Ritalin 5 mg/1
methylphenidate hydrochloride · TABLET · Novartis Pharmaceuticals Corporation
Ritalin is a tablet containing methylphenidate hydrochloride at 5 mg/1, taken oral. Manufactured by Novartis Pharmaceuticals Corporation.
Key Facts
- Brand Name
- Ritalin
- Generic Name
- methylphenidate hydrochloride
- NDC Code (Product)
0078-0439- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- NDA010187
- Marketing Start
- 12/31/1955
Recall History
Novartis Pharmaceuticals Corp.
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Novartis Pharmaceuticals Corp.
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ritalin is indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended ( 2.2 ). • Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg ( 2.2 ). 2.1 Pretreatment Screening Prior to treating patients with Ritalin, 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 Ritalin [see Warnings and Precautions ( 5.10 )]. 2.2 General Dosing Information Pediatric Patients 6 years and Older : Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5-to 10-mg weekly. Daily dosage above 60 mg is not recommended. Adults : Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 …
Contraindications
4 CONTRAINDICATIONS • Hypersensitivity to methylphenidate or other components of Ritalin. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [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 crises [see Drug Interactions ( 7.1 )] . • Known hypersensitivity to methylphenidate or other product components of Ritalin ( 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 ). 7.1 Clinically Important Drug Interactions with Ritalin Table 1 presents clinically important drug interactions with Ritalin. Table 1: Clinically Important Drug Interactions with Ritalin Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including Ritalin 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 Ritalin with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical Impact Ritalin 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. Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and Ritalin may increase the risk of sudden blood pressure and heart rate increase du…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] • Known hypersensitivity to methylphenidate or other ingredients of Ritalin [see Contraindications ( 4 )] • Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] • 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 )]…
Frequently Asked Questions
What is Ritalin used for?
Ritalin contains methylphenidate hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ritalin a controlled substance?
Yes, Ritalin is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Ritalin?
The generic name for Ritalin is methylphenidate hydrochloride. There are 11 other brand versions of methylphenidate hydrochloride.
What is the NDC code for Ritalin 5 mg/1?
The NDC (National Drug Code) for Ritalin 5 mg/1 is 0078-0439, listed by Novartis Pharmaceuticals Corporation.
Other Ritalin Dosages
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)