Some studies suggest that certain nutritional supplements and herbal remedies can relieve ADHD symptoms. We'll show you which ones are worth trying. People with ADHD are often misunderstood by others unfamiliar with the condition. We'll lay to rest four common myths associated with ADHD. Staying organized can be a challenge, and people living with ADHD might need more help than others. We rounded up our favorite products to help you…. Health Conditions Discover Plan Connect.
Adderall vs. Ritalin: What's the Difference? Medically reviewed by Alan Carter, Pharm. Drug Features. Share on Pinterest. How they work. Cost, availability, and insurance. Side effects. Use with other medical conditions. Drug interactions. Making a Decision. Read this next. Medically reviewed by Timothy J. Legg, Ph. Medically reviewed by Debra Rose Wilson, Ph.
Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Ritalin LA treatment. CNS stimulants cause an increase in blood pressure mean increase approximately 2 to 4 mmHg and heart rate mean increase approximately 3 to 6 beats per minute. Individuals may have larger increases.
Monitor all patients for hypertension and tachycardia. CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode e. CNS stimulants, at recommended doses, may cause psychotic or manic symptoms e. If such symptoms occur, consider discontinuing Ritalin LA.
In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0. Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose.
Priapism has also appeared during a period of drug withdrawal drug holidays or during discontinuation. Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
Further clinical evaluation e. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months to the ages of years , suggests that consistently medicated pediatric patients i.
Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The clinical program for Ritalin LA consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6 to 12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers.
These studies included a total of subjects; children with ADHD and 61 healthy adult volunteers. The subjects received Ritalin LA in doses of 10 to 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. A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of Ritalin LA in children with ADHD aged 6 to 12 years.
All subjects received Ritalin LA for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week double-blind treatment phase of this study, patients received either placebo or Ritalin LA at their individually-titrated dose range, 10 to 40 mg. In the single-blind titration period of this study, subjects received Ritalin LA for up to 4 weeks.
The adverse events leading to discontinuation were anger 2 patients , hypomania, anxiety, depressed mood, fatigue, migraine, and lethargy. The following adverse reactions have been identified during the post approval use of methylphenidate products. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Blood and the Lymphatic System Disorders: leukopenia, thrombocytopenia, anemia. Immune System Disorders: hypersensitivity reactions, including angioedema and anaphylaxis. Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in children. Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis sometimes with visual and tactile hallucinations , depressed mood.
Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoathetoid movements, drowsiness, convulsions, cerebrovascular disorders including vasculitis, cerebral hemorrhages and cerebrovascular accidents , serotonin syndrome in combination with serotonergic drugs.
Eye Disorders: blurred vision, difficulties in visual accommodation. Cardiac Disorders: tachycardia, palpitations, increased blood pressure, arrhythmias, angina pectoris.
Gastrointestinal Disorders: dry mouth, nausea, vomiting, abdominal pain, dyspepsia. Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury.
Skin and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura. Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis.
The list below shows adverse reactions not listed with Ritalin, Ritalin-SR, or Ritalin LA formulations that have been reported with other methylphenidate-containing products.
Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas. Psychiatric Disorders: affect lability, mania, disorientation, libido changes.
Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole. Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea. Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption. Musculoskeletal, Connective Tissue, and Bone Disorders: myalgia, muscle twitching. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Ritalin LA during pregnancy.
Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy see Clinical Considerations.
However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents see Data.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U. CNS stimulants, such as Ritalin LA, can cause vasoconstriction and thereby decrease placental perfusion. Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0. There are no reports of adverse effects on the breastfed infant and no effects on milk production.
Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. The safety and effectiveness of Ritalin LA in pediatric patients less than 6 years have not been established.
Growth should be monitored during treatment with stimulants, including Ritalin LA. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions 5. Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The clinical significance of the long-term behavioral effects observed in rats is unknown.
Abuse is characterized by impaired control over drug use despite harm, and craving. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death [see Overdosage 10 ].
Physical dependence which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist may occur in patients treated with CNS stimulants, including Ritalin and Ritalin-SR. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions which may be followed by coma , euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, hypotension, tachypnea, mydriasis, dryness of mucous membranes, and rhabdomyolysis.
Ritalin LA extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled Ritalin LA capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.
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 Inactive ingredients: ammonio methacrylate copolymer, black iron oxide 10 and 40 mg capsules only , gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide 10 and 40 mg capsules only , sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide 10, 30, and 40 mg capsules only.
Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known. Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers.
Methylphenidate hydrochloride is CNS stimulant. The mode of therapeutic action in ADHD is not known.. Methylphenidate is racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
The effect of dexmethylphenidate, the pharmacologically active d-enantiomer of Ritalin, on the QT interval was evaluated in double-blind, placebo- and open-label active moxifloxacin -controlled study following single doses of dexmethylphenidate XR 40 mg maximum recommended adult total daily dosage in 75 healthy volunteers.
Electrocardiograms were collected up to 12 hours postdose. This was below the threshold of clinical concern and there was no evident-exposure response relationship.. Ritalin LA produces bi-modal plasma concentration-time profile i. No accumulation of methylphenidate is expected following multiple once daily oral dosing with Ritalin LA, however, there is slight upward trend in the methylphenidate area under the curve and peak plasma concentrations Cmax1 and Cmax2 after oral administration of Ritalin LA 20 mg and 40 mg capsules to adults.
