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Strattera

These highlights do not include all the information needed to use STRATTERA safely and effectively. See full prescribing information for STRATTERA. STRATTERA (atomoxetine) CAPSULES for Oral Use Initial U.S. Approval: 2002

Approved
Approval ID

fd1c71bc-1445-4ac6-8a8d-79050e61b03a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 20, 2014

Manufacturers
FDA

TYA Pharmaceuticals

DUNS: 938389038

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Atomoxetine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64725-3228
Application NumberNDA021411
Product Classification
M
Marketing Category
C73594
G
Generic Name
Atomoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2013
FDA Product Classification

INGREDIENTS (8)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
Atomoxetine hydrochlorideActive
Quantity: 25 mg in 1 1
Code: 57WVB6I2W0
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 2/21/2013

WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/21/2013

1 INDICATIONS AND USAGE

1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)

STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15) . [see Clinical Studies ( )] 14

1.2 Diagnostic Considerations

A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.

The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.

For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive- Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can't wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.

1.3 Need for Comprehensive Treatment Program

STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

Key Highlight

STRATTERA is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( ) ®1.1

DRUG INTERACTIONS SECTION

LOINC: 34073-7Updated: 2/21/2013

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity . [see Contraindications ( )] 4.2

7.2 Effect of CYP2D6 Inhibitors on Atomoxetine

In extensive metabolizers (EMs), inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to those observed in poor metabolizers (PMs). In EM individuals treated with paroxetine or fluoxetine, the AUC of atomoxetine is approximately 6- to 8-fold and C , is about 3- to 4-fold greater than atomoxetine alone. ssmax

In vitro studies suggest that coadministration of cytochrome P450 inhibitors to PMs will not increase the plasma concentrations of atomoxetine.

7.3 Antihypertensive Drugs and Pressor Agents

Because of possible effects on blood pressure, STRATTERA should be used cautiously with antihypertensive drugs and pressor agents (e.g., dopamine, dobutamine) or other drugs that increase blood pressure.

7.4 Albuterol

STRATTERA should be administered with caution to patients being treated with systemically-administered (oral or intravenous) albuterol (or other beta agonists) because the action of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure. Albuterol (600 mcg iv over 2 hours) induced increases in heart rate and blood pressure. These effects were potentiated by atomoxetine (60 mg BID for 5 days) and were most marked after the initial coadministration of albuterol and atomoxetine. However, these effects on heart rate and blood pressure were not seen in another study after the coadministration with inhaled dose of albuterol (200-800 mcg) and atomoxetine (80 mg QD for 5 days) in 21 healthy Asian subjects who were excluded for poor metabolizer status. 2

7.5 Effect of Atomoxetine on P450 Enzymes

Atomoxetine did not cause clinically important inhibition or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6, and CYP2C9.

— Coadministration of STRATTERA (60 mg BID for 12 days) with midazolam, a model compound for CYP3A4 metabolized drugs (single dose of 5 mg), resulted in 15% increase in AUC of midazolam. No dose adjustment is recommended for drugs metabolized by CYP3A. CYP3A Substrate (e.g., Midazolam)

— Coadministration of STRATTERA (40 or 60 mg BID for 13 days) with desipramine, a model compound for CYP2D6 metabolized drugs (single dose of 50 mg), did not alter the pharmacokinetics of desipramine. No dose adjustment is recommended for drugs metabolized by CYP2D6. CYP2D6 Substrate (e.g., Desipramine)

7.6 Alcohol

Consumption of ethanol with STRATTERA did not change the intoxicating effects of ethanol.

7.7 Methylphenidate

Coadministration of methylphenidate with STRATTERA did not increase cardiovascular effects beyond those seen with methylphenidate alone.

7.8 Drugs Highly Bound to Plasma Protein

In vitro drug-displacement studies were conducted with atomoxetine and other highly-bound drugs at therapeutic concentrations. Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin. Similarly, these compounds did not affect the binding of atomoxetine to human albumin.

7.9 Drugs that Affect Gastric pH

Drugs that elevate gastric pH (magnesium hydroxide/aluminum hydroxide, omeprazole) had no effect on STRATTERA bioavailability.

Key Highlight
  • Monoamine Oxidase Inhibitors. ( , ) 4.27.1
  • CYP2D6 Inhibitors - Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. ( ) 7.2
  • Antihypertensive Drugs and Pressor Agents - Possible effects on blood pressure. ( ) 7.3
  • Albuterol (or other beta agonists) - Action of albuterol on cardiovascular system can be potentiated. ( ) 27.4

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 2/20/2014

RECENT MAJOR CHANGES

Contraindications:

Severe Cardiovascular Disorders ( ) 4.5

08/2013

Warnings and Precautions:

Effects on Blood Pressure and Heart Rate ( ) 5.4

08/2013

Aggressive Behavior or Hostility ( ) 5.7

08/2013

DOSAGE FORMS & STRENGTHS SECTION

LOINC: 43678-2Updated: 4/21/2010

3 DOSAGE FORMS AND STRENGTHS

Each capsule contains atomoxetine HCl equivalent to 10 mg (Opaque White, Opaque White), 18 mg (Gold, Opaque White), 25 mg (Opaque Blue, Opaque White), 40 mg (Opaque Blue, Opaque Blue), 60 mg (Opaque Blue, Gold), 80 mg (Opaque Brown, Opaque White), or 100 mg (Opaque Brown, Opaque Brown) of atomoxetine.

Key Highlight

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. ( , , ) 31116

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Strattera - FDA Drug Approval Details