Methylphenobarbital

Last updated
Methylphenobarbital
Methylphenobarbital.svg
Clinical data
Trade names Mebaral, generics
AHFS/Drugs.com International Drug Names
MedlinePlus a605022
Pregnancy
category
  • US: D (Evidence of risk)
    Routes of
    administration
    By mouth (tablets)
    ATC code
    Legal status
    Legal status
    Pharmacokinetic data
    Protein binding 70–76%
    Metabolism Liver
    Elimination half-life 34 hours
    Identifiers
    CAS Number
    PubChem CID
    DrugBank
    ChemSpider
    UNII
    KEGG
    ChEBI
    ChEMBL
    CompTox Dashboard (EPA)
    ECHA InfoCard 100.003.714 OOjs UI icon edit-ltr-progressive.svg
    Chemical and physical data
    Formula C13H14N2O3
    Molar mass 246.266 g·mol−1
    3D model (JSmol)
       (verify)

    Methylphenobarbital (INN), also known as mephobarbital (USAN, JAN) and mephobarbitone (BAN), marketed under brand names such as Mebaral, Mephyltaletten, Phemiton, and Prominal, is a drug which is a barbiturate derivative and is used primarily as an anticonvulsant, [1] but also as a sedative and anxiolytic. It is the N-methylated analogue of phenobarbital and has similar indications, therapeutic value, and tolerability.

    Contents

    Approval history

    The company further stated in a letter on its website [2] that under the FDA's Unapproved Drugs Initiative, FDA is no longer willing to allow the drug to be grandfathered. A new drug application would have needed to have been submitted to gain marketing approval, which would have taken an estimated five years, during which time patients would be required to change their therapies in any case. The last available tablets bore an expiration date of March 31, 2012, and the drug will no longer be available in the US when supplies are depleted.

    Overdose

    Symptoms of overdose of mephobarbital include confusion, decrease in or loss of reflexes, somnolence, fever, irritability, hypothermia, poor judgment, shortness of breath or slow/troubled breathing, slow heartbeat, slurred speech, staggering, trouble in sleeping, unusual movements of the eyes, weakness.

    See also

    Related Research Articles

    GlaxoSmithKline British pharmaceutical company

    GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical company headquartered in Brentford, England. Established in 2000, by a merger of Glaxo Wellcome and SmithKline Beecham, GSK was the world's sixth largest pharmaceutical company according to Forbes as of 2019, after Pfizer, Novartis, Roche, Sanofi, and Merck & Co. GSK is the tenth largest pharmaceutical company and #296 on the 2019 Fortune 500, ranked behind other pharmaceutical companies including China Resources, Johnson & Johnson, Roche, Sinopharm, Pfizer, Novartis, Bayer, Merck, and Sanofi.

    Generic drug pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use

    A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.

    Biogen Pharmaceutical company

    Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide.

    Pharmaceutical industry develops, produces, and markets drugs or pharmaceuticals licensed for use as medications

    The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients, with the aim to cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.

    Stanozolol pharmaceutical drug

    Stanozolol, sold under many brand names, is an androgen and anabolic steroid (AAS) medication derived from dihydrotestosterone (DHT). It is used to treat hereditary angioedema.[12] It was developed by American pharmaceutical company Winthrop Laboratories in 1962, and has been approved by the U.S. Food and Drug Administration for human use, though it is no longer marketed in the USA. It is also used in veterinary medicine. Stanozolol has mostly been discontinued, and remains available in only a few countries. It is given by mouth in humans or by injection into muscle in animals.

    Lundbeck Danish pharmaceutical company

    H. Lundbeck A/S is a Danish international pharmaceutical company engaged in the research and development, production, marketing, and sale of drugs for the treatment of disorders in the central nervous system (CNS), including depression, schizophrenia, Alzheimer's disease and Parkinson's disease.

    Ovation Pharmaceuticals is an American manufacturer and distributor of pharmaceuticals products. It was founded in 2000 by Jeffrey Aronin and is headquartered in Deerfield, Illinois. A major office is also located near Lebanon, New Jersey. Ovation is a privately held corporation based on a business model of acquiring mature but under-promoted pharmaceuticals, as well as pharmaceutical candidates which are far along the development and FDA certification processes. Since 2009 the company has been wholly owned by the Danish pharmaceutical company Lundbeck.

    Bioequivalence a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug

    Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.

    Dr. Reddy's Laboratories is a multinational pharmaceutical company. The company was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad, India. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.