The relative bioavailability of Ritalin LA given once daily is comparable to the same total dose of Ritalin tablets given in doses hours apart in both children and adults. The initial rate of absorption for Ritalin LA is similar to that of Ritalin tablets as shown by the similar rate parameters between the formulations, i.
The mean time to the interpeak minimum Tminip , and time to the second peak Tmax2 are also similar for Ritalin LA given once daily and Ritalin tablets given in doses hours apart see Figure and Table 1 , although the ranges observed are greater for Ritalin LA.
Ritalin LA given once daily exhibits lower second peak concentration Cmax2 , higher interpeak minimum concentrations Cminip , and less peak and trough fluctuations than Ritalin tablets given in doses given hours apart. This is due to an earlier onset and more prolonged absorption from the delayed-release beads see Figure and Table 4. When Ritalin LA was administered with high fat breakfast to adults, Ritalin LA had 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 effect of 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. Effect of AlcoholAn 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.
The results with the 40 mg capsule are considered to be representative of the other available capsule strengths. The volume of distribution was 2. EliminationThe systemic clearance is 0.
In studies with Ritalin LA and Ritalin tablets in adults, methylphenidate from Ritalin tablets is eliminated from plasma with an average half-life of about 3.
In children the average half-life is about 2. The rapid half-life in both children and adults may result in un-measurable concentrations between the morning and mid-day doses with Ritalin tablets. No accumulation of methylphenidate is expected following multiple once day oral dosing with Ritalin LA. The half-life of ritalinic acid is about to hours. Biotransformation of methylphenidate by the carboxylesterase CES1A1 is rapid and extensive leading to the main, de-esterified metabolite -phenylpiperidine acetic acid ritalinic acid , which has little or no pharmacologic activity.
Only small amounts of hydroxylated metabolites e. Therapeutic activity is principally due to the parent compound. Studies in Specific PopulationsMale and Female PatientsThere were no apparent gender differences in the pharmacokinetics of methylphenidate between healthy male and female adults when administered Ritalin LA.
Racial or Ethnic GroupsThere is insufficient experience with the use of Ritalin LA to detect ethnic variations in pharmacokinetics. Fifteen of these children were between 10 and 12 years of age. The time until the between peak minimum, and the time until the second peak were delayed and more variable in children compared to adults. After mg dose of Ritalin LA, concentrations in children were approximately twice the concentrations observed in 18 to 35 year old adults.
This higher exposure is almost completely due to the smaller body size and total volume of distribution in children, as apparent clearance normalized to body weight is independent of age.
Hepatic impairment is expected to have minimal effect on the pharmacokinetics of methylphenidate since it is metabolized primarily to ritalinic acid by nonmicrosomal hydrolytic esterases that are widely distributed throughout the body.. The doses used were the optimal doses established in previous individual dose titration phase. The change from baseline of the CADS-T scores during the last week of treatment was analyzed as the primary efficacy parameter.
Patients treated with Ritalin LA showed statistically significant improvement in symptom scores from baseline [Mean final score baseline Ritalin LA extended-release capsules is an extended-release formulation of methylphenidate for oral administration with bi-modal release profile.
Each bead-filled Ritalin LA capsule contains half the dose as immediate-release beads and half as enteric-coated beads, thus providing an immediate release of methylphenidate and second delayed release of methylphenidate. The active substance in Ritalin LA is methyl -phenylpiperidineacetate hydrochloride, and its structural formula is Methylphenidate hydrochloride USP is 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 Inactive ingredients: ammonio methacrylate copolymer, black iron oxide 10 and 40 mg capsules only , gelatin, methacrylic acid copolymer, polyethylene glycol, red iron oxide 10 and 40 mg capsules only , sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide 10, 30, and 40 mg capsules only..
Ritalin LA structural formula. Administer orally once daily in the morning 2. Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce 2. Should not be crushed, chewed, or divided 2. Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in mg increments. Doses above 60 mg daily are not recommended 2. For patients currently using Ritalin: Dosage is based on current dose regimen 2.
If switching from other methylphenidate products, discontinue treatment and titrate with Ritalin LA 2. The recommended starting dose for Ritalin LA is 20 mg once daily.
Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When lower initial dose is appropriate, patients may begin treatment with 10 mg. Administer Ritalin LA orally once daily in the morning. Ritalin LA may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on small amount of applesauce see specific instructions below.
The capsules may be carefully opened and the beads sprinkled over spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation.
The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Ritalin, and adjust dosage as needed.. The recommended dose of Ritalin LA for patients currently taking Ritalin twice daily is provided below.
If switching from other methylphenidate products, discontinue that treatment, and titrate with Ritalin LA using the titration schedule. Do not substitute for other methylphenidate products on milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles [see Description 11 , Clinical Pharmacology Clinical judgment should be used when selecting the starting dose.
Daily dosage above 60 mg is not recommended.. If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin LA. If improvement is not observed after appropriate dosage adjustment over one-month period, the drug should be discontinued.
Extended-release capsules: 10 mg, 20 mg, 30 mg, and 40 mg.
0コメント