Quillivant XR 300 mg/60mL
methylphenidate hydrochloride · SUSPENSION, EXTENDED RELEASE · NextWave Pharmaceuticals, Inc
Quillivant XR is a liquid suspension of methylphenidate, a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) in children. It is designed to release the medication gradually throughout the day to provide long-lasting symptom control.
Key Facts
- Brand Name
- Quillivant XR
- Generic Name
- methylphenidate hydrochloride
- NDC Code (Product)
24478-321- Manufacturer
- NextWave Pharmaceuticals, Inc
- Strength
- 300 mg/60mL
- Dosage Form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA202100
- Marketing Start
- 10/01/2012
Recall History
Pfizer Inc
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Pfizer Inc.
Failed Dissolution Specifications
Pfizer Inc.
Failed Dissolution Specifications
Pfizer Inc
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Pfizer Inc
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 ) ]. Limitations of Use The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. QUILLIVANT XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ( 1 ) Limitations of Use The use of QUILLIVANT XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Before administering the dose, vigorously shake bottle for at least 10 seconds. ( 2.2 ) May be taken with or without food. ( 2.3 ) For patients 6 years and above, recommended starting dose is 20 mg given orally once daily in the morning. Dosage may be increased weekly in increments of 10 mg to 20 mg per day. Daily dosage above 60 mg is not recommended. ( 2.2 ) Reconstitution instructions for the pharmacist: Tap bottle until powder flows freely. Remove bottle cap, add specified amount of water for reconstitution. Insert bottle adapter into neck of bottle. Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension. ( 2.6 ) 2.1 Pretreatment Screening Prior to treating patients with 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) ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating QUILLIVANT XR [see Warnings and Precautions (5.10) ]. 2.2 Recommended Dosage Before administering the dose, …
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to methylphenidate or product components. ( 4.1 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. ( 4.2 , 7.1 ) 4.1 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 ( 6.2 ) ]. 4.2 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 ( 7.1 ) ].
Drug Interactions
7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. ( 7 ) 7.1 Clinically Important Drug Interactions MAOI 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. Antihypertensive Drugs QUILLIVANT XR may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the hypertensive drug as needed [see Warnings and Precautions (5.3) ]. Halogenated Anesthetics Concomitant use of halogenated anesthetics and QUILLIVANT XR may increase the risk of sudden blood pressure and heart rate increase during surgery. Monitor blood pressure and avoid use of QUILLIVANT XR in patients being treated with anesthetics on the day of surgery. Risperidone Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in …
Adverse Reactions
6 ADVERSE REACTIONS 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 (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2 , 9.3 )] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [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 in Pediatric Patients [see Warnings and Precautions (5.7) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.8) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.9) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.10) ] Based on accumul…
Frequently Asked Questions
What is Quillivant XR used for?
Quillivant XR is a liquid suspension of methylphenidate, a stimulant medication used to treat attention-deficit/hyperactivity disorder (ADHD) in children. It is designed to release the medication gradually throughout the day to provide long-lasting symptom control.
Is Quillivant XR a controlled substance?
Yes, Quillivant XR is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Quillivant XR?
The generic name for Quillivant XR is methylphenidate hydrochloride. There are 12 other brand versions of methylphenidate hydrochloride.
What is the NDC code for Quillivant XR 300 mg/60mL?
The NDC (National Drug Code) for Quillivant XR 300 mg/60mL is 24478-321, listed by NextWave Pharmaceuticals, Inc.
Other Methylphenidate Brands
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- Methylphenidate Hydrochloride54 mg/10527-3313
- METHYLPHENIDATE HYDROCHLORIDE5 mg/116729-478
- QuilliChew ER40 mg/124478-076
- Methylphenidate Hydrochloride5 mg/143386-571
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- Methylphenidate Hydrochloride27 mg/150268-546
- Methylphenidate Hydrochloride10 mg/155466-102
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)