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Aviptadil is the emerging pharmacological therapy in ARDS. It is the injectable synthetic formulation of human vasoactive intestinal polypeptide (VIP). Oxyptadil is the first ever VIP introduced by Zuventus in the management of ARDS. With this, our goal is to provide patients with a chance to lead a healthy life.

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.