• Sufentanil, sold under the brand names Dsuvia and Sufenta, is a synthetic opioid analgesic drug approximately 5 to 10 times as potent as its parent drug, fentanyl, and 500 times as potent as morphine. (wikipedia.org)
  • It is available as a sublingual tablet under the trade name Dsuvia. (wikipedia.org)
  • In 2018, the Food and Drug Administration (FDA) approved Dsuvia, a sublingual tablet form of the drug, that was developed in a collaboration between AcelRx Pharmaceuticals and the United States Department of Defense for use in battlefield settings where intravenous (IV) treatments may not be readily available. (wikipedia.org)
  • Dsuvia is a tablet that would be used in hospital settings only. (healthline.com)
  • In November of 2018, its lead product candidate DSUVIA® (sufentanil sublingual tablet 30 mcg) was approved by the U.S. Food and Drug Administration. (asra.com)
  • The Company's product candidates, DSUVIA™ (known as ARX-04 outside of the United States) and are designed to deliver sufentanil, a strong opioid analgesic, via a non-invasive, sublingual formulation in medical supervised settings. (chemical.report)
  • DSUVIA is designed to deliver sublingual tablets containing 30 mcg sufentanil via a disposable, pre-filled, single-dose applicator. (chemical.report)
  • Its lead product candidate is DSUVIA and DZUVEO, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain. (stockinvest.us)
  • Dsuvia is a new brand name for a prescription opioid painkiller , sufentanil, which is a very potent narcotic analgesic. (serenityatsummit.com)
  • Dsuvia, in particular, and sufentanil in general, is designed to treat acute, severe pain when other pain medications are ineffective. (serenityatsummit.com)
  • Currently sufentanil is the most potent opioid painkiller available for use in humans. (wikipedia.org)
  • The decision to approve this new potent synthetic opioid came under criticism from politicians and from the chair of the FDA advisory committee, who fear that the tablets will be easily diverted to the illegal drug market. (wikipedia.org)
  • It contains 30 micrograms of a synthetic opioid painkiller known as sufentanil, which is 5 to 10 times more potent than fentanyl, and 1,000 times more potent than morphine. (healthline.com)
  • This opioid medication is prescribed in sublingual tablets, using the mucous membranes in the mouth to quickly release pain-killing medication into the blood so that it can bind with opioid receptors in the brain and bring rapid relief. (serenityatsummit.com)
  • Although Dsuvia's primary ingredient, sufentanil, is a Schedule II medication, opioid drugs related to it (like fentanyl) have been diverted, produced illicitly, and widely abused. (serenityatsummit.com)
  • An increase in illicit fentanyl production and distribution - it is often mixed into heroin or cocaine - has led to a spike in opioid overdose deaths around the United States because fentanyl and its analogs, like sufentanil, are much more potent than morphine and heroin. (serenityatsummit.com)
  • Fentanyl Pills In the mid-1990s, fentanyl was introduced for palliative use with the fentanyl patch, followed in the next decade by the introduction of the fentanyl lollipop, dissolving tablets, and sublingual spray which are resorbed through the skin inside the mouth.As of 2012 fentanyl was the most widely used synthetic opioid in medicine.In 2013, 1700 kilograms were used globally. (assuredpharmaceutical.com)
  • If bicalutamide is discontinued, consider growing the sufentanil injection dose until stable drug effects are achieved and monitor for evidence of opioid withdrawal. (page.tl)
  • In a review the FDA found sublingual sufentanil tablets to be efficacious for moderate-to-severe acute pain but had concerns over the maximum dosing and the risk of misplaced tablets due to their small size. (prescriberight.com)
  • In addition, the company has also received approval for a patient controlled analgesia system (PCA) in the EU, known as Zalviso® (sufentanil sublingual tablet system). (asra.com)
  • The company's non-invasive, sublingual formulation technology is designed to efficiently deliver highly lipophilic drugs with consistent pharmacokinetic profiles. (asra.com)
  • AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. (salesandmarketingnetwork.com)
  • Structurally, sufentanil differs from fentanyl through the addition of a methoxymethyl group on the piperidine ring (which increases potency but is believed to reduce duration of action), and the replacement of the phenyl ring by thiophene. (wikipedia.org)
