Local application of Ivermectin ointment safe and effective therapy for patients with Demodex blepharitis: Study

Local application of Ivermectin ointment safe and effective therapy for patients with Demodex blepharitis suggests a study published in Graefe’s Archive for Clinical and Experimental Ophthalmology.

A study was done to evaluate the efficacy of topical ivermectin 1% ointment, for the treatment of Demodex blepharitis. A retrospective study was designed to review electronic medical records of patients seen between January 2017 and December 2022, who had a diagnosis of Demodex blepharitis, treated with topical ivermectin 1% with at least 6 months of follow-up (Centro de Ojos Quilmes, Buenos Aires, Argentina). The presence of collarettes was graded from 0 to 4. An imaging system (Keratograph) was used, to evaluate tear meniscus height (TMH), non-invasive tear break-up time (NIKBUT), and degree of conjunctival redness. In addition, the ocular surface disease index (OSDI) test was performed. Results were compared before and after ivermectin treatment, which was performed once a day for 2 months. Results: A total of 2157 patients (4314 eyes) were included. The mean age was 50.43 ± 15.3 years, and the follow-up time was 26.1 ± 8.5 months. No one discontinued treatment due to intolerance, although 14 cases (0.6 %) reported occasional discomfort. The grade of collarettes decreased with statistical significance, from 3.37 ± 0.7 to 0.1 ± 0.3 (p < 0.01), as well as conjunctival redness from 1.32 ± 0.3 to 0.94 ± 0.4 (p < 0.01) and OSDI score from 58.74 ± 17.9 to 17.1 ± 10.5 (p = 0.02). TMH and NIKBUT improved without statistical difference. Treatment with ivermectin 1% topical ointment, once daily for 2 months, was effective in reducing the presence of collarettes and in improving symptoms in patients with Demodex blepharitis.

Reference:

Valvecchia, F., Greco, L., Perrone, F. et al. Topical ivermectin ointment treatment of Demodex blepharitis: a 6-year retrospective study. Graefes Arch Clin Exp Ophthalmol 262, 1281–1288 (2024). https://doi.org/10.1007/s00417-023-06281-0

Keywords:

Local application, Ivermectin, ointment, safe, effective therapy, patients Demodex blepharitis, study, Graefe’s Archive for Clinical and Experimental Ophthalmology, Valvecchia, F., Greco, L., Perrone, Demodex, Ivermectin, Blepharitis, Ocular surface

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New AAO-HNSF guideline provides evidence-based recommendations for Age-related Hearing Loss

The American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) published the Clinical Practice Guideline: Age-Related Hearing Loss today in Otolaryngology-Head and Neck Surgery. This clinical practice guideline (CPG) sheds lights on a global public health problem affecting approximately 466 million people worldwide and identifies quality improvement opportunities and provide clinicians trustworthy, evidence-based recommendations regarding the identification and management of age-related hearing loss (ARHL) in patients 50 years and older.

“Age-related hearing loss is underdiagnosed and undertreated despite being the most common sensory deficit in the aging population. With almost 50% of the population over 75 reporting hearing loss, having a clinical practice guideline allows all clinicians to provide better healthcare to those with hearing loss based on research and best practices. Not only does this CPG provide screening recommendations and management of the hearing loss, it also educates clinicians and care partners how to communicate with those suffering from hearing loss,” said Betty S. Tsai Do, MD, the CPG Development Group Chair.

ARHL is the most common sensory disorder in the older population. Between ages of 65 to 74, one in three adults experience hearing loss. ARHL is a type of hearing loss that occurs over time as individuals age. It develops gradually and symmetrically, meaning it affects both ears similarly and is associated with various sociodemographic factors and health risks including dementia, depression, cardiovascular disease, and falls. It is caused by both genetic and environmental factors such as exposure to loud noises, medication that can harm the ears, cigarette smoking, and alcohol consumption.

This guideline presents clinicians with an evidenced-based framework, which includes 11 evidenced-based Key Action Statements (KAS), to prioritize identifying patients at risk of ARHL as well as managing it.

