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Description

Generic Name

Methylphenidate hydrochloride

Active Ingredient

Methylphenidate hydrochloride

Chemical Name and Composition

Methylphenidate hydrochloride is chemically described as methyl α-phenyl-2-piperidineacetate hydrochloride.

Methylphenidate hydrochloride is a white, odorless, fine crystalline powder. Its solutions are acidic to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. It has a molecular weight of about 269.77.

Medication Classification

Ritalin is a central nervous system (CNS) stimulant. It is thought to work by blocking the reuptake of norepinephrine and dopamine in the brain, which increases the levels of these chemicals and helps improve attention and control impulsive behavior.

Ritalin is a Schedule II (CII) controlled substance under U.S. federal law.

Indications

Ritalin is indicated for:

• Attention deficit hyperactivity disorder (ADHD) in patients as part of a total treatment program that may include other measures, such as psychological, educational, and social support
• Narcolepsy

Dosage Forms and Available Strengths

• Dosage Forms:
• • Immediate-release oral tablets (Ritalin)
  • Extended-release oral tablets (Ritalin SR)
  • Extended-release oral capsules (Ritalin LA)
• Route of Administration: Oral
• Common Strengths:
• • Immediate-release tablets: 5 mg, 10 mg, and 20 mg
  • Extended-release tablets: 20 mg
  • Extended-release capsules: 10 mg, 20 mg, 30 mg, and 40 mg

Formulations and strengths may vary by manufacturer. Confirm the exact strength on your product label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Immediate-release tablets may contain lactose, magnesium stearate, polyethylene glycol, starch, sucrose, talc, tragacanth, and colorants that differ by tablet strength. Extended-release forms may contain cellulose compounds, hypromellose, and other release-controlling agents. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Ritalin exactly as prescribed by your healthcare provider. Your provider will start with a low dose and adjust it slowly based on your response. Use the lowest effective dose. Do not change your dose or stop taking it without medical guidance.

How to Take Ritalin

• Immediate-release tablets: Swallow with water. These are usually taken two or three times a day.
• Extended-release tablets (Ritalin SR): Swallow the tablet whole. Do not crush, chew, or break it, as this can release too much medicine at once.
• Extended-release capsules (Ritalin LA): Swallow the capsule whole. If you have trouble swallowing, you may open the capsule and sprinkle the contents onto a small amount of soft food, such as applesauce. Swallow the mixture right away without chewing. Do not save it for later use.
• Do not take more than prescribed, and do not take it more often than directed.
• Avoid taking Ritalin late in the day, as it may cause trouble sleeping.

Food Considerations

• Immediate-release tablets are usually taken 30 to 45 minutes before meals.
• Extended-release capsules may be taken with or without food, but should be taken in a consistent way each day.
• Avoid alcohol while taking Ritalin, as it may increase side effects and, with some formulations, cause the medicine to release too quickly.

Missed Dose Instructions

• If you miss a dose, take it as soon as you remember, unless it is late in the day.
• Do not take Ritalin in the late afternoon or evening, as it may cause trouble sleeping.
• If it is close to the time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Protect from light where the product labeling directs.
• Keep out of the reach of children.

Disposal

Because Ritalin is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Children: Ritalin is used in children as part of a complete ADHD treatment program under a provider's care. It is not recommended for children under 6 years of age, as safety and effectiveness in this group have not been established. Give the medicine exactly as prescribed, and keep it out of reach. Your provider may monitor your child's growth during treatment. If a child takes more than prescribed, seek emergency care immediately.

Elderly Patients: Ritalin has not been widely studied in older adults. Because older patients may be more sensitive to its effects on the heart, blood pressure, and nervous system, a provider may start at a lower dose and monitor closely.

Patients with Heart, Liver, or Kidney Problems: Use with caution. Tell your provider about any heart conditions before starting. Dose adjustments and closer monitoring may be needed based on your overall health.

Caregivers: Give the medication exactly as prescribed. Watch for chest pain, shortness of breath, fainting, new or worsening mood or behavior changes, unusual movements, or signs of poor circulation in the fingers or toes, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Ritalin suddenly after prolonged use or after using higher doses. Watch for withdrawal-like symptoms such as extreme tiredness, depression, and sleep changes.
• Your provider may recommend reducing the dose gradually and monitoring you as the medicine is stopped.
• Stopping suddenly can unmask severe depression or the underlying symptoms the medicine was treating.
• Tell your provider if you notice unusual symptoms after reducing or stopping the medication.

Overdose Warning

An overdose of Ritalin can be serious and may be fatal. Symptoms of overdose may include:

• Vomiting, agitation, or restlessness
• Tremors or muscle twitching
• Confusion, hallucinations, or delirium
• A fast, pounding, or irregular heartbeat
• High blood pressure
• Sweating and flushing
• Headache
• High body temperature
• Seizures
• Loss of consciousness or coma

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Ritalin and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Cardiovascular events: Chest pain, shortness of breath, or fainting, especially during exertion. Sudden death, stroke, and heart attack have been reported, mainly in people with existing heart problems. Increases in blood pressure and heart rate can also occur.
• Psychiatric symptoms: New or worsening agitation, aggression, anxiety, or hostility; new psychotic symptoms such as hearing voices, believing things that are not true, or being suspicious; new manic symptoms; or thoughts of harming yourself.
• Serious allergic reactions: Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Growth concerns (in children): Slowing of growth (height and weight) with long-term use. Your provider may monitor your child's growth.
• Priapism: A painful erection lasting more than 4 hours. This requires emergency treatment to prevent lasting damage.
• Circulation problems (peripheral vasculopathy, including Raynaud's phenomenon): Fingers or toes that feel numb, cool, or painful, or that change color to pale, blue, or red. In rare cases, skin breakdown or sores may occur.
• Serotonin syndrome: Agitation, hallucinations, fast heartbeat, fever, sweating, shivering, muscle stiffness, twitching, or loss of coordination, especially when taken with certain other medicines.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Decreased appetite
• Trouble sleeping (insomnia)
• Headache
• Nausea or stomach pain
• Dry mouth
• Nervousness or restlessness
• Dizziness
• Increased heart rate
• Weight loss
• Mood changes or irritability
• Sweating

