Amphetamine Extended-Release Oral Suspension

AMPHETAMINE EXTENDED-RELEASE ORAL SUSPENSION- amphetamine suspension, extended release
Prasco Laboratories

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Amphetamine extended-release oral suspension, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2 , 9.3) ].

1 INDICATIONS AND USAGE

Amphetamine extended-release oral suspension is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Pre-Treatment Screening

Prior to treating patients with Amphetamine extended-release oral suspension, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Amphetamine extended-release oral suspension use [see Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

2.2 Dosing Considerations for All Patients

Administer Amphetamine extended-release oral suspension orally once daily in the morning with or without food. The dose should be individualized according to the therapeutic needs and response of the patient.

Shake the bottle of Amphetamine extended-release oral suspension before administering the dose. Do not add Amphetamine extended-release oral suspension to food or mix Amphetamine extended-release oral suspension with other liquids before consuming.

2.3 Pediatric Patients

The recommended starting dose for patients 6 to 17 years of age is 6.3 mg (5 mL) once daily in the morning. Increase in increments of 3.1 mg (2.5 mL) or 6.3 mg (5 mL) at weekly intervals. The maximum dose is 18.8 mg (15 mL) daily for patients 6 to 12 years, and 12.5 mg (10 mL) daily for patients 13 to 17 years.

2.4 Adults

The recommended dose of Amphetamine extended-release oral suspension for adults is 12.5 mg (10 mL) daily.

2.5 Switching from Other Amphetamine Products

Patients taking ADDERALL XR may be switched to Amphetamine extended-release oral suspension at the equivalent dose taken once daily [see Clinical Pharmacology (12)]. Refer to Table 1 for equivalent doses of Amphetamine extended-release oral suspension and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).

Table 1: Equivalent Doses of Amphetamine extended-release oral suspension and ADDERALL XR (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules
Amphetamine extended-release oral suspension 3.1 mg(2.5 mL) 6.3 mg(5 mL) 9.4 mg(7.5 mL) 12.5 mg(10 mL) 15.7 mg(12.5 mL) 18.8 mg(15 mL)
ADDERALL XR Mixed salts of single-entity amphetamine product extended-releasecapsules (MAS ER) 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg

If switching from any other amphetamine products, discontinue that treatment, and titrate with Amphetamine extended-release oral suspension using the titration schedule [see Dosage and Administration (2.3, 2.4)].

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine salt compositions and differing pharmacokinetic profiles [see Warnings and Precautions (5.8)].

2.6 Dosage Modifications Due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust Amphetamine extended-release oral suspension dosage accordingly [see Drug Interactions (7.1)].

3 DOSAGE FORMS AND STRENGTHS

Extended-release oral suspension contains 1.25 mg amphetamine per mL.

4 CONTRAINDICATIONS

Amphetamine extended-release oral suspension is contraindicated:

  • In patients known to be hypersensitive to amphetamine, or other components of Amphetamine extended-release oral suspension. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2)].
  • In patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7)Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse or Dependence

CNS stimulants, including Amphetamine extended-release oral suspension, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke, and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Amphetamine extended-release oral suspension treatment.

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