“I am excited to see a key action statement focusing on social determinants of health and how it impacts access and patient preferences on the management of hearing healthcare. The focus of individualized healthcare is the future of medicine, and as such, it is important that this CPG incorporated that into the recommendations,” shared Dr. Tsai Do.

The ARHL CPG recommends that all patients aged 50 and above should be screened for hearing loss because detecting hearing loss early and taking appropriate steps can help minimize the negative effects associated with untreated hearing loss.

“Our guideline development group used the AAO-HNSF methodology to create evidence-based recommendations on the management of age-related hearing loss. We hope that the CPG will be useful in improving awareness and decreasing the morbidity of untreated age-related hearing loss in an effort to improve a patient’s overall health and quality of life,” said Dr. Tsai Do.

The guideline development group (GDG) consisted of experts in otolaryngology (ear, nose, and throat), otology (ear), audiology (hearing), neurology (nervous system, including the brain), geriatrics (care of aging population) and primary care. The group also included a consumer representative, a public health expert, and staff members from the AAO-HNSF.

Reference:

Betty S. Tsai Do, Matthew L. Bush, Heather M. Weinreich, Seth R. Schwartz, Samantha Anne, Oliver F. Adunka, Kaye Bender, Teresa A. Keenan, Ana H. Kim, Denée J. Moore, Carrie L. Nieman, Catherine V. Palmer, Clinical Practice Guideline: Age-Related Hearing Loss, Otolaryngology Head & Neck Surgery, https://doi.org/10.1002/ohn.750.

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Urinary Incontinence Linked to Poor Stroke Outcomes Regardless of Severity: Study

Urinary incontinence (UI) is a common complication in stroke patients, but its impact across the spectrum of stroke severity is not well understood. A recent study aimed to assess the association between UI and health outcomes in stroke patients of varying severity, filling a gap in the existing literature. This study was published in the journal BJU International by Fry C. and colleagues.

Despite advances in stroke care, understanding the influence of UI on stroke outcomes, especially in patients with milder strokes, remains limited. Identifying predictors of poor outcomes, such as UI, is crucial for improving patient care and resource allocation.

Data were prospectively collected from the Sentinel Stroke National Audit Programme, including 1593 men and 1591 women admitted to four UK hyperacute stroke units (HASUs) from 2014 to 2016. Patients were stratified based on stroke severity using the National Institutes of Health Stroke Scale (NIHSS) scores ranging from 0 to 42. Multivariable logistic regression analysis was performed to assess the relationship between UI and various health outcomes, adjusting for confounding factors.

Key Findings:

  • Among patients with mild strokes (NIHSS scores of 0-4), those with UI had significantly higher risks of in-hospital mortality, disability at discharge, pneumonia, urinary tract infection, prolonged hospital stay, palliative care by discharge, and discharge to care home compared to those without UI.

  • Similar associations were observed in patients with moderate strokes (NIHSS scores of 5-15), with UI patients being at greater risk for poor outcomes, except for palliative care and activity of daily living (ADL) support.

  • In patients with the most severe strokes (NIHSS scores of 16-48), UI was still associated with poor outcomes, although the odds ratios decreased as stroke severity increased.

The study highlights UI as a significant predictor of poor short-term outcomes in stroke patients, irrespective of stroke severity. Healthcare professionals should consider UI as an indicator of increased risk and tailor interventions accordingly to improve patient outcomes. This research provides valuable insights for identifying at-risk individuals and implementing targeted interventions in stroke care.

Reference:

Fry, C. H., Fluck, A., Affley, B., Kakar, P., Sharma, P., Fluck, D., & Han, T. S. Urinary incontinence indicates mortality, disability, and infections in hospitalised stroke patients. BJU International,2024. https://doi.org/10.1111/bju.16320

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Late Preterm Steroids Not Linked to Adverse Neurodevelopmental Outcomes at Age 6: JAMA

Researchers have found that the administration of late preterm corticosteroids, while originally beneficial in improving short-term neonatal respiratory outcomes, did not negatively impact neurodevelopmental outcomes in children at the age of 6 years or older. This finding stems from a follow-up study to the Antenatal Late Preterm Steroids (ALPS) trial, which initially revealed increased rates of neonatal hypoglycemia following antenatal betamethasone at 34 to 36 weeks. This study was published in JAMA Network by Cynthia Gyamfi-Bannerman and colleagues.

