Quillivant XR (Methylphenidate Hydrochloride Extended Release Oral …

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Quillivant XR Dosage

Generic name: METHYLPHENIDATE HYDROCHLORIDE 300mg in 60mL
Dosage form: powder, for oral suspension, extended release

Medically reviewed on October 17, 2018.

2.1 Pre-treatment Screening

Prior to treating children, adolescents, and adults with CNS stimulants including QUILLIVANT XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [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 re-evaluate the need for QUILLIVANT XR use [see Boxed Warning , Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9 )].

2.2 General Dosing Information

Before administering the dose, VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least 10 seconds, to ensure that the proper dose is administered.

The recommended starting dose of QUILLIVANT XR for patients 6 years and above is 20 mg once daily in the morning. The dose may be titrated weekly in increments of 10 mg to 20 mg. Daily doses above 60 mg have not been studied and are not recommended. As with any CNS stimulant, during titration of QUILLIVANT XR, the prescribed dose should be adjusted, if necessary, until a well‑tolerated, therapeutic dose is achieved.

Pharmacologic treatment of ADHD may be needed for extended periods. Health care providers should periodically re-evaluate the long-term use of QUILLIVANT XR, and adjust dosage as needed.

Patients should be advised to avoid alcohol while taking QUILLIVANT XR [see Clinical Pharmacology ( 12.3 )].

2.3 Administration Instructions

QUILLIVANT XR should be orally administered once daily in the morning with or without food [see Clinical Pharmacology ( 12.3 )].

2.4 Switching from other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with QUILLIVANT XR using the above titration schedule.

Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because of different methylphenidate base compositions and differing pharmacokinetic profiles [see Description ( 11 ), Clinical Pharmacology ( 12.3 )].

2.5 Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. QUILLIVANT XR should be periodically discontinued to assess the child’s condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

2.6 Reconstitution Instructions for the Pharmacist

QUILLIVANT XR is supplied as a powder for oral suspension which must be reconstituted with water prior to dispensing. Preparation instructions: Tap bottle until powder flows freely. Remove bottle cap, and add specified amount of water to the bottle (see Table 1 below). Fully insert bottle adapter into neck of bottle [see Instructions for Use , Figures F and G]. Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension.

Table 1. Product Reconstitution Instructions
Amount of drug in bottleAmount of water to add to bottleFinal reconstituted volume (yield)
300 mg53 mL60 mL
600 mg105 mL120 mL
750 mg131 mL150 mL
900 mg158 mL180 mL

Store reconstituted QUILLIVANT XR at 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF). Dispense in original packaging (bottle in carton) with bottle adapter inserted and with enclosed oral dosing dispenser. QUILLIVANT XR is stable for up to 4 months after reconstitution.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about Quillivant XR (methylphenidate)

  • Quillivant XR Side Effects
  • During Pregnancy or
    Breastfeeding
  • Drug Interactions
  • Support Group
  • En Español
  • 16 Reviews
  • Generic Availability
  • Drug class: CNS stimulants

Consumer resources

  • Quillivant XR
  • Quillivant XR (Advanced Reading)

Other brands: Concerta , Ritalin , Daytrana , Methylin , … +9 more

Professional resources

  • Quillivant XR (FDA)
  • Methylphenidate Hydrochloride (AHFS Monograph)

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Quillivant XR

  • Generic Name: methylphenidate hydrochloride extended release oral suspension, cii
  • Brand Name: Quillivant XR
Last reviewed on RxList: 11/21/2017

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Drug Description

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QUILLIVANT XR®
(methylphenidate hydrochloride) for Extended Release Oral Suspension

WARNING

ABUSE AND DEPENDENCE

CNS stimulants, including QUILLIVANT XR, 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 WARNINGS AND
PRECAUTIONS , Drug Abuse And Dependence ].

DESCRIPTION

QUILLIVANT XR is a powder that, after reconstitution with
water, forms an extended-release oral suspension formulation of methylphenidate
intended for once daily oral administration. QUILLIVANT XR contains
approximately 20% immediate-release and 80% extended-release methylphenidate.
After reconstitution, QUILLIVANT XR is available in a 25 mg per 5 mL (5 mg per mL)
extended-release oral suspension.

Methylphenidate HCl is a central nervous system (CNS)
stimulant. The chemical name is methyl α-phenyl-2-piperidineacetate hydrochloride,
and its structural formula is shown in Figure 1.

Figure 1: Methylphenidate HCl structure

QUILLIVANT XR® (methylphenidate hydrochloride) - Structural Formula Illustration

C14H19NO2 •HCl     Mol. Wt.
269.77

Methylphenidate HCl is a white, odorless crystalline
powder. Its solutions are acid to litmus . It is freely soluble in water and in methanol,
soluble in alcohol, and slightly soluble in chloroform and in acetone.

QUILLIVANT XR also contains the following inactive
ingredients: sodium polystyrene sulfonate, povidone, triacetin, polyvinyl acetate,
sucrose, anhydrous trisodium citrate, anhydrous citric acid, sodium benzoate,
sucralose, poloxamer 188, corn starch, xanthan gum, talc, banana flavor, and
silicon dioxide.

Indications & Dosage

INDICATIONS

QUILLIVANT XR is indicated for the treatment of Attention
Deficit Hyperactivity Disorder ( ADHD )[ see Clinical Studies ].

DOSAGE AND ADMINISTRATION

Pre-treatment Screening

Prior to treating children, adolescents, and adults with
CNS stimulants including QUILLIVANT XR, assess for the presence of cardiac
disease (i.e., perform a careful history, family history of sudden death or
ventricular arrhythmia , and physical exam) [see WARNINGS AND PRECAUTIONS ].

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 re-evaluate the need for QUILLIVANT XR use [see BOXED
WARNING
, WARNINGS AND PRECAUTIONS , Drug Abuse And Dependence ].

