doxylamine/pyridoxine / Generic mfg. - LARVOL DELTA

The Pharmacological and Clinical Roles of Antiemetics: A Narrative Review. (PubMed, Cureus) - "The present investigation reviews different classes of antiemetics and specific clinical uses for each based on pharmacological action. In addition, a few emerging treatment options are discussed, including cannabinoids, vitamin B6 (pyridoxine), and combination formulations such as Diclegis (doxylamine-pyridoxine), prompting avenues for future roles in the management of emesis."

Journal • Review • Gastroenterology • Gastrointestinal Disorder

Assessing the approaches to nausea and vomiting in pregnancy: insights from a nationwide survey of Italian gynecologists (PURITY light). (PubMed, Front Med (Lausanne)) - "54.78% prescribed medication in mild cases, mainly the doxylamine/pyridoxine combination (64.97%)...Many physicians treat only severe cases of NVP, perceiving it as a transient discomfort, which may lead to poor management. Balanced care is needed to improve the quality of life for pregnant women with NVP."

Journal • Rare Diseases

Changes in doxylamine-pyridoxine dispensation in Ontario following media attention: Time-series analysis. (PubMed, Can Fam Physician) - "Despite nationwide media attention questioning the efficacy of doxylamine-pyridoxine in early 2018, trends in dispensation rates of doxylamine-pyridoxine were only modestly affected and only in Ontario. Within Ontario, a small but significant reduction in doxylamine-pyridoxine dispensations was noted based on prescriptions from family physicians or general practitioners but not based on those written by obstetrician-gynecologists. Factors associated with the ongoing use of doxylamine-pyridoxine despite evidence of lack of benefit require further research."

Journal • Obstetrics

AGA Clinical Practice Update on Pregnancy-Related Gastrointestinal and Liver Disease: Expert Review. (PubMed, Gastroenterology) - "In addition to standard diet and lifestyle measures, stepwise treatment consists of symptom control with vitamin B6 and doxylamine, hydration, and adequate nutrition; ondansetron, metoclopramide, promethazine, and intravenous glucocorticoids may be required in moderate to severe cases...Treatment options include dietary fiber, lactulose, and polyethylene glycol-based laxatives...Biologic agents should be continued throughout pregnancy and the postpartum period; use of methotrexate, thalidomide, and ozanimod must be stopped at least 6 months before conception...Treatment should be offered with oral ursodeoxycholic acid in a total daily dose of 10-15 mg/kg...Daily aspirin prophylaxis for patients at risk for pre-eclampsia or hemolysis, elevated liver enzymes, and low platelets syndrome is advised beginning at week 12 of gestation...Patients not on treatment but with a serum hepatitis B virus DNA level >200,000 IU/mL during the third trimester of pregnancy should be..."

Clinical guideline • Journal • Review • Cholestasis • Constipation • Dermatology • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Gynecology • Hematological Disorders • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Liver Cirrhosis • Pancreatitis • Pruritus • Rare Diseases • Transplantation

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ May 2024 | Trial primary completion date: Dec 2024 ➔ May 2024

Trial completion • Trial completion date • Trial primary completion date

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Valenta Pharm JSC

New P1 trial

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy. (PubMed, Ann Intern Med) - No abstract available

Journal

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy. (PubMed, Ann Intern Med) - No abstract available

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Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy. (PubMed, Ann Intern Med) - No abstract available

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Therapeutic Implications of Acutaping on Nausea and Vomiting During Pregnancy (clinicaltrials.gov) - P=N/A | N=27 | Completed | Sponsor: Kafrelsheikh University

New trial

Nausea and Vomiting of Pregnancy and its Management with the Dual-Release Formulation of Doxylamine and Pyridoxine. (PubMed, Geburtshilfe Frauenheilkd) - "Hence, the dual-release formulation can improve the quality of life of pregnant women suffering from NVP. Additionally, large epidemiological trials have shown no increased risk of adverse effects to newborns, demonstrating that its use is not teratogenic."

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The Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum (Green-top Guideline No. 69). (PubMed, BJOG) - "[Grade A] There are safety and efficacy data for first line antiemetics such as anti (H1) histamines, phenothiazines and doxylamine/pyridoxine (Xonvea®) and they should be prescribed initially when required for NVP and HG (Appendix III). [Grade A] There is evidence that ondansetron is safe and effective...[Grade B] Metoclopramide is safe and effective and can be used alone or in combination with other antiemetics...[Grade D] All therapeutic measures should have been tried before considering termination of pregnancy. [Grade C]."