The ALPS trial previously demonstrated that antenatal betamethasone administration between 34 and 36 weeks reduced neonatal respiratory morbidity. However, this positive outcome was coupled with an increased risk of neonatal hypoglycemia. The long-term effects of late preterm steroids on childhood neurodevelopmental outcomes remained unclear until this follow-up study.

This prospective follow-up study evaluated children aged 6 years or older whose birthing parent had enrolled in the original ALPS trial. The study included 13 centers from the Maternal-Fetal Medicine Units (MFMU) Network. The follow-up period spanned from 2017 to 2022.

The study focused on the administration of 12 milligrams of intramuscular betamethasone, administered twice 24 hours apart. The primary outcome was a General Conceptual Ability score less than 85 (−1 SD) on the Differential Ability Scales, 2nd Edition (DAS-II). Secondary outcomes included the Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores.

The key findings of the study were:

  • Of 2,831 eligible children, 1,026 enrolled and 949 (479 betamethasone, 470 placebo) completed the DAS-II at a median age of 7 years (IQR, 6.6-7.6 years).

  • A general conceptual ability score less than 85 occurred in 17.1% of the betamethasone group and 18.5% of the placebo group. This difference was not statistically significant (adjusted relative risk, 0.94; 95% CI, 0.73-1.22).

  • The study found no differences in secondary outcomes, including Gross Motor Function Classification System level and Social Responsiveness Scale and Child Behavior Checklist scores, between the betamethasone and placebo groups.

  • Sensitivity analyses using inverse probability weighting or assigning outcomes to children lost to follow-up did not reveal differences between the groups.

In conclusion, the follow-up study of the ALPS trial suggests that antenatal corticosteroids administered to individuals at risk of late preterm delivery do not pose adverse childhood neurodevelopmental outcomes at age 6 years or older. This finding supports the continued use of antenatal betamethasone for improving short-term neonatal respiratory outcomes without causing long-term neurodevelopmental harm.

Reference:

Gyamfi-Bannerman, C., Clifton, R. G., Tita, A. T. N., Blackwell, S. C., Longo, M., de Voest, J. A., O’Shea, T. M., Bousleiman, S. Z., Ortiz, F., Rouse, D. J., Metz, T. D., Saade, G. R., Rood, K. M., Heyborne, K. D., Thorp, J. M., Jr, Swamy, G. K., Grobman, W. A., Gibson, K. S., El-Sayed, Y. Y., … Eunice Kennedy Shriver Maternal-Fetal Medicine Units Network. (2024). Neurodevelopmental outcomes after late preterm antenatal corticosteroids: The ALPS follow-up study. JAMA: The Journal of the American Medical Association. https://doi.org/10.1001/jama.2024.4303

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Self-Administered Acupressure Eases Knee Osteoarthritis Pain, finds JAMA Study

Researchers have found that self-administered acupressure can provide some relief from symptoms of knee osteoarthritis (OA), according to a randomized trial conducted in Hong Kong. The trial compared patients who performed acupressure on themselves twice daily with those who received an educational program on knee health. Patients performing the acupressure experienced reductions in pain scores compared to controls, suggesting a potential low-cost alternative or adjunct to traditional treatments for knee OA.

Knee osteoarthritis is a common condition among older adults, causing pain, stiffness, and limited mobility. While antiplatelet therapy is recommended for acute ischemic stroke, new approaches such as acupressure are being explored to provide additional symptom relief. Acupressure, a practice based on traditional Chinese medicine, involves applying pressure to specific points on the body. This study was published in JAMA Network Open by Yeung and colleagues.