General Dosing Information

Before administering the dose, VIGOROUSLY SHAKE the
bottle of QUILLIVANT XR for at least 10 seconds, to ensure that the proper dose
is administered.

The recommended starting dose of QUILLIVANT XR for
patients 6 years and above is 20 mg once daily in the morning. The dose may be
titrated weekly in increments of 10 mg to 20 mg. Daily doses above 60 mg have
not been studied and are not recommended. As with any CNS stimulant, during
titration of QUILLIVANT XR, the prescribed dose should be adjusted, if necessary,
until a well-tolerated, therapeutic dose is achieved.

Pharmacologic treatment of ADHD may be needed for
extended periods. Health care providers should periodically re-evaluate the
long-term use of QUILLIVANT XR, and adjust dosage as needed.

Patients should be advised to avoid alcohol while taking
QUILLIVANT XR [see CLINICAL PHARMACOLOGY ].

Administration Instructions

QUILLIVANT XR should be orally administered once daily in
the morning with or without food [ see CLINICAL PHARMACOLOGY ].

Switching From Other Methylphenidate Products

If switching from other methylphenidate products,
discontinue that treatment, and titrate with QUILLIVANT XR using the above titration
schedule.

Do not substitute for other methylphenidate products on a
milligram -per-milligram basis, because of different methylphenidate base
compositions and differing pharmacokinetic profiles [see DESCRIPTION , CLINICAL
PHARMACOLOGY
].

Dose Reduction And Discontinuation

If paradoxical aggravation of symptoms or other adverse
effects occur, reduce dosage, or, if necessary, discontinue the drug. QUILLIVANT
XR should be periodically discontinued to assess the child’s condition. If
improvement is not observed after appropriate dosage adjustment over a
one-month period, the drug should be discontinued.

Reconstitution Instructions For The Pharmacist

QUILLIVANT XR is supplied as a powder for oral suspension
which must be reconstituted with water prior to dispensing.

Preparation instructions: Tap bottle until powder flows
freely. Remove bottle cap, and add specified amount of water to the bottle (see
Table 1 below). Fully insert bottle adapter into neck of bottle [see Instructions
for Use
, Figures F and G]. Replace bottle cap. Shake with vigorous back and
forth motion for at least 10 seconds to prepare suspension.

Table 1: Product Reconstitution Instructions

Amount of drug in bottleAmount of water to add to bottleFinal reconstituted volume (yield)
300 mg53 mL60 mL
600 mg105 mL120 mL
750 mg131 mL150 mL
900 mg158 mL180 mL

Store reconstituted QUILLIVANT XR at 25°C (77°F);
excursions permitted from 15° to 30°C (59° to 86°F). Dispense in original packaging
(bottle in carton) with bottle adapter inserted and with enclosed oral dosing
dispenser. QUILLIVANT XR is stable for up to 4 months after reconstitution.

HOW SUPPLIED

Dosage Forms And Strengths

Extended-release oral suspension (after reconstitution
with water): 25 mg per 5 mL (5 mg per mL).

QUILLIVANT XR is supplied as powder that, after
reconstitution with water, forms an extended-release oral suspension. The product
is supplied in a carton. Each carton also contains one bottle, one oral dosing
dispenser, and one bottle adapter.

The product must be reconstituted only by the pharmacist
and not by the patient or caregiver. After reconstitution, the product is a
light beige to tan viscous suspension containing 25 mg per 5 mL (5 mg per mL)
of methylphenidate hydrochloride.

Bottles of 300 mg powder (to prepare 60 mL suspension)
NDC 24478-190-10

Bottles of 600 mg powder (to prepare 120 mL suspension)
NDC 24478-200-20

Bottles of 750 mg powder (to prepare 150 mL suspension)
NDC 24478-205-25

Bottles of 900 mg powder (to prepare 180 mL suspension)
NDC 24478-210-30

Storage And Handling

Store at 25°C (77°F); excursions permitted from 15°C to
30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

Dispense in original container.

Disposal

Comply with local laws and regulations on drug disposal
of CNS stimulants. Dispose of remaining, unused, or expired QUILLIVANT XR 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 QUILLIVANT XR 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 QUILLIVANT XR in the
household trash.

Distributed by: NextWave Pharmaceuticals, Inc., A
subsidiary of Pfizer Inc., New York, NY 10017. Manufactured by: Tris Pharma,
Inc., Monmouth Junction, NJ 08852. Revised: Jun 2017.

Side Effects

SIDE EFFECTS

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

  • Known hypersensitivity to methylphenidate products or
    other ingredients of QUILLIVANT XR[ see CONTRAINDICATIONS ]
  • Hypertensive Crisis When Used Concomitantly with
    Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS , DRUG INTERACTIONS ]
  • Drug Dependence [see BOXED WARNING , WARNINGS
    AND PRECAUTIONS
    , Drug Abuse And Dependence]
  • Serious Cardiovascular Reactions [see WARNINGS AND
    PRECAUTIONS
    ]
  • Blood Pressure and Heart Rate Increases [see WARNINGS
    AND PRECAUTIONS
    ]
  • Psychiatric Adverse Reactions [see WARNINGS AND
    PRECAUTIONS
    ]
  • Priapism [see WARNINGS AND PRECAUTIONS ]
  • Peripheral Vasculopathy, including Raynaud’s phenomenon [see
    WARNINGS AND PRECAUTIONS
    ]
  • Long-Term Suppression of Growth [see WARNINGS AND
    PRECAUTIONS
    ]

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 clinical practice.

