Brand Name Drug: Concerta
Active Ingredient Drug: methylphenidate hydrochloride
Indication: Treatment of attention deficit hyperactivity disorder in children over age 6
Company Name: ALZA Corporation
Availability: Approved by FDA on August 1, 2000
For several years, the medicine Ritalin (methylphenidate) has benefited children with attention deficit hyperactivity disorder (ADHD), estimated to afflict about 3-5% of American school-age children. But this drug must be taken 2-3 times a day, often necessitating a trip by the child to the nurse’s office at lunchtime to take the midday dose.
Today, a new formulation of methylphenidate has been approved by the FDA, which only requires once-daily dosing. It is called Concerta and is manufactured by ALZA Corporation. The drug is taken in the morning, freeing the child to go about daily activities without the inconvenience or potential embarrassment of taking another dose at school. Concerta, produced in 18 mg and 36 mg tablets, is expected to be available by prescription before the start of the 2000-2001 school year.
How It Works
Concerta is a central nervous system stimulant. The mode of therapeutic action in ADHD is not known. Concerta is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Concerta: Clinical Study Results
The efficacy of Concerta was evaluated in three double-blind, active- and placebo-controlled studies of 416 children ages 6-12 (ref. 1). The product was evaluated in multiple settings — including community schools, laboratory schools (specialized schools used to monitor children with ADHD for treatment evaluation purposes), and at home.
Concerta once daily (18, 36, or 54 mg) was compared to methylphenidate given thrice daily (15, 30, or 45 mg total daily dose) over 12 hours and placebo in three double-blind trials. In these three studies, teachers and parents consistently reported a statistically significant improvement in attention and reduction in overactivity throughout the day among children taking once-daily Concerta versus placebo.
Both teachers and parents used the IOWA Conners scale, one of the most commonly used and recognized scales for evaluating children with ADHD in clinical studies. The IOWA Conners scales rate inattention and overactivity on a scale from one to 15, with lower numbers representing improved behavior. In one of the three studies, a large-scale 13-center trial including 282 children ages 6-12, community teachers using the IOWA Conners scale rated children an average of 5.98 for Concerta and 9.77 for placebo.
What the Patient Should Know
Concerta should be taken in the morning, with or without breakfast. Concerta tablets must be swallowed whole with the aid of liquid and must not be chewed, divided, or crushed.
In the largest controlled clinical study with patients using Concerta, the most common side effects reported were headache (14%), upper respiratory tract infection (8%), stomach ache (7%), vomiting (4%), loss of appetite (4%), sleeplessness (4%), increased cough (4%), sore throat (4%), sinusitis (3%), and dizziness (2%).
Concerta should not be taken by patients who have significant anxiety, tension, or agitation since Concerta may make these conditions worse; those who are allergic to methylphenidate or any of the other ingredients in Concerta; patients with glaucoma; those who have tics or Tourette’s syndrome, or a family history of Tourette’s syndrome; or patients who are taking a prescription monoamine oxidase inhibitor.
Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence.
Concerta should not be used in children under six years since safety and efficacy in this age group have not been established. Concerta should not be administered to patients with preexisting severe gastrointestinal narrowing.
Like any medication, Concerta can have side effects. It’s important to note that not everyone will experience these side effects, and their severity can vary. Common side effects of Concerta may include:
- Insomnia or Sleep Disturbances: Concerta is a stimulant that can affect sleep patterns, leading to difficulty falling or staying asleep.
- Loss of Appetite: Stimulant medications like Concerta can sometimes suppress appetite, leading to weight loss.
- Nervousness or Anxiety: Some individuals may experience increased nervousness or anxiety.
- Increased Heart Rate: Concerta can cause an increase in heart rate or blood pressure.
- Stomach Upset: Gastrointestinal issues such as nausea, pain, or vomiting may occur.
- Headache: Headaches are a reported side effect of Concerta.
- Mood Changes: Some people may experience mood swings or emotional changes.
- Dizziness: Dizziness or lightheadedness can occur, especially when standing up quickly.
- Sweating: Excessive sweating is another potential side effect.
- Tics or Twitching: In some cases, stimulant medications can exacerbate tics or cause new ones to develop.
Report any side effects to the healthcare provider. Concerta, like other stimulant medications, may have more severe side effects in rare cases. These can include cardiovascular effects, psychiatric symptoms, and allergic reactions. It’s crucial to promptly discuss any concerns or unusual symptoms with your healthcare provider.
This list is not exhaustive, and individual responses to medications can vary. Always follow your healthcare provider’s instructions and communicate openly about your experiences with the medication.
Concerta (methylphenidate extended-release) can interact with various medications and substances, potentially affecting its effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all the medications, supplements, and herbal products you are taking. Some potential interactions with Concerta include:
- Monoamine Oxidase Inhibitors (MAOIs): Concurrent use of Concerta with MAOIs can lead to serious, potentially life-threatening interactions, including hypertensive crisis. MAOIs should be discontinued for at least 14 days before starting Concerta.
- Antidepressant Medications: Combining Concerta with certain antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), may increase the risk of serotonin syndrome.
- Blood Pressure Medications: Concerta can increase blood pressure and heart rate, so caution is advised with other medications that affect blood pressure.
- Antacids: Certain antacids containing aluminum hydroxide or magnesium hydroxide may decrease the absorption of Concerta. It’s advisable to take antacids at least one hour before or two hours after taking Concerta.
- CYP2D6 Inhibitors: Medications that inhibit the CYP2D6 enzyme (e.g., certain antidepressants and antipsychotics) may affect the metabolism of Concerta, potentially altering its effectiveness.
- CYP2D6 Inducers: Medications that induce the CYP2D6 enzyme (e.g., rifampin) may increase the metabolism of Concerta, potentially reducing its efficacy.
- Anticoagulants: There is a potential for increased blood pressure and heart rate when Concerta is used with anticoagulant medications.
- Caffeine: Combining Concerta with high doses of caffeine may increase the risk of cardiovascular side effects.
Always consult your healthcare provider before starting or stopping any medication. Tell them your complete medical history and all the substances you are taking to ensure a safe and effective treatment plan. Your healthcare provider can help manage potential interactions and adjust your treatment plan accordingly.