METHYLPHENIDATE HYDROCHLORIDE tablet, extended release (2024)

Methylphenidate Hydrochloride (meth il fen i date hye droe klor ide) Extended-release Tablets, USP CII

Read the Medication Guide that comes with methylphenidate hydrochloride extended-release tabletsbefore you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with methylphenidate hydrochloride extended-release tablets.

What is the most important information I should know about methylphenidate hydrochloride extended-release tablets?

The following have been reported with use of methylphenidate HCl and other stimulant medicines:

1. Heart-related problems:

sudden death in patients who have heart problems or heart defects

stroke and heart attack in adults

increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting methylphenidate hydrochloride extended-release tablets.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release tablets.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride extended-release tablets.

2. Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking methylphenidate hydrochloride extended-release tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Painful and prolonged erections (priapism)

Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away.

Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

4. Circulation problems in fingers and toes

[Peripheral vasculopathy, including Raynaud’s phenomenon]:

• fingers or toes may feel numb, cool, painful

• fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release tablets.

What is methylphenidate hydrochloride?

Methylphenidate hydrochloride is a central nervous system stimulant prescription medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Methylphenidate hydrochloride extended-release tabletsmay help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Methylphenidate hydrochloride extended-release tabletsshould be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methylphenidate hydrochloride extended-release tabletis a federally controlled substance (CII) because it can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release tabletsin a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release tabletsmay harm others, and is against the law.

Tell your doctor if you or your child has (or has a family history of) ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Who should not take methylphenidate hydrochloride extended-release tablets?

Methylphenidate hydrochloride extended-release tabletsshould not be taken if you or your child:

• is very anxious, tense, or agitated

• has an eye problem called glaucoma

• has tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are hard-to-control repeated movements or sounds.

• is taking or has taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.

• is allergic to anything in methylphenidate hydrochloride extended-release tablets. See the end of this Medication Guide for a complete list of ingredients.

Methylphenidate hydrochloride extended-release tabletsshould not be used in children less than 6 years old because it has not been studied in this age group.

Methylphenidate hydrochloride extended-release tabletsmay not be right for you or your child. Before starting methylphenidate hydrochloride extended-release tablets, tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, or high blood pressure

• mental problems including psychosis, mania, bipolar illness, or depression

• tics or Tourette’s syndrome

• seizures or have had an abnormal brain wave test (EEG)

• circulation problems in fingers and toes

• esophagus, stomach, or small or large intestine problems

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can methylphenidate hydrochloride extended-release tabletsbe taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylphenidate hydrochloride extended-release tabletsand some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking methylphenidate hydrochloride extended-release tablets.

Your doctor will decide whether methylphenidate hydrochloride extended-release tabletscan be taken with other medicines.

Especially tell your doctor if you or your child takes:

• antidepression medicines including MAOIs

• seizure medicines

• blood thinner medicines

• blood pressure medicines

• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking methylphenidate hydrochloride extended-release tabletswithout talking to your doctor first.

How should methylphenidate hydrochloride extended-release tabletsbe taken?

• Take methylphenidate hydrochloride extended-release tabletsexactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.

• Do not chew, crush, or divide the tablets. Swallow methylphenidate hydrochloride extended-release tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow methylphenidate hydrochloride extended-release tabletswhole. A different medicine may need to be prescribed.

• Methylphenidate hydrochloride extended-release tablets can be taken with or without food.

• Take methylphenidate hydrochloride extended-release tabletsonce each day in the morning. Methylphenidate hydrochloride is an extended-release tablet. It releases medication into your or your child’s body throughout the day.

• The methylphenidate hydrochloride extended-release tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.

• From time to time, your doctor may stop methylphenidate hydrochloride extended-release tabletstreatment for a while to check ADHD symptoms.

• Your doctor may do regular checks of the blood, heart, and blood pressure while taking methylphenidate hydrochloride extended-release tablets. Children should have their height and weight checked often while taking methylphenidate hydrochloride extended-release tablets. Methylphenidate hydrochloride extended-release tabletstreatment may be stopped if a problem is found during these checkups.

• If you or your child takes too much methylphenidate hydrochlorideor overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of methylphenidate hydrochloride extended-release tablets?

See “What is the most important information I should know about methylphenidate hydrochloride extended-release tablets?” for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children

• seizures, mainly in patients with a history of seizures

• eyesight changes or blurred vision

• blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs

Common side effects include:

• decreased appetite

• headache

• dry mouth

• nausea

• trouble sleeping

• anxiety

• dizziness

• weight loss

• stomach ache

• irritability

• increased sweating

Stimulants may impair the ability of you or your child to operate potentially hazardous machinery or vehicles. You or your child should exercise caution until you or your child is reasonably certain that methylphenidate hydrochloride extended-release tablets does not adversely affect your or your child’s ability to engage in such activities.

Talk to your doctor if you or your child has side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784.

How should I store methylphenidate hydrochloride extended-release tablets?

• Store methylphenidate hydrochloride extended-release tabletsin a safe place at room temperature, 20°C to 25°C (68°F to 77°F). Protect from moisture.

• Keep methylphenidate hydrochloride extended-release tabletsand all medicines out of the reach of children.

General information about methylphenidate hydrochloride extended-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride extended-release tabletsfor a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release tabletsto other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about methylphenidate hydrochloride extended-release tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate hydrochloride extended-release tablets that was written for healthcare professionals. For more information about methylphenidate hydrochloride extended-release tabletscall 1-888-375-3784.

What are the ingredients in methylphenidate hydrochloride extended-release tablets?

Active Ingredient: methylphenidate HCl

Inactive Ingredients: butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, phosphoric acid, poloxamer, polyethylene oxide, povidone, sodium chloride, stearic acid, succinic acid.