The study included 314 patients aged 50 and older, who were randomly assigned to perform twice-daily acupressure on themselves or receive an educational program on knee health. The acupressure group targeted eight recognized acupressure points, while the education group received information on exercise, weight loss, drug treatments, and traditional Chinese therapeutic diets.

The primary outcome was self-reported pain scores on a 10-point scale after 12 weeks. Secondary outcomes included changes in the Western Ontario-McMaster Universities Osteoarthritis Index (WOMAC), Short Form-6 Dimensions (SF-6D), Timed Up and Go results, and fast gait speed.

The key findings of the study were:

  • The acupressure group experienced a reduction in pain scores with a mean difference of -0.54 points after 12 weeks (95% CI -0.97 to -0.10 points, P=0.02).

  • SF-6D utility scores improved significantly in the acupressure group compared to the control group (mean difference 0.03 points, 95% CI 0.003-0.01).

  • Other measures, such as WOMAC and Timed Up and Go results, did not differ significantly between groups.

  • Both groups showed improvements from baseline in most secondary measures.

The findings suggest that self-administered acupressure may offer a viable alternative or adjunctive treatment for knee osteoarthritis, providing moderate relief in symptoms such as pain and quality of life measures. Patients showed high acceptability and compliance with the self-administered acupressure training program, highlighting the potential for widespread adoption.

The study supports the use of self-administered acupressure as a cost-effective option for managing knee osteoarthritis. While limitations such as unblinded design and potential cultural predispositions may affect the results, acupressure remains a promising alternative for symptom relief in knee osteoarthritis.

Reference:

Yeung, W.-F., Chen, S.-C., Cheung, D. S. T., Wong, C. K.-H., Chong, T. C., Ho, Y. S., Suen, L. K. P., Ho, L. M., & Lao, L. (2024). Self-administered acupressure for probable knee osteoarthritis in middle-aged and older adults: A randomized clinical trial. JAMA Network Open, 7(4), e245830. https://doi.org/10.1001/jamanetworkopen.2024.5830

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Ultrasound-guided paravertebral block vs. erector spinae plane block for postoperative analgesia following percutaneous nephrolithotomy: A randomized Study

Opioid therapy is often required after percutaneous nephrolithotomy (PCNL) due to the usual postoperative pain and discomfort. For PCNL surgery, postoperative analgesia is achieved by using both general anaesthesia (GA) and regional anaesthesia procedures such as paravertebral block (PVB), intercostal nerve block, erector spinae plane block (ESPB), and epidural block. A recent research comparing the length of analgesia after ultrasonography-guided (USG) PVB and ESPB in patients having PCNL surgery was published.

In this research, sixty PCNL patients were randomly assigned to one of two groups after general anaesthesia: Group P (n = 30, which underwent ultrasound-guided [USG] PVB) or Group E (n = 30, which received USG ESPB). Blocks were applied using 20 ml of 0.25% bupivacaine at the T10 level on the surgical site. When the procedure was finished, the trachea was extubated. The length of analgesia was the main result; postoperative pain levels, analgesic use, ease of block performance, block time, and complications between the two groups were the secondary outcomes. Categorical data were evaluated using Pearson’s Chi-square test, while continuous variables were compared using an independent sample t-test.

The demographic characteristics of the two groups were similar. For Group P, the mean (standard deviation [SD]) time of initial rescue analgesia was 16.6 (20.4) (95% confidence interval [CI]: 9.02–20.32) h, while for Group E, it was 16.3 (21.8) (95% CI: 8.17–24.51) h (P = 0.95). The number of analgesic doses administered and the postoperative pain assessments were similar across the groups (P > 0.05). Comparing the duration of PVB with ESPB, the former required significantly more time (P = 0.01).