Clinical Trials Experience With Other Methylphenidate
Products In Children, Adolescents, And Adults With ADHD

Commonly reported (≥2% of the methylphenidate group
and at least twice the rate of the placebo group) adverse reactions from placebo-controlled
trials of methylphenidate products include: appetite decreased, weight
decreased, nausea, abdominal pain, dyspepsia , dry mouth , vomiting, insomnia,
anxiety, nervousness, restlessness, affect lability , agitation, irritability, dizziness,
vertigo , tremor , blurred vision, blood pressure increased, heart rate
increased, tachycardia , palpitations , hyperhidrosis , and pyrexia.

Clinical Trials Experience With QUILLIVANT XR In Children
And Adolescents With ADHD

There is limited experience with QUILLIVANT XR in
controlled trials. Based on this limited experience, the adverse reaction profile
of QUILLIVANT XR appears similar to other methylphenidate extended-release
products. The most common (≥2% in the QUILLIVANT XR group and greater
than placebo) adverse reactions reported in the Phase 3 controlled study
conducted in 45 ADHD patients (ages 6–12 years) were affect lability,
excoriation, initial insomnia, tic , decreased appetite, vomiting, motion sickness ,
eye pain, and rash.

Table 2: Common Adverse Reactions occurring in
≥2% of subjects on QUILLIVANT XR and greater than placebo during the
controlled cross-over phase

Adverse reactionQUILLIVANT XR
N= 45
Placebo
N= 45
Affect lability9%2%
Excoriation4%0
Initial Insomnia2%0
Tic2%0
Decreased appetite2%0
Vomiting2%0
Motion Adverse2%0
Eye pain2%0
Rash2%0

Postmarketing Experience

The following adverse reactions have been identified
during post approval use of methylphenidate products. Because these reactions
are reported voluntarily from a population of uncertain size, it is not
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure. These adverse reactions are as follows:

Blood and Lymphatic System Disorders:
Pancytopenia , Thrombocytopenia , Thrombocytopenic purpura

Cardiac Disorders: Angina pectoris , Bradycardia ,
Extrasystole , Supraventricular tachycardia , Ventricular extrasystole

Eye Disorders: Diplopia , Mydriasis , Visual
impairment

General Disorders: Chest pain, Chest discomfort,
Hyperpyrexia

Hepatobiliary Disorders: Severe hepatocellular
injury

Immune System Disorders: Hypersensitivity
reactions such as Angioedema , Anaphylactic reactions, Auricular swelling,
Bullous conditions, Exfoliative conditions, Urticarias, Pruritus NEC, Rashes,
Eruptions, and Exanthemas NEC

Investigations: Alkaline phosphatase increased,
Bilirubin increased, Hepatic enzyme increased, Platelet count decreased, White
blood cell count abnormal

Musculoskeletal, Connective Tissue and Bone Disorders:
Arthralgia , Myalgia , Muscle twitching , Rhabdomyolysis

Nervous System Disorders: Convulsion , Grand mal
convulsion, Dyskinesia , Serotonin syndrome in combination with serotonergic
drugs

Psychiatric Disorders: Disorientation, Hallucination ,
Hallucination auditory, Hallucination visual, Libido changes, Mania

Urogenital System: Priapism

Skin and Subcutaneous Tissue Disorders: Alopecia ,
Erythema

Vascular Disorders: Raynaud’s phenomenon

Drug Interactions

DRUG INTERACTIONS

Clinically Important Drug Interactions

MAO Inhibitors

Do not administer QUILLIVANT XR concomitantly with
monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI
treatment. Concomitant use of MAOIs and CNS stimulants can cause hypertensive
crisis. Potential outcomes include death, stroke , myocardial infarction , aortic
dissection , ophthalmological complications, eclampsia , pulmonary edema , and
renal failure.

Drug Abuse And Dependence

Controlled Substance

QUILLIVANT XR contains methylphenidate, a Schedule II
controlled substance.

Abuse

CNS stimulants including QUILLIVANT XR, other
methylphenidate-containing products, and amphetamines have a high potential for
abuse. Abuse is characterized by impaired control over drug use, compulsive
use, continued 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, suicidal or homicidal ideation have also been
observed.  Abusers of CNS stimulants may chew, snort , inject, or use other
unapproved routes of administration which can result in overdose and death [see
OVERDOSAGE ].

To reduce the abuse of CNS stimulants including
QUILLIVANT XR, assess the risk of abuse prior to prescribing. After prescribing,
keep careful prescription records, educate patients and their families about
abuse and on proper storage and disposal of CNS stimulants, monitor for signs
of abuse while on therapy, and re-evaluate the need for QUILLIVANT XR use.

Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a
drug results in a reduction of the drug’s desired and/or undesired effects over
time) can occur during chronic therapy with CNS stimulants including QUILLIVANT
XR.

Dependence

Physical dependence (a state of adaptation manifested by
a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or
administration of an antagonist ) can occur in patients treated with CNS
stimulants including QUILLIVANT XR. Withdrawal symptoms after abrupt cessation
following prolonged high-dosage administration of CNS stimulants include dysphoric
mood; fatigue; vivid, unpleasant dreams ; insomnia or hypersomnia; increased
appetite; and psychomotor retardation or agitation.

Warnings & Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Potential For Abuse and Dependence

CNS stimulants, including QUILLIVANT XR, 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 Drug Abuse And
Dependence
].

Serious Cardiovascular Reactions

Stroke and myocardial infarction have occurred in adults
treated with CNS stimulants at recommended doses. Sudden death has occurred in
children and adolescents with structural cardiac abnormalities and other
serious cardiac problems, and in adults taking CNS stimulants at recommended
doses for ADHD . Avoid use in patients with known structural cardiac abnormalities,
cardiomyopathy , serious cardiac arrhythmias, coronary artery disease , or other
serious cardiac problems. Further evaluate patients who develop exertional
chest pain, unexplained syncope , or arrhythmias during treatment with QUILLIVANT
XR.

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 .

Psychiatric Adverse Reactions

Exacerbation Of Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior
disturbance and thought disorder in patients with a pre-existing psychotic
disorder.

