DEXEDRINE SPANSULE- dextroamphetamine sulfate capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXTROAMPHETAMINE SULFATE (UNII: JJ768O327N) (DEXTROAMPHETAMINE - UNII:TZ47U051FI)

Available from:

Amneal Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DEXEDRINE is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and 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. 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 m

Product summary:

DEXEDRINE SPANSULE capsules Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5-mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10-mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15-mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. 5 mg 90s:                                             NDC 64896-673-10 10 mg 90s:                                           NDC 64896-674-10 15 mg 90s:                                           NDC 64896-675-10 Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Dispense in a tight, light-resistant container. Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 Distributed by: Amneal Specialty, a division of Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2023-02 For additional copies of the printed medication guide, please visit www.amneal.com or contact us at 1-877-835-5472.

Authorization status:

New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
MEDICATION GUIDE
DEXEDRINE®(dek-suh-drin)
(dextroamphetamine sulfate) SPANSULE® sustained-release capsules, CII
What is the most important information I should know about DEXEDRINE?
DEXEDRINE may cause serious side effects, including:
•
Abuse misuse, and addiction. DEXEDRINE has a high chance for abuse and
misuse and may lead
to substance use problems, including addiction. Misuse and abuse of
DEXEDRINE, other
amphetamine containing medicines, and methylphenidate containing
medicines, can lead to
overdose and death. The risk of overdose and death is increased with
higher doses of
DEXEDRINE or when it is used in ways that are not approved, such as
snorting or injection.
•
Your healthcare provider should check you or your child’s risk for
abuse, misuse, and
addiction before starting treatment with DEXEDRINE and will monitor
you or your child
during treatment.
•
DEXEDRINE may lead to physical dependence after prolonged use, even if
taken as
directed by your healthcare provider.
•
Do not give DEXEDRINE to anyone else. See “What is DEXEDRINE?” for
more
information.
•
Keep DEXEDRINE in a safe place and properly dispose of any unused
medicine. See
“How should I store DEXEDRINE?” for more information.
•
Tell your healthcare provider if you or your child have ever abused or
been dependent on
alcohol, prescription medicines, or street drugs.
•
Risks for people with serious heart disease: Sudden death has happened
in people who have heart
defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for
heart problems before
starting DEXEDRINE. Tell your healthcare provider if you or your child
have any heart
problems, heart disease, or heart defects.
Call your healthcare provider right away or go to the nearest hospital
emergency room right away
if you or your child have any signs of heart problems such as chest
pain, shortness of breath, or
fainting during treatment with DEXEDRINE.
•
Increased bloo

Summary of Product characteristics

DEXEDRINE SPANSULE- DEXTROAMPHETAMINE SULFATE CAPSULE, EXTENDED
RELEASE
AMNEAL PHARMACEUTICALS LLC
----------
DEXEDRINE
(DEXTROAMPHETAMINE SULFATE) SPANSULE SUSTAINED-RELEASE CAPSULES, CII
RX ONLY
WARNING: ABUSE, MISUSE, AND ADDICTION
DEXEDRINE HAS A HIGH POTENTIAL FOR ABUSE AND MISUSE, WHICH CAN LEAD TO
THE DEVELOPMENT OF A SUBSTANCE USE DISORDER, INCLUDING ADDICTION.
MISUSE AND ABUSE OF CNS STIMULANTS, INCLUDING DEXEDRINE, CAN RESULT IN
OVERDOSE AND DEATH _[SEE OVERDOSAGE]_, AND THIS RISK IS INCREASED WITH
HIGHER DOSES OR UNAPPROVED METHODS OF ADMINISTRATION, SUCH AS SNORTING
OR INJECTION.
BEFORE PRESCRIBING DEXEDRINE, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION. EDUCATE PATIENTS AND THEIR FAMILIES ABOUT THESE
RISKS, PROPER STORAGE OF THE DRUG, AND PROPER DISPOSAL OF ANY UNUSED
DRUG. THROUGHOUT DEXEDRINE TREATMENT, REASSESS EACH PATIENT’S RISK
OF
ABUSE, MISUSE, AND ADDICTION AND FREQUENTLY MONITOR FOR SIGNS AND
SYMPTOMS OF ABUSE, MISUSE, AND ADDICTION _[SEE WARNINGS _AND _DRUG_
_ABUSE AND DEPENDENCE]_.
DESCRIPTION
DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the
compound _d_,_l_-
amphetamine sulfate, a sympathomimetic amine of the amphetamine group.
Chemically,
dextroamphetamine is _d_-alpha-methylphenethylamine, and is present in
all forms
of DEXEDRINE as the neutral sulfate.
Structural formula:
SPANSULE CAPSULES
Each SPANSULE sustained-release capsule is so prepared that an initial
dose is released
promptly and the remaining medication is released gradually over a
prolonged period.
Each capsule, with brown cap and natural body, contains
dextroamphetamine sulfate.
The 5-mg capsule is imprinted in white with IX and 5 mg on the brown
cap and is
imprinted in white with 673 and 5 mg on the natural body. The 10-mg
capsule is
®
®
imprinted in white with IX and 10 mg on the brown cap and is imprinted
in white with
674 and 10 mg on the natural body. The 15-mg capsule is imprinted in
white with IX and
15 mg on the brown cap and is imprinted in white with 675 and 15 mg on
the natur