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ritalin LA 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, and 40 mg capsules provide in a single dose the same amount of methylphenidate as dosages of 5, 10, 15, or 20 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
Ritalin LA® (methylphenidate hydrochloride) Structural Formula Illustration
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: ammonio methacrylate copolymer, black iron oxide (10 and 40 mg capsules only), gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide (10 and 40 mg capsules only), sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10, 30, and 40 mg capsules only).
This medication is used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Methylphenidate belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.
How to use Ritalin LA
Read the Medication Guide provided by your pharmacist before you start taking methylphenidate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
There are different brands and forms of this medication available. They may not have the same effects and may not be interchangeable. Do not change brands or forms without consulting your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually once daily before or with breakfast. If you have upset stomach, you may take this medication with food. Taking this medication late in the day may cause trouble sleeping (insomnia).
Do not break, crush, or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Swallow the capsules whole. If you have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a spoonful of cool applesauce. Swallow all of the mixture right away without chewing it. Then drink a glass of cool liquid to make sure you have swallowed all of the dose. Do not prepare the mixture ahead of time.
Do not drink alcoholic beverages while you are taking this medication. Drinking alcohol may increase the amount of this medication in your body which may cause serious side effects.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
The dosage is based on your medical condition and response to treatment. Your doctor may direct you to gradually increase or decrease your dose. Also, if you have used it for a long time, do not suddenly stop using this drug without consulting your doctor.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When used for a long time, this medication may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your condition does not improve or if it worsens
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 antico agulants,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.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.
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 -denantiomers of methylphenidate did not relevantly inhibit cytochrome P450 1A2, 2C8, 2C9, 2C19, 2D6,2E1 or 3A.
coadministration did not increase plasma concentrations of the CYP2D6 substrate desipramine
An interaction with the anticoagulant ethylbis,coumacetate 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.
DOSAGE AND ADMINISTRATION
Administration of Dose
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is 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.
Dosage should be individualized according to the needs and responses of the patients.
The recommended starting dose of Ritalin LA is 20 mg once daily. Dosage may be adjusted in weekly 10 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending on tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended. When in the judgement of the clinician a lower initial dose is appropriate, patients may begin treatment with Ritalin LA 10 mg.
Patients Currently Receiving Methylphenidate
The recommended dose of Ritalin LA for patients currently taking methylphenidate b.i.d. or sustained release (SR) is provided below.
Previous Methylphenidate Dose Recommended Ritalin LA® Dose
5 mg methylphenidate-b.i.d. 10 mg q.d.
10 mg methylphenidate b.i.d. or 20 mg methylphenidate–SR 20 mg q.d.
15 mg methylphenidate b.i.d. 30 mg q.d.
20 mg methylphenidate b.i.d. or 40 mg of methylphenidate–SR 40 mg q.d.
30 mg methylphenidate b.i.d. or 60 mg methylphenidate–SR 60 mg q.d.
For other methylphenidate regimens, clinical judgment should be used when selecting the starting dose. Ritalin LA dosage may be adjusted at weekly intervals in 10 mg increments.
Daily dosage above 60 mg is not recommended.
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Ritalin LA. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Ritalin LA for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose Reduction and Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or to dexmethylphenidate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood circulation problems (such as Raynaud’s disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (especially anxiety, tension, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal/family history of uncontrolled muscle movements (motor tics, Tourette’s syndrome), overactive thyroid (hyperthyroidism), seizure disorder, throat/stomach/intestinal problems (such as narrowing/blockage).
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Some brands of this medication may contain sugar. Caution is advised if you have diabetes, fructose intolerance, or any other condition that requires you to limit/avoid sugar in your diet. Ask your doctor or pharmacist about using this medication safely.
If used for a long time, this drug may affect a child’s growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child’s weight and height regularly, and consult your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping, weight loss, or chest pain.
During pregnancy, methylphenidate should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
Upset stomach or throwing up.
Nervous and excitable.
Not able to sleep.
Belly pain or heartburn.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
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