Methylin Oral Solution
"March 4, 2013 -- Nearly 30% of children with ADHDÂcontinue to struggle with the condition as adults, and some may develop other mental health issues, commit suicide, or end up in jail, a new study shows.
"We suffer from the misconceptio"...
Methylin Oral Solution
Methylin Oral Solution
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Methylphenidate is a racemic mixture comprised of the d-and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer.
Methylphenidate HCl is a central nervous system (CNS) stimulant.
The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
There is neither specific evidence which clearly establishes the mechanism whereby Methylin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Methylin Oral Solution is readily absorbed. Following oral administration of Methylin Oral Solution, peak plasma methylphenidate concentrations are achieved at 1 to 2 hours. Methylin Oral Solution has been shown to be bioequivalent to Ritalin® tablet. The mean Cmax following a 20 mg dose is approximately 9 ng/mL.
In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of Methylin Oral Solution at a dose of 20 mg, the presence of food delayed the peak by approximately 1 hour (1.7 hours, fasted and 2.7 hours, fed). Overall, a high-fat meal increased the Cmax of Methylin Oral Solution by about 13% and the AUC by about 25%, on average. Through a cross-study comparison, the magnitude of increase in Cmax and AUC is found to be comparable between the Methylin Oral Solution and Ritalin, the immediate release tablet.
Metabolism and Excretion
In humans, methylphenidate is metabolized primarily via deesterification to alphaphenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.
After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose.
The pharmacokinetics of the Methylin Oral Solution have been studied in healthy adult volunteers. The mean terminal half-life (t½) of methylphenidate following administration of 20 mg Methylin (t½ = 2.7 hours) is comparable to the mean terminal t½ following administration of Ritalin (methylphenidate hydrochloride immediate-release tablets) (t½ = 2.8h) in healthy adult volunteers.
Gender – The effect of gender on the pharmacokinetics of methylphenidate after Methylin Oral Solution administration has not been studied.
Race – The influence of race on the pharmacokinetics of methylphenidate after Methylin Oral Solution administration has not been studied.
Age – The pharmacokinetics of methylphenidate after Methylin Oral Solution administration have not been studied in pediatrics.
There is no experience with the use of Methylin Oral Solution in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid. Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of Methylin Oral Solution.
There is no experience with the use of Methylin Oral Solution in patients with hepatic insufficiency.
Last reviewed on RxList: 7/1/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Methylin Oral Solution Information
Methylin Oral Solution - User Reviews
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