Methylin (methylphenidate HCI)

Generic drug: methylphenidate HCI

Brand name: Methylin

Methylin Chewable Tablets (methylphenidate HCI) is a prescription medicine used to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Methylin Chewable Tablets may be used alone or with other medications.

Methylin Chewable Tablets belongs to a class of drugs called Stimulants; ADHD Agents.

It is not known if Methylin Chewable Tablets is safe and effective in children younger than 6 years of age.

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• chest pain,
• lightheadedness,
• hallucinations,
• new behavior problems,
• aggression,
• hostility,
• paranoia,
• numbness,
• pain,
• cold feeling,
• unexplained wounds,
• skin color changes (pale, red, or blue appearance) in your fingers or toes, and
• penis erection that is painful or lasts 4 hours or longer

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Methylin Chewable Tablets include:

• excessive sweating,
• mood changes,
• nervousness,
• irritableness,
• sleep problems (insomnia),
• fast heart rate,
• pounding heartbeats,
• fluttering in your chest,
• increased blood pressure,
• loss of appetite,
• weight loss,
• dry mouth,
• nausea,
• stomach pain, and
• headache

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

These are not all the possible side effects of Methylin Chewable Tablets. For more information, ask your doctor or pharmacist.

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

• Methylin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
• Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Longterm follow-up may be required because of the patient's basic personality disturbances.

Dosage should be individualized according to the needs and responses of the patient.

Directions

Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.

Adults

• Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals.
• Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily.
• In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Children (6 years and over)

• Methylin should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
• If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
• Chewable Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
• If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
• Methylin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
• Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

Monoamine Oxidase Inhibitors (MAOI)

• Concomitant use of MAOIs and CNS stimulants, including Methylin can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Concomitant use of Methylin with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.

Antihypertensive Drugs

• Methylin may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.

Risperidone

• Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS). Monitor for signs of EPS.
• Methylin may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.
• Human pharmacologic studies have shown that Methylin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Methylin.

• Adequate animal reproduction studies to establish safe use of Methylin during pregnancy have not been conducted. 
• Methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.
• There is no information available on Methylin and its effects on breastfeeding women or their infants.