Induction Of A Manic Episode In Patients With Bipolar
Disorder

CNS stimulants may induce a manic or mixed 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 QUILLIVANT XR. 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.

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.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon

CNS stimulants, including QUILLIVANT XR, 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 of
digital changes is necessary during treatment with ADHD stimulants. Further
clinical evaluation (e.g., rheumatology referral ) may be appropriate for
certain patients.

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 nonmedication treatment groups over 14 months, as well as in
naturalistic subgroups of newly methylphenidate-treated and nonmedicationtreated
pediatric 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 QUILLIVANT XR. Patients who are
not growing or gaining height or weight as expected may need to have their
treatment interrupted.

Patient Counseling Information

Advise patients to read the FDA-approved patient labeling
( Medication Guide and Instructions for Use ).

Controlled Substance Status/Potential For Abuse And Dependence

Advise patients and their caregivers that QUILLIVANT XR
is a federally controlled substance, and it can be abused and lead to dependence
[see Drug Abuse and Dependence ]. Instruct patients that they should not
give QUILLIVANT XR to anyone else. Advise patients to store QUILLIVANT XR in a
safe place, preferably locked, to prevent abuse. Advise patients to comply with
laws and regulations on drug disposal. Advise patients to dispose of remaining,
unused, or expired QUILLIVANT XR through a medicine take-back program if
available [see WARNINGS AND PRECAUTIONS, Abuse and Dependence].

Instructions For Using The Enclosed Oral Dosing Dispenser

Provide the following instructions on administration to
the patient or caregiver:

  • The pharmacist should provide this medicine in its
    original packaging (bottle within carton) with the bottle adapter fully inserted
    and the accompanying oral dosing dispenser. Use only with the oral dosing
    dispenser provided with this product.
  • Check and make sure that the QUILLIVANT XR bottle
    contains liquid medicine. If QUILLIVANT XR is in powder form, do not use it.
    Return it to your pharmacist.
  • VIGOROUSLY SHAKE the bottle of QUILLIVANT XR for at least
    10 seconds before each dose, to ensure that the proper dose is administered.
  • Remove the bottle cap. Confirm that the bottle adapter
    has been inserted into top of the bottle.
  • Insert the tip of the oral dosing dispenser provided with
    this product into the bottle adapter.
  • Turn bottle upside down and withdraw prescribed amount of
    QUILLIVANT XR into the oral dosing dispenser.
  • Remove filled oral dosing dispenser from bottle and
    dispense QUILLIVANT XR directly into mouth.
  • Replace bottle cap and store bottle as directed.
  • Wash oral dosing dispenser after each use (components are
    dishwasher-safe).
Serious Cardiovascular Risks

Advise patients, caregivers, and family members that
there is a potential for serious cardiovascular risks including sudden death,
myocardial infarction , and stroke with QUILLIVANT XR use. Instruct patients to
contact a health care provider immediately if they develop symptoms such as
exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac
disease [see WARNINGS AND PRECAUTIONS].

Blood Pressure And Heart Rate Increases

Advise patients that QUILLIVANT XR can elevate blood
pressure and heart rate [see WARNINGS AND PRECAUTIONS].

Psychiatric Risks

Advise patients that QUILLIVANT XR, at recommended doses,
can cause psychotic or manic symptoms, even in patients without a prior history
of psychotic symptoms or mania [see WARNINGS AND PRECAUTIONS].

Priapism

Advise patients, caregivers, and family members of the
possibility of painful or prolonged penile erections (priapism). Instruct the
patient to seek immediate medical attention in the event of priapism
[see
WARNINGS AND PRECAUTIONS
].

Circulation Problems In Fingers And Toes [Peripheral
Vasculopathy, Including Raynaud’s Phenomenon]
  • Instruct patients beginning treatment with QUILLIVANT XR
    about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and
    associated signs and symptoms: fingers or toes may feel numb, cool, painful,
    and/or may change color from pale, to blue, to red.
  • Instruct patients to report to their physician any new
    numbness, pain, skin color change, or sensitivity to temperature in fingers or
    toes.
  • Instruct patients to call their physician immediately
    with any signs of unexplained wounds appearing on fingers or toes while taking
    QUILLIVANT XR.
  • Further clinical evaluation (e.g., rheumatology referral)
    may be appropriate for certain patients.
Suppression Of Growth

Advise patients, families, and caregivers that QUILLIVANT
XR can cause slowing of growth and weight loss[ see WARNINGS AND PRECAUTIONS].

Alcohol Effect

Patients should be advised to avoid alcohol while taking
QUILLIVANT XR Oral Suspension. Consumption of alcohol while taking QUILLIVANT
XR may result in a more rapid release of the dose of methylphenidate [see CLINICAL
PHARMACOLOGY
].

This product’s label may have been updated. For current
full prescribing information, please visit www.pfizer.com.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

In a lifetime carcinogenicity study carried out in B6C3F1
mice, methylphenidate caused an increase in hepatocellular adenomas and, in
males only, an increase in hepatoblastomas, at a daily dose of approximately 60
mg/kg/day. This dose is approximately 4 times the maximum recommended human
dose on a mg/m² basis. Hepatoblastoma is a relatively rare rodent malignant
tumor type. There was no increase in total malignant hepatic tumors. The mouse
strain used is sensitive to the development of hepatic tumors, and the
significance of these results to humans is unknown.

Methylphenidate did not cause any increase in tumors in a
lifetime carcinogenicity study carried out in F344 rats; the highest dose used
was approximately 45 mg/kg/day, which is approximately 5 times the maximum
recommended human dose on a mg/m² basis.

Mutagenesis

Methylphenidate was not mutagenic in the in vitro Ames
reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation
assay. Sister chromatid exchanges and chromosome aberrations were increased,
indicative of a weak clastogenic response, in an in vitro assay in cultured
Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in an in vivo mouse
bone marrow micronucleus assay.

