Buy online Adderall XR 30 mg +1-909-545-6717  is a prescription medicine used to treat the symptoms of narcolepsy and attention deficit hyperactivity disorder (ADHD). Adderall XR 30 mg may be used alone or with other medications.

Adderall XR 30 mg belongs to a class of drugs called stimulants.

It is not known if Adderall XR 30 mg is safe and effective in children younger than 3 years.

What are the possible side effects of Adderall XR 30 mg?

Adderall XR 30 mg may cause serious side effects including:

chest pain,

trouble breathing,

lightheadedness,

hallucinations,

new behavior problems,

aggression,

hostility,

paranoia,

numbness,

pain,

cold feeling,

unexplained wounds,

skin color changes (pale, red, or blue appearance) in fingers or toes,

seizures (convulsions),

muscle twitches, and

vision changes

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Adderall XR 30 mg include:

stomach pain,

nausea,

loss of appetite,

weight loss,

mood changes,

feeling nervous or irritable,

fast heart rate,

headache,

dizziness,

sleep problems (insomnia), and

dry mouth

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Adderall XR 30 mg. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNING

POTENTIAL FOR ABUSE

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence. Pay particular attention to the possibility of subjects obtaining amphetamines for nontherapeutic use or distribution to others and the drugs should be prescribed or dispensed sparingly [see Drug Abuse And Dependence].

Misuse of amphetamine may cause sudden death and serious cardiovascular adverse reactions.

DESCRIPTION

Adderall XR 30 mg is a once-daily extended-release, single-entity amphetamine product. Adderall XR 30 mg combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The Adderall XR 30 mg capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from Adderall XR 30 mg compared to the conventional ADDERALL (immediate-release) tablet formulation.

Each capsule contains:5 mg10 mg15 mg20 mg25 mg30 mg

Dextroamphetamine Saccharate1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg

Amphetamine Aspartate Monohydrate1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg

Dextroamphetamine Sulfate USP1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg

Amphetamine Sulfate USP1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg

Total amphetamine base equivalence3.1 mg6.3mg9.4 mg12.5mg15.6 mg18.8 mg

Inactive Ingredients and Colors

The inactive ingredients in Adderall XR 30 mg capsules include gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, poetry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.

Indications

INDICATIONS

Attention Deficit Hyperactivity Disorder

Adderall XR 30 mg® is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

The efficacy of Adderall XR 30 mg in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met DSM-IV® criteria for ADHD [see Clinical Studies].

A diagnosis of ADHD (DSM-IV®) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and was present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six 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 six 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 for turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

The specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social recredits. 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.

Need for Comprehensive Treatment Program

Adderall XR 30 mg 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. Stimulants are 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 and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.

Long-Term Use

The effectiveness of Adderall XR 30 mg for long-term use, i.e., for more than 3 weeks in children and 4 weeks in adolescents and adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Adderall XR 30 mg for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

QUESTION

The abbreviated term ADHD denotes the condition commonly known as:

See Answer

Dosage

DOSAGE AND ADMINISTRATION

Dosing Considerations For All Patients

Individualize the dosage according to the therapeutic needs and response of the patient. Administer Adderall XR 30 mg at the lowest effective dosage.

Based on bioequivalence data, patients taking divided doses of immediate-release ADDERALL, (for example, twice daily), may be switched to Adderall XR 30 mg at the same total daily dose taken once daily. Titrate at weekly intervals to appropriate efficacy and tolerability as indicated.

Adderall XR 30 mg capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

Adderall XR 30 mg may be taken with or without food.

Adderall XR 30 mg should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia.

Where possible, Adderall XR 30 mg therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Children

In children with ADHD who are 6-12 years of age and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children is 30 mg/day; doses greater than 30 mg/day of Adderall XR 30 mg have not been studied in children. Adderall XR 30 mg has not been studied in children under 6 years of age.

Adolescents

The recommended starting dose for adolescents with ADHD who are 13-17 years of age and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled.

Adults

In adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day.

HOW SUPPLIED

Dosage Forms And Strengths

Adderall XR 30 mg 5 mg capsules: Clear/blue (imprinted Adderall XR 30 mg 5 mg)

Adderall XR 30 mg 10 mg capsules: Blue/blue (imprinted Adderall XR 30 mg 10 mg)

Adderall XR 30 mg 15 mg capsules: Blue/white (imprinted Adderall XR 30 mg 15 mg)

Adderall XR 30 mg 20 mg capsules: Orange/orange (imprinted Adderall XR 30 mg 20 mg)

Adderall XR 30 mg 25 mg capsules: Orange/white (imprinted Adderall XR 30 mg 25 mg)

Adderall XR 30 mg 30 mg capsules: Natural/orange (imprinted Adderall XR 30 mg 30 mg)

Storage And Handling

Adderall XR 30 mg 5 mg capsules: Clear/blue (imprinted Adderall XR 30 mg 5 mg), bottles of 100, NDC 54092-381-01

Adderall XR 30 mg 10 mg capsules: Blue/blue (imprinted Adderall XR 30 mg 10 mg), bottles of 100, NDC 54092-383-01

Adderall XR 30 mg 15 mg capsules: Blue/white (imprinted Adderall XR 30 mg 15 mg), bottles of 100, NDC 54092-385-01

Adderall XR 30 mg 20 mg capsules: Orange/orange (imprinted Adderall XR 30 mg 20 mg), bottles of 100, NDC 54092-387-01

Adderall XR 30 mg 25 mg capsules: Orange/white (imprinted Adderall XR 30 mg 25 mg), bottles of 100, NDC 54092-389-01

Adderall XR 30 mg 30 mg capsules: Natural/orange (imprinted Adderall XR 30 mg 30 mg), bottles of 100, NDC 54092-391-01

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) [see USP Controlled Room Temperature]

Manufactured for Shire US Inc., Wayne, PA 19087. Revised: Apr 2015

Side Effects

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Studies Experience

The premarketing development program for Adderall XR 30 mg included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed.

