METHYLPHENIDATE HYDROCHLORIDE capsule, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Available from:
Granules Pharmaceuticals Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14)] . - Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)]. - Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules during pregnancy.Healthcare providers are encouraged to register patients by calling th
Product summary:
Methylphenidate hydrochloride extended-release capsules are supplied as: 10 mg: Hard gelatin capsules, yellow opaque cap printed with “G 10mg” and white opaque body printed with “012” contains white to off-white pellets. Bottles of 100 NDC 70010-012-01 20 mg: Hard gelatin capsules, white opaque cap printed with “G 20mg” and white opaque body printed with “013” contains white to off-white pellets. Bottles of 100 NDC 70010-013-01 30 mg: Hard gelatin capsules, yellow opaque cap printed with “G 30mg” and yellow opaque body printed with “014” contains white to off-white pellets. Bottles of 100 NDC 70010-014-01 40 mg: Hard gelatin capsules, yellow opaque cap printed with “G 40mg” and yellow opaque body printed with “015” contains white to off-white pellets. Bottles of 100 NDC 70010-015-01 60 mg: Hard gelatin capsules, yellow opaque cap printed with “G 60mg” and yellow opaque body printed with “016” contains white to off-white pellets. Bottles of 30 NDC 70010-016-03 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature] Dispense in a tight container as defined in the USP with a child-resistant closure. Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules by a medicine take- back program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride extended-release capsules with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard methylphenidate hydrochloride extended-release capsules in the household trash.
Authorization status:
Abbreviated New Drug Application
Authorization number:
70010-012-01, 70010-013-01, 70010-014-01, 70010-015-01, 70010-016-03

Granules Pharmaceuticals Inc.

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SPL MEDGUIDE SECTION

MEDICATION GUIDE

Methylphenidate Hydrochloride Extended-Release CapsulesCII

(METH-il-FEN-i-date HYE-droe-KLOR-ide)

What is the most important information I should know about methylphenidate hydrochloride extended-

release

capsules?

Methylphenidate hydrochloride extended-release capsules is a federal controlled substance (CII)

because

abused

lead

dependence.

Keep methylphenidate hydrochloride extended-release capsules in a safe place to prevent misuse and

abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules may harm

others, and is against the law. Tell your doctor if you or your child have ever abused or been dependent

alcohol,

prescription

medicines

street

drugs.

The following have been reported with use of methylphenidate hydrochloride and other stimulant

medicines.

Heart-related problems:

sudden death in patients who have heart problems or heart defects

stroke and heart attack in adults

increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a

family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting

methylphenidate hydrochloride extended-release capsules.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment

with

methylphenidate

hydrochloride

extended-release

capsules.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain,

shortness of breath, or fainting while taking methylphenidate hydrochloride extended-release capsules.

Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

new psychotic symptoms (such as hearing voices, believing things that are not true, are

suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of

suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or

problems while taking methylphenidate hydrochloride extended-release capsules, especially seeing or

hearing things that are not real, believing things that are not real, or are suspicious.

What are methylphenidate hydrochloride extended-release capsules?

Methylphenidate hydrochloride extended-release capsules are a central nervous system stimulant

prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder

(ADHD). Methylphenidate hydrochloride extended-release capsules may help increase attention and

decrease impulsiveness and hyperactivity in patients with ADHD.

Methylphenidate hydrochloride extended-release capsules should be used as a part of a total treatment

program for ADHD that may include counseling or other therapies.

It is not known if methylphenidate hydrochloride extended-release capsules are safe and effective in

children under 6 years of age.

Who should not take methylphenidate hydrochloride extended-release capsules?

methylphenidate hydrochloride extended-release capsules should not be taken if you or your child:

are allergic to methylphenidate hydrochloride, or any of the ingredients in in methylphenidate

hydrochloride extended-release capsules. See the end of this Medication Guide for a complete

list of ingredients in methylphenidate hydrochloride extended-release capsules.

are taking or have taken within the past 14 days an anti-depression medicine called a

monoamine oxidase inhibitor or MAOI.

Methylphenidate hydrochloride extended-release capsules may not be right for you or your child.

