Generic drug: methylphenidate HCI
Brand name: Methylin
What is Methylin (methylphenidate HCI), and how does it work?
Methylin Oral Solution (methylphenidate HCI) is a prescription medicine used to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Methylin Oral Solution may be used alone or with other medications.
Methylin Oral Solution belongs to a class of drugs called Stimulants; ADHD Agents.
It is not known if Methylin Oral Solution is safe and effective in children younger than 6 years of age.
What are the side effects of Methylin?
Methylin Oral Solution may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- chest pain,
- trouble breathing,
- 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 Oral Solution include:
- excessive sweating,
- mood changes,
- nervousness,
- irritableness,
- 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 Oral Solution. 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.
Does Methylin cause addiction or withdrawal symptoms?
- 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. Long-term follow-up may be required because of the patient's basic personality disturbances.
What is the dosage for Methylin?
- Dosage should be individualized according to the needs and responses of the patient.
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.
- 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.
What drugs interact with Methylin?
- 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.
Is Methylin safe to use while pregnant or breastfeeding?
- Adequate animal reproduction studies to establish safe use of Methylin during pregnancy have not been conducted.
- Until more information is available, 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 data available on the effects of Methylin on breastfeeding
mothers and their infants.