Methylphenidate Hydrochloride Tablets, USP
Methylphenidate Hydrochloride Extended-release Tablets, USP
Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant. Methylphenidate hydrochloride is available as 5, 10, and 20 mg tablets for oral administration. A 20 mg extended-release tablet for oral administration is also available. Methylphenidate hydrochloride is methyl a-phenyl-2-piperi-dineeacetate hydrochloride.

Methylphenidate hydrochloride is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and sliglhtly soluble in chloroform and in acetone. Its molecular weight is 269.77.

Inactive Ingredients: Methylphenidate hydrochloride tablets; lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate; 5 mg contains D&C Yellow #10; 10 mg contains FD&C Green #3, and 20 mg contains FD&C Yellow #6.

Methylphenidate hydrochloride extended-release tablets: cetyl alcohol, ethylcellulose, lactose and magnesium stearate.


INDICATIONS

Attention Deficit Disorders, Narcolepsy: Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children).

Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.

Methylphenidate hydrochloride is indicated as an integral proof of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms; moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Special Diagnostic Considerations: Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.

Characteristics commonly reported include: Chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired.The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.

drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial-intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.


DOSAGE AND ADMINISTRATION

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

Adult

Tablets: 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..

Extended-Release Tablets: Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.

Children (6 years and over)

Methylphenidate hydrochloride 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.

Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.

Extended-Release Tablets: Methylphenidale hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.

Methylphenidate 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.

HOW SUPPLIED

Methylphenidate hydrochloride tablets are supplied as-

Tablets, 5 mg: Round, yellow, uncoated, unscored, (debossed 531 and MD) in bottles of 100 and 1,000.
Tablets, 10 mg: Round, pale blue/green, uncoated, scored, (debossed 530 and MD) in bottles of 100 and 1,000.
Tablets, 20 mg: Round, orange, uncoated, scored, (debossed 532 and MD) in bottles of 100 and 1,000.
Extended-release Tablets, 20 mg: Round, white, uncoated, unscored, (debossed 562 and MD) in bottles of 100.
NOTE: Extended-release tablets are color-additive free.

PHARMACIST: Dispense in a tight light-resistant container as defined in the USP with a child-resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from moisture.


WARNINGS

Methylphenidate should not be used in children under six years, since safety and efficacy in this age group have not been established.

Sufficient data on safety and efficacy of long-term use of methylphenidate hydrochloride in children are not yet available. Although a causal relationship has not been established, suppression of growth ( i.e., weight gain, and/or height) has been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored. Methylphenidate should not be used for severe depression of either exogenous or endogenous origin. Clinical experience suggests that in psychotic children, administration of methylphenidate may exacerbate symptoms of behavior disturbance and thought disorder
Methylphenidals should not be used for the prevention or treatment of normal fatigue states. There is some clinical evidence that methylphenidate may lower the convulsive threshold in patients with prior history of seizures, with prior EEG abnormalities in absence of seizures, and very rarely, in absence of history of seizures and no prior EEG evidence of seizures. Safe concomitant use of anticonvulsants and methylphenidate has not been established. In the presence of seizures, the drug should be discontinued. Use cautiously in patients with hypertension. Blood pressure should be monitored at appropriate intervals in all patients taking methylphenidate, especially those with hypertension.

Symptoms of visual disturbances have been encountered in rare cases. Difficulties with accommodation and blurring of vision have been reported.

drug Interactions

Methylphenidate may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents and MAO inhibitors. Human pharmacologic studies have shown that methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, phenytoin, primidone), phenylbutazone, and tricyclic anti-depressants (imipramine, clomipramnine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with methylphenidate.

Usage In Pregnancy

Adequate animal reproduction studies to establish safe use of methylphenidate during pregnancy have not been conducted. Therefore, until more information is available, methylphenidate hydrochloride should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.


PRECAUTIONS

Patients with an element of agitation may react adversely; discontinue therapy if necessary. Periodic C.C. differential, and platelet counts are advised during prolonged therapy.

drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe methylphenidate should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with methylphenidate is usually not indicated.

Long-term effects of methylphenidate in children have not been well established.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 2.5 times the maximum recommended human dose on a mg/kg and mg/mē basis respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.

Methylphenlidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 4 times the maximum recommended human dose on a mg/kg and mg/mē basis, respectively.

Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. The genotoxic potential of methylphenidate has not been evaluated in an in vitro assay.

Post deleted by Moderator. Please do not post unless you have information or comments about this medicine.

Thanks

Could someone explain this in laymens terms? I take ritalin, and I probably will for a long time, or forever. I am curious about any long term side effects or whatever. Or someone could pm me.
Thanks

Basically ,in english. Thelast partmeansyourchildrenwillbe normal (at least as far a # of digits, heads). Unless you take 20 x the typicall dose -prolonged you don't have to worry much about tumors etc. On the tumor test they typically increase dosage until tumors develop (thus the sacchrine scare - tumors at 2500 x the typical dose)

Since no kidney or liver toxicity wasmentioned assumelow risk.