Before starting methylphenidate hydrochloride extended-release capsules tell your or your child’s

doctor about all health conditions (or a family history of) including:

heart problems, heart defects, high blood pressure

mental problems including psychosis, mania, bipolar illness, or depression

circulation problems in fingers or toes

if you are pregnant or plan to become pregnant. It is not known if methylphenidate

hydrochloride extended-release capsules will harm your unborn baby.

There is a pregnancy registry for females who are exposed to ADHD medications, including

methylphenidate hydrochloride extended-release capsules during pregnancy. The purpose of the

registry is to collect information about the health of females exposed to methylphenidate

hydrochloride extended-release capsules and their baby. If you or your child becomes pregnant

during treatment with methylphenidate hydrochloride extended-release capsules, talk to your

healthcare provider about registering with the National Pregnancy Registry of ADHD

medications at 1-866-961-2388 or visit online at https://womensmentalhealth.org/adhd-

medications/.

if you are breastfeeding or plan to breastfeed. Methylphenidate hydrochloride passes into your

breast milk. Talk to your healthcare provider about the best way to feed the baby during

treatment with methylphenidate hydrochloride extended-release capsules.

Tell your doctor about all of the medicines that you or your child take including prescription and over-

the-counter medicines, vitamins, and herbal supplements. Methylphenidate hydrochloride extended-

release capsules and some medicines may interact with each other and cause serious side effects.

Sometimes the doses of other medicines will need to be adjusted while taking methylphenidate

hydrochloride extended-release capsules.

Your doctor will decide whether methylphenidate hydrochloride extended-release capsules can be

taken with other medicines.

Especially tell your doctor if you or your child takes:

anti-depression medicines including MAOIs

blood pressure medicines (anti-hypertensive)

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your

doctor

pharmacist.

Do not start any new medicine while taking methylphenidate hydrochloride extended-release capsules

without talking to your doctor first.

How should methylphenidate hydrochloride extended-release capsules be taken?

Take methylphenidate hydrochloride extended-release capsules exactly as prescribed. Your

doctor may adjust the dose until it is right for you or your child.

Take methylphenidate hydrochloride extended-release capsules once a day in the morning.

methylphenidate hydrochloride extended-release capsules are an extended-release capsule.

Do not chew or crush methylphenidate hydrochloride extended-release capsules or the medicine

inside the capsule. Swallow methylphenidate hydrochloride extended-release capsules whole

with water or other liquids.

If you cannot swallow the capsule whole, open it and sprinkle the medicine over a spoonful of

applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a

drink of water or other liquid.

You should avoid drinking alcohol during treatment with methylphenidate hydrochloride

extended-release capsules. This may cause a faster release of methylphenidate hydrochloride

extended-release capsules.

From time to time, your doctor may stop methylphenidate hydrochloride extended-release

capsules treatment for a while to check ADHD symptoms.

Your doctor may do regular checks of the blood, heart, and blood pressure while taking

methylphenidate hydrochloride extended-release capsules. Children should have their height

and weight checked often while taking methylphenidate hydrochloride extended-release

capsules. methylphenidate hydrochloride extended-release capsules treatment may be stopped if

a problem is found during these check-ups.

In case of poisoning, call your poison control center at 1-800-222-1222 right away or go to the nearest

hospital emergency room.

What are possible side effects of methylphenidate hydrochloride extended-release capsules?

See " What is the most important information I should know about methylphenidate

hydrochloride extended-release capsules?" for information on reported heart and mental

problems.

painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your

child develops priapism, seek medical help right away. Because of the potential for lasting

damage, priapism should be evaluated by a doctor immediately.

circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud's

phenomenon):

fingers

toes

feel

numb,

cool,

painful

o fingers or toes may change color from pale, to blue, to red

Tell your doctor if you or your child have numbness, pain, skin color change, or sensitivity to

temperature in the fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds

appearing on fingers or toes while taking methylphenidate hydrochloride extended-release

capsules.

slowing of growth (height and weight) in children

Common side effects include:

fast heartbeat

sweating a lot

abnormal heartbeat (palpitations)

decreased appetite

headache

dry mouth

trouble sleeping

nausea

nervousness

stomach pain

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

FDA- 1088.

How should I store methylphenidate hydrochloride extended-release capsules?

Store methylphenidate hydrochloride extended-release capsules in a safe place and in a tightly

closed container at room temperature, 68°F to 77°F (20°C to 25°C).

Protect from moisture.

Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release

capsules by a medicine take-back program at authorized collection sites such as retail

pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back

program or authorized collector is available, mix methylphenidate hydrochloride extended-

release capsules with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee

grounds to make it less appealing to children and pets. Place the mixture in a container such as

a sealed plastic bag and throw away (discard) methylphenidate hydrochloride extended-release

capsules in the household trash.

Keep methylphenidate hydrochloride extended-release capsules and all medicines out of the

reach of children.

General information about the safe and effective use methylphenidate hydrochloride extended-release

capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You

can ask your pharmacist or doctor for information about methylphenidate hydrochloride extended-

release capsules that is written for healthcare professionals. Do not use methylphenidate hydrochloride

extended-release capsules for a condition for which it was not prescribed. Do not give methylphenidate

hydrochloride extended-release capsules to other people, even if they have the same symptoms. It may

harm them and it is against the law.

What

ingredients

methylphenidate

hydrochloride

extended-release

capsules?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: Acetyltributyl citrate, cellaburate, corn starch, gelatin, hypromellose acetate

succinate, polyethylene glycol, sucrose, talc, and titanium dioxide. The 10 mg, 30 mg, 40 mg, and 60

mg capsules contain FD & C Yellow #6. The 10 mg, 30 mg, and 60 mg capsules also contain FD&C

Yellow #5. The 40 mg and 60 mg capsules contain D&C Yellow #10. In addition, capsule printing ink

contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac glaze.

Methylphenidate Hydrochloride Extended-Release Capsules contain FD&C Yellow #5 (tartrazine).

Dispense

with

Medication

Guide

also

available

http://www.granulesindia.com/U.S.ProductCatalog.php

Manufactured

Granules

Pharmaceuticals

Inc.,

Chantilly,

20151

Rev.

10/2020

For more information, call 1-877-770-3183.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 10/2020

Document Id: b13cb331-6a6f-7ec3-e053-2a95a90a7b06

34391-3

Set id: 27ea91ad-f64e-43d7-ab10-6f988bca5379

Version: 5

Effective Time: 20201009

Granules Pharmaceuticals Inc.

METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride capsule, extended

release

Granules Pharmaceuticals Inc.

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.

These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE

EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES.

METHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII

Initial U.S. Approval: 1955

WARNING: DRUG DEPENDENCE

See full prescribing information for complete boxed warning.

CNS stimulants, including methylphenidate hydrochloride extended-release capsules, other

methylphenidate containing products, and amphetamines, have a high potential for abuse and

dependence ( 5.1, 9.2, 9.3).

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on

therapy ( 5.1, 9.2)

RECENT MAJOR CHANGES

Boxed Warning 1/2019

Contraindications (4) 1/2019

Warnings and Precautions (5) 1/2019

INDICATIONS AND USAGE

Methylphenidate hydrochloride extended-release capsule is a central nervous system (CNS) stimulant indicated for the

treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age. (1)

DOSAGE AND ADMINISTRATION

Administer orally once daily in the morning (2.2)

Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce (2.2)

Should not be crushed, chewed, or divided (2.2)

Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10 mg increments. Doses above 60

mg daily are not recommended (2.3)

For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-

release tablets: Dosage is based on current dose regimen (2.4)

If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate

hydrochloride extended-release capsules (2.4)

DOSAGE FORMS AND STRENGTHS

Extended-release capsules: 10mg, 20mg, 30mg, 40mg and 60 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to methylphenidate or product components (4)

Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days

WARNINGS AND PRECAUTIONS

Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual

doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden

death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac

abnormalities, cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease (5.2).

Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider the benefits and risk in patients

for whom an increase in blood pressure or heart rate would be problematic (5.3).

Psychiatric Adverse Reactions: Use of stimulants may cause psychotic or manic symptoms in patients with no prior

history or exacerbation of symptoms in patients with preexisting psychiatric illness. Evaluate for preexisting psychotic

or bipolar disorder prior to methylphenidate hydrochloride extended-release capsules use (5.4).

Priapism: Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate

products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or

priapism are observed (5.5)

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants used to treat ADHD are associated with

peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during

treatment with ADHD stimulants (5.6).

Long-Term Suppression of Growth: Monitor height and weight at appropriate intervals in pediatric patients (5.7).

