Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : METHYLPHENIDATE HYDROCHLORIDE

Granules Pharmaceuticals Inc.

TABLET, EXTENDED RELEASE

Strength 10 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 Granules Pharmaceuticals Inc.. It is available in strength of 10 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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No data

CNS stimulants, including Methylphenidate hydrochloride extended-release 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 n n n .n n
WARNING: ABUSE AND DEPENDANCE
See full prescribing information for complete boxed warning.

CNS stimulants, including Methylphenidate hydrochloride extended-release tablets, other methylphenidate-containing products, and amphetamine, have a high potential for abuse and dependence (n n n , n n n , n n n ).n n n
Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy (n n n , n n n )n n n

Boxed Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2019
Contraindications n n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2019n nn
Warnings and Precautions n n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 1/2019n nn

Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of:
Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy

Methylphenidate hydrochloride extended-release tablets n n n :n nn

May switch to Methylphenidate hydrochloride extended-release tablets when the 8-hour dosage of Methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride tablets.
Must be swallowed whole and never crushed or chewed

Extended-Release Tablets: 10 mg and 20 mg

No data

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 extended-release 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 Methylphenidate hydrochloride extended-release tablets
Infections and Infestations:
Blood and the Lymphatic System Disordersn n n n
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 extended-release tablets 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 Granules Pharmaceuticals Inc. at 1-877-770-3138 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 1 presents clinically important drug interactions with Methylphenidate hydrochloride extended-release tablets
Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Tablets

Antihypertensive drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed n n n n
Halogenated anesthetics: Avoid use of Methylphenidate hydrochloride extended-release tablets on the day of surgery if halogenated anesthetics will be used n n n n

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.

Methylphenidate hydrochloride extended-release tablets, USP contains methylphenidate hydrochloride a CNS stimulant. It is available as extended-release tablets of 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, 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.
Methylphenidate hydrochloride extended-release tablets, USP contains the following inactive ingredients: hypromellose, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate.
FDA approved dissolution test differs from the USP dissolution test.

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/kg/day given to children on mg/mn n n 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.n nn
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/mn n n basis.n nn
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 n n n Ames reverse mutation assay, in the n n n mouse lymphoma cell forward mutation assay, or in the n n n 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 (CHO) cells. Methylphenidate was negative n n n in males and females in the mouse bone marrow micronucleus assay.n nn
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 10 times the MRHD of 60 mg/day given to adolescents on a mg/mn n n basis.n nn

Methylphenidate hydrochloride extended-release tablets, USP are available as follows:
10 mg: White to off white, round shaped, uncoated, tablets debossed with u201cFM4u201d on one side and u201cplainu201d on other side.
Bottles of 100 tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70010-042-01
20 mg: White to off white, round shaped, uncoated, tablets debossed with u201cFM5u201d on one side and u201cplainu201d on other side.
Bottles of 100 tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70010-043-01
NOTE:
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted between 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [See USP Controlled Room Temperature].
Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Disposal
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Methylphenidate hydrochloride extended-release tablets, USP 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 Methylphenidate hydrochloride extended-release tablets, USP 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 extended-release tablets, USP 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 extended-release tablets are controlled substances, and they can be abused and lead to dependence. Instruct patients that they should not give Methylphenidate hydrochloride extended-release tablets to anyone else. Advise patients to store Methylphenidate hydrochloride extended-release 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 extended-release tablets by a medicine take-back program if available n n n n .n nn
Serious Cardiovascular Risks
Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with Methylphenidate hydrochloride extended-release 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 n n n
Blood Pressure and Heart Rate Increases
Instruct patients that Methylphenidate hydrochloride extended-release tablets can cause elevations of their blood pressure and pulse rate n n n .n nn
Psychiatric Risks
Advise patients that Methylphenidate hydrochloride extended-release tablets at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania n n n 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 n n n .n nn
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 extended-release tablets. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients n n n .n nn
Suppression of Growth
Advise patients that Methylphenidate hydrochloride extended-release tablets may cause slowing of growth and weight loss n n n 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 extended-release tablets, during pregnancy n n n n .n nn
The Medication Guide may also be obtained by calling 877-770-3183.
Manufactured for:
Granules Pharmaceuticals Inc.
3701 Concorde Pkwy
Chantilly, VA 20151
Rev. 11/2019

This Medication Guide has been approved by the U.S. Food and Drug Administrationu00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0Revised November 2019

Package Label u2013 10 mg
NDC 70010-042-01
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII
10 mg
PHARMACIST: Dispense the enclosed Medication Guide to each patient
Rx Only
Arrayn- 100 Tablets
Arrayn- Array

Package Label u2013 20 mg
NDC 70010-043-01
Methylphenidate Hydrochloride Extended-Release Tablets, USP CII
20 mg
PHARMACIST: Dispense the enclosed Medication Guide to each patient
Rx Only
100 Tablets
Arrayn- Array

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Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

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Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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