Journal • Rare Diseases

Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers (clinicaltrials.gov) - P=N/A | N=28 | Completed | Sponsor: Valenta Pharm JSC | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Sep 2022 | Trial primary completion date: Dec 2022 ➔ Sep 2022

Trial completion • Trial completion date • Trial primary completion date

"However, in 2019, @CFPJournal published a rather 'interesting' review of Xonvea https://t.co/XQHhBo0HIQ" (@pash22)

Review

"Xonvea is not exactly virgin white. It is actually an ancient drug w/ a long history which was voluntarily withdrawn in 1983 by Merrell Dow, citing litigation burdens and adverse publicity affecting the product." (@pash22)

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial. (PubMed, Ann Intern Med) - P3 | "The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone. The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team."

Clinical • Journal • Small for Gestational Age

Bioavailability of Cariban Capsules: A Modified-Release Fixed-Dose Combination of Doxylamine and Pyridoxine to Relieve Nausea and Vomiting During Pregnancy. (PubMed, Drugs R D) - "Cariban behaves as a prolonged-release formulation, which correlates with rapid absorption and arising of the actives in the plasma, but also long-lasting and sustained bioavailability, especially when administered following the complete posology. These results would underlie its demonstrated efficacy to relieve nausea and vomiting of pregnancy (NVP) under clinical settings."

Journal

In utero exposure to the antiemetic Bendectin linked to the occurrence of colorectal cancer 35 to 45 years later? [Google Translation] (Medscape) - "'If these results are real, I'm not sure they are actionable or useful, given that current recommendations call for screening to begin at age 45, which would encompass all individuals who have been exposed to the drug. Bendectin in utero until 1976,' said Dr. Venook."

Media quote

In utero exposure to anti-emetic and risk of adult-onset colorectal cancer. (PubMed, JNCI Cancer Spectr) - "Higher risk of CRC in offspring exposed in utero may be driven by dicyclomine contained in the three-part formulation of Bendectin used during the 1960s. Experimental studies are needed to clarify these findings and identify mechanisms of risk."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

Reply Letter - to Urso et al "Comment on: Comparative dissolution profiles of two anti-emetic delayed release dosage forms of doxylamine and pyridoxine: Xonvea® tablets vs. Cariban® capsules". (PubMed, Eur Rev Med Pharmacol Sci) - No abstract available

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Comment on: Comparative dissolution profiles of two anti-emetic delayed-release dosage forms of doxylamine and pyridoxine: Xonvea® tablets vs. Cariban® capsules. (PubMed, Eur Rev Med Pharmacol Sci) - No abstract available

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Patterns of antiemetic medication use during pregnancy: A multi-country retrospective cohort study. (PubMed, PLoS One) - "In this large cohort study, we observed an overall increase in antiemetic use during pregnancy, and patterns of use varied across jurisdictions. Continued monitoring of antiemetic use and further research are warranted to better understand the reasons for differences in use of these medications and to assess their benefit-risk profile in this population."

Journal • Retrospective data

Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers (clinicaltrials.gov) - P=N/A | N=28 | Recruiting | Sponsor: Valenta Pharm JSC

New trial

Chemometric Quality Assessment of Doxylamine Succinate with Its Degradation product; Implementation of Two Predictive Models on UV-Spectrophotometric Data of Anti-emetic binary Mixture. (PubMed, J AOAC Int) - "The study of drug breakdown pathways is very important nowadays. So, even in the presence of degradation and extreme spectral overlapping, the suggested PLS and PCR spectrophotometric approaches were able to identify PYR and DOX."

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Comparative dissolution profiles of two anti-emetic delayed release dosage forms of doxylamine and pyridoxine: Xonvea® tablets vs. Cariban® capsules. (PubMed, Eur Rev Med Pharmacol Sci) - "At pH 6.8, complete and faster release of the fixed dose combination for Xonvea® gastro-resistant tablets compared to Cariban® capsules could possibly explain the greater Cmax observed in vivo for the tablet's formulation. This could translate into faster onset of action and relief of nausea for pregnant women taking the tablets vs. the capsules."

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