Most of the above (platlets/plasma counts) are geared toward ADOLESCENT use in developing children for ADD.

The worst long term effect(in Narcolepsy) is loss of effectivity. Tumors kill you slow, having a cataleptic/narcoleptic seizure and falling in front of a bus kills you fast!

I am on Ritalin LA 30 mgs twice a day. The origional post only stated Ritalin being available in 5, 10 or 20 mg doses. Am I on an unusually large dose of Ritalin?

No, everyone's dosage is different. Even with the 20mg of regular Ritalin(not the LA) some are prescribed 3 or 4 a day, and that is normal. I have read of people being prescribed alot higher than that.

Well, I think it's too much for me anyway. It makes me irritable and feel like sh*t. I am just trying it, I usually take Adderall but I just went backto Adderall instead, it works better. I was on 40 mgs of Adderall a day and the side effects were so bad that I wanted to go off it or try something else, which is why I went on Ritalin. But instead I have reduced my dosage of Adderall to 20 mgs a day, broken up into two 10 mg capsules insead of two 20 mg capsules and that is working much better for me. No more pissy-but-organized Zilla! I just can't handle that much amphetamine in my body, I get aggrivated and nauseated all day long.

I have never been prescribed adderall but I would like to try it out. The only side effect I get from ritalin is headaches. I am supposed to take 10mg 3 times a day, I tried taking 20mg at once and it made me very irritable. I play around a bit w/ the dosage cause I am still not sure if I like it or not.

I think Adderall is better than Ritalin, because it lasts much longer, there are not all the "ups and downs" like on Ritalin and especially because there is none of that "coming down" feeling like with Ritalin. I would try it out, start with 10 mgs twice a day and see how it works for you.

Re adderall -
Yes dexadrine is much better than ritilan. But be careful on adderall dose - the available dexadrine in adderall is NOT the adderal mg. amount. Adderal has dexadrine SORBATE and dexadrine SUCCINATE. For example a 30mg adderall tablet contains 18mg dexadrine. With a 10MG adderall you have about 5mg of dexadrine - better off taking the hearts(5mg dex)

Here it is an interesting piece of information regarding Ritalin,

BACKGROUND: The purposes of this study were to investigate the pharmacokinetics of methylphenidate hydrochloride (Ritalin) in the human brain, to compare them with those of cocaine, and to evaluate whether cocaine and methylphenidate compete for the same binding sites. METHODS: We used positron emission tomography to measure the temporal and spatial distribution of carbon 11 (11C)-labeled methylphenidate. These results were compared with those obtained previously for [11C]cocaine. Eight healthy male subjects, 20 to 51 years of age, were scanned with [11C]methylphenidate. Three were tested twice to assess test-retest variability, four were tested at baseline and after administration of methylphenidate, and one was tested with [11C]methylphenidate and [11C]cocaine. Two baboons were scanned to evaluate whether there was competition between cocaine and methylphenidate for the same binding sites in the brain. RESULTS: The uptake of [11C]methylphenidate in the brain was high (mean +/- SD, 7.5% +/- 1.5%), and the maximal concentration occurred in striatum. Pretreatment with methylphenidate decreased binding only in striatum (40%). Although the regional distribution of [11C]methylphenidate, was identical to that of [11C]cocaine and they competed with each other for the same binding sites, these two drugs differed markedly in their pharmacokinetics. Clearance of [11C]methylphenidate from striatum (90 minutes) was significantly slower than that of [11C]cocaine (20 minutes). For both drugs, their fast uptake in striatum paralleled the experience of the "high." For methylphenidate, the high decreased very rapidly despite significant binding of the drug in the brain. In contrast, for cocaine, the decline in the high paralleled its fast rate of clearance from the brain. CONCLUSION: We speculate that because the experience of the high is associated with the fast uptake of cocaine and methylphenidate in the brain, the slow clearance of methylphenidate from the brain may serve as a limiting factor in promoting its frequent self-administration.

