CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Consider the possibility of support before prescribing and look for indications of abuse or addiction during therapy [see the Warnings and Precautions (5.1) and the Drug Abuse and Dependence (9.2, 9.3)].
INDICATIONS AND USAGE
Ritalin, as well as Ritalin-SR, is recommended to treat:
Attention Deficit Hyperactivity Disorder (ADHD) in children patients older than six years and adults.
DOSAGE AND ADMINISTRATION
Pretreatment Screening
Before treating children and adults taking Central nervous system (CNS) stimulants, like Buy Ritalin Online or Ritalin-SR, whether there is a cardiac disease (i.e. abide an exhaustive history, including relatives with a medical history, sudden death or ventricular arrhythmias, and physical examination) (see Warnings and Precautions (5.2)[5.2]].
Examine the possibility of misuse before prescribing and look for indicators of dependence and abuse while in treatment. Maintain accurate medical records, educate patients on abuse, look out for indicators of abuse and overdoses, and frequently evaluate the necessity of Ritalin or Ritalin-SR [see Boxed Warnings, Warnings and Warnings (5.1) and drug Abuse and Dependence (9.2, 9.3)].
General Dosing Information
Ritalin Tablets
Pediatric Patients 6 Years and older: Begin by taking 5 mg every day (before eating breakfast or lunch). Gradually increase the dosage by increments of 5 to 10 mg weekly. A dosage that is more than 60 mg daily is not advised.
Adults: Average dose is 20-30 mg per day. Take orally in doses divided 2-3 times daily and preferably 30 to 45 minutes before meals. The maximum daily dosage can be 60 mg. Patients who cannot sleep when taking medication late in the day must have their last dose taken before 6 p.m.
Ritalin-SR Tablets
Ritalin-SR tablets provide a duration of action of around 8 hours. Thus, Ritalin-SR tablets can be used instead of Ritalin tablets if the 8-hour dose of Ritalin-SR corresponds to the titrated eight-hour dose of Ritalin. Ritalin-SR tablets should be taken whole and not chewed or crushed.
Treatment with pharmacological methods for ADHD could be required for prolonged periods. It is essential to periodically review the long-term use of Ritalin and Ritalin-SR and alter dosage as needed.
Dose Reduction and Discontinuation
If a paradoxical increase in symptoms and other side effects are observed, decrease the dose or, if required, stop using Ritalin and Ritalin-SR. If no improvement is observed after a dose adjustment that is appropriate within a month, it is recommended that the drug be withdrawn.
DOSAGE FORMS AND STRENGTHS
Tablets
5 mg round, yellow flat, with CIBA monogram on one side. NDC#7 on the reverse.
10 mg circular, light green biconvex, pale green with CIBA monograms on the one side, and NDC# 3, as well as a partial bisection of the other
20 mg circular, yellow biconvex, pale yellow with CIBA monograms on the one side, and NDC# 34, as well as an incomplete bisection on the reverse
Extended-Release Tablets
Tablets with the extended release of 20 mg white to off-white biconvex, coated with the monogram ‘CIBA’ and the number 16 on the other side, printed with black ink
CONTRAINDICATIONS
Hypersensitivity to methylphenidate as well as the other ingredients of Ritalin as well as Ritalin-SR. Hypersensitivity reactions, including anaphylactic and angioedema, have been observed in patients receiving methylphenidate therapy [see adverse reactions (6.1)[see Adverse Reactions (6.1)].
Treatment with monoamine oxidase inhibitors (MAOIs) at least 14 days after the discontinuation of the therapy using an MAOI due to the potential for hypertensive crises (see the section on Drug Interactions (7.1)[see Drug Interactions (7.1)].
WARNINGS AND PRECAUTIONS
Potential for Abuse and Dependence
CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Examine the potential for misuse before prescribing and watch for indications of abuse or addiction during therapy [see Boxed Warn and Drug Abuse and Dependence (9.2, 9.3)].
Serious Cardiovascular Reactions
Death by sudden accident, stroke and myocardial infarction have all been reported in adults receiving CNS stimulant therapy in the doses recommended for the condition. Deaths have been observed in children with abnormalities in the structure of their heart and severe heart conditions who are taking CNS stimulants in the recommended dosages for ADHD. Do not use it in patients with significant structural cardiac anomalies or cardiomyopathy, heart rhythm disorders and coronary artery disease and other serious heart-related problems. Examine patients who experience unprovoked chest pain, arrhythmias or syncope while taking Ritalin and Ritalin-SR therapy.
Blood Pressure and Heart Rate Increase
CNS stimulants can cause an elevation in blood pressure (mean increase of 2 to 4 millimeters) and heartbeat (mean gain of 3 to 6 beats every minute). Some individuals may experience higher increases. Be sure to monitor all patients for hypertension or tachycardia.
Psychiatric Adverse Reactions
Exacerbation of Preexisting Psychosis
CNS stimulants can exacerbate behavioral disturbance and thoughts disorder symptoms in people with an existing psychotic disorder.
Induction of Manic Episodes in Bipolar Disorder
CNS stimulants can trigger an agitated or mixed mood disorder in patients. Before starting treatment, test patients for the possibility of experiencing a manic episode (e.g. an underlying comorbidity, an underlying depressive disorder or a family history of bipolar disorder, suicide or depressive disorder).
New Psychotic or Manic Symptoms
CNS stimulants, in the dosages that are recommended, can cause manic or psychotic symptoms (e.g. hallucinations, delusional thoughts, or manic symptoms) for those who do not have a previous diagnosis of psychotic illness or manic episodes. If these symptoms are present, you should consider Buy Ritalin and Ritalin-SR. In a pooled study of several placebo-controlled short-term research studies on CNS stimulants, Manic or psychotic symptoms were reported in around 0.1 per cent of CNS stimulant-treated patients, compared to 0 in placebo-treated subjects.
Priapism
The painful and prolonged erections, which sometimes require surgery, are reported in methylphenidate products for both children and adult patients. It was not reported at the beginning of the medication but was observed over time after taking it, usually in response to an increase in dosage. It may also occur during withdrawal (drug holidays or after discontinuation). Patients who experience abnormally long-lasting or painful and frequent erections need immediate medical treatment.
Peripheral Vasculopathy, Including Raynaud’s Phenomenon
CNS stimulants, like Ritalin and Ritalin-SR, that are used in the treatment of ADHD are linked to peripheral vasculopathy, which includes Raynaud’s condition. The symptoms and signs are typically minimal and infrequent. However, rare sequelae may consist of digital ulceration or the breakdown of soft tissues. The effects of peripheral vasculopathy, including Raynaud’s phenomenon, have been seen in postmarketing studies at different times and therapeutic doses for all ages throughout treatment. The signs and symptoms usually improve upon dose reduction or medication discontinuation. A careful eye on digital changes is required when using ADHD stimulants. Further evaluation by a physician (e.g. or rheumatology referral) could be recommended for specific patients.
