whereas, partial improvement (defined as partial disappearance of original symptoms and no further requirement of antibiotics) was observed in 35% (n=189) of patients. Adverse events were reported in 11% of the entire study population and were mild in nature. There was no serious adverse event reported during the study period.

Conclusion: The present post-marketing study confirmed that at the given doses and duration of therapy, Netromax'?' exhibited remarkable antibacterial efficacy with no serious incidences of toxicity. Thereby giving evidence that Netromax TM treatment is safe and effective among the Indian pediatric population.

ABSTRACT

Objective: The present study was undertaken to assess the impact of intravenous iron sucrose (Feronia IV) in the treatment of iron-deficiency anemia observed in gynecological and obstetrical practice. Methods•77 practicing gynecologists and obstetricians throughout India collaborated in the recruitment of 145 women over a period of 1 year, of which 143 were analyzable cases.

Results: The overall mean rise in hemoglobin level was observed to be 2.43 gm% at the end of 4 weeks. The dose of Iron Sucrose administered ranged from 100 mg to 1050 mg. In women who received 200 mg of the drug, the mean Hb rise was found to be 2.21 ± 1.06 gm%. Highest observable rise in hemoglobin level was 5.5 gm% with 800 mg of Iron Sucrose. No serious adverse reactions were reported during the observation period.

Conclusion: Intravenous Iron sucrose is a safe and effective treatment for the rapid reversal of iron-deficiency anemia, in obstetric and gynecological settings.