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Methylphenidate hydrochloride is a central nervous system (CNS) stimulant.
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is an extended-release
formulation of methylphenidate with a bi-modal release profile. Ritalin LA® uses the proprietary
SODAS® (Spheroidal Oral Drug Absorption System) technology. Each bead-filled Ritalin LA capsule
contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads,
thus providing an immediate release of methylphenidate and a second delayed release of
methylphenidate. Ritalin LA 10, 20, 30, and 40 mg capsules provide in a single dose the same amount
of methylphenidate as dosages of 5, 10, 15, or 20 mg of Ritalin® tablets given b.i.d.

 

Methylphenidate hydrochloride USP 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 slightly soluble in
chloroform and in acetone. Its molecular weight is 269.77.

 

Food Effects
Administration times relative to meals and meal composition may need to be individually titrated.
When Ritalin LA was administered with a high fat breakfast to adults, Ritalin LA had a longer lag time
until absorption began and variable delays in the time until the first peak concentration, the time until
the interpeak minimum, and the time until the second peak. The first peak concentration and the extent
of absorption were unchanged after food relative to the fasting state, although the second peak was
approximately 25% lower. The effect of a high fat lunch was not examined.
There were no differences in the pharmacokinetics of Ritalin LA when administered with applesauce,
compared to administration in the fasting condition. There is no evidence of dose dumping in the
presence or absence of food

 

Alcohol Effect
Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including Ritalin. It is
therefore advisable for patients to abstain from alcohol during treatment. An in vitro study was
conducted to explore the effect of alcohol on the release characteristics of methylphenidate from the
Ritalin LA® 40 mg capsule dosage form. At an alcohol concentration of 40% there was a 98% release
of methylphenidate in the first hour. The results with the 40 mg capsule are considered to be
representative of the other available capsule strengths.

 

Long-Term Use
The effectiveness of Ritalin LA for long-term use, i.e., for more than 2 weeks, has not been
systematically evaluated in controlled trials. Therefore, the physician who elects to use Ritalin LA for
extended periods should periodically re-evaluate the long-term usefulness of the drug for the
individual patient

 

CONTRAINDICATIONS
Agitation
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is contraindicated in marked
anxiety, tension, and agitation, since the drug may aggravate these symptoms.
Hypersensitivity to Methylphenidate
Ritalin LA is contraindicated in patients known to be hypersensitive to methylphenidate or other
components of the product.
Glaucoma
Ritalin LA is contraindicated in patients with glaucoma.

 

OVERDOSAGE
Signs and Symptoms
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central
nervous system and from excessive sympathomimetic effects, may include the following: vomiting,
agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria,
confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia,
palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Poison Control Center
Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and
advice.

 

WARNINGS
Serious Cardiovascular Events
Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems
Children and Adolescents
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children
and adolescents with structural cardiac abnormalities or other serious heart problems. Although some
serious heart problems alone carry an increased risk of sudden death, stimulant products generally
should not be used in children or adolescents with known serious structural cardiac abnormalities,
cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place
them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults
Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at
usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults
have a greater likelihood than children of having serious structural cardiac abnormalities,
cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac
problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

 

ADVERSE REACTIONS
The clinical program for Ritalin LA® (methylphenidate hydrochloride) extended-release capsules
consisted of six studies: two controlled clinical studies conducted in children with ADHD aged 6-12
years and four clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The
subjects received Ritalin LA in doses of 10-40 mg per day. Safety of Ritalin LA was assessed by
evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body
weight.

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Food Effects
Administration times relative to meals and meal composition may need to be individually titrated. We are the only pharmacy where you can Buy Ritalin Online Overnight.
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Alcohol Effect
Alcohol may exacerbate the adverse CNS effects of psychoactive drugs, including Ritalin. Buy Ritalin 10mg Online Australia from us for It istherefore advisable for patients to abstain from alcohol during treatment. An in vitro study wasconducted to explore the effect of alcohol on the release characteristics of methylphenidate from the Ritalin LA® 40 mg capsule dosage form. Buy Ritalin 10mg Online Australia for discount purposes. At an alcohol concentration of 40% there was a 98% release of methylphenidate in the first hour. The results with the 40 mg capsule are considered to be representative of the other available capsule strengths. Buy Ritalin 10mg Online Australia from us.

 

Long-Term Use
The effectiveness of Ritalin LA for long-term use, i.e., for more than 2 weeks, has not been
systematically evaluated in controlled trials. Therefore, the physician who elects to use Ritalin LA for
extended periods should periodically re-evaluate the long-term usefulness of the drug for the
individual patient

 

CONTRAINDICATIONS
Agitation
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules is contraindicated in marked
anxiety, tension, and agitation, since the drug may aggravate these symptoms.
Hypersensitivity to Methylphenidate
Ritalin LA is contraindicated in patients known to be hypersensitive to methylphenidate or other
components of the product.
Glaucoma
Ritalin LA is contraindicated in patients with glaucoma.

 

OVERDOSAGE
Signs and Symptoms
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central
nervous system and from excessive sympathomimetic effects, may include the following: vomiting,
agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria,
confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia,
palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Poison Control Center
Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and
advice.

 

WARNINGS
Serious Cardiovascular Events
Sudden Death and Pre-Existing Structural Cardiac Abnormalities or Other Serious Heart Problems
Children and Adolescents
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children
and adolescents with structural cardiac abnormalities or other serious heart problems. Although some
serious heart problems alone carry an increased risk of sudden death, stimulant products generally
should not be used in children or adolescents with known serious structural cardiac abnormalities,
cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place
them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults
Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at
usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults
have a greater likelihood than children of having serious structural cardiac abnormalities,
cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac
problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

 

ADVERSE REACTIONS
The clinical program for Ritalin LA® (methylphenidate hydrochloride) extended-release capsules
consisted of six studies: two controlled clinical studies conducted in children with ADHD aged 6-12
years and four clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The
subjects received Ritalin LA in doses of 10-40 mg per day. Safety of Ritalin LA was assessed by
evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body
weight.

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