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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): PRESCRIBING INFORMATION

DESCRIPTION

Adderall-XR description


DOSAGE and ADMINISTRATION

Adderall-XR dosage and administration


DOSAGE FORMS AND STRENGTHS

Adderall-XR 5 mg capsules: clear / blue (imprinted "ADDERALL XR 5 mg")
Adderall-XR 10 mg capsules: blue / blue (imprinted "ADDERALL XR 10 mg")
Adderall-XR 15 mg capsules: blue / white (imprinted "ADDERALL XR 15 mg")
Adderall-XR 20 mg capsules: orange / orange (imprinted "ADDERALL XR 20 mg")
Adderall-XR 25 mg capsules: orange / white (imprinted "ADDERALL XR 25 mg")
Adderall-XR 30 mg capsules: natural / orange (imprinted "ADDERALL XR 30 mg")


INDICATIONS AND USAGE

Adderall-XR indications and usage


CONTRAINDICATIONS

Mixed salts of Amphetamine and Dextroamphetamine (Adderall-XR) administration is contraindicated in patients with the following conditions:

  • Symptomatic cardiovascular disease
  • Advanced arteriosclerosis
  • Moderate to severe hypertension
  • Known hypersensitivity or idiosyncrasy to the sympathomimetic amines (e.g., angioedema, anaphylaxis, serious skin rashes)
  • Hyperthyroidism
  • Glaucoma
  • History of drug abuse
  • Agitated states
  • During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result)


    CLINICAL PHARMACOLOGY

    Adderall-XR clinical pharmacology


    NONCLINICAL TOXICOLOGY

    Adderall-XR nonclinical toxicology


    CLINICAL STUDIES

    Adderall-XR clinical studies


    WARNINGS

    Adderall-XR warnings


    PRECAUTIONS

    Adderall-XR precautions


    USE IN SPECIFIC POPULATIONS

    Adderall-XR use in specific populations


    ADVERSE REACTIONS

    Adderall-XR adverse reactions


    DRUG INTERACTIONS

    Adderall-XR drug interactions


    DRUG ABUSE AND DEPENDENCE

    Controlled Substance

    Adderall-XR (Amphetamines) is a Schedule II controlled substance in The USA.

    Abuse and Dependence

    Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to levels many times higher than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines may include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.


    OVERDOSAGE

    Adderall-XR overdosage


    HOW SUPPLIED / STORAGE AND HANDLING

    Adderall-XR 5 mg capsules: clear/blue (imprinted ADDERALL XR 5 mg), bottles of 100
    Adderall-XR 10 mg capsules: blue/blue (imprinted ADDERALL XR 10 mg), bottles of 100
    Adderall-XR 15 mg capsules: blue/white (imprinted ADDERALL XR 15 mg), bottles of 100
    Adderall-XR 20 mg capsules: orange/orange (imprinted ADDERALL XR 20 mg), bottles of 100
    Adderall-XR 25 mg capsules: orange/white (imprinted ADDERALL XR 25 mg), bottles of 100
    Adderall-XR30 mg capsules: natural/orange (imprinted ADDERALL XR 30 mg), bottles of 100

    Dispense in a tight, light-resistant container as defined in the USP.

    Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F)

    Manufactured and distributed by Shire, Duramed Pharmaceuticals and their divisions.

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