ADVERSE REACTIONS

Most common adverse reactions (greater than 5% during incidence) were headache, insomnia, upper abdominal pain,

appetite decreased and anorexia (6).

To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Antihypertensive drugs: Monitor blood pressure and heart. Adjust dosage of antihypertensive drug as needed (7).

Avoid use of methylphenidate hydrochloride extended-release capsules on the day of surgery if halogenated

anesthetics will be used (7).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ABUSE AND DEPENDENCE

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

2.2 General Dosing Information

2.3 Patients Currently Using Methylphenidate Hydrochloride Tablets and Methylphenidate

Hydrochloride Extended-Release Tablets

2.4 Switching from other Methylphenidate Products

2.5 Dose Reduction and Discontinuation

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

5.2 Serious Cardiovascular Reactions

5.3 Blood Pressure and Heart Rate Increases

5.4 Psychiatric Adverse Reactions

5.5 Priapism

5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon

5.7 Long-Term Suppression of Growth

5.8 Risk of Allergic Reactions Due to Tartrazine

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Children and Adolescents

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

WARNING: ABUSE AND DEPENDENCE

WARNING: ABUSE AND DRUG DEPENDENCE

CNS stimulants, including methylphenidate hydrochloride extended-release capsules, other

methylphenidate-containing products, and amphetamines, 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 Warning and Precautions (5.1), Drug Abuse and

Dependence( 9.2, 9.3)] .

1 INDICATIONS AND USAGE

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention

Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies

(14)] .

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to initiating treatment with central nervous system (CNS) stimulants, including methylphenidate

hydrochloride extended-release capsules, assess for the presence of cardiac disease (i.e., perform a

careful history including family history of sudden death or ventricular arrhythmia, and physical

examination) [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 reevaluate the need for methylphenidate hydrochloride extended-release

capsules use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9)] .

2.2 General Dosing Information

The recommended starting dose for methylphenidate hydrochloride extended-release capsule is 20 mg

once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not

recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.

Administer methylphenidate hydrochloride extended-release capsules orally once daily in the morning.

Methylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or

may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific

instructions below).Methylphenidate hydrochloride extended-release capsules and/or their contents

should not be crushed, chewed, or divided.

The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The

applesauce should not be warm because it could affect the modified release properties of this

formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The

drug and applesauce mixture should not be stored for future use.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the

long-term use of methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-

release tablets, and adjust dosage as needed.

2.3 Patients Currently Using Methylphenidate Hydrochloride Tablets and Methylphenidate

Hydrochloride Extended-Release Tablets

The recommended dose of methylphenidate hydrochloride extended-release capsules for patients

currently taking methylphenidate hydrochloride tablets twice daily or methylphenidate hydrochloride

extended-release tablets is provided below.

TABLE 1: Recommended Dose Conversion from Methylphenidate Hydrochloride Tablets and

Methylphenidate Hydrochloride Extended-Release Tablets

Previous Methylphenidate Hydrochloride

Tablets or Methylphenidate Hydrochloride

Extended-Release Tablets Dose

Recommended Methylphenidate Hydrochloride

Extended-Release Capsules Dose

5 mg methylphenidate hydrochloride tablets twice

daily

10 mg once daily

10 mg methylphenidate hydrochloride tablets

twice daily or 20 mg methylphenidate

hydrochloride extended-release tablets

20 mg once daily

15 mg methylphenidate hydrochloride tablets

twice daily

30 mg once daily

20 mg methylphenidate hydrochloride tablets

twice daily or 40 mg methylphenidate

hydrochloride extended-release tablets

40 mg once daily

30 mg methylphenidate hydrochloride tablets

twice daily or 60 mg methylphenidate

hydrochloride extended-release tablets

60 mg once daily

2.4 Switching from other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with

methylphenidate hydrochloride extended-release capsules using the titration schedule.

Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because

different methylphenidate base compositions and differing pharmacokinetic profiles [see Description

(11), Clinical Pharmacology (12.3)] .

Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not

recommended.

2.5 Dose Reduction and Discontinuation

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if

necessary, discontinue methylphenidate hydrochloride extended-release capsules. If improvement is not

observed after appropriate dosage adjustment over a one-month period, the drug should be

discontinued.

3 DOSAGE FORMS AND STRENGTHS

10 mg

Hard gelatin capsules, yellow opaque cap printed with“G 10mg” and white opaque body printed with

“012” contains white to off-white pellets.

