Drugplain

Dexmethylphenidate Hydrochloride Extended-Release 35 mg/1

dexmethylphenidate hydrochloride · CAPSULE, EXTENDED RELEASE · Lannett Company, Inc.

No Recall History
Plain English

Dexmethylphenidate Hydrochloride Extended-Release is a capsule, extended release containing dexmethylphenidate hydrochloride at 35 mg/1, taken oral. Manufactured by Lannett Company, Inc..

Key Facts

Brand Name
Dexmethylphenidate Hydrochloride Extended-Release
Generic Name
dexmethylphenidate hydrochloride
NDC Code (Product)
0527-8112
Manufacturer
Lannett Company, Inc.
Strength
35 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA210279
Marketing Start
10/09/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective221 reports
nausea57 reports
disturbance in attention53 reports
feeling abnormal48 reports
decreased appetite47 reports
headache47 reports
fatigue45 reports
product substitution issue45 reports
dizziness43 reports
anxiety42 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Dexmethylphenidate Hydrochloride Extended-release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14) ] . Dexmethylphenidate Hydrochloride Extended-release Capsules is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Dexmethylphenidate Hydrochloride Extended-release Capsules is for oral administration once daily in the morning. Dexmethylphenidate Hydrochloride Extended-release Capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate 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 mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Dosage should be individualized according to the needs and responses of the patient. Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2 ). Patients currently on methylphenidate: Dexmethylphenidate Hydrochloride Extended-release Capsules dosage is half the current total daily dosage of methylphenidate ( 2.2 ). Patients currently on d…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity to methylphenidate or other components of Dexmethylphenidate 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) ] . Known hypersensitivity to methylphenidate or other components of Dexmethylphenidate Hydrochloride Extended-release Capsules ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). Halogenated Anesthetics: Avoid use of Dexmethylphenidate Hydrochloride Extended-release Capsules on the day of surgery if halogenated anesthetics will be used ( 7.1 ). 7.1 Clinically Important Interactions with Dexmethylphenidate Hydrochloride Extended-Release Capsules Table 5 presents clinically important drug interactions with Dexmethylphenidate Hydrochloride Extended-release Capsules. Table 5: Clinically Important Drug Interactions with Dexmethylphenidate Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including Dexmethylphenidate Hydrochloride Extended-Release Capsules, can 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 Dexmethylphenidate Hydrochloride Extended-Release Capsules with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examp…

Adverse Reactions

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 Dexmethylphenidate Hydrochloride Extended-release Capsules [see Contraindications (4) ] Hypertensive Crisis with Concomitant Use of 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) ] The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo): Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety ( 6.1 ). Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety ( 6.1 ). …

Frequently Asked Questions

What is Dexmethylphenidate Hydrochloride Extended-Release used for?

Dexmethylphenidate Hydrochloride Extended-Release contains dexmethylphenidate hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Dexmethylphenidate Hydrochloride Extended-Release a controlled substance?

Yes, Dexmethylphenidate Hydrochloride Extended-Release is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Dexmethylphenidate Hydrochloride Extended-Release?

The generic name for Dexmethylphenidate Hydrochloride Extended-Release is dexmethylphenidate hydrochloride. There are 11 other brand versions of dexmethylphenidate hydrochloride.

What is the NDC code for Dexmethylphenidate Hydrochloride Extended-Release 35 mg/1?

The NDC (National Drug Code) for Dexmethylphenidate Hydrochloride Extended-Release 35 mg/1 is 0527-8112, listed by Lannett Company, Inc..

Product NDC

0527-8112

Package NDC

0527-8112-37

Other Dexmethylphenidate Hydrochloride Extended-Release Dosages

Other Dexmethylphenidate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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