The results of the study showed that although PVB and ESPB were both equally effective for providing postoperative analgesia to patients after PCNL surgery, ESPB was much faster and simpler to administer. According to a number of writers, practitioners see PVB as a difficult procedure that has a high learning curve and a chance of complications like pneumothorax. According to a national study conducted in France among anesthesiologists, the primary obstacles to the widespread use of PVB are technical in nature, such as complexity, danger, and time commitment. The author came to the realisation that although accessing the PVB space is technically very difficult, USG identifying of the space is easy. Prior research has shown that mastering PVB has a steeper learning curve than mastering ESPB. The authors conclude that whereas ESPB is much faster and simpler to do than USG PVB, both techniques are similarly effective and may be used as postoperative analgesia for PCNL surgery.

Reference –

Khot, Prajna Pandit; Desai, Sameer N.; Bale, Sushmitha P.; Aradhya, Bhuvanesh N.1. Comparison of ultrasound-guided paravertebral block versus erector spinae plane block for postoperative analgesia after percutaneous nephrolithotomy – A randomised, double-blind, controlled study. Indian Journal of Anaesthesia 67(12):p 1110-1115, December 2023. | DOI: 10.4103/ija.ija_355_23

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Air pollution and depression linked with heart disease deaths in middle-aged adults, claims study

A study in more than 3,000 US counties, with 315 million residents, has suggested that air pollution is linked with stress and depression, putting under-65-year-olds at increased risk of dying from cardiovascular disease. The research is presented today at ESC Preventive Cardiology 2024, a scientific congress of the European Society of Cardiology (ESC).

“Our study indicates that the air we breathe affects our mental well-being, which in turn impacts heart health,” said study lead author Dr. Shady Abohashem of Harvard Medical School, Boston, US.

According to the World Health Organization, air pollution is estimated to have caused 4.2 million premature deaths worldwide in 2019. Mental illness has also been linked with premature death. This study examined whether air pollution and poor mental health are interrelated and have a joint impact on death from cardiovascular disease.

The study focused on particles less than 2.5 micrometres in diameter, also referred to as fine particles or PM2.5. They come from vehicle exhaust fumes, power plant combustion, and burning wood, and present the highest health risk. To conduct the study, county-level data on annual PM2.5 levels were obtained from the Centers for Disease Control and Prevention (CDC). PM2.5 exposure was categorised as high or low according to World Health Organization (WHO) standards. The researchers gathered data on the average number of days (age-standardised) that county residents experienced mental health issues-including stress, depression, and emotional problems-from the CDC. Each county was then categorised into three groups based on these numbers. Counties in the top third reported the most days of poor mental health (PMH). Age-adjusted premature cardiovascular mortality rates (under 65 years of age) per county, were obtained from the CDC. County characteristics were sourced from the County Health Rankings project.

The study included 3,047 US counties, representing 315,720,938 residents (with over 207 million aged 20 to 64 years and 50% females) in 2013. Between 2013 and 2019, some 1,079,656 (0.34%) participants died from cardiovascular disease before the age of 65 years. The researchers analysed the associations between pollution, mental health, and premature cardiovascular mortality after adjusting for factors that could influence the relationships.

Counties with dirty air (high PM2.5 concentrations) were 10% more likely to report high levels of PMH days compared to counties with clean air (low PM2.5 concentrations). That risk was markedly greater in counties with a high prevalence of minority groups or poverty. The link between PMH and premature cardiovascular mortality was strongest in counties with higher levels (above WHO recommended levels: ≥10 µm2) of air pollution. In these counties, higher levels of PMH were associated with a three-fold increase in premature cardiovascular mortality compared to lower PMH levels. Further, one-third of the pollution-related risk of premature cardiovascular deaths was explained by increased burden of PMH.

Dr. Abohashem said: “Our results reveal a dual threat from air pollution: it not only worsens mental health but also significantly amplifies the risk of heart-related deaths associated with poor mental health. Public health strategies are urgently needed to address both air quality and mental wellbeing in order to preserve cardiovascular health.”

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Fentanyl has statistically significantly longer recovery time than sufentanil among children after inguinal hernia repair: Study

Inguinal hernias are reported to occur in 1-5% of the pediatric population, and surgical repair is a common procedure in children. With advancements in minimally invasive surgery, the laparoscopic approach is now the most common procedure for repairing inguinal hernias.

