methylphenidate hydrochloride CD 50 mg/1
methylphenidate hydrochloride · CAPSULE, EXTENDED RELEASE · Lannett Company, Inc.
methylphenidate hydrochloride CD is a capsule, extended release containing methylphenidate hydrochloride at 50 mg/1, taken oral. Manufactured by Lannett Company, Inc..
Key Facts
- Brand Name
- methylphenidate hydrochloride CD
- Generic Name
- methylphenidate hydrochloride
- NDC Code (Product)
0527-4583- Manufacturer
- Lannett Company, Inc.
- Strength
- 50 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA021259
- Marketing Start
- 03/21/2006
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Methylphenidate HCl Extended-Release Capsules CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD 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 )] . Methylphenidate HCl Extended-Release Capsules CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. ( 1 ) Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD is not recommended in pediatric patients younger than 6 years of age because they had higher 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 Take orally once daily in the morning, before breakfast. Swallow whole with the aid of liquids, or sprinkle contents onto a small amount of applesauce and give immediately. Do not crush or chew the capsule or capsule contents ( 2.1 ) Recommended starting dose is 20 mg once daily. Dosage may be increased 10-20 mg at weekly intervals; do not exceed 60 mg per day ( 2.2 ) 2.1 Pretreatment Screening Prior to treating patients with Methylphenidate HCl Extended-Release Capsules CD, 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 ( 5.10 )] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Methylphenidate HCl Extended-Release Capsules CD [see Warnings and Precautions ( 5.10 )] . 2.2 Dosage Recommendations The recommended starting dose of Methylphenidate HCl Extended-Release Capsules CD is 20 mg once daily. Dosage may be adjusted in weekly 10 mg to 20 mg increments to the maximum recommended dose of 60 mg per day. Dosage should be individualized according to th…
Contraindications
4 CONTRAINDICATIONS Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients with: known hypersensitivity to methylphenidate or other component of Methylphenidate HCl Extended-Release Capsules CD. Angioedema has been reported in patients treated with Methylphenidate HCl Extended-Release Capsules CD. Anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions ( 6 )] . Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis [see Drug Interactions ( 7 )] . Methylphenidate HCl Extended-Release Capsules CD contains sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Known hypersensitivity to methylphenidate or other components of Methylphenidate HCl Extended-Release Capsules CD ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ) Use in patients with patients with hereditary problems of fru…
Drug Interactions
7 DRUG INTERACTIONS Table 3 presents clinically important drug interactions with Methylphenidate HCl Extended-Release Capsules CD. Table 3: Clinically Important Drug Interactions with Methylphenidate HCl Extended-Release Capsules CD Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: Concomitant use of MAOIs and CNS stimulants, including Methylphenidate HCl Extended-Release Capsules CD, 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 Methylphenidate HCl Extended-Release Capsules CD with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical Impact: Methylphenidate HCl Extended-Release Capsules CD may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )] . Intervention: Adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical Impact: Concomitant use of halogenated anesthetics and Methylphenidate HCl Extended-R…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to Methylphenidate and Other Component of Methylphenidate HCl Extended-Release Capsules CD [see Contraindications ( 4 )] Hypertensive Crisis when Used Concomitantly with MAOIs [see Contraindications (4) and Drug Interactions ( 7 )] 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 )] The most common adverse…
Frequently Asked Questions
What is methylphenidate hydrochloride CD used for?
methylphenidate hydrochloride CD contains methylphenidate hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is methylphenidate hydrochloride CD a controlled substance?
Yes, methylphenidate hydrochloride CD is classified as CII under the DEA Controlled Substances Act.
What is the generic name for methylphenidate hydrochloride CD?
The generic name for methylphenidate hydrochloride CD is methylphenidate hydrochloride. There are 12 other brand versions of methylphenidate hydrochloride.
What is the NDC code for methylphenidate hydrochloride CD 50 mg/1?
The NDC (National Drug Code) for methylphenidate hydrochloride CD 50 mg/1 is 0527-4583, listed by Lannett Company, Inc..
Other Methylphenidate Brands
See all →- Methylphenidate Hydrochloride5 mg/5mL72162-1992
- Methylphenidate Hydrochloride27 mg/172162-2395
- Methylphenidate Hydrochloride54 mg/10527-3313
- METHYLPHENIDATE HYDROCHLORIDE5 mg/116729-478
- QuilliChew ER40 mg/124478-076
- Methylphenidate Hydrochloride5 mg/143386-571
- Methylphenidate Hydrochloride5 mg/5mL43386-930
- Methylphenidate Hydrochloride27 mg/150268-546
- Methylphenidate Hydrochloride10 mg/155466-102
- Methylphenidate Hydrochloride5 mg/164980-222
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)