20 mg

Hard gelatin capsules, white opaque cap printed with “G 20mg” and white opaque body printed with

“013” contains white to off-white pellets.

30 mg

Hard gelatin capsules, yellow opaque cap printed with “G 30mg” and yellow opaque body printed with

“014” contains white to off-white pellets.

40 mg

Hard gelatin capsules, yellow opaque cap printed with “G 40mg” and yellow opaque body printed with

“015” contains white to off-white pellets.

60 mg

Hard gelatin capsules, yellow opaque cap printed with “G 60mg” and yellow opaque body printed with

“016” contains white to off-white pellets.

4 CONTRAINDICATIONS

Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride

extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic

reactions have been reported in patients treated with methylphenidate [see Adverse Reactions (6.1)].

Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following

discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug

Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants, including methylphenidate hydrochloride extended-release capsules, other

methylphenidate-containing products, and amphetamines, 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 pediatric patients 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 rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate

patients who develop exertional chest pain, unexplained syncope, or arrhythmias during methylphenidate

hydrochloride extended-release capsules treatment.

5.3 Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and

heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all

patients for hypertension and tachycardia.

5.4 Psychiatric Adverse Reactions

Exacerbation of Preexisting Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with

a preexisting psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment,

screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive

symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations,

delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such

symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release capsules. In a

pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or

manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in

placebo-treated patients.

5.5 Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with

methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug

initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism

has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients

who develop abnormally sustained or frequent and painful erections should seek immediate medical

attention.

5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon

CNS stimulants, including methylphenidate hydrochloride extended-release capsules, used to treat

ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and

symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration

and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon,

were observed in post-marketing reports at different times and at therapeutic doses in all age groups

throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or

discontinuation of drug. Careful observation for digital changes is necessary during treatment with

ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for

certain patients.

5.7 Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to

either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic

subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months (to the

ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days

per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2

cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth

rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including

methylphenidate hydrochloride extended-release capsules, Patients who are not growing or gaining

height or weight as expected may need to have their treatment interrupted.

5.8 Risk of Allergic Reactions Due to Tartrazine

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions

(including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C

Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients

who also have aspirin hypersensitivity.

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

Abuse and Dependence [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and

Dependence(9.2, 9.3)]

Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride

extended-release capsules [see Contraindications (4)]

Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see

Contraindications (4), Drug Interactions (7.1)]

Serious cardiovascular reactions [see Warnings and Precautions (5.2)]

Blood pressure and heart rate increases [see Warnings and Precautions (5.3)]

Psychiatric adverse reactions [see Warnings and Precautions (5.4)]

Priapism [see Warnings and Precautions (5.5)]

Peripheral vasculopathy, including Raynaud’s phenomenon [see Warnings and Precautions (5.6)]

Long-term suppression of growth [see Warnings and Precautions (5.7)]

6.1 Clinical Trials Experience

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 practice.

The clinical program for methylphenidate hydrochloride extended-release capsules consisted of 6

studies: 2 controlled clinical studies conducted in children with ADHD aged 6 to 12 years and 4

clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of

256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received

methylphenidate hydrochloride extended-release capsules in doses of 10 to 40 mg per day. Safety of

methylphenidate hydrochloride extended-release capsules was assessed by evaluating frequency and

nature of adverse events, routine laboratory tests, vital signs, and body weight. A placebo-controlled,

double-blind, parallel-group study was conducted to evaluate the efficacy and safety of methylphenidate

hydrochloride extended-release capsules in children with ADHD aged 6 to 12 years. All subjects

received methylphenidate hydrochloride extended-release capsules for up to 4 weeks, and had their

dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week double-blind

treatment phase of this study, patients received either placebo or methylphenidate hydrochloride

extended-release capsules at their individually-titrated dose (range 10 mg to 40 mg).

Adverse reactions with an incidence greater than 5% during the initial 4-week single-blind

methylphenidate hydrochloride extended-release capsules titration period of this study were headache,

insomnia, upper abdominal pain, appetite decreased, and anorexia.

