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Ritalin
Overview
What is Ritalin?
Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Ritalin LA capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate. Ritalin LA 10, 20, 30, 40, and 60 mg capsules provide in a single dose the same amount of methylphenidate as dosages of 5, 10, 15, 20, or 30 mg of Ritalin tablets given b.i.d.
The active substance in Ritalin LA is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77.
Inactive ingredients:
What does Ritalin look like?
What are the available doses of Ritalin?
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What should I talk to my health care provider before I take Ritalin?
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How should I use Ritalin?
Ritalin LA (methylphenidate hydrochloride) extended-release capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of Ritalin LA in the treatment of ADHD was established in 1 controlled trial of children aged 6 to 12 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met.
Ritalin LA (methylphenidate hydrochloride) extended-release capsules are for oral administration once daily in the morning. Ritalin LA 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). Ritalin LA 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 applesauce should not be warm because it could affect the modified release properties of this formulation. 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. Patients should be advised to avoid alcohol while taking Ritalin LA.
What interacts with Ritalin?
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What are the warnings of Ritalin?
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What are the precautions of Ritalin?
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What are the side effects of Ritalin?
Sorry No records found
What should I look out for while using Ritalin?
What might happen if I take too much Ritalin?
How should I store and handle Ritalin?
Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Preserve in tight, light-resistant containers. Protect from moisture.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.Ritalin LA capsules 10 mg: white/light brown (imprinted NVR R10)Bottles of 100………………………………………………………NDC 0078-0424-05Ritalin LA capsules 20 mg: white (imprinted NVR R20)Bottles of 100………………………………………………………NDC 0078-0370-05Ritalin LA capsules 30 mg: yellow (imprinted NVR R30)Bottles of 100………………………………………………………NDC 0078-0371-05Ritalin LA capsules 40 mg: light brown (imprinted NVR R40)Bottles of 100………………………………………………………NDC 0078-0372-05Ritalin LA capsules 60 mg: light brown/yellow (imprinted NVR R60)Bottles of 30……..…………………………………………………NDC 0078-0658-15Store at 25°C (77°F), excursions permitted 15°C-30°C (59°F-86°F). [See USP controlled room temperature]Dispense in tight container (USP).Ritalin LA is a trademark of Novartis AG. SODAS is a registered trademark of Alkermes Pharma Ireland Limited. This product is covered by US patents including US 5,837,284 and 6,228,398.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Methylphenidate is metabolized primarily by de-esterification (nonmicrosomal hydrolytic esterases) to ritalinic acid and not through oxidative pathways.The effects of gastrointestinal pH alterations on the absorption of methylphenidate from Ritalin LA have not been studied. Since the modified release characteristics of Ritalin LA are pH dependent, the coadministration of antacids or acid suppressants could alter the release of methylphenidate.
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Because of possible effects on blood pressure, methylphenidate should be used cautiously with pressor agents.
As an inhibitor of dopamine reuptake, methylphenidate may be associated with pharmacodynamic interactions when coadministered with direct and indirect dopamine agonists (including DOPA and tricyclic antidepressants) as well as dopamine antagonists (antipsychotics, e.g., haloperidol).
Case reports suggest a potential interaction of methylphenidate with coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine) but pharmacokinetic interactions were not confirmed when explored at higher sample sizes. Downward dose adjustment of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentrations (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.
Methylphenidate is not metabolized by cytochrome P450 to a clinically relevant extent. Inducers or inhibitors of cytochrome P450 are not expected to have any relevant impact on methylphenidate pharmacokinetics. Conversely, the - and -enantiomers of methylphenidate did not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A.
Methylphenidate coadministration did not increase plasma concentrations of the CYP2D6 substrate desipramine.
An interaction with the anticoagulant ethylbiscoumacetate in 4 subjects was not confirmed in a subsequent study with a higher sample size (n=12).
Other specific drug-drug interaction studies with methylphenidate have not been performed in vivo.
Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
The clinical program for Ritalin LA (methylphenidate hydrochloride) extended-release capsules consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6-12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received Ritalin LA in doses of 10-40 mg per day. Safety of Ritalin LA was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, MedDRA terminology has been used to classify reported adverse events. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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