ADHD Medication Adderall and Adderall XR | Belinda Alexi, PharmD Intern | RxEconsult
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History, Efficacy, Contraindications, And Side Effects Of Adderall And Adderall XR ADHD Medications Category: ADHD, Autism, Seizures, by - November 3, 2017 | Views: 721 | Likes: 0 | Comment: 0  

ADHD medication Adderall and Adderall XR

The History Of Adderall: Adderall Versus Adderall XR 

Adderall contains mixed amphetamine/dextroamphetamine salts. It was approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) in February 1996. It had previously been marketed by another company under the name Obetrol and it was approved for the treatment of obesity and ADHD. 

Richwood Pharmaceuticals acquired the company, including formulation and manufacturing rights to Obetrol, and renamed the product to Adderall in 1994. Adderall is an immediate-release (IR) formulation available in different doses. The first dose is given on awakening, with additional doses at 4 to 6-hour intervals. In 1997, Shire Pharmaceuticals acquired Richwood and launched Adderall XR in 2001. Adderall XR is an extended-release version of Adderall that lasts up to 12 hours. Shire still manufacturers brand name Adderall XR, but not Adderall IR. In 2006, Shire sold rights to the Adderall name to DuraMed Pharmaceuticals. This company was later acquired by Teva Pharmaceuticals during its acquisition of Barr Pharmaceuticals, which included Barr’s Duramed division. Ten different companies produce generic Adderall IR, while Teva, Actavis, and Barr manufacturer Adderall XR.

How does Adderall work?

Adderall tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Amphetamines block the reuptake of the neurotransmitters dopamine and norepinephrine into storage sites and also increase the release of the neurotransmitters into the brain.

What is Adderall used for and how well does it work?

Adderall is used for the treatment of attention deficit hyperactivity disorder (ADHD). It is also used to treat narcolepsy, specifically the excessive daytime sleepiness that is caused by narcolepsy. Adderall XR is used for the treatment of ADHD.

In children ages 6 to 12 years old, the efficacy of Adderall XR in the treatment of ADHD was established in one 3-week outpatient, controlled trial and one analogue classroom, controlled trial. In the outpatient trial, there was significant improvements in child behavior, based upon teacher ratings of attention and hyperactivity, compared to subjects who received placebo. The classroom study of 51 students also demonstrated significant improvements in teacher-rated behavior and performance measures when compared to students treated with placebo. 

In adolescents aged 13 to 17, the efficacy o Adderall determined in a one 4-week controlled trial in adolescents with ADHD. The primary efficacy variable was the Attention Deficit Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) total score. Improvements were statistically significantly greater in the active treatment groups compared with the placebo group. 

Efficacy in adults was determined in one 4-week controlled trial in adults with ADHD. Significant improvement was measured with an 18-item rating scale that measures the core symptoms of ADHD.

Place in Therapy

The FDA reports that both the IR and the XR Adderall versions contain the same ingredients in the same proportion. Thus, the efficacy of the two different formulations are not considered to be significantly different. The IR formulation is in tablet form, while XR is available as a capsule. The XR capsules contain 50% of immediate-release beads and 50% of delayed-release beads. Thus, patients taking Adderall XR only need to take the drug in the morning as opposed to every 4 to 6 hours when taking Adderall IR. Neither version of the drug is superior to the other. Individual preferences for one formulation over the other are due to the duration in which a person needs the psychostimulant effect.

Both formulations have the same classification by the DEA as Schedule II controlled substances. Although both have a high potential for abuse, the IR version is more likely to be abused because the tablet form makes the drug easier to crush into a powder and snort. The XR version consists of many beads in the capsule that would need to be individually crushed to form a powder.

Adderall Contraindications

Adderall is contraindicated in patients with:

  • Advanced arteriosclerosis
  • Agitated states
  • Concomitant use or use within 14 days of MAOI administration
  • Glaucoma
  • History of drug abuse
  • Hypersensitivity to amphetamine or other product components
  • Hyperthyroidism
  • Moderate to severe hypertension
  • Symptomatic cardiovascular disease

Common side effects of Adderall

The listed common side effects of  Adderall include: 

  • Headache
  • Abdominal pain
  • Insomnia
  • Decreased appetite
  • Irritability
  • Dizziness

Adderall XR has a similar side effect profile as the immediate-release Adderall. In a three-week clinical trial, the most common side effects experienced by children ages 6 to 12 years taking Adderall XR include:

  • Loss of appetite (22%)
  • Insomnia (17%)
  • Abdominal pain (14%)
  • Adolescents aged 13 to 17 years old in a four-week clinical trial commonly experience these side effects:
  • Loss of appetite (36%)
  • Insomnia (12%)
  • Abdominal pain (11%)

The most common side effects observed in adult patients with ADHD taking Adderall XR in a four-week clinical study include:

  • Dry mouth (35%)
  • Loss of appetite (33%)
  • Insomnia (27%)
  • Headache (26%)

 

Sources

Adderall – FDA Package Insert and Medication Guide

Adderall XR – FDA Package Insert

Center Watch – Adderall XR

Gaffney A. (2016). How ADHD was Sold. New Republic.

Micromedex Solutions | Truven Health Analytics - Adderall

 


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