Adverse reactions with an incidence greater than 2% among methylphenidate hydrochloride extended-

release capsules-treated subjects, during the 2-week double blind phase of the clinical study, are shown

in Table 2:

Table 2: Adverse Reactions in Greater Than 2% Methylphenidate Hydrochloride Extended-

Release Capsules-Treated Subjects in the 2-Week Double-Blind Phase

Preferred Term

Methylphenidate

Hydrochloride Extended-

Release Capsules

N = 65

N (%)

Placebo

N = 71

N (%)

Anorexia

2 (3.1)

0 (0)

Insomnia

2 (3.1)

0 (0)

Adverse Events Associated with Discontinuation of Treatment

In the 2-week double-blind treatment phase of a placebo-controlled parallel-group study in children

with ADHD, one methylphenidate hydrochloride extended-release capsules -treated subject (1/65,

1.5%) discontinued due to an adverse event (depressed mood).

In the single-blind titration period of this study, subjects received methylphenidate hydrochloride

extended-release capsules for up to 4 weeks. During this period a total of 6 subjects (6/161, 3.7%)

discontinued due to adverse events. The adverse events leading to discontinuation were anger (2

patients), hypomania, anxiety, depressed mood, fatigue, migraine and lethargy.

6.2 Postmarketing Experience

The following adverse reactions have been identified during the post approval use of methylphenidate

products. Because these reactions were reported voluntarily from a population of uncertain size, it is

not always possible to estimate their frequency reliably or to establish a causal relationship to drug

exposure.

Adverse Reactions Reported with methylphenidate hydrochloride tablets, methylphenidate

hydrochloride extended-release tablets, and methylphenidate hydrochloride extended-release capsules

Infections and Infestations: nasopharyngitis

Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia

Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis

Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of

growth during prolonged use in children

Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and

tactile hallucinations), depressed mood

Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoathetoid movements,

drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and

cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs

Eye Disorders: blurred vision, difficulties in visual accommodation

Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris

Respiratory, Thoracic and Mediastinal Disorders: cough

Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia

Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic

injury

Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp

hair loss, erythema multiforme rash, thrombocytopenic purpura

Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis

Investigations: weight loss (adult ADHD patients)

Adverse Reactions Reported with Other Methylphenidate-Containing Products

The list below shows adverse reactions not listed with methylphenidate hydrochloride tablets,

methylphenidate hydrochloride extended-release tablets, or methylphenidate hydrochloride extended-

release capsules formulations that have been reported with other methylphenidate-containing products.

Blood and Lymphatic Disorders: pancytopenia

Immune System Disorders: hypersensitivity reactions such as auricular swelling, bullous conditions,

eruptions, exanthemas

Psychiatric Disorders: affect lability, mania, disorientation, libido changes,

Nervous System disorders: migraine

Eye Disorders: diplopia, mydriasis

Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole

Vascular Disorders: peripheral coldness, Raynaud's phenomenon

Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea

Gastrointestinal Disorders: diarrhea, constipation

Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption

Musculoskeletal, Connective Tissue and Bone Disorders: myalgia, muscle twitching

Renal and Urinary Disorders: hematuria

Reproductive System and Breast Disorders: gynecomastia

General Disorders: fatigue, hyperpyrexia

Urogenital Disorders: priapism

7 DRUG INTERACTIONS

7.1 Clinically Important Interactions with methylphenidate hydrochloride extended-release

caps ules

Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-

release capsules

Table 3: Drugs Having Clinically Important Drug Interactions with Methylphenidate Hydrochloride

Extended-Release Capsules

Monoamine Oxidase Inhibitors (MAOI)

Clinical Impact

Concomitant use of MAOIs and CNS stimulants, including methylphenidate

hydrochloride

extended-release

capsules,

cause

hypertensive

crisis.

Potential

outcomes

include

death,

stroke,

myocardial

infarction,

aortic

dissection, ophthalmological complications, eclampsia, pulmonary edema, and

renal failure [see Contraindications (4)] .

Intervention

Concomitant use of methylphenidate hydrochloride extended-release capsules

with

MAOIs

within

days

after

discontinuing

MAOI

treatment

contraindicated.

Examples

selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene

blue

Antihypertensive Drugs

Clinical Impact

Methylphenidate hydrochloride extended-release capsules may decrease the

effectiveness of drugs used to treat hypertension [see Warnings and

Precautions(5.3)].

Intervention

Monitor blood pressure and adjust the dosage of the antihypertensive drug as

needed.