Impairment Of Fertility

Methylphenidate did not impair fertility in male or
female mice that were fed diets containing the drug in an 18-week Continuous Breeding
study. The study was conducted at doses of up to 160 mg/kg/day, approximately
8-fold the maximum recommended human dose on a mg/m² basis.

Use In Specific Populations

Pregnancy

Risk Summary

There are limited published studies and small case series
that report on the use of methylphenidate in pregnant women; however, the data
are insufficient to inform any drug-associated risks. There are clinical
considerations [see Clinical Considerations]. No teratogenic effects
were observed in embryo-fetal development studies with oral administration of methylphenidate
to pregnant rats and rabbits during organogenesis at doses 2 and 11 times,
respectively, the maximum recommended human dose (MRHD). However, spina bifida
was observed in rabbits at a dose 40 times the MRHD [see Data].

In the U.S. general population, the estimated background
risk of major birth defects and miscarriage in clinically recognized pregnancies
is 2–4% and 15–20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

CNS stimulant medications, such as QUILLIVANT XR, 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 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. Teratogenic effects (increased incidence of
fetal spina bifida) were observed in rabbits at the highest dose, which is
approximately 40 times the maximum recommended human dose (MRHD) on a mg/m² basis.
The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day
(11 times the MRHD on a mg/m² basis). There was no evidence of specific
teratogenic activity in rats, although increased incidences of fetal skeletal
variations were seen at the highest dose level (7 times the MRHD on a mg/m²
basis), which was also maternally toxic. The no effect level for embryo-fetal
development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m² basis).

Lactation

Risk Summary

Limited published literature 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 from
CNS stimulant exposure are unknown. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical need for
QUILLIVANT XR and any potential adverse effects on the breastfed infant from QUILLIVANT
XR or from the underlying maternal condition.

Clinical Considerations

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

Pediatric Use

The safety and effectiveness of QUILLIVANT XR have been
established in pediatric patients ages 6 to 17 years. Use of QUILLIVANT XR in
pediatric patients 6 to 12 years of age is supported by one adequate and
well-controlled study [see Clinical Studies ]. Use in 12 to 17 year olds
is supported by the adequate and well-controlled studies of QUILLIVANT XR in
younger pediatric patients and additional pharmacokinetic data in adolescents,
along with safety information from other methylphenidate-containing products.
The long-term efficacy of methylphenidate in pediatric patients has not been
established. Safety and efficacy in pediatric patients below the age of 6 years
have not been established.

Long Term Suppression Of Growth

Growth should be monitored during treatment with CNS
stimulants, including QUILLIVANT XR. Children who are not growing or gaining
weight as expected may need to have their treatment interrupted [see WARNINGS
AND PRECAUTIONS
].

Juvenile Animal 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 6 times the maximum recommended human dose (MRHD) on
a mg/m² basis.

In the 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 13–14), decreased spontaneous locomotor activity was observed
in males and females previously treated with 50 mg/kg/day (approximately 6 times
the maximum recommended human dose [MRHD] on a mg/m² basis) or greater, and a
deficit in the acquisition of a specific learning task was observed in females
exposed to the highest dose (12 times the MRHD on a mg/m² basis). The no effect
level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half
the MRHD on a mg/m² basis). The clinical significance of the long-term
behavioral effects observed in rats is unknown.

Geriatric Use

QUILLIVANT XR has not been studied in patients over the
age of 65 years.

Overdosage

OVERDOSE

Consult with a Certified Poison Control Center
(1-800-222-1222) for up-to-date guidance and advice on the management of overdosage
with methylphenidate. Signs and symptoms of acute methylphenidate overdosage,
resulting principally from overstimulation of the CNS and from excessive
sympathomimetic effects, may include the following: nausea, vomiting, diarrhea,
restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching ,
convulsions (may be followed by coma), euphoria , confusion, hallucinations,
delirium , sweating, flushing, headache, hyperpyrexia, tachycardia ,
palpitations , cardiac arrhythmias, hypertension , hypotension , tachypnea ,
mydriasis , dryness of mucous membranes, and rhabdomyolysis .

Contraindications

CONTRAINDICATIONS

Hypersensitivity To Methylphenidate Or Other Components Of
QUILLIVANT XR

QUILLIVANT XR is contraindicated in patients known to be
hypersensitive to methylphenidate, or other components of QUILLIVANT XR.
Hypersensitivity reactions such as angioedema and anaphylactic reactions have
been reported in patients treated with other methylphenidate products [see ADVERSE
REACTIONS
].

Monoamine Oxidase Inhibitors

QUILLIVANT XR is contraindicated during treatment with
monoamine oxidase inhibitors (MAOIs), and also within 14 days following
discontinuation of treatment with a monoamine oxidase inhibitor ( MAOI ), because
of the risk of hypertensive crisis [see DRUG INTERACTIONS ].

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Mechanism Of Action

Methylphenidate HCl is a central nervous system (CNS)
stimulant.

Pharmacodynamics

Methylphenidate is a racemic mixture comprised of the d- and
l-isomers. The d-isomer is more pharmacologically active than the l-isomer. The
mode of therapeutic action in ADHD is not known. Methylphenidate blocks the
reuptake of norepinephrine and dopamine into the presynaptic neuron and
increases the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Absorption

Following a single, 60 mg oral dose of QUILLIVANT XR in
28 healthy adult subjects in a crossover study under fasting conditions, d-methylphenidate
(d- MPH ) mean ( ± SD) peak plasma concentrations of 13.6 ( ± 5.8) ng/mL occurred
at a median time of 5.0 hours after dosing (Figure 2). The relative
bioavailability of QUILLIVANT XR compared to Methylphenidate IR oral solution
(2×30 mg, q6h) is 95%.

