Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules

The Journal of Pain : Official Journal of the American Pain Society
Franklin JohnsonJoseph Stauffer

Abstract

The recent withdrawal of hydromorphone hydrochloride extended-release capsules (Palladone; Purdue Pharma L.P., Stamford, CT) from the market after pharmacokinetic data revealed a risk of alcohol-induced dose-dumping prompted a re-examination of the risk-benefit profiles of extended-release drugs. Although warnings on concomitant alcohol use are included on opioid product labels, further investigations of extended-release formulations to determine the risk of dose-dumping were recommended by the US Food and Drug Administration. The present study was undertaken to assess the single-dose relative bioavailability of polymer-coated, extended-release morphine sulfate capsules (KADIAN, 100 mg; Alpharma Pharmaceuticals LLC, Piscataway, NJ). This open-label, randomized, 3-way crossover study with an additional index arm, conducted among 32 healthy male volunteers, found no significant evidence of a formulation interaction between KADIAN and alcohol, in vivo. The pharmacokinetics of serum morphine did not differ significantly among subjects taking KADIAN with water (fasted) or with 240 mL 40% alcohol under fasted or fed conditions. Analysis of variance ratios of least-squares means for ln-transformed AUC(infinity) and C(max) satisfied th...Continue Reading

References

Jan 19, 2002·European Journal of Pain : EJP·R F Reder

❮ Previous
Next ❯

Citations

Apr 25, 2013·International Journal of Pharmaceutics·F J O VarumA W Basit
Oct 1, 2014·Clinical Pharmacokinetics·Lingtak-Neander Chan, Gail D Anderson
Sep 10, 2011·Postgraduate Medicine·Robert L BarkinAllan Gordon
Jan 3, 2012·The Journal of Pain : Official Journal of the American Pain Society·William D FiskeIrma H Benedek
Jul 30, 2010·International Journal of Pharmaceutics·Anjanette P SmithWilliam H Doub
May 20, 2011·Journal of Clinical Pharmacology·Franklin K JohnsonJoseph Stauffer
Jul 11, 2012·Pharmaceutical Development and Technology·Safwan Abdel RahimNizar Al-Zoubi
Mar 27, 2013·Journal of Pain & Palliative Care Pharmacotherapy·Jeffrey A Gudin
Jul 15, 2015·AAPS PharmSciTech·Chaitanya Yogananda GujjarVallabh Subashrao Deulkar
Sep 2, 2015·Journal of Analytical Toxicology·Kamisha L Johnson-Davis, Matthew H Slawson
Dec 5, 2017·Pharmaceutical Development and Technology·Nizar Al-ZoubiAl-Sayed Sallam
Sep 23, 2009·American Journal of Therapeutics·Robert L BarkinEric Kinzler
May 29, 2020·Journal of General Internal Medicine·Simeon KimmelAlexander Y Walley

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.