Concerta 18mg ER Tablets

Methylphenidate is a central nervous system (CNS) stimulant. Its therapeutic effects in ADHD are thought to be due to its ability to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. This leads to increased concentrations of norepinephrine and dopamine in the synaptic cleft, enhancing neurotransmission in brain regions associated with attention and behavior.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes
Severe headache, dizziness, or fainting
Joint pain
Purple patches on the skin or mouth
Changes in vision or eye pain, swelling, or redness
Seizures
Shakiness
Difficulty controlling body movements
Trouble controlling sounds, such as humming, throat clearing, yelling, or making loud noises
Excessive sweating
Restlessness
Changes in skin color (pale, blue, gray, purple, or red) on hands, feet, or other areas
Numbness, pain, tingling, or cold sensation in hands or feet
Sores or wounds on fingers or toes
Muscle pain or weakness, dark urine, or difficulty urinating
Changes in sex drive
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Sudden death has occurred in people with certain heart problems or defects; if you have a heart condition or a family history of abnormal heart rhythms or sudden death, inform your doctor
Heart problems: chest pain, abnormal heartbeat, shortness of breath, or severe dizziness or fainting
Prolonged or painful erections (lasting more than 4 hours); if not treated promptly, this can lead to lasting sexual dysfunction
New or worsening behavioral and mood changes, such as altered thinking, anger, or hallucinations; if you or a family member has a history of mental health conditions (e.g., depression, bipolar disorder) or suicidal tendencies, inform your doctor
Serotonin syndrome: a potentially life-threatening condition that can occur when taking this medication with certain other drugs; seek medical help immediately if you experience agitation, balance problems, confusion, hallucinations, fever, rapid or abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, stomach upset, or vomiting, or severe headache

Other Possible Side Effects

While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following:

Dizziness or headache
Drowsiness
Dry mouth
Stomach pain, upset stomach, vomiting, or decreased appetite
Heartburn
Weight loss
Feeling nervous or excitable
Difficulty sleeping
Nose or throat irritation

If any of these side effects or others bother you or persist, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Certain health conditions, including:
+ Glaucoma
+ Agitation
+ Anxiety
+ Overactive thyroid (hyperthyroidism)
If you or a family member has a history of:
+ Blood vessel disease
+ High blood pressure (hypertension)
+ Heart structure problems or other heart conditions
+ Tourette's syndrome or tics
If you have ever experienced a stroke
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
Difficulty swallowing this product whole
Presence of certain gastrointestinal conditions, including:
+ Cystic fibrosis
+ Narrowing of the gastrointestinal (GI) tract
+ Bowel blockage or other GI problems
+ Short gut syndrome
+ Slow-moving esophagus or bowel tract
+ Peritonitis
Concurrent use of certain medications, such as:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to have surgery, be sure to discuss this with your doctor beforehand.

To ensure your safety, avoid driving and engaging in activities that require alertness until you understand how this medication affects you. As directed by your doctor, have regular blood tests, blood pressure checks, and heart rate monitoring. You may also need to undergo certain heart tests before starting this medication. If you have any questions or concerns, consult with your doctor.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, limit your intake of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat.

If you have high blood pressure, it is crucial to discuss with your doctor before using any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you notice that this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.

This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult with your doctor to determine if you are at a higher risk of seizures while taking this medication.

For certain brands of this medication, you may notice the tablet shell in your stool. This is a normal occurrence and not a cause for concern. However, if you have any questions, consult with your doctor.

If you are undergoing x-rays near the abdominal area, inform your doctor that you are taking this medication.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the benefits and risks of this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)

• Vasopressors (e.g., phenylephrine, dopamine, epinephrine, norepinephrine) - risk of hypertensive crisis
• Halogenated Anesthetics (e.g., halothane, isoflurane, enflurane, desflurane, sevoflurane) - risk of sudden blood pressure and heart rate increases during surgery
• Anticoagulants (e.g., coumarin, warfarin) - may inhibit metabolism, increasing anticoagulant effect
• Anticonvulsants (e.g., phenobarbital, phenytoin, primidone) - may inhibit metabolism, increasing anticonvulsant levels
• Antidepressants (e.g., tricyclic antidepressants, SSRIs) - may inhibit metabolism, increasing antidepressant levels

• Antihypertensive drugs - may reduce the hypotensive effect of these drugs
• Dopaminergic drugs (e.g., antipsychotics, levodopa) - potential for additive effects or antagonism
• Alcohol - may increase systemic exposure of methylphenidate

• Not available

• Chest pain
• Shortness of breath
• Syncope
• Palpitations
• New or worsening aggression
• Hallucinations
• Delusions
• Mania
• Severe anxiety
• Agitation
• Numbness, coolness, or pain in digits (Raynaud's phenomenon)
• Unexplained wounds on fingers or toes
• Priapism (prolonged erections)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown some evidence of teratogenicity at high doses. Limited human data suggest no increased risk of major congenital malformations, but some studies suggest a small increased risk of cardiac malformations.

Methylphenidate is excreted into human milk. Caution should be exercised when Concerta is administered to a nursing woman. Monitor the infant for adverse reactions such as agitation, insomnia, or decreased weight gain.

Approved for children 6 years and older. Monitor growth (height and weight) and cardiovascular parameters. Risk of new or worsening psychiatric symptoms. Long-term safety and efficacy in children younger than 6 years have not been established.

Safety and efficacy in patients over 65 years of age have not been established. Use with caution due to potential for increased sensitivity to stimulant effects and higher prevalence of cardiovascular disease.

• Concerta utilizes the OROS (Osmotic Release Oral System) technology, which allows for a controlled, extended release of methylphenidate over approximately 12 hours. This system results in a 'ghost tablet' (the empty shell) being excreted in the stool, which is a normal occurrence and does not indicate that the medication was not absorbed.
• It is crucial to take Concerta in the morning to avoid insomnia due to its long duration of action.
• Patients should be advised not to crush, chew, or divide the tablets, as this will disrupt the extended-release mechanism and could lead to a rapid release of the entire dose, increasing the risk of adverse effects and overdose.
• Regular monitoring of blood pressure and heart rate is essential, especially in patients with pre-existing cardiovascular conditions or risk factors.
• For pediatric patients, growth monitoring (height and weight) is important due to the potential for growth suppression with long-term stimulant use. Drug holidays may be considered to mitigate this effect.
• Concerta has a high potential for abuse and dependence; careful assessment of abuse risk and ongoing monitoring are necessary.

• Other methylphenidate formulations (e.g., Ritalin, Focalin, Daytrana, Quillivant XR, Aptensio XR, Jornay PM)
• Amphetamine-based stimulants (e.g., Adderall, Vyvanse, Dexedrine)
• Non-stimulant medications (e.g., Atomoxetine (Strattera), Guanfacine ER (Intuniv), Clonidine ER (Kapvay), Viloxazine (Qelbree))
• Behavioral therapy and psychotherapy for ADHD

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.