Figure 2: Mean d-Methylphenidate Plasma
Concentration-Time Profiles

Mean d-Methylphenidate Plasma
Concentration-Time Profiles Structural Formula Illustration

The single dose pharmacokinetics of d-MPH under fed
conditions are summarized (Table 3) from studies in children and adolescents
with ADHD, and healthy adults following an oral dose of 60 mg QUILLIVANT XR.

Table 3: d-MPH PK Parameters (mean ± SD) after 60 mg oral
dosing of QUILLIVANT XR*

PK ParameterChildren†
(n=3)
Adolescent†
(n=4)
Adult
(n=27)
Tmax (hr)‡4.05
(3.98-6.0)
2.0
(1.98-4.0)
4.0
(1.3-7.3)
T½ (hr)5.2 ± 0.15.0 ± 0.25.2 ± 1.0
Cmax (ng/mL)34.4 ± 14.021.1 ± 5.917.0 ± 7.7
AUCinf (hr*ng/mL)378 ± 175178 ± 54.2163.2 ± 80.3
Cl (L/hr/kg)4.27 ± 0.705.06 ± 1.425.66 ± 2.15
*Breakfast was given 30 min prior to drug administration
†total MPH measured in children (9-12 years old) and adolescents (13-15 years
old), l-MPH <2% of d- MPH in circulation
‡data presented as median (range)

Food Effects

In a study in adult volunteers to investigate the effects
of a high-fat meal on the bioavailability of QUILLIVANT XR at a dose of 60 mg,
the presence of food reduced the time to peak concentration by approximately 1
hour (fed: 4 hours vs. fasted: 5 hours). Overall, a high-fat meal increased the
average C of QUILLIVANT XR by about 28% and the AUC by about 19%. These changes
are not considered clinically significant.

Elimination

Following a single 60 mg oral dose of QUILLIVANT XR in 28
healthy adult subjects under fasting conditions, the mean plasma terminal
elimination half-life of d-methylphenidate was 5.6 ( ± 0.8) hours.

Metabolism

In humans, methylphenidate is metabolized primarily via
deesterification to alpha-phenyl-piperidine acetic acid (PPAA). The metabolite
has little or no pharmacologic activity.

Excretion

After oral dosing of radiolabeled methylphenidate in
humans, about 90% of the radioactivity was recovered in urine. The main urinary
metabolite was PPAA, accounting for approximately 80% of the dose.

Alcohol Effect

An in vitro study was conducted to explore the effect of
alcohol on the release characteristics of methylphenidate from QUILLIVANT XR
Oral Suspension. At alcohol concentrations of 5% and 10%, there was no effect
of alcohol on the release characteristics of methylphenidate. At 20% alcohol
concentration, there was on average a 20% increase in drug exposure [see DOSAGE
AND ADMINISTRATION
].

Specific Populations

Sex

There is insufficient experience with the use of
QUILLIVANT XR to detect gender variations in pharmacokinetics.

Race

There is insufficient experience with the use of
QUILLIVANT XR to detect ethnic variations in pharmacokinetics.

Age

The pharmacokinetics of methylphenidate after QUILLIVANT
XR administration were studied in pediatric patients with ADHD between 9 and 15
years of age. After a single oral dose of 60 mg QUILLIVANT XR, plasma
concentrations of methylphenidate in children (9-12 years old; n=3) were
approximately twice the concentrations observed in adults. The plasma concentrations
in adolescent patients (13-15 years old; n=4) were similar to those in adults.

Renal Impairment

There is no experience with the use of QUILLIVANT XR in
patients with renal insufficiency. After oral administration of radiolabeled
methylphenidate in humans, methylphenidate was extensively metabolized and
approximately 80% of the radioactivity was excreted in the urine in the form of
PPAA. Since renal clearance is not an important route of methylphenidate clearance,
renal insufficiency is expected to have little effect on the pharmacokinetics
of QUILLIVANT XR.

Hepatic Impairment

There is no experience with the use of QUILLIVANT XR in
patients with hepatic insufficiency.

Clinical Studies

The efficacy of QUILLIVANT XR was evaluated in a
laboratory classroom study conducted in 45 pediatric patients (ages 6 to 12
years) with ADHD. Patients in the trial met Diagnostic and Statistical Manual
of Mental Diseases, 4th edition ( DSM-IV ®) criteria for ADHD. The
study began with an open-label dose optimization period (4 to 6 weeks) with an
initial QUILLIVANT XR dose of 20 mg once daily in the morning. The dose could
be titrated weekly in increments of 10 or 20 mg until a therapeutic dose or the
maximum dose of 60 mg/day was reached. At the end of the dose optimization
period, approximately 5% of subjects were receiving 20 mg/day; 39%, 30 mg/day;
31%, 40 mg/day; 10%, 50 mg/day; and 15%, 60 mg/day. Subjects then entered a 2-week
randomized, double-blind, crossover treatment with the individually optimized
dose of QUILLIVANT XR or placebo. At the end of each week, school teachers and
raters evaluated the attention and behavior of the subjects in a laboratory
classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating
scale. The primary efficacy endpoint was the SKAMP-Combined score at 4 hours
post-dosing. The key secondary efficacy endpoints were the SKAMPCombined scores
at 0.75, 2, 8, 10, and 12 hours post-dosing.

Results from the first double-blind, placebo-controlled
week of the study are summarized in Figure 3. SKAMP-Combined scores were
statistically significantly lower (improved) at all time points (0.75, 2, 4, 8,
10, 12 hours) post-dosing with QUILLIVANT XR compared to placebo.

Figure 3: Absolute SKAMP-Combined Score after
treatment with QUILLIVANT XR or Placebo during Period 1.

