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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): PRECAUTIONS

Long-Term Suppression of Growth

Monitor growth in children during treatment with stimulants, including Adderall-XR capsules. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

In a controlled trial of Adderall-XR (Amphetamine, Dextroamphetamine) capsules in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 lbs. and -2.8 lbs., respectively, for patients receiving 10 mg and 20 mg Adderall-XR. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment. Chronic use of amphetamines can be expected to cause a similar suppression of growth.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in the absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, Adderall-XR (Amphetamine, Dextroamphetamine) should be discontinued.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Tics

Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome. Therefore, clinical evaluation for tics and Tourette's syndrome in patients and their families should precede use of stimulant medications.

Prescribing and Dispensing

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Adderall-XR (Amphetamine, Dextroamphetamine mixed salts) should be used with caution in patients who use other sympathomimetic drugs.



Adderall-XR related pharmaceutical drugs and medications

Trade name of the drug Pharmaceutical forms and doses Companies
Metrans-XR - Methylphenidate Hydrochloride
  • Tablets, Prolonged Release; Oral; Methylphenidate Hydrochloride 20 mg
  • Andromaco Laboratorios
  • Bromatanil - Bromazepam
  • Tablets; Oral; Bromazepam 3 mg
  • Tablets; Oral; Bromazepam 6 mg
  • Hexal


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