    Mylan N.V. is a global generic and specialty pharmaceuticals company domiciled in the Netherlands, with principal executive offices in Hatfield, Hertfordshire, UK and a "Global Center" in Canonsburg, Pennsylvania, US. In 2007, Mylan acquired a controlling interest in India-based Matrix Laboratories Limited, a top producer of active pharmaceutical ingredients (APIs) for generic drugs, and the generics business of Germany-based Merck KGaA. Through these acquisitions, Mylan grew from the third-largest generic and pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world.

    Takeda Oncology,, is a biopharmaceutical company based in Cambridge, Massachusetts. It is a fully owned subsidiary of Takeda Pharmaceutical.

    Ethotoin is an anticonvulsant drug used in the treatment of epilepsy. It is a hydantoin, similar to phenytoin.

    Sodium oxybate chemical compound

    Sodium oxybate is a prescription medication used to treat two symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness. It is used sometimes in France and Italy as an anesthetic given intravenously; it is also used in Italy to treat alcohol addiction and alcohol withdrawal syndrome.

    BioMarin Pharmaceutical Inc. is an American biotechnology company headquartered in San Rafael, California. It has offices and facilities in the United States, South America, Asia, and Europe. BioMarin's core business and research is in enzyme replacement therapies (ERTs). BioMarin was the first company to provide therapeutics for mucopolysaccharidosis type I, by manufacturing laronidase. BioMarin was also the first company to provide therapeutics for phenylketonuria (PKU).

    Donnatal is a combination medication that provides natural belladonna alkaloids in a specific fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation. Donnatal is manufactured for Concordia Pharmaceuticals by IriSys, LLC. It is distributed by RedHill Biopharma, Inc. It is available as tablets and 5 mL elixir. Active ingredients are listed as: phenobarbital (16.2 mg), hyoscyamine sulfate (0.1037 mg), atropine sulfate (0.0194 mg), and scopolamine hydrobromide (0.0065 mg). The latter two ingredients are found in plants of the family Solanaceae, such as Belladonna.

    Wyeth defunct pharmaceutical company

    Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as John Wyeth and Brother. It was later known as American Home Products before being renamed to Wyeth in 2002. Its headquarters moved to Collegeville, Pennsylvania, and Madison, New Jersey, before its headquarters were consolidated with Pfizer's in New York City after the 2009 merger. Most of Wyeth's pharmaceutical assets were acquired by Pfizer in 2009, while its infant and maternal nutrition business was acquired by Nestlé in 2012.

    Actelion Swiss biopharmaceutical company

    Actelion is a pharmaceuticals and biotechnology company established in December 1997, headquartered in Allschwil near Basel in Switzerland.

    Brexpiprazole A dopamine D2 receptor partial agonist and "serotonin–dopamine activity modulator"

    Brexpiprazole, sold under the brand name Rexulti, is an atypical antipsychotic. It is a dopamine D2 receptor partial agonist and has been described as a "serotonin–dopamine activity modulator" (SDAM). The drug received FDA approval on July 13, 2015 for the treatment of schizophrenia, and as an adjunctive treatment for depression. It has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).

    Catalyst Pharmaceuticals is a biopharmaceutical company based in Coral Gables, Florida. The company is developing therapeutics for rare neurological diseases, including the phosphate salt of amifampridine for the treatment of Lambert–Eaton myasthenic syndrome (LEMS) under the trade name "Firdapse" which was approved by the United States Food and Drug Administration (FDA) for use in Adult LEMS patients on November 28, 2018 and commercially launched in January of 2019. On February 4, 2019, Bernie Sanders, United States Senator from Vermont, requested an explanation—including financial and non-financial information—from Catalyst that would justify Catalyst resetting Firdapse's list price at $375,000 a year. Prior to the FDA approval, patients were able to get an experimental version of the drug for free through compassionate use programs in accordance with FDA Rules and Guidelines.

    Alvogen is an American pharmaceuticals company founded in 2009. In 2014 a controlling stake in the company was acquired by CVC Capital Partners and Temasek Holdings. Alvogen has about 350 different medical and non-medical products, and both produces its own products and markets the products of brand name pharmaceutical companies.

    References

    1. S. D. Shorvon; David R. Fish; Emilio Perucca; W. Edwin Dodson, eds. (2004). The Treatment of Epilepsy (2nd ed.). Blackwell. ISBN   0-632-06046-8.
    2. Letter from Lundbeck to prescribers