Absolute SKAMP-Combined Score after
treatment with QUILLIVANT XR or Placebo during Period 1 Illustration

Medication Guide

PATIENT INFORMATION

QUILLIVANT XR®
(\kwil-e-vant\)
(methylphenidate hydrochloride) for Extended-Release Oral
Suspension

What is the most important information I should know
about QUILLIVANT XR?

QUILLIVANT XR is a federally controlled substance
(CII) because it can be abused or lead to dependence. Keep QUILLIVANT XR in a
safe place to prevent misuse and abuse. Selling or giving away QUILLIVANT XR
may harm others, and is against the law.

Tell your health care provider if you or your child have
(or have a family history of) ever abused or been dependent on alcohol, prescription
medicines or street drugs.

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

1. 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 health care provider if you or your child have
any heart problems, heart defects, high blood pressure , or a family history of
these problems.

Your health care provider should check you or your child
carefully for heart problems before starting QUILLIVANT XR.

Your health care provider should check your or your
child’s blood pressure and heart rate regularly during treatment with QUILLIVANT
XR.

Call your health care provider right away if you or
your child has any signs of heart problems such as chest pain, shortness of
breath, or fainting while taking QUILLIVANT XR.

2. Mental (Psychiatric) problems:

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices,
    believing things that are not true, are suspicious) or new
  • manic symptoms

Tell your health care provider about any mental problems
you or your child have, or about a family history of suicide, bipolar illness,
or depression.

Call your health care provider right away if you or
your child have any new or worsening mental symptoms or problems while taking
QUILLIVANT XR, especially seeing or hearing things that are not real, believing
things that are not real, or are suspicious.

3. Circulation problems in fingers and toes
[Peripheral vasculopathy, including Raynaud’s phenomenon]:

  • Fingers or toes may feel numb, cool, painful
  • Fingers or toes may change color from pale, to blue, to
    red

Tell your health care provider if you have or your child
has numbness, pain, skin color change, or sensitivity to temperature in the
fingers or toes.

Call your health care provider right away if you have
or your child has any signs of unexplained wounds appearing on fingers or toes
while taking QUILLIVANT XR.

What is QUILLIVANT XR?

QUILLIVANT XR is a central nervous system stimulant
prescription medicine. QUILLIVANT XR is a liquid medicine that you take
by mouth.

It is used for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
QUILLIVANT XR may help increase attention
and decrease impulsiveness and hyperactivity in people with ADHD .

It is not known if QUILLIVANT XR is safe and effective in
children under 6 years of age.

Do not take QUILLIVANT XR if you or your child:

  • are allergic to methylphenidate hydrochloride, or any of
    the ingredients in QUILLIVANT XR. See the end of this Medication Guide for a
    complete list of ingredients in QUILLIVANT XR.
  • are taking or have taken within the past 14 days a type
    of anti-depression medicine called a monoamine oxidase inhibitor ( MAOI ).

QUILLIVANT XR may not be right for you or your child.
Before starting QUILLIVANT XR tell your or your child’s health care provider
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 and toes
  • if you are pregnant or plan to become pregnant. It is not
    known if QUILLIVANT XR will harm your unborn baby. Talk to your health care
    provider if you are pregnant or plan to become pregnant.
  • if you are breastfeeding or plan to breast feed.
    QUILLIVANT XR passes into your breast milk. You and your doctor should decide
    if you will take QUILLIVANT XR or breast feed.

Tell your health care provider about all of the
medicines that you or your child take including prescription and nonprescription
medicines, vitamins, and herbal supplements.
QUILLIVANT XR 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 QUILLIVANT
XR.

Your health care provider will decide whether QUILLIVANT XR
can be taken with other medicines.

Especially tell your health care provider if you or
your child takes:

  • anti-depression medicines including MAOIs

Know the medicines that you or your child takes. Keep a
list of your medicines with you to show your health care provider and pharmacist.

Do not start any new medicine while taking QUILLIVANT
XR without talking to your health care provider first.

How should QUILLIVANT XR be taken?

  • Read the step-by-step instructions for using
    QUILLIVANT XR extended-release suspension at the end of this Medication Guide.
  • Take QUILLIVANT XR exactly as prescribed. Your health
    care provider may adjust the dose, if needed, until it is right for you or your
    child. During dose adjustment, you or your child may still have ADHD symptoms.
  • QUILLIVANT XR should be used with the oral dosing
    dispenser provided with the product. If the oral dosing dispenser is missing or
    not provided, please contact your pharmacist for a replacement.
  • Check and make sure that the QUILLIVANT XR bottle
    contains liquid medicine. If QUILLIVANT XR is in powder form, do not use it.
    Return it to your pharmacist.
  • Check and make sure that the bottle adapter was fully
    inserted into the bottle by the pharmacist. If the bottle adapter is not fully
    inserted, insert the adapter into the bottle.
  • Take QUILLIVANT XR 1 time each day in the morning.
    QUILLIVANT XR is an extended-release suspension. It releases medicine into your
    body throughout the day.
  • QUILLIVANT XR can be taken with or without food. Taking
    QUILLIVANT XR with food may shorten the time it takes for the medicine to start
    working.
  • From time to time, your health care provider may stop
    QUILLIVANT XR treatment for a while to check ADHD symptoms.
  • Your health care provider may do regular checks of the
    blood, heart, and blood pressure while taking QUILLIVANT XR.
  • Children should have their height and weight checked
    often while taking QUILLIVANT XR. QUILLIVANT XR 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.
  • If a dose is missed, you or your child should talk to
    your health care provider about dosing.

What should I avoid while taking QUILLIVANT XR?

  • QUILLIVANT XR should not be taken with MAOI medicines. Do
    not start taking QUILLIVANT XR if you stopped taking an MAOI in the last 14
    days.
  • Do not drink alcohol while taking QUILLIVANT XR. This may
    cause a faster release of your methylphenidate dose.