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Warnings & Precautions

Conditions to Disclose to Your Healthcare Provider

Before taking Ritalin, tell your healthcare provider if you have or have had any of the following:

• Heart problems, heart defects, high blood pressure, or a family history of sudden death or heart rhythm problems
• A history of stroke
• Mental health conditions, including depression, bipolar disorder, psychosis, or thoughts of suicide
• A family history of suicide, bipolar disorder, or depression
• Seizures or a seizure disorder
• Circulation problems in the fingers or toes
• Overactive thyroid (hyperthyroidism)
• Glaucoma
• Tics or Tourette's syndrome, or a family history of tics
• Liver or kidney problems
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Ritalin if you:

• Have marked anxiety, tension, or agitation, since the medicine may make these worse
• Have glaucoma
• Have motor tics, or a family history or diagnosis of Tourette's syndrome
• Are taking, or have taken within the past 14 days, a monoamine oxidase inhibitor (MAOI), because this can cause a dangerous rise in blood pressure (hypertensive crisis)
• Have a known hypersensitivity to methylphenidate or any component of the formulation

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• Monoamine oxidase inhibitors (MAOIs): Combined use, or use within 14 days of an MAOI, can cause a serious and possibly fatal rise in blood pressure. This combination is contraindicated.
• Blood pressure medicines: Ritalin can raise blood pressure and may reduce the effect of medicines used to control it. Your provider may need to monitor your blood pressure and adjust your treatment.
• Antacids and acid-reducing medicines: Products that change stomach acidity may affect how some extended-release forms are released. Tell your provider if you use antacids, proton pump inhibitors, or H2 blockers.
• Serotonergic drugs: Combined use with certain antidepressants (such as SSRIs, SNRIs, and tricyclics) or other serotonergic medicines may increase the risk of serotonin syndrome.
• Other stimulants or decongestants: Combining these with Ritalin may increase the risk of high blood pressure, fast heart rate, and other side effects.
• Certain seizure medicines and blood thinners: Ritalin may affect the levels of some anticonvulsants (such as phenytoin) and blood thinners (such as warfarin). Dose adjustments may be needed.

Monitoring Requirements

Your healthcare provider may monitor:

• Blood pressure and heart rate, before and during treatment
• Heart health, especially in patients with existing heart conditions
• Growth (height and weight) in children during long-term use
• New or worsening mood, behavior, or mental health changes
• Signs of circulation problems in the fingers or toes
• Your response to treatment
• Signs of tolerance, dependence, or misuse

Abuse, Dependence, and Misuse Warnings

Ritalin is a Schedule II controlled substance.

• Ritalin is a stimulant with a high potential for abuse and may be a target for people who misuse prescription medicines.
• Misuse can cause serious heart problems and sudden death.
• Physical and psychological dependence can occur, particularly with prolonged use or higher-than-prescribed doses.
• Tell your provider if you or a family member have a history of alcohol or drug abuse or dependence.
• Do not increase your dose on your own.
• Do not sell or give away Ritalin. Doing so may harm others and is against the law.

Long-Term Use Considerations

• If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
• Growth should be monitored in children during long-term use, and treatment may be paused if growth slows.
• Long-term effects, especially in children, are not fully known and should be weighed against the benefits.
• Physical and psychological dependence may develop with continued use. Any decision to stop treatment should involve your provider.

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Patient Counseling Information

Safe Medication Use

• Take Ritalin exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Take it earlier in the day and avoid late-day doses to reduce trouble sleeping.
• Swallow extended-release tablets whole. Do not crush, chew, or break them.
• If you have trouble swallowing extended-release capsules, you may sprinkle the contents on a small amount of soft food and take it right away.
• Do not stop taking Ritalin suddenly after regular use. Talk to your healthcare provider first.
• Do not share Ritalin with anyone else. Sharing is dangerous and against the law.
• Keep Ritalin in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Heart health: Report chest pain, shortness of breath, or fainting right away, as these may signal a serious heart problem.
• Mental health: Tell your provider about any new or worsening mood, behavior, or thinking changes, including agitation, aggression, hallucinations, or thoughts of self-harm.
• Circulation: Tell your provider if your fingers or toes feel numb, cool, or painful, or change color.
• MAOIs: Never take Ritalin within 14 days of an MAOI.
• Alcohol: Avoid alcohol while taking Ritalin, as it may increase side effects.
• Driving and machinery: Ritalin may affect alertness or cause dizziness. Do not drive or operate machinery until you know how it affects you.
• Pregnancy: Tell your provider if you are pregnant or plan to become pregnant, so treatment can be managed safely.
• Breastfeeding: Methylphenidate can pass into breast milk. Talk to your provider before breastfeeding while taking Ritalin.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have chest pain, shortness of breath, or fainting
• Have a fast, pounding, or irregular heartbeat
• Develop new or worsening agitation, aggression, anxiety, hallucinations, unusual thoughts, or thoughts of harming yourself
• Have a severe allergic reaction, such as swelling of the face or throat, hives, or trouble breathing
• Have an erection that lasts more than 4 hours
• Notice numbness, coolness, pain, or color changes in your fingers or toes
• Develop signs of serotonin syndrome, such as agitation, fast heartbeat, fever, or muscle stiffness
• Notice slowed growth in a child taking this medicine
• Have any symptom that concerns you or does not go away