Ritalin, also known as Methylphenidate, is a drug that is used to treat ADHD and even sleep disorders. Ritalin aids a person in staying focused by increasing the effectiveness of the dopamine produced by your brain and so can help in many situations even other than if you suffer from ADHD, such as helping students in studying for exams, as it increases your stamina as well as keeping you more alert at the same time. You can now even buy ritalin online without prescription and most people do this because it tends to be more affordable than if you buy from a medical store which requires prescription.#
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; it is available as sustained-release tablets of 20 mg for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Ritalin-SR tablets: Cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.
- Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
DOSAGE AND ADMINISTRATION
Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including Ritalin or Ritalin- SR, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see WARNINGS AND PRECAUTIONS].
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Ritalin or Ritalin-SR use [see BOX WARNING, WARNINGS AND PRECAUTIONS , Drug Abuse And Dependence].
General Dosing Information
Pediatric Patients 6 years and Older
Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.
Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Ritalin-SR tablets have a duration of action of approximately 8 hours. Therefore, Ritalin-SR tablets may be used in place of Ritalin tablets when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage. Ritalin-SR tablets must be swallowed whole and never crushed or chewed.
Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of Ritalin and Ritalin-SR, and adjust dosage as needed.
Dose Reduction And Discontinuation
If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin-SR. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Dosage Forms And Strengths
- 5 mg, round, yellow, flat with CIBA monograpm on one side and NDC# 7 on the reverse side
- 10 mg, round, pale green, biconvex with CIBA monograpm on one side and NDC# 3 and a partial bisection on the reverse side
- 20 mg, round, pale yellow, biconvex with CIBA monograpm on one side and NDC# 34 and a partial bisection on the reverse side
- 20 mg extended-release tablets, white to off-white, round, bicinvex, film coated with the ‘CIBA’ monograpm and ‘16’ on one side printed in black ink
Storage And Handling
5 mg tablets (NDC 0078-0439-05) round, yellow, (imprinted CIBA 7) supplied in bottles of 100
10 mg tablets (NDC 0078-0440-05) round, pale green, scored, (imprinted CIBA 3) supplied in bottles of 100
20 mg tablets (NDC 0078-0441-05) round, pale yellow, scored, (imprinted CIBA 34) supplied in bottles of 100
Store at 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature] Protect from light.
Dispense in tight, light-resistant container (USP).
Ritalin-SR Extended-Release Tablets
20 mg SR extended-release tablets (NDC 0078-0442-05), round, white, coated, (imprinted CIBA 16) supplied in bottles of 100
Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]
Protect from moisture.
Dispense in tight, light-resistant container (USP).
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Ritalin and Ritalin-SR by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix Ritalin or Ritalin-SR with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Ritalin or Ritalin-SR in the household trash.
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: Jan 201
The following are discussed in more detail in other sections of the labeling:
- Abuse and Dependence [see BOX WARNING , WARNINGS AND PRECAUTIONS , Drug Abuse And Dependence]
- Known hypersensitivity to methylphenidate or other ingredients of Ritalin and Ritalin-SR [see CONTRAINDICATIONS]
- Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS , DRUG INTERACTIONS]
- Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- Peripheral Vasculopathy, including Raynaud’s Phenomenon [see WARNINGS AND PRECAUTIONS]
- Long-term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
The following adverse reactions associated with the use of all Ritalin, Ritalin-SR, and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. 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.
Adverse Reactions Reported With Ritalin And Ritalin-SR
Infections and Infestations: nasopharyngitis
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 pediatric patients
Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood
Nervous System Disorders: headache, dizziness, tremor, dyskinesia including choreoatheetoid 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
Respiratory, Thoracic and Mediastinal Disorders: cough
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
Investigations: weight loss (adult ADHD patients)