http://www.biopsychiatry.com/methcomp.htm

I do not know if I can post about this correctly or not .I had a injury were I hurt my head sometime back.I get a disabilty check and one of the reasons I get it is because I have heavy brain damage .I have not been able to see my regular doctor in sometime now because he is to far away from me and I do not have a way to go see him now .He is a pediatrician[not sure I spelled that right] .I had told him that I had a friend that gave me her sons ritalin and they helped me .I only took 20 to 30 mg a day .He told me he had children on higher dosages than that.I have a heart condition also and he would not prescribe it to me .My friends son stated getting dexadrine and I really can not remember if they were any better than the ritalin.
This summer I ordered some Ciba brand ritalin from a IOP and they helped me as long as I would not take but one 10 mg tablet 3 times a day .I would take 2 10 mg tablets every now and then .I had a hard time sleeping when I took them .I have been thinking seriously about ordering some more ritalin but was wondering if I would do better if I would get some valium also to take at night so I can sleep.
I have a bad nervous condition but really not sure if ritalin or valium would help me .The ritalin does not stimulate me except for the first few days I take it .It actually seems to calm me down more than valium without making me drowsy ,another reason for me to take it.
Whatever works is that the old saying .I do not get the ritalin or valium for recreational purposes.I have not been doing well for some time now and want to get something to help me whatever that may be.I just do not seem to be able to get interested in anything now or seem to be able to do just simple jobs that I would normally do with little or no problem .
I have been studying about other drugs that are more specific for people that have brain damage .I think the latest term for them are nootropics.I am not sure what I need to be taking .
I hope I did not post about this in the wrong section .

harley88

Harley,

Have you done any research on provigil or adrafinil? There is some good information out there about both of these drugs. Just do a google search or pm me.

i am looking for an online pharmacy no rx req, for a rx of dexedrine, ritalin, adderall- prefer generic or brand ok if cheap. (unemployed- the not focusing, can't sit still doesn't work so will in the business world...)
thanks so much.

Thanks ,I have never heard of either one of them .


harley88

Post deleted by newk8

Post deleted by newk8

I was wondering I use on-line Pharms for my pain meds are there any sites that you know of that treat ADD or ADHD?
Thanks

How much Ritalin does Concerta 56 MG have in it? Is Concerta the same as Ritalin?

Why don't you use Ritalin instead of Welbutrin if the condition is ADD? Ritalin will interact with some medications so I would ask a doc.

To the poster looking for adderall or dexedrine, you just can't find it online. It sounds like you have adult add, why not get a script?

Newguy, Ritalin is different than Concerta. They treat a similar condition but they are not the same thing.

Why do adults take Ritalin?

Man, who don;t need energy.? Thanks!

I ordered from Heeb and took one and nothing, I don't feel the energy. How many does an adult have to take for energy?

I posted this in another forum and decided it belongs in here instead.
This posts refers to our experience with RITALIN LA 20mg.
Please don't bash my choice of going this route with my son. Been there and done that. Unless you see him in action, you have no idea.
I have boy/girl twins that just turned 5.
My son has pervasive developmental disorder and suffers from an anxiety disorder. We have been seeing a pyc and therapist for 10 months now. He started celexa about 6 months ago and that has helped ALOT with his anxiety.
2 months ago, the dr started talking about maybe needing a stimulant so we went and had an ECG to make sure his heart is okay, etc.
So Thursday at his appt, she gave him RITALIN LA 20mg once daily to avoid having to dose him while in school.
This is when the trouble started. He had an "adverse" reaction to it according to doctor. The reason for my post is to ask/beg any of you who know anything to please shed some light on this for me.
I opened the capsule and spread it over applesauce like the dr and manufactor said could be done. Within 20 minutes, he was NUTS! He went and took Christmas glasses out of the cabinet, I didn't even know he knew about them. He sat on the floor in the living room rearranging these glasses for 3+ hours. Wouldn't look at us, wouldn't talk to us, just keep rearranging the glasses into different patterns, shapes, etc. We tried to redirect him to things he loves to do, nope, nothing. Finally I picked him up and took him upstairs, screaming and fighting. He proceeded to puke 4 times. The fixation at that point was to make himself puke. For 2 hours all he did was put a pan up to his face and make sounds like vomiting.
Since he was all dirty, I put him in the tub where he remained palaying with water for a few hours, while I sat there watching him.
Finally after 14 hours of this, he went to sleep and woke up normal this morning. I spoke to his doctor a few times and she sais he can't take it (dah) and called it an "adverse" reaction.
We will talk next week about the future plans.
Anyone ever hear of this response before? I am freaked out to say the least!
Thanks!
BTW, he is 44 pounds and 44 inches. I was thinking it was too much med but he didn't have classic signs of "overdose" aka...too much medicine.

Twinsa2b,

You really have your hands full and I feel for you. I can definately see why you are freaking out.

What type of doctor gave your son the ritalin? From your post it sounds like it was a psychiatrist. Did you ask the doctor what it would do and why he/she was prescribing it? I am not informed about pervasive developmental disorder so I have no idea how all of these factors play out together.

I have never heard about these types of reactions but obviously your son did have an adverse reaction. Horrible. Poor thing. I think I would sit down and write down a bunch of questions for his doctor and find out just why he/she prescribed ritalin. You definitely need help. I am sure you are at your wits end. What does your doctor specialize in?

Other than that I have no answers for you but I do feel for you. Two sets of twins would put me over the edge for sure, even without the medical problem. I give you a lot of credit. Keep us informed ok?

Peace,
Alice