In addition 18 mg contains Opadry Purple (FD&C Blue #2/Indigo Carmine Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 27 mg contains Opadry Pink (D&C Red #27/Phloxine Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 36 mg contains Opadry Orange (FD&C Red #40/Allura Red AC Aluminum Lake, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide), 54 mg contains Opadry Blue (FD&C Blue #2/Indigo Carmine Aluminum Lake, hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol, polysorbate, titanium dioxide).

Opacode Black contains black iron oxide, hypromellose 6 mPas, propylene glycol.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

To reorder additional Medication Guides contact Dr. Reddy’s Customer Service at 1-866-733-3952.

Rx only

Manufactured By:

Dr. Reddy’s Laboratories Louisiana, LLC

Shreveport, LA 71106 USA

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton NJ 08540 USA

Issued: 0420

METHYLPHENIDATE HYDROCHLORIDE tablet, extended release (2024)

FAQs

METHYLPHENIDATE HYDROCHLORIDE tablet, extended release? ›

Methylphenidate hydrochloride extended-release (ER) is a drug approved by FDA to treat attention deficit-hyperactivity disorder (ADHD) in adults and children ages six and older. Concerta is one brand of methylphenidate hydrochloride ER tablets.

What does methylphenidate hydrochloride extended-release do? ›

Methylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children.

Is methylphenidate the same as Adderall? ›

Adderall is the brand name for a mix of two stimulants called amphetamine-dextroamphetamine. Ritalin is the brand name for a stimulant called methylphenidate.

Is methylphenidate HCl the same as Concerta? ›

Concerta and Ritalin are stimulant medications used to treat attention deficit hyperactivity disorder (ADHD). They're both different brand-name versions of the same drug, called methylphenidate hydrochloride.

How long does it take for methylphenidate (ER) to kick in? ›

The onset of action for extended-release (ER) formulations is as follows: Extended-release (ER) formulations: capsules (Metadate CD, Ritalin LA), tablets (Concerta): 20 to 60 minutes. Immediate-release (IR) formulations: chewable tablet, oral solution, tablet (Methylin, Ritalin): 20 to 60 minutes.

Is Ritalin stronger than Adderall? ›

Ritalin works sooner and reaches peak performance more quickly than Adderall does. However, Adderall stays active in your body longer than Ritalin does.

How does methylphenidate hydrochloride make you feel? ›

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease.

What is the strongest ADHD medication? ›

Adderall: Often hailed as one of the most potent ADHD medications, Adderall combines amphetamine and dextroamphetamine to boost dopamine and norepinephrine levels. Its rapid onset and effectiveness in enhancing focus make it a popular choice among individuals with ADHD.

How much weight will I lose on Ritalin? ›

The idea that Ritalin is a guaranteed way to shed pounds is inaccurate, as weight loss is not a universal outcome for those taking the medication. Weight loss is often more likely to occur as a result of the medication's side effect of appetite suppression, rather than a direct effect on metabolism.

What is methylphenidate most similar to? ›

Methylphenidate (Ritalin), a psychostimulant used in the treatment of Attention-Deficit Hyperactivity Disorder, has pharmacological effects similar to cocaine and amphetamine.

Is methylphenidate HCL discontinued? ›

Patriot discontinued methylphenidate extended-release tablets (authorized generic) in January 2023. Rhodes has Aptensio XR capsules available. Sandoz has methylphenidate (LA) capsules and Ritalin LA capsules available. Sun Pharma discontinued methylphenidate extended-release tablets.

What happens if I take Concerta without ADHD? ›

People without ADHD or attention deficit disorder (ADD) should not consider Concerta, as they may experience edginess, anger or anxiety. It's important to only take Concerta if you have a valid prescription.

Why is Concerta so expensive? ›

Years of research and testing are needed to ensure that brand-name drugs are safe and effective. This testing can make the drugs expensive. The manufacturer of a brand-name drug can sell the drug for up to 20 years. After that, other drugmakers can create generic versions.

Is 27 mg of methylphenidate a lot? ›

Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. The average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.

What happens when a normal person takes methylphenidate? ›

As stimulant drugs, methylphenidate and the methylphenidate-based drugs can make you feel very 'up', awake, excited, alert and energised, but they can also make you feel agitated and aggressive. They may also stop you from feeling hungry.

What time of day is best to take methylphenidate? ›

Standard tablets or capsules are usually taken 2 or 3 times a day – in the morning, at midday and in the late afternoon. Leave at least 4 hours between doses. If you have problems swallowing pills, some brands of standard tablets can be crushed and added to food.

What are the benefits of methylphenidate hydrochloride? ›

It's not known exactly how methylphenidate works. It's thought to boost the levels of chemicals called dopamine and noradrenaline in the brain. This can increase activity in the parts of your child's brain that control attention and behaviour. This makes them less hyperactive or impulsive.

What does methylphenidate hydrochloride do to the brain? ›

Methylphenidate increases extracellular dopamine (DA) levels in the brain by blocking the DA transporters in the synapse. Its short-term safety has been documented in many studies, and its efficacy is among the highest of all psychiatric medications.

What happens if you take methylphenidate hydrochloride without ADHD? ›

For people without ADHD, who may be tempted to take Ritalin or Adderall as a study drug, this can end up making them feel jittery and anxious, causing them to focus too much on smaller, less-important details, while losing the bigger picture.

Does methylphenidate hydrochloride help you sleep? ›

Summary: Treatment with methylphenidate appears to have beneficial effects on sleep parameters in adults with ADHD, including increased sleep efficiency and a feeling of improved restorative value of sleep.

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