Methylin 5 mg/5mL

Methylphenidate Hydrochloride · SOLUTION · SHIONOGI INC.

No Recall HistoryCurrently in Shortage

Plain English

Methylin is a solution containing methylphenidate hydrochloride at 5 mg/5mL, taken oral. Manufactured by SHIONOGI INC..

Key Facts

Brand Name: Methylin
Generic Name: Methylphenidate Hydrochloride
NDC Code (Product): 59630-750
Manufacturer: SHIONOGI INC.
Strength: 5 mg/5mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA021419
Marketing Start: 12/19/2002

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,051 reports

headache402 reports

anxiety372 reports

fatigue372 reports

off label use364 reports

nausea338 reports

toxicity to various agents326 reports

drug abuse296 reports

product substitution issue283 reports

somnolence277 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Methylin is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older Narcolepsy Methylin is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years of age and older ( 1 ) Narcolepsy ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Pediatric patients 6 years and older: Starting dose is 5 mg twice daily (before breakfast and lunch); increase the dose 5 mg to 10 mg weekly; daily dosage above 60 mg is not recommended. ( 2.2 ) Adults: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Maximum recommended daily dosage is 60 mg. ( 2 ) 2.1 Pretreatment Screening Prior to treating patients with Methylin, 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 [see Warnings and Precautions ( 5.10 )] . 2.2 General Dosing Information Pediatric Patients 6 years of Age and Older The recommended starting dosage is 5 mg orally twice daily before breakfast and lunch (preferably 30 to 45 minutes before meals). Increase the dosage gradually, in increments of 5 mg to 10 mg weekly. Daily dosage above 60 mg is not recommended. Adults Administer orally in divided doses 2 or 3 times daily, pref…

Contraindications

4 CONTRAINDICATIONS Methylin is contraindicated in patients: with known hypersensitivity to methylphenidate or other components of Methylin. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6 )] . receiving 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 )] . Known hypersensitivity to methylphenidate or other components of Methylin ( 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 Methylin Table 1 presents clinically important drug interactions with Methylin. Table 1: Clinically Important Drug Interactions with Methylin Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: Concomitant use of MAOIs and CNS stimulants, including Methylin, 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 Methylin with monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical Impact: Methylin 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 Methylin may increase the risk of sudden…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions 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 )] Known hypersensitivity to methylphenidate or other components of Methylin [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ), 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 following adv…

Frequently Asked Questions

What is Methylin used for?

Methylin contains Methylphenidate Hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is Methylin a controlled substance?

Yes, Methylin is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Methylin?

The generic name for Methylin is Methylphenidate Hydrochloride. There are 12 other brand versions of Methylphenidate Hydrochloride.

What is the NDC code for Methylin 5 mg/5mL?

The NDC (National Drug Code) for Methylin 5 mg/5mL is 59630-750, listed by SHIONOGI INC..

Product NDC

59630-750

Package NDC

59630-750-50

Other Methylphenidate Brands

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

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