A study led by Wen Chen et al. and colleagues, published in BMC Surgery, concluded that Anesthesia induction with fentanyl or sufentanil is associated with different postoperative recovery times following laparoscopic inguinal hernia repair in children belonging to other age groups.
Researchers conducted a pilot randomized clinical trial from February to December 2022 to evaluate postoperative recovery times in children undergoing laparoscopic inguinal hernia repair with anaesthesia induced by fentanyl compared to sufentanil. There were two age groups, 2-6 and 6-12 years old, and children were randomly assigned into either the fentanyl (2 µg/kg) or sufentanil (0.2 µg/kg) group. Postoperative recovery time was the primary outcome, while secondary outcomes included surgical and anaesthetic durations, intubation duration, and intraoperative hemorrhage.
Key findings from the study are:
• Each group had 75 children, with a total of 300 children.
• Children in the 2-6-year-old group receiving fentanyl had shorter postoperative recovery times compared to those receiving sufentanil.
• On the contrary, children in the 6–12-year-old group who received fentanyl had longer postoperative recovery times than children who received sufentanil.
• There were comparable Baseline characteristics and secondary outcomes between the two groups.
In this study, we showed that fentanyl and sufentanil resulted in different postoperative recovery times in pediatric patients in other age groups, they said.
This is the first study to compare fentanyl and sufentanil in different age groups of children. The findings of our study highlighted that different analgesic medications should be considered in children of various ages.
The main limitations were the small sample size in a single research center and the exclusion of pain intensity or potential side effects from the medications.
Reference:
Chen, W., Guoyang, H., Yu, H. et al. Comparisons of fentanyl and sufentanil on recovery time after inguinal hernia repair in children: a randomized clinical trial. BMC Surg 24, 55 (2024). https://doi.org/10.1186/s12893-024-02346-x

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SC slams IMA, allows Patanjali to file contempt plea against doctors’ body chief

New Delhi: The Supreme Court has permitted the filing of a contempt application against the Indian Medical Association (IMA) chief for allegedly making disparaging remarks against the judiciary. The apex court turned its attention to IMA chief while hearing the contempt case against Patanjali Ayurved founders Baba Ramdev and Acharya Balkrishna on Tuesday.

Appearing before a bench of Justices Hima Kohli and Ahsanuddin Amanullah, Senior Advocate Mukul Rohatgi, representing Patanjali, highlighted an interview given by IMA President Dr RV Ashokan to the press the previous day. In the interview, the IMA chief reportedly criticized the Supreme Court’s observations regarding IMA’s response to complaints of unethical practices by doctors.

Describing the interview as ‘disturbing’, Rohatgi quoted the IMA President’s comments where he termed the Supreme Court’s observations as “unfortunate” and “vague.” The bench requested Rohatgi to submit the interview for the record.

“He (the IMA President) says why has the Court turned its fingers at us…The court is making vague and irrelevant statements…The Court is taking a broadside at us…We have done a great job…Our people have died…This is direct interference with the course of proceedings in this case…he says that these are unfortunate comments…demoralizing private doctors. What is this?”, Rohatgi said.

Also Read: Is Your Apology The Same Size As Your Advertisement? SC Slams Baba Ramdev

In response to the submission, Justice Ahsanuddin Amanullah remarked, as quoted by Livelaw;

“This is more serious than what we have been doing till now…After all that is happening, you [IMA] do this. Be prepared for more serious consequences.”

Justice Hima Kohli, addressing IMA’s counsel, also commented;

“Self-certification does not help anybody. If what has been said by the other side is correct, you have not covered yourself with glory. There is something you will have to say to explain how would you decide which way we should be…”.

The bench recorded in its order;

“Mr. Rohatgi has also sought to bring attention of this court to an interview given by the current President of petitioner No.1 (IMA), which it is his submission is critical of this Court’s order dated April 23. He seeks leave to file a copy of the publication carrying the interview. Needful shall be done within 2 days.”