What are the possible side effects of QUILLIVANT XR?

QUILLIVANT XR may cause serious side effects,
including:

  • See “What is the most important information I
    should know about QUILLIVANT XR?”
    for information on reported heart
    and mental problems.

Other serious side effects include:

  • painful and prolonged erections ( priapism ) have occurred
    with methylphenidate. If you or your child develop priapism seek medical help
    right away. Because priapism can cause long lasting damage, it should be
    checked by a health care provider right away.
  • slowing of growth (height and weight) in children

The most common side effects of QUILLIVANT XR include:

  • decreased appetite
  • indigestion
  • dizziness
  • increased blood pressure
  • trouble sleeping
  • stomach pain
  • irritability
  • nausea
  • weight loss
  • mood swings
  • vomiting
  • anxiety
  • fast heart beat

These are not all the possible side effects of QUILLIVANT
XR.

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

How should I store QUILLIVANT XR?

  • Store QUILLIVANT XR in a safe place at 59°F to 86°F (15°C
    to 30°C).
  • Keep QUILLIVANT XR and all medicines out of the reach
    of children.

General information about the safe and effective use
of QUILLIVANT XR

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use QUILLIVANT XR for a
condition for which it was not prescribed. Do not give QUILLIVANT XR to other
people, even if they have the same condition. It may harm them.

You can ask your pharmacist or health care provider for
information about QUILLIVANT XR that was written for health care professionals.

What are the ingredients in QUILLIVANT XR?

Active Ingredient: methylphenidate hydrochloride

Inactive Ingredients: sodium polystyrene
sulfonate, povidone, triacetin, polyvinyl acetate, sucrose, anhydrous trisodium
citrate, anhydrous citric acid, sodium benzoate, sucralose, poloxamer 188, corn
starch, xanthan gum, talc, banana flavor, and silicon dioxide.

For more information, go to www.quillivantxr.com or call
1-800-438-1985.

This Medication Guide has been approved by the U.S. Food
and Drug Administration.
This product’s label may have been updated. For current
full prescribing information, please visit www.pfizer.com.

Instructions for Use

QUILLIVANT XR®
(\kwil-e-vant\)
(methylphenidate hydrochloride) for extended-release oral
suspension

Read this Instructions for Use before using QUILLIVANT XR
and each time you get a refill. There may be new information. This leaflet does
not take the place of talking with the health care provider about your or your
child’s medical condition or treatment.

Step 1. Remove the QUILLIVANT XR bottle and oral
dosing dispenser from the box (See Figure A). If the oral dosing dispenser is
missing or not provided, please contact your pharmacist for a replacement.

Figure A

QUILLIVANT XR bottle and oral dosing dispenser - Illustration

Step 2. Check and make sure that the QUILLIVANT XR
bottle contains liquid medicine (See Figure B). If QUILLIVANT XR is still in
powder form, do not use it. Return it to your pharmacist.

Figure B

Check and make sure that the QUILLIVANT XR
bottle contains liquid medicine - Illustration

Step 3. Shake the bottle well (up and down) for at
least 10 seconds before each use (See Figure C).

Figure C

Shake the bottle well (up and down) for at
least 10 seconds - Illustration

Step 4. Uncap the bottle and check that the bottle
adapter has been fully inserted into the bottle (See Figure D).

Figure D

Uncap the bottle and check that the bottle
adapter has been fully inserted into the bottle - Illustration

Step 4 (continued). If bottle adapter (See Figure
E) has not been inserted by the pharmacist into the bottle, insert adapter into
the bottle as shown (See Figure F and Figure G).

Figure E

If bottle adapter has not been inserted by the pharmacist into the bottle - Illustration

Figure F

Insert adapter into
the bottle as shown - Illustration

After the bottle adapter has been fully inserted into the
bottle (See Figure G), it should not be removed. If the bottle adapter has not
been inserted and is missing from the box, contact your pharmacist.

The bottle adapter must be fully inserted and should be
even with the mouth of the bottle and must remain in place to allow the child
resistant cap to work the right way.

Figure G

The bottle adapter must be fully inserted and should be
even - Illustration

Step 5. Check the QUILLIVANT XR dose in
milliliters (mL) as prescribed by your health care provider. Locate this number
on the oral dosing dispenser (See Figure H).

Figure H

Check the QUILLIVANT XR dose in
milliliters - Illustration

Step 6. Insert tip of the oral dosing dispenser
into the upright bottle and push the plunger all the way down (See Figure I).

Figure I

Insert tip of the oral dosing dispenser - Illustration

Step 7. With the oral dosing dispenser in place,
turn the bottle upside down. Pull the plunger to the number of mL you need (the
amount of liquid medicine in Step 5 – See Figure J).

Figure J

Pull the plunger to the number of mL you need - Illustration

Step 7 (continued). Measure the number of mL of
medicine from the white end of the plunger (See Figure K)

Figure K

Measure the number of mL of
medicine from the white end of the plunger - Illustration

Step 8. Remove the oral dosing dispenser from the
bottle adapter.

Step 9. Slowly squirt QUILLIVANT XR directly into your
or your child’s mouth (See Figure L).

Figure L

Slowly squirt QUILLIVANT XR directly into your
or your child's mouth - Illustration

Step 10. Cap the bottle tightly. Store the bottle
upright at 59°F to 86°F (15°C to 30°C) (See Figure M)

Figure M

Cap the bottle tightly - Illustration

Step 11. Clean the oral dosing dispenser after
each use by placing in the dishwasher, or by rinsing with tap water (See Figure
N).

Figure N

Clean the oral dosing dispenser after
each use - Illustration

These Instructions for Use have been approved by the U.S.
Food and Drug Administration.

This product’s label may have been updated. For current
full prescribing information, please visit www.pfizer.com.

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