FLEQSUVY

A pharmacokinetic study in heathy adult male and female subjects under fasting conditions at 20 mg dose level demonstrated similar bioavailability for baclofen oral suspension and oral tablets.

AbsorptionThe peak plasma concentrations of baclofen were achieved in about 1 hour from administration of FLEQSUVY oral suspension in the fasted state, and the apparent elimination half-life is about 5.6 hours. Effect of Food Administration of FLEQSUVY with a high-fat meal resulted in 9% decrease in AUC ...

The efficacy of FLEQSUVY is based upon a bioavailability study in healthy adults comparing baclofen oral tablets to FLEQSUVY [see Clinical Pharmacology ( 12.3 )] .

The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of FLEQSUVY [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions (...

FLEQSUVY is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when FLEQSUVY is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue FLEQSUVY before delivery. ( 5.2 ) FLEQSUVY can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous syste...

7 DRUG INTERACTIONS 7.1 CNS Depressants and Alcohol FLEQSUVY can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )] .