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Before Using
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 under 6 years of age.
Geriatric
Appropriate studies on the relationship of age to the effects of Concerta® extended release tablets have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.
No information is available on the relationship of age to the effects of Ritalin® in geriatric patients.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breastfeeding
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.
Drug Interactions
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
- Selegiline
- Toloxatone
- Tranylcypromine
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
Other Interactions
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Agitation, severe or
- Anxiety, severe or
- Glaucoma or
- Motor tics (repeated muscle movements) or
- Tension, severe or
- Tourette's syndrome, or family history of—Should not be used in patients with these conditions.
- Alcohol abuse, history of or
- Drug abuse or dependence, history of—Dependence may be more likely to develop.
- Bipolar disorder (manic-depressive illness), history of or
- Blood vessel problems or
- Coronary artery disease or
- Depression, history of or
- Heart attack, recent or
- Heart disease (e.g., cardiomyopathy) or
- Heart failure or
- Heart rhythm problems (e.g., ventricular arrhythmia), history of or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid) or
- Psychosis (mental illness), history of or
- Seizures, history of or
- Stroke, history of or
- Tachycardia (rapid heart rate)—May make these conditions worse.
- Cystic fibrosis or
- Stomach or bowel problems (e.g., bowel blockage, Meckel's diverticulum, peritonitis, short gut syndrome) or
- Trouble with swallowing—Concerta® extended release tablets should not be given in patients with these conditions.