  • Although more potent narcotic pain medications do exist, all medications stronger than sufentanil are approved for veterinary use only. (wikipedia.org)
  • citation needed] Because sufentanil is very potent, practitioners must be prepared to reverse the effects of the drug should the patient exhibit symptoms of overdose such as respiratory depression or respiratory arrest. (wikipedia.org)
  • It's a tablet that dissolves under a patient's tongue to deliver fast pain relief during extreme trauma, such as a broken femur or a gunshot wound. (healthline.com)
  • and entitled "Evaluation of Sufentanil Sublingual Tablet 30 mcg for Perioperative Pain Management of In-Office Rhinology Procedures. (acelrx.com)
  • But at the same time, the head of FDA's own advisory committee warned the administration that approval of the new version of sufentanil will only make overdoses that much more likely. (healthline.com)
  • The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval of sublingual sufentanil tablets. (prescriberight.com)
  • An FDA Advisory Committee voted 10-0 to recommend prucalopride tablets for the treatment of adults with chronic idiopathic constipation. (prescriberight.com)
  • Use a mortar and pestle to grind sixteen 90-mg diltiazem hydrochloride regular-release tablets into a fine powder. (pdr.net)
  • The concomitant use of DSUVIA with all cytochrome P450 3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug reactions and may cause potentially fatal respiratory depression. (dsuvia.com)
  • Sufentanil, sold under the brand names Dsuvia and Sufenta, is a synthetic opioid analgesic drug approximately 5 to 10 times as potent as its parent drug, fentanyl, and 500 times as potent as morphine. (wikipedia.org)
  • It is available as a sublingual tablet under the trade name Dsuvia. (wikipedia.org)
  • In 2018, the Food and Drug Administration (FDA) approved Dsuvia, a sublingual tablet form of the drug, that was developed in a collaboration between AcelRx Pharmaceuticals and the United States Department of Defense for use in battlefield settings where intravenous (IV) treatments may not be readily available. (wikipedia.org)
  • The FDA issued a warning letter to AcelRx Pharmaceuticals for misleading promotion of its potent opioid analgesic Dsuvia (sufentanil sublingual tablet) . (medpagetoday.com)
  • Its lead product candidate is DSUVIA and DZUVEO, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain. (stockanalysis.com)
  • The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed sufentanil ( Dzuveo , FGK Representative Service GmbH) for the management of acute moderate to severe pain in adult patients. (medscape.com)
  • Dzuveo will be available as 30-microgram sublingual tablets. (medscape.com)
  • An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Co. (trialstracker.net)
  • Measurable ketoconazole plasma concentrations have been observed in pre-term infants (single or daily doses of 3 to 10 mg/kg) and in pediatric patients 5 months of age and older (daily doses of 3 to 13 mg/kg) when the drug was administered as a suspension, tablet or crushed tablet. (nih.gov)
  • Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. (nih.gov)
  • Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. (nih.gov)
  • Absorption of ketoconazole tablets is reduced in subjects with reduced gastric acidity, such as subjects taking medications known as acid neutralizing medicines (e.g. aluminum hydroxide) and gastric acid secretion suppressors (e.g. (nih.gov)
  • Absorption of ketoconazole under fasted conditions in these subjects is increased when ketoconazole tablets are administered with an acidic beverage (such as non-diet cola). (nih.gov)
  • Following absorption from the gastrointestinal tract, ketoconazole tablets are converted into several inactive metabolites. (nih.gov)
  • Limited pharmacokinetic data are available on the use of ketoconazole tablets in the pediatric population. (nih.gov)
  • Ketoconazole tablets USP is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. (nih.gov)
  • Depending on the amount administered, it can reverse the respiratory depression and, if enough is administered, completely reverse the effects of sufentanil. (wikipedia.org)
  • Oral bioavailability is maximal when the tablets are taken with a meal. (nih.gov)
  • In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in sufentanil plasma concentration. (dsuvia.com)