The Court was addressing a petition filed by the IMA, initiating a contempt case against Patanjali Ayurved, its MD Acharya Balkrishna, and Baba Ramdev for publishing misleading medical advertisements in violation of a court undertaking.

Medical Dialogues had earlier reported that issuing a caution to the petitioner medical association about the complaints of unethical practices by allopathic doctors, the Supreme Court bench of Justices Hima Kohli and Ahsanuddin Amanullah observed, “The petitioner (IMA) needs to put its own house in order regarding alleged unethical acts of the organisation where medicines are prescribed, which is expensive and unnecessary.”

The apex court said that wherever there is a misuse of the position by the IMA to prescribe expensive medicines and the line of treatment, it needs “closer examination”.

It further told IMA that while it is pointing fingers at Patanjali, four fingers are pointing back at them. The bench asked,Your (IMA) doctors also endorsing medicines in the allopathic field, if that’s happening, why should we not turn the beam at you (IMA)?”

“Your (IMA) members also endorsed such products… your members are prescribing medicines,” the bench said, while hearing the case filed by IMA against an alleged smear campaign carried out by Patanjali Ayurveda Ltd and its founders against the COVID-19 vaccination drive and modern medicine

On April 16, the apex court had warned Ramdev and Balkrishna against any attempt to “degrade allopathy” and permitted them to tender a “public apology and show contrition” within a week in the contempt proceedings in the misleading advertisements case against Patanjali Ayurved Ltd.

Earlier, on two occasions, they tendered unconditional and unqualified apology with regard to the issue of advertisement. However, the bench refused to accept their affidavits, tendering apologies, and slammed them for the misleading advertisements carried out by them and the company. The apex court also slammed the Uttarakhand government for being “hand-in-glove” with errant licencing officers who failed to take action against Patanjali for publishing misleading advertisements.

The top court had earlier also directed Patanjali not to publish false advertisements in the future and later issued contempt of court notices to the company, Ramdev and Balkrishna.

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Alkem Laboratories Gets CDSCO Panel Nod to Study Amoxicillin,Clavulanate Powder for reconstitution into suspension

New Delhi: Reviewing the revised Phase IV clinical trial (CT) protocol of antimicrobial drug Amoxicillin Trihydrate plus Potassium Clavulanate powder for reconstitution into suspension presented by the drug major Alkem Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the Phase IV CT of the proposed FDC.

This came after the drug major Alkem Laboratories presented the revised Phase-IV CT protocol before the committee. Phase-IV CT is a type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market.

Amoxicillin trihydrate is a hydrate that is the trihydrate form of amoxicillin; a semisynthetic antibiotic used either alone or in combination with potassium clavulanate.

Amoxicillin trihydrate treats bacterial infections like chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It’s often prescribed for children, to treat ear infections and chest infections.

Amoxicillin is a penicillin derivative used for the treatment of infections caused by gram-positive bacteria, in particular streptococcal bacteria causing upper respiratory tract infections. Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin-binding proteins. Penicillin-binding proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin-binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.

Clavulanic acid is a medication that can be used in conjunction with amoxicillin to manage and treat bacterial infections, specifically bacteria that are beta-lactamase producers. It is in the beta-lactamase inhibitor class of medications.

Potassium Clavulanate is used in the treatment of bacterial infections. Potassium Clavulanate is a beta-lactamase inhibitor. It works by blocking an enzyme (beta-lactamase) produced by bacteria to inactivate antibiotics. This reduces resistance and enhances the activity of antibiotics against bacteria.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the revised Phase IV CT protocol of the FDC Amoxicillin Trihydrate plus Potassium Clavulanate powder for reconstitution into suspension.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase-IV CT as per the presented protocol.

Accordingly, the expert panel suggested that the firm should submit a Phase-IV CT report for further review by the committee.

Also Read:Novo Nordisk Gets CDSCO Panel Nod to Study new medicine NNC0519-0130

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