Concerta

DRUG DESCRIPTION

CONCERTA® (methylphenidate extended-release tablets) is a central nervous system (CNS) stimulant. CONCERTA® (methylphenidate extended-release tablets) is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HC1 USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HC1 is d,l (racemic) methyl ?-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2•HCl. Its structural formula is:

CONCERTA®
  (methylphenldate HC1) Structural Formula Illustration

Methylphenidate HCl USP is a white, odorless 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.

CONCERTA® (methylphenidate extended-release tablets) also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.

System Components and Performance

CONCERTA® (methylphenidate extended-release tablets) uses osmotic pressure to deliver methylphenidate HCl at a controlled rate.

The system, which resembles a conventional tablet in appearance, comprises an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice. The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug concentration gradient incorporated into the two drug layers of CONCERTA® (methylphenidate extended-release tablets) . The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that CONCERTA® (methylphenidate extended-release tablets) extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.

What are the possible side effects of methylphenidate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking methylphenidate and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • aggression, restlessness, hallucinations, unusual behavior, or motor tics...

Read All Potential Side Effects and See Pictures of Concerta »

What are the precautions when taking methylphenidate extended-release tablets (Concerta)?

Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe anxiety/tension, certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, glaucoma, motor tics.

Before using this medication, tell your...

Read All Potential Precautions of Concerta »


Concerta Consumer (continued)

SIDE EFFECTS: Headache, stomach pain, loss of appetite, trouble sleeping, dizziness, nausea, vomiting, lightheadedness, irritability, nervousness, blurred vision, dry mouth, constipation or (rarely) drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Inactive parts of this drug may be passed in your stool as a harmless soft mass that may look like the original tablet. This is normal for this drug.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: uncontrolled movements (motor tics or tremor), verbal tics (e.g., Tourette's syndrome), weight loss, fast/pounding/irregular heartbeat, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts), difficulty urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, chest pain, jaw/left arm pain, fainting, seizures, blurred vision, weakness on one side of the body, slurred speech, confusion.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe anxiety/tension, certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, glaucoma, motor tics.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (hypertension), family history of sudden death/irregular heartbeat/rhythm/heart disease (e.g., heart failure, recent heart attack, abnormal heart rhythm), overactive thyroid (hyperthyroidism), family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), seizures, esophagus/stomach/intestine problems (e.g., narrowing of the gut, gut motility disorders), verbal tics (diagnosis or family history of Tourette's syndrome).

This drug may make you dizzy, lightheaded, (rarely) drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking this medication.

The tablet shells may be visible on an X-ray. Make sure X-ray personnel know that you use this drug.

Though uncommon, depression itself can lead to thoughts or attempts of suicide. If you are being treated for depression, tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes. Keep all medical appointments so your doctor can monitor your progress closely.

Children younger than 6 years may be at greater risk for the side effects of this medication.

This drug may affect your child's growth rate, weight, and final adult height, especially in children younger than 6 years. To reduce the risk, the doctor may recommend temporarily stopping the medication from time to time. Check your child's weight and height, and consult your doctor or pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Concerta Patient Information Including Side Effects

Brand Names: Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin LA, Ritalin-SR

Generic Name: methylphenidate (Pronunciation: METH il FEN i date)

  • What is methylphenidate (Concerta)?
  • What are the possible side effects of methylphenidate?
  • What is the most important information I should know about methylphenidate?
  • What should I discuss with my healthcare provider before taking methylphenidate?
  • How should I take methylphenidate?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking methylphenidate?
  • What other drugs will affect methylphenidate?
  • Where can I get more information?

What is methylphenidate (Concerta)?

Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Methylphenidate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of methylphenidate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking methylphenidate and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeats;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
  • easy bruising, purple spots on your skin; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • stomach pain, nausea, vomiting, loss of appetite;
  • vision problems, dizziness, mild headache;
  • sweating, mild skin rash;
  • numbness, tingling, or cold feeling in your hands or feet;
  • nervous feeling, sleep problems (insomnia); or
  • weight loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about methylphenidate?

Do not use methylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use methylphenidate before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to methylphenidate or if you have glaucoma, overactive thyroid, severe high blood pressure, tics or Tourette's syndrome, angina, heart failure, heart rhythm disorder, recent heart attack, a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, or severe anxiety, tension, or agitation.

Methylphenidate may be habit-forming and should be used only by the person it was prescribed for. Methylphenidate should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Related Drug Centers
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