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Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : METHYLPHENIDATE HYDROCHLORIDE

Amneal Pharmaceuticals of New York LLC

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 (Methylphenidate Hydrochloride) which is also known as METHYLPHENIDATE HYDROCHLORIDE and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 5 mg/1 per ml. Read more

Methylphenidate Hydrochloride (Methylphenidate Hydrochloride) 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

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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.

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
  • WARNING: ABUSE AND DEPENDENCE
  • See full prescribing information for complete boxed warning.
  • CNS stimulants, including methylphenidate hydrochloride tablets, 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 (, )
  • Boxed Warning u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2019Contraindications () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2019Warnings and Precautions () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2019
  • u00a0Methylphenidate hydrochloride tablets are indicated for the treatment of:
  • Methylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ().
  • Methylphenidate Hydrochloride Tablets
  • 2.2
  • Pediatric Patients 6 years and older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5 mg to 10 mg increments. Dosages above 60 mg/day are not recommended.
  • Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.
  • Tablets
  • Tablets: 5 mg, 10 mg, 20 mg ().
  • u00a0n
  • Known hypersensitivity to methylphenidate or other product components of methylphenidate hydrochloride tablets ().
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ().
  • 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 methylphenidate hydrochloride tablets 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 n- Methylphenidate Hydrochloride
  • Infections and Infestations:
  • Blood and the Lymphatic System Disordersn
  • 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 methylphenidate hydrochloride 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 ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Table 1 presents clinically important drug interactions with methylphenidate hydrochloride.
  • Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride
  • Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ().
  • Halogenated anesthetics: Avoid use of methylphenidate hydrochloride tablets on the day of surgery if halogenated anesthetics will be used ().
  • No data
  • No data
  • No data
  • Methylphenidate Hydrochloride Tablets, USP contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg and 20 mg strength for oral administration.
  • Methylphenidate hydrochloride is methyl u03b1-phenyl-2-piperidineacetate hydrochloride, and its structural formula is:
  • Methylphenidate hydrochloride USP is a white to off-white 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.
  • Methylphenidate hydrochloride tablets, USP, contain the following inactive ingredients: Lactose monohydrate, microcrystalline cellulose, stearic acid and FD&C Yellow No. 6 Aluminum Lake.
  • 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 mg/kg/day 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 assay in cultured Chinese Hamster Ovary (CHO) 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.
  • Methylphenidate Hydrochloride Tablets, USP
  • 5 mgn- cor n- 237
  • 10 mgn- cor n- bisect n- 238
  • 20 mgn- cor n- 239 n- bisect
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Protect from light.
  • 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 methylphenidate hydrochloride tablets by a medicine take-back program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give methylphenidate hydrochloride tablets to anyone else. Advise patients to store methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets 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 methylphenidate hydrochloride tablets 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 n
  • Blood Pressure and Heart Rate Increases
  • Instruct patients that methylphenidate hydrochloride tablets can cause elevations of their blood pressure and pulse rate .
  • Psychiatric Risks
  • Advise patients that methylphenidate hydrochloride tablets, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania n
  • 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 methylphenidate hydrochloride tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients .
  • Suppression of Growth
  • Advise patients that methylphenidate hydrochloride tablets may cause slowing of growth and weight loss n
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including methylphenidate hydrochloride tablets, during pregnancy .
  • Distributed by:n Bridgewater, NJ 08807n Rev. 01-2020-01
  • Methylphenidate Hydrochloride
  • Tablets, CII
  • What is the most important information I should know about methylphenidate hydrochloride tablets?
  • Methylphenidate hydrochloride is a federal controlled substance (CII) because it can be abused or lead to dependence.
  • Tell your doctor if you or your child have abused or been dependent on alcohol, prescription medicines, or street drugs.
  • The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines:
  • 1. n n- :
  • Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
  • Your doctor should check you or your child carefully for heart problems before starting methylphenidate hydrochloride tablets.
  • Your doctor should check you or your childu2019s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride tablets.
  • Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking methylphenidate hydrochloride tablets.
  • 2. n n- :
  • All Patients
  • Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
  • Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking methylphenidate hydrochloride tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
  • What are methylphenidate hydrochloride tablets?
  • It is not known if methylphenidate hydrochloride tablets are safe and effective in children under 6 years of age.
  • Who should not take methylphenidate hydrochloride tablets?
  • Methylphenidate hydrochloride tablets should not be taken if you or your child:
  • Methylphenidate hydrochloride tablets may not be right for you or your child. Before starting methylphenidate hydrochloride tablets tell your or your childu2019s doctor about all health conditions (or a family history of) including:
  • Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Your doctor will decide whether methylphenidate hydrochloride tablets can be taken with other medicines.
  • Especially tell your doctor if you or your child takes:
  • Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
  • Do not start any new medicine while taking methylphenidate hydrochloride tablets without talking to your doctor first.
  • How should methylphenidate hydrochloride tablets be taken?
  • What are the possible side effects of methylphenidate hydrochloride tablets?
  • Methylphenidate hydrochloride tablets may cause serious side effects, including:
  • Tell your doctor if you or your child have, numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
  • Common side effects include:
  • Call your doctor for medical advice about side effects. n
  • How should I store methylphenidate hydrochloride tablets?
  • General information about the safe and effective use of methylphenidate hydrochloride tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about methylphenidate hydrochloride tablets that is written for healthcare professionals. Do not use methylphenidate hydrochloride tablets for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
  • What are the ingredients in n- methylphenidate hydrochloride tabletsn- ?
  • Active ingredient:
  • Inactive ingredients:
  • Distributed by:n Bridgewater, NJ 08807n For more information call, 1-877-835-5472.n This Medication Guide has been approved by the U.S. Food and Drug Administration.n Rev. 01-2020-01
  • No data
  • No data
  • No data

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