When returning the Vicodin formulations listed below, Abbott will issue credit to you through your wholesaler for full or partial bottles of product in original Abbott containers that have not expired. How do I return the original formulation of Vicodin? In order to minimize confusion or the potential for medication errors. What happened to the original Vicodin formulation?Ībbott discontinued manufacturing and distribution of its original formulations of Vicodin (Vicodin ® 5 mg/500 mg, Vicodin ES ® 7.5 mg/750 mg, and Vicodin HP ® 10 mg/660 mg), which contained higher strengths of acetaminophen.Ībbott has been working with pharmacy wholesalers and pharmacies to process returns of the original Vicodin formulations, Is still a CIII product, no samples will be available. The new National Drug Code (NDC) associated with each strength is listed in the chart below:Ībbott is working with pharmacies to help ensure the availability of the new Vicodin formulations. The reformulated Vicodin is available in bottles of 100 and 500 tablets for each strength. The original 7.5 mg/750 mg version of Vicodin ES has a "not to exceed" total daily dose of 5 tablets. *The total daily dosing regimen for the new Vicodin ES 7.5 mg/300 mg is slightly different from the previous product. The original formulation did not have the strength debossed on the tablet. However, new formulations of Vicodin, Vicodin ES, and Vicodin HP will show: Both are white, capsule-shaped, scored tablets. New Vicodin tablets will look slightly different than the original formulations. The new Vicodin is being introduced as a branded generic product, which means that patients will pay a generic co-pay at the pharmacy. Vicodin HP (hydrocodone bitartrate and acetaminophen tablets, USP) 10 mg/300 mg Vicodin ES (hydrocodone bitartrate and acetaminophen tablets, USP) 7.5 mg/300 mg Vicodin (hydrocodone bitartrate and acetaminophen tablets, USP) 5 mg/300 mg The new Vicodin formulations contain 300 mg of acetaminophen per tablet, which is lower than the amount mandated by the FDA. What are the details about the new Vicodin? Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The concomitant use with other central nervous system (CNS) depressants and monoamine oxidase (MAO) inhibitors or tricyclic antidepressants may increase the effect of either drug. It may cause dose-related respiratory depression in sensitive patients and caution should be exercised when prescribing to elderly or debilitated patients. VICODIN formulations contain hydrocodone which is an opioid agonist and a schedule III controlled substance with an abuse liability and dependence. VICODIN, VICODIN ES, and VICODIN HP tablets are contraindicated in patients who have hypersensitivity to the drugs or their inactive ingredients. MOST CASES OF LIVER INJURY ARE ASSOCIATED WITH DOSES THAT EXCEED 4000 MG/DAY. HEPATOTOXICITY: ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. The indication for the new Vicodin formulations has remained the same: Vicodin, Vicodin ES, and Vicodin HP (hydrocodone bitartrate and acetaminophen tablets, USP) are indicated for the relief of moderate to moderately severe pain. What is the indication of the reformulated Vicodin? How is Abbott responding to the FDA guidance?Ībbott is complying with this directive more than 1 year ahead of the FDA's requested deadline of January 2014, and is now introducing new formulations of Vicodin, Vicodin ES, and Vicodin HP (hydrocodone bitartrate and acetaminophen tablets, USP). 1 (Please visit the FDA website for more information on acetaminophen dosing: ) The FDA has stated that limiting the amount of acetaminophen per dosage unit in prescription products may reduce the risk of severe liver injury from acetaminophen overdosing. Food and Drug Administration (FDA) asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, including combination acetaminophen and opioid products, to no more than 325 mg per tablet, capsule, or other dosage unit. Introduction of newly reformulated Vicodin ®, Vicodin ES ®, and Vicodin HP ® (hydrocodone bitartrate and acetaminophen tablets, USP) NEWLY REFORMULATED VICODIN ® LAUNCH ANNOUNCEMENT Pharmacist e-Connect Flash: Reformulated Pain Medication Now Available At A Generic Price
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