Examples

Potassium-sparing and thiazide diuretics, calcium channel blockers, ACE

inhibitors, ARBs, beta blockers, centrally acting alpha-2 receptor agonists.

Halogenated Anesthetics

Clinical Impact

Concomitant use of halogenated anesthestics and methylphenidate

hydrochloride extended-release capsules may increase the risk of sudden

blood pressure and heart rate increase during surgery.

Intervention

Avoid use of methylphenidate hydrochloride extended-release capsules in

patients being treated with anesthetics on the day of surgery.

Examples

halothane, isoflurane, enflurane, desflurane, sevoflurane

8 USE IN SPECIFIC POPULATIONS

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD

medications, including methylphenidate hydrochloride extended-release capsules during

pregnancy.Healthcare providers are encouraged to register patients by calling the National Pregnancy

registry for ADHD medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-

medications/.

8.1 Pregnancy

Risk Summary

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a

drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be

risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical

Considerations). No effects on morphological development were observed in embryo-fetal development

studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at

doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day

given to adolescents on a mg/m

basis. However, spina bifida was observed in rabbits at a dose 52 times the

MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal

development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at

doses 6 times the MRHD given to adolescents (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is

unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the

U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically

recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

CNS stimulants such as methylphenidate hydrochloride, can cause vasoconstriction and thereby decrease

placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of

therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight

infants have been reported in amphetamine-dependent mothers.

Data

Animal Data

In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally

at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Malformations

(increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is

approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m

basis. The no effect level

for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a

mg/m

basis). There was no evidence of morphological development effects in rats, although increased

incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day

given to adolescents on a mg/m

basis), which was also maternally toxic. The no effect level for embryo-fetal

development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m

basis). When methylphenidate was

administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body

weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a

mg/m

basis), but no other effects on postnatal development were observed. The no effect level for pre- and

postnatal development in rats was 15 mg/kg/day (~2 times the MRHD given to adolescents on a mg/m

basis).

8.2 Lactation

Risk Summary

Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is

present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal weight-adjusted

dosage and a milk/plasma ratio ranging between 1.1 and 2.7. There are no reports of adverse effects on

the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants

2

2

2

2

2

2

2

from stimulant exposure are unknown. The developmental and health benefits of breastfeeding should be

considered along with the mother’s clinical need for methylphenidate hydrochloride extended-release

capsules and any potential adverse effects on the breastfed infant from methylphenidate hydrochloride

extended-release capsules or from the underlying maternal condition.

Clinical Considerations

Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced

weight gain.

8.4 Pediatric Use

The safety and effectiveness of methylphenidate hydrochloride extended-release capsules for the

treatment of ADHD have been established in pediatric patients 6 to 12 years.

The safety and effectiveness of methylphenidate hydrochloride extended-release capsules in pediatric

patients less than 6 years have not been established. The long-term efficacy of methylphenidate

hydrochloride extended-release capsules in pediatric patients has not been established.

Long-Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride

extended-release capsules. Pediatric patients who are not growing or gaining weight as expected may

need to have their treatment interrupted [see Warnings and Precautions (5.7)].

Juvenile Animal Toxicity Data

Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a

decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning

task was observed in females only. The doses at which these findings were observed are at least 4

times the MRHD of 60 mg/day given to children on a mg/m

basis.

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100

mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through

sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to

14), decreased spontaneous locomotor activity was observed in males and females previously treated

with 50 mg/kg/day (approximately 4 times the MRHD of 60 mg/day given to children on a mg/m

basis)

or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the

highest dose (8 times the MRHD given to children on a mg/m

basis). The no effect level for juvenile

neurobehavioral development in rats was 5 mg/kg/day (approximately 0.5 times the MRHD given to

children on a mg/m

basis). The clinical significance of the long-term behavioral effects observed in

rats is unknown.

8.5 Geriatric Use

Methylphenidate hydrochloride extended-release capsules has not been studied in the geriatric

population.

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, a

Schedule II controlled substance.

9.2 Abuse

CNS stimulants, including methylphenidate hydrochloride extended-release capsules, have a high

potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and

craving.

Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood

pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss

of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility,

aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants

may chew, snort, inject, or use other unapproved routes of administration which may result in overdose

and death [see Overdosage (10)]

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