Adverse Reactions Leading to Discontinuation of Treatment

In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of Adderall XR 30 mg-treated patients discontinued due to adverse reactions (including 3 patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo.

The most frequent adverse reactions leading to discontinuation of Adderall XR 30 mg in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to Adderall XR 30 mg for 12 months or more.

In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among Adderall XR 30 mg-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Adderall XR 30 mg-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0% ) discontinued treatment due to adverse events among Adderall XR 30 mg-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e. leading to discontinuation in at least 1% of Adderall XR 30 mg-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness(1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2).

Adverse Reactions Occurring in Controlled Trials

Adverse reactions reported in a 3-week clinical trial of children and a 4-week clinical trial in adolescents and adults, respectively, treated with Adderall XR 30 mg or placebo are presented in the tables below.

Table 1 : Adverse Reactions Reported by 2% or More of Children (6-12 Years Old) Receiving Adderall XR 30 mg with Higher Incidence Than on Placebo in a 584-Patient Clinical Study

Body SystemPreferred TermAdderall XR 30 mg

(n=374)Placebo

(n=210)

GeneralAbdominal Pain (stomachache)14%10%

Fever5%2%

Infection4%2%

Accidental Injury3%2%

Asthenia (fatigue)2%0%

Digestive SystemLoss of Appetite22%2%

Vomiting7%4%

Nausea5%3%

Dyspepsia2%1%

Nervous SystemInsomnia17%2%

Emotional Lability9%2%

Nervousness6%2%

Dizziness2%0%

Metabolic/ NutritionalWeight Loss4%0%

Table 2: Adverse Reactions Reported by 5% or More of Adolescents (13-17 Years Old) Weighing ≤ 75 kg/165 lbs Receiving Adderall XR 30 mg with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study*

Body SystemPreferred TermAdderall XR 30 mg

(n=233)Placebo

(n=54)

GeneralAbdominal Pain (stomachache)11%2%

Digestive SystemLoss of Appetite36%2%

Nervous SystemInsomniab12%4%

Nervousness6%6%a

Metabolic/ NutritionalWeight Loss9%0%

*Included doses up to 40 mg

a Appears the same due to rounding

b Dose-related adverse reactions

Note: The following reactions did not meet the criterion for inclusion in Table 2 but were reported by 2% to 4% of adolescent patients receiving Adderall XR 30 mg with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting.

Table 3 : Adverse Reactions Reported by 5% or More of Adults Receiving Adderall XR 30 mg with Higher Incidence Than on Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study*

Body SystemPreferred TermAdderall XR 30 mg

(n=191)Placebo

(n=64)

GeneralHeadache26%13%

Asthenia6%5%

Digestive SystemDry Mouth35%5%

Loss of Appetite33%3%

Nausea8%3%

Diarrhea6%0%

Nervous SystemInsomnia27%13%

Agitation8%5%

Anxiety8%5%

Dizziness7%0%

Nervousness13%13%a

Cardiovascular SystemTachycardia6%3%

Metabolic/ NutritionalWeight Loss10%0%

Urogenital SystemUrinary Tract Infection5%0%

*Included doses up to 60 mg.

a Appears the same due to rounding

Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adult patients receiving Adderall XR 30 mg with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence.

Hypertension

[see WARNINGS AND PRECAUTIONS]

In a controlled 4-week outpatient clinical study of adolescents with ADHD, isolated systolic blood pressure elevations ≥ of 15 mmHg were observed in 7/64 (11%) placebo-treated patients and 7/100 (7%) patients receiving Adderall XR 30 mg 10 or 20 mg. Isolated elevations in diastolic blood pressure ≥ 8 mmHg were observed in 16/64 (25%) placebo-treated patients and 22/100 (22%) Adderall XR 30 mg-treated patients. Similar results were observed at higher doses.

In a single-dose pharmacokinetic study in 23 adolescents with ADHD, isolated increases in systolic blood pressure (above the upper 95% CI for age, gender, and stature) were observed in 2/17 (12%) and 8/23 (35%), subjects administered 10 mg and 20 mg Adderall XR 30 mg, respectively. Higher single doses were associated with a greater increase in systolic blood pressure. All increases were transient, appeared maximal at 2 to 4 hours post-dose, and not associated with symptoms.

Adverse Reactions Associated With The Use of Amphetamine, Adderall XR 30 mg, Or ADDERALL

The following adverse reactions have been associated with the use of amphetamine, Adderall XR 30 mg, or ADDERALL:

Cardiovascular

Palpitations. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, tics, aggression, anger, logorrhea, dermatillomania, paresthesia (including formication), and bruxism.

Eye Disorders

Vision blurred, mydriasis.

Gastrointestinal

Unpleasant taste, constipation, other gastrointestinal disturbances.

Allergic

Urticaria, rash, hypersensitivity reactions including angioedema, and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.