Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : Methylphenidate Hydrochloride

Granules Pharmaceuticals Inc.

CAPSULE, EXTENDED RELEASE

Strength 20 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 20 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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WARNING: ABUSE AND DRUG DEPENDENCEn- CNS stimulants, including methylphenidate hydrochloride extended-release capsules, 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

Boxed Warning 1/2019
Contraindications (4) 1/2019
Warnings and Precautions (5) 1/2019

Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age n .n
Methylphenidate hydrochloride extended-release capsule is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age.

No data

Administer orally once daily in the morning n n
Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce n n
Should not be crushed, chewed, or divided (2.2)
Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10 mg increments. Doses above 60 mg daily are not recommended n n
For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release tablets: Dosage is based on current dose regimen n n
If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules n n

10 mg
Hard gelatin capsules, yellow opaque cap printed withu201cG 10mgu201d and white opaque body printed with u201c012u201d contains white to off-white pellets.
20 mg
Hard gelatin capsules, white opaque cap printed with u201cG 20mgu201d and white opaque body printed with u201c013u201d contains white to off-white pellets.
30 mg
Hard gelatin capsules, yellow opaque cap printed with u201cG 30mgu201d and yellow opaque body printed with u201c014u201d contains white to off-white pellets.
40 mg
Hard gelatin capsules, yellow opaque cap printed with u201cG 40mgu201d and yellow opaque body printed with u201c015u201d contains white to off-white pellets.
60 mg
Hard gelatin capsules, yellow opaque cap printed with u201cG 60mgu201d and yellow opaque body printed with u201c016u201d contains white to off-white pellets.
Extended-release capsules: 10mg, 20mg, 30mg, 40mg and 60 mg

No data

Known hypersensitivity to methylphenidate or product components n n
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:
Most common adverse reactions (greater than 5% during incidence) were headache, insomnia, upper abdominal pain, appetite decreased and anorexia n .n
To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7.1 Clinically Important Interactions with methylphenidate hydrochloride extended-release capsules
Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-release capsules
Table 3: Drugs Having Clinically Important Drug Interactions with Methylphenidate Hydrochloride Extended-Release Capsules

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

Pregnancy Exposure Registry

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 capsules contains methylphenidate hydrochloride, a CNS stimulant.
Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each bead-filled methylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.
The active substance in methylphenidate hydrochloride extended-release capsules is methyl u03b1-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Arrayn- Inactive ingredients:

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 a mg/m 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
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 n basis.n
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 Ames reverse mutation assay, in the n mouse lymphoma cell forward mutation assay, or in the 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 in males and females in the mouse bone marrow micronucleus assay.n
Impairment of Fertility
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 maximum recommended dose of 60 mg/day given to adolescents on a mg/m n basis.n

Methylphenidate hydrochloride extended-release capsules was evaluated in a randomized, double-blind, placebo-controlled, parallel group clinical study in which 134 children, ages 6 to 12, with DSM-IV diagnoses of ADHD received a single morning dose of methylphenidate hydrochloride extended-release capsules in the range of 10 to 40 mg/day, or placebo, for up to 2 weeks. The doses used were the optimal doses established in a previous individual dose titration phase. In that titration phase, 53 of 164 patients (32%) started on a daily dose of 10 mg and 111 of 164 patients (68%) started on a daily dose of 20 mg or higher. The patientu2019s regular schoolteacher completed the Conners ADHD/DSM-IV Scale for Teachers (CADS-T) at baseline and the end of each week. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline of the (CADS-T) scores during the last week of treatment was analyzed as the primary efficacy parameter. Patients treated with methylphenidate hydrochloride extended-release capsules showed a statistically significant improvement in symptom scores from baseline [Mean (final score - baseline) = -10.7 points] over patients who received placebo [Mean (final score - baseline) = +2.8 points]. The lower the final score on the CADS-T scale from baseline, the less severe the disease is. This demonstrates that a single morning dose of methylphenidate hydrochloride extended-release capsules exerts a treatment effect in ADHD.
Figure 2: CADS-T Total Subscale - Mean Change From Baseline*

Methylphenidate hydrochloride extended-release capsules are supplied as:
10 mg:
Hard gelatin capsules, yellow opaque cap printed with u201cG 10mgu201d and white opaque body printed with u201c012u201d contains white to off-white pellets.
Bottles of 100 NDC 70010-012-01
20 mg:
Hard gelatin capsules, white opaque cap printed with u201cG 20mgu201d and white opaque body printed with u201c013u201d contains white to off-white pellets.
Bottles of 100 NDC 70010-013-01
30 mg:
Hard gelatin capsules, yellow opaque cap printed with u201cG 30mgu201d and yellow opaque body printed with u201c014u201d contains white to off-white pellets.
Bottles of 100 NDC 70010-014-01
40 mg:
Hard gelatin capsules, yellow opaque cap printed with u201cG 40mgu201d and yellow opaque body printed with u201c015u201d contains white to off-white pellets.
Bottles of 100 NDC 70010-015-01
60 mg:
Hard gelatin capsules, yellow opaque cap printed with u201cG 60mgu201d and yellow opaque body printed with u201c016u201d contains white to off-white pellets.
Bottles of 30 NDC 70010-016-03
Store at 20 to 25u00b0C (68 to 77u00b0F). [See USP Controlled Room Temperature]
Dispense in a tight container as defined in the USP with a child-resistant closure.n n n n
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride extended-release capsules 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 extended-release capsules 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 capsules 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 capsule is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give methylphenidate hydrochloride extended-release capsules to anyone else. Advise patients to store methylphenidate hydrochloride extended-release capsules 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 capsules by a medicine take-back program if available n .n
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 capsules 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
Blood Pressure and Heart Rate Increases
Instruct patients that methylphenidate hydrochloride extended-release capsules can cause elevations of their blood pressure and pulse rate n .n
Psychiatric Risks
Advise patients that methylphenidate hydrochloride extended-release capsules, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania 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
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaudu2019s Phenomenon]
Instruct patients beginning treatment with methylphenidate hydrochloride extended-release capsules 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 capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients n .n
Suppression of Growth
Advise patients that methylphenidate hydrochloride extended-release capsules may cause slowing of growth and weight loss n n
Alcohol Effect
Advise patients to avoid alcohol while taking methylphenidate hydrochloride extended-release capsules. Consumption of alcohol while taking methylphenidate hydrochloride extended-release capsules may result in a more rapid release of the dose of methylphenidate n n
Pregnancy Registry
Dispense with Medication Guide is also available at: n n
Manufactured by:
Granules Pharmaceuticals Inc.,
Chantilly, VA 20151
Rev. 10/2020

MEDICATION GUIDE
Methylphenidate Hydrochloride Extended-Release Capsulesn- Arrayn- CII
(METH-il-FEN-i-date n- HYE-droe-KLOR-ide)
This Medication Guide has been approved by the U.S. Food and Drug Administration.

No data

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Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : Methylphenidate Hydrochloride

CAPSULE, 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

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Methylphenidate Hydrochloride (Methylphenidate Hydrochloride)

Trade Name : Methylphenidate Hydrochloride

CAPSULE, 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)

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Losartan Potassium (Losartan Potassium)

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