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Methylphenidate Hydrochloride (Ritalin)

Trade Name : Ritalin

Novartis Pharmaceuticals Corporation

TABLET

Strength 5 mg/1

METHYLPHENIDATE HYDROCHLORIDE Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Methylphenidate Hydrochloride (Ritalin) which is also known as Ritalin and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5 mg/1 per ml. Read more

Methylphenidate Hydrochloride (Ritalin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy .
  • WARNING: ABUSE AND DEPENDENCE
  • See full prescribing information for complete boxed warning.
  • CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence (, , ).
  • Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy (, ).
  • No data
  • Ritalin and Ritalin-SR are indicated for the treatment of:
  • Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ().
  • Ritalin Tablets
  • Ritalin-SR Extended-release Tablets
  • Tablets
  • Extended-release Tablets
  • Tablets: 5 mg, 10 mg, and 20 mg ()
  • Extended-release Tablets: 20 mg ()
  • No data
  • Known hypersensitivity to methylphenidate or other product components of Ritalin or Ritalin-SR ().nttttttttt
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ().nttttttttt
  • No data
  • Serious Cardiovascular Events
  • Blood Pressure and Heart Rate Increases
  • Psychiatric Adverse Reactions
  • Priapism
  • Peripheral Vasculopathy, Including Raynaudu2019s Phenomenon
  • Long-Term Suppression of Growth
  • The following are discussed in more detail in other sections of the labeling:
  • 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:
  • Blood and the Lymphatic System Disorders:
  • Immune System Disorders:
  • Metabolism and Nutrition Disorders:
  • Psychiatric Disorders:
  • Nervous System Disorders:
  • Eye Disorders:
  • Cardiac Disorders:
  • Respiratory, Thoracic and Mediastinal Disorders:
  • Gastrointestinal Disorders:
  • Hepatobiliary Disorders:
  • Skin and Subcutaneous Tissue Disorders:
  • Musculoskeletal and Connective Tissue Disorders:
  • Investigations:
  • Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products
  • The list below shows adverse reactions not listed for Ritalin and Ritalin-SR that have been reported with other methylphenidate-containing products.
  • Blood and Lymphatic Disorders:
  • Immune System Disorders:
  • Psychiatric Disorders:
  • Nervous System Disorders:
  • Eye Disorders:
  • Cardiac Disorders:
  • Vascular Disorders:
  • Respiratory, Thoracic and Mediastinal Disorders:
  • Gastrointestinal Disorders:
  • Skin and Subcutaneous Tissue Disorders:
  • Musculoskeletal, Connective Tissue and bone Disorders:
  • Renal and Urinary Disorders:
  • Reproductive System and Breast Disorders:
  • General Disorders:
  • Urogenital Disorders:
  • Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain ().
  • Table 1 presents clinically important drug interactions with Ritalin and Ritalin-SR.
  • Antihypertensive Drugs:
  • Halogenated Anesthetics:
  • No data
  • No data
  • Human Experience
  • 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.
  • Overdose Management
  • Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.
  • Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration.
  • Ritalin-SR contains methylphenidate hydrochloride, a CNS stimulant. It is available as extended-release tablets of 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl u03b1-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:
  • u00a0n
  • 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 g/mol.ntttttt
  • Ritalin tablets contains the following inactive ingredients: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).
  • Ritalin-SR extended-release tablets contains the following inactive ingredients: cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.
  • No data
  • Carcinogenesis
  • 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 2 times the MRHD of 60 mg/day given to children on mg/m basis. 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.
  • Methylphenidate did not cause any increase 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 4 times the MRHD (children) on a mg/m basis.
  • In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60 to 74 mg/kg/day of methylphenidate.
  • Mutagenesis
  • Methylphenidate was not mutagenic in the Ames reverse mutation assay, in the mouse lymphoma cell forward mutation assay, or in the chromosomal aberration assay using human lymphocytes. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary cells. Methylphenidate was negative in males and females in the mouse bone marrow micronucleus assay.
  • Impairment of Fertility
  • No human data on the effect of methylphenidate on fertility are available. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week continuous breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 10times the MRHD of 60 mg/day given to adolescents on a mg/m basis.
  • Ritalin Tablets
  • 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 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [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 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [See USP controlled room temperature].
  • Protect from moisture.
  • Dispense in tight, light-resistant container (USP).
  • Disposal
  • 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.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Controlled Substance Status/High Potential for Abuse and Dependence
  • Advise patients that Ritalin and Ritalin-SR are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give Ritalin or Ritalin-SR to anyone else. Advise patients to store Ritalin and Ritalin-SR in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired Ritalin and Ritalin-SR by a medicine take-back program if available .
  • Serious Cardiovascular Risks
  • Advise patients that there is a potential serious cardiovascular risk, including sudden death, myocardial infarction, stroke, and hypertension with Ritalin and Ritalin-SR use. Instruct patients to contact a healthcare provider immediately if they develop symptoms, such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease .
  • Blood Pressure and Heart Rate Increases
  • Instruct patients that Ritalin and Ritalin-SR can cause elevations of their blood pressure and pulse rate .
  • Psychiatric Risks
  • Advise patients that Ritalin and Ritalin-SR, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania .
  • Priapism
  • Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct them to seek immediate medical attention in the event of priapism .
  • Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaudu2019s Phenomenon]
  • Instruct patients about the risk of peripheral vasculopathy, including Raynaudu2019s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
  • Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Ritalin and Ritalin-SR. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients .
  • Suppression of Growth
  • Advise patients that Ritalin and Ritalin-SR may cause slowing of growth and weight loss .
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Ritalin and Ritalin-SR, during pregnancy .
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • T2019-126
  • No data
  • No data
  • NDC 0078-0439-05
  • Ritalin HCL
  • methylphenidate HCL USP
  • 5 mg
  • 100 tablets
  • Rx only
  • Dispense with Medication Guideattached or provided separately.
  • NOVARTIS
  • NDC 0078-0440-05
  • Ritalin HCL
  • methylphenidate HCL USP
  • 10 mg
  • 100 tablets
  • Rx only
  • Dispense with Medication Guideattached or provided separately.
  • NOVARTIS
  • NDC 0078-0441-05
  • Ritalin HCL
  • methylphenidate HCL USP
  • 20 mg
  • 100 tablets
  • Rx only
  • Dispense with Medication Guideattached or provided separately.
  • NOVARTIS

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