Methylin ER

Methylin ER is a prescription medication used to control symptoms of attention deficit hyperactivity disorder in children aged 6 years and older, adolescents, and adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Methylin Er. See the “Methylin ER Precautions” section.

Common side effects of Methylin ER include the following:

• upper abdominal pain
• decreased appetite
• headache
• dry mouth
• nausea
• insomnia
• anxiety
• dizziness
• weight loss
• irritability
• increased sweating

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended starting dose of Methylin ER for children and adolescents is 18 mg/day. The recommended starting dose of Methylin ER for adults is 18 or 36 mg/day. The dose may be increased slowly according to patient response and tolerability.

If you take too much Methlyin ER, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Methylin ER is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Methylphenidate is also used to treat narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of methylphenidate have not been performed in the geriatric population.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Use with caution. Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or
• Depression, history of or
• Hypertension (high blood pressure) or
• Priapism (painful or prolonged erection of the penis) or
• Psychosis (mental illness), history of or
• Raynaud disease or
• Seizures, history of or
• Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.

• Coronary artery disease or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Heart failure or
• Heart rhythm problems (eg, ventricular arrhythmia), history of or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of—Use with caution. May make side effects become worse.

• Phenylketonuria—The chewable tablet contains aspartame, which can make this condition worse.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Immediate release tablets (Ritalin, Methylin, methylphenidate):
Initial Dose: 10 mg orally 2 or 3 times daily, preferably 30 to 45 minutes before meals.
Maintenance dose: Doses may be increased weekly in increments of 5 to 10 mg up to a maximum of 60 mg per day. In some patients, 10 to 15 mg daily may suffice. For patients who have trouble sleeping at night while receiving methylphenidate, the last dose should be taken before 6 PM.

Sustained release tablets (Ritalin SR, Metadate ER):
Initial Dose: Methylphenidate is also available as a 10 mg and 20 mg sustained release tablets with a duration of action of approximately 8 hours. If dose of the sustained release tablet corresponds with the titrated dose of methylphenidate regular tablets (taken not more frequently than every 8 hours), then the sustained release tablets may be used instead of the regular tablets.
Maintenance Dose: The dose may be increased in weekly increments of 10 mg, up to a maximum of 60 mg/day, with the first dose taken before breakfast. Tablets should not be crushed or chewed.

Extended release capsules (Metadate CD):
Initial Dose: 20 mg orally once a day in the morning before breakfast.
Maintenance Dose: Doses may be increased weekly in increments of 20 mg up to a maximum of 60 mg once daily in the morning. The capsules should not be opened, chewed, or crushed.

Extended release tablets (Concerta):
Initial: (Methylphenidate- naive patients) 18 mg once daily in the morning before breakfast.
For patients already receiving methylphenidate:
If switching from immediate release tablets 5 mg 2 or 3 times a day: 18 mg once daily.
If switching from immediate release tablets 10 mg 2 or 3 times a day: 36 mg once daily.
If switching from immediate release tablets 15 mg 2 or 3 times a day: 54 mg once daily.
If switching from immediate release tablets 20 mg 2 or 3 times a day: 72 mg once daily.
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Maintenance: May increase by 18 mg increments at weekly intervals up to a maximum of 72 mg once daily in the morning before breakfast. Tablets should not be chewed, divided, or crushed.

Methylphenidate is contraindicated in patients with glaucoma, motor tics, and Tourette's syndrome, and within 14 days of taking MAO inhibitors.

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

It is recommended to avoid use of stimulants, including methylphenidate, in patients with known structural cardiac abnormalities as cases of sudden death, primarily in children, have been reported.

Blood pressure and pulse should also be monitored at appropriate intervals in all patients taking methylphenidate, especially in patients with hypertension.

Data are inadequate to determine whether chronic administration of methylphenidate may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Methylphenidate should be discontinued if no improvement is noted after appropriate dosage adjustment over one month.