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Methylphenidate Hydrochloride - (La) (Methylphenidate Hydrochloride)

Trade Name : Methylphenidate Hydrochloride

Teva Pharmaceuticals USA, 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 - (La) (Methylphenidate Hydrochloride) which is also known as Methylphenidate Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 20 mg/1 per ml. Read more

Methylphenidate Hydrochloride - (La) (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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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
  • WARNING: ABUSE AND DEPENDENCE
  • See full prescribing information for complete boxed warning.
  • CNS stimulants, including n- methylphenidate hydrochloride extended-release capsulesn- , other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence (, , ).
  • u00a0n- Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy (, ).
  • No data
  • 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 .
  • Methylphenidate hydrochloride extended-release capsules are 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. ()
  • Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce. ()
  • Should not be crushed, chewed, or divided. ()
  • 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. ()
  • For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release tablets: Dosage is based on current dose regimen. ()
  • If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules. ()
  • 10 mg extended-release capsules light brown opaque cap and white opaque body, imprinted TEVA on the cap and 5345 on the body
  • 20 mg extended-release capsules white opaque cap and white opaque body, imprinted TEVA on the cap and 5346 on the body
  • 30 mg extended-release capsules ivory opaque cap and ivory opaque body, imprinted TEVA on the cap and 5347 on the body
  • 40 mg extended-release capsules light brown opaque cap and light brown opaque body, imprinted TEVA on the cap and 5348 on the body
  • Extended-release capsules: 10 mg, 20 mg, 30 mg, and 40 mg ()
  • No data
  • Known hypersensitivity to methylphenidate or product components. ()
  • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days. ()
  • No data
  • Serious Cardiovascular Events
  • Bn- lood Pressure and Heart Rate Increases
  • Psychiatric Adverse Reactions
  • Pn- riapisn- m
  • Pen- ripheral 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, decreased appetite, and anorexia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 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. ()
  • Avoid use of methylphenidate hydrochloride extended-release capsules on the day of surgery if halogenated anesthetics will be used. ()
  • Pregnancy Exposure Registryn
  • 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.n
  • Overdose Management
  • Consult with a Certified Poison Control Center (1-800-222-1222) for the latest recommendations.n
  • Methylphenidate Hydrochloride Extended-Release Capsules contain methylphenidate hydrochloride, USP, a CNS stimulant.
  • Methylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of methylphenidate for oral administration with a bi-modal release profile. Each Methylphenidate Hydrochloride Extended-Release Capsule contains pellets, with half the dose as immediate-release and half as delayed-release, thus providing an immediate release of methylphenidate and a second delayed release of methylphenidate.n
  • The active substance in Methylphenidate Hydrochloride Extended-Release Capsules is methyl u03b1-phenyl-2-piperidineacetate hydrochloride. Its structural formula is as follows:
  • M.W. 269.77
  • 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.n
  • Each capsule, for oral administration, has the following inactive ingredients: ammonio methacrylate copolymer, black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, propylene glycol, shellac glaze (modified), sugar spheres, talc, titanium dioxide and triethyl citrate. The 10 mg and 40 mg capsule shell contains FD&C blue no. 1, FD&C red no. 40 and FD&C yellow no. 6. The 30 mg capsule shell contains D&C red no. 33 and D&C yