Methylphenobarbital (
INN
Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they also provided accommo ...
), also known as mephobarbital (
USAN,
JAN
Jan, JaN or JAN may refer to:
Acronyms
* Jackson, Mississippi (Amtrak station), US, Amtrak station code JAN
* Jackson-Evers International Airport, Mississippi, US, IATA code
* Jabhat al-Nusra (JaN), a Syrian militant group
* Japanese Article Num ...
) and mephobarbitone (
BAN
Ban, or BAN, may refer to:
Law
* Ban (law), a decree that prohibits something, sometimes a form of censorship, being denied from entering or using the place/item
** Imperial ban (''Reichsacht''), a form of outlawry in the medieval Holy Roman ...
), marketed under
brand names such as Mebaral, Mephyltaletten, Phemiton, and Prominal, is a
drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...
which is a
barbiturate
Barbiturates are a class of depressant drugs that are chemically derived from barbituric acid. They are effective when used medically as anxiolytics, hypnotics, and anticonvulsants, but have physical and psychological addiction potential as we ...
derivative and is used primarily as an
anticonvulsant
Anticonvulsants (also known as antiepileptic drugs or recently as antiseizure drugs) are a diverse group of pharmacological agents used in the treatment of epileptic seizures. Anticonvulsants are also increasingly being used in the treatment of b ...
, but also as a
sedative
A sedative or tranquilliser is a substance that induces sedation by reducing irritability or excitement. They are CNS depressants and interact with brain activity causing its deceleration. Various kinds of sedatives can be distinguished, but t ...
and
anxiolytic. It is the ''N''-methylated analogue of
phenobarbital and has similar indications, therapeutic value, and tolerability.
Approval history
* 1935 – Mebaral was introduced by Winthrop Pharmaceuticals.
* 2001 – Methylphenobarbital discontinued in the UK.
* 2003 – Mebaral was acquired by Ovation Pharmaceuticals (a specialty pharmaceutical company that acquired under-promoted branded pharmaceutical products).
* 2009 – Ovation was acquired by
Lundbeck, which now markets Mebaral.
* 2012 – Lundbeck announced that they were abandoning the product in the US as of January 6, 2012. The stated reason was because "the company thoroughly evaluated all avenues for keeping Mebaral available to patients, but ultimately concluded that no matter what steps they
.e. Lundbecktook, patients would be forced to transition to a new therapy."
The company further stated in a letter on its website
Letter from Lundbeck to prescribers
/ref> that under the FDA's Unapproved Drugs Initiative Unapproved Drugs Initiative is a program by the U.S Food and Drug Administration announced in June 2006 to remove unapproved drugs from the market.
some 14 categories of drugs have been affected.
It has been controversial due to the resulting inc ...
, 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
Somnolence (alternatively sleepiness or drowsiness) is a state of strong desire for sleep, or sleeping for unusually long periods (compare hypersomnia). It has distinct meanings and causes. It can refer to the usual state preceding falling asleep ...
, fever
Fever, also referred to as pyrexia, is defined as having a body temperature, temperature above the human body temperature, normal range due to an increase in the body's temperature Human body temperature#Fever, set point. There is not a single ...
, 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
* Hexobarbital
Hexobarbital or hexobarbitone, sold both in acid and sodium salt forms as Citopan, Evipan, and Tobinal, is a barbiturate derivative having hypnotic and sedative effects. It was used in the 1940s and 1950s as an agent for inducing anesthesia for su ...
* Metharbital
* Phenobarbital
References
{{GABAAergics
Anticonvulsants
Barbiturates
GABAA receptor positive allosteric modulators