APTENSIO XR (- methylphenidate hydrochloride capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)

Available from:

Rhodes Pharmaceuticals L.P.

INN (International Name):

METHYLPHENIDATE HYDROCHLORIDE

Composition:

METHYLPHENIDATE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

APTENSIO XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)]. Limitations of Use Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss [see Use in Specific Populations (8.4)]. - Hypersensitivity to methylphenidate or other components of the product. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see Adverse Reactions (6.1)]. - Concomitant treatment with monoamine oxidase inhibitors, and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor, because of the risk of hypertensive crisis [see Drug Interactions (7.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to APTENSIO XR durin

Product summary:

APTENSIO XR (methylphenidate hydrochloride extended-release) capsules are available as follows: 10 mg Capsules – light turquoise blue cap/white body, (imprinted with "APTENSIO XR" on cap and "10 mg" on the body) 15 mg Capsules – orange cap/white body, (imprinted with "APTENSIO XR" on cap and "15 mg" on the body) 20 mg Capsules – yellow cap/white body, (imprinted with "APTENSIO XR" on cap and "20 mg" on the body) 30 mg Capsules – blue violet cap/white body, (imprinted with "APTENSIO XR" on cap and "30 mg" on the body) 40 mg Capsules – pink cap/white body, (imprinted with "APTENSIO XR" on cap and "40 mg" on the body) 50 mg Capsules – green cap/white body, (imprinted with "APTENSIO XR" on cap and "50 mg" on the body) 60 mg Capsules – gray cap/white body, (imprinted with "APTENSIO XR" on cap and "60 mg" on the body) Storage and Handling APTENSIO XR (methylphenidate hydrochloride extended-release) capsules should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

New Drug Application

Patient Information leaflet

Rhodes Pharmaceuticals L.P.
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MEDICATION GUIDE
APTENSIO XR® (APP-TEN-SEE-O)
(METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE)
CAPSULES, CII
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 10/2023
What is the most important information I should know about APTENSIO
XR?
APTENSIO XR may cause serious side effects, including:
•
Abuse, misuse, and addiction. APTENSIO XR has a high chance for abuse
and misuse and may
lead to substance use problems, including addiction. Misuse and abuse
of APTENSIO XR, other
methylphenidate containing medicines, and amphetamine containing
medicines, can lead to
overdose and death. The risk of overdose and death is increased with
higher doses of APTENSIO
XR 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 APTENSIO XR and will monitor
you or your
child during treatment.
•
APTENSIO XR may lead to physical dependence after prolonged use, even
if taken as
directed by your healthcare provider.
•
Do not give APTENSIO XR to anyone else. See "What is APTENSIO XR?" for
more
information.
•
Keep APTENSIO XR in a safe place and properly dispose of any unused
medicine. See
"How should I store APTENSIO XR?" 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 treatment with APTENSIO XR. Tell your healthcare provider if
you or your child have
any heart problems, heart disease, or heart defects.
Your healthcare provider should check you or your child's blood
pressure and heart rate regularly
during treatment with APTENSIO XR.
Call your hea

Summary of Product characteristics

APTENSIO XR- (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE
RHODES PHARMACEUTICALS L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APTENSIO XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APTENSIO XR .
APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE) CAPSULES,
FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 1955
WARNING: ABUSE, MISUSE, AND ADDICTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
APTENSIO XR 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 APTENSIO XR, CAN RESULT IN OVERDOSE AND
DEATH (5.1, 9.2,
10):
BEFORE PRESCRIBING APTENSIO XR, 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 TREATMENT, REASSESS EACH PATIENT'S RISK AND FREQUENTLY
MONITOR FOR SIGNS
AND SYMPTOMS OF ABUSE, MISUES, AND ADDICTION.
RECENT MAJOR CHANGES
Boxed Warning
10/2023
Dosage and Administration (2.1, 2.3, 2.4)
10/2023
Warnings and Precautions (5.1, 5.2, 5.7, 5.8, 5.9, 5.10)
10/2023
INDICATIONS AND USAGE
APTENSIO XR is a central nervous system (CNS) stimulant indicated for
the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in patients 6 years and older. (1)
Limitations of Use:
Pediatric patients younger than 6 years of age experienced higher
plasma exposure than patients 6 years
and older at the same dose and high rates of adverse reactions, most
notably weight loss. (8.4)
DOSAGE AND ADMINISTRATION
Recommended starting dose for patients 6 years and older: 10 mg once
daily with or without food in the
morning. Dosage may be increased weekly in increments of 10 mg per
day. Daily dosage above 60 mg
is not recommended. (2.1)
Capsules may be swallowed whole or opened and the entire contents
sprinkled onto applesauce. (2.1)
DOSAGE FORMS AN