MedlinePlus a605022 ATC code N03AA01 (WHO) CAS ID 115-38-8 | Routes of
administration By mouth (tablets) Molar mass 246.3 g/mol | |
AHFS/Drugs.com International Drug Names Pregnancy
category US: D (Evidence of risk) Legal status CA: Schedule IV
DE: Anlage III (Prescription only)
UK: Class B
US: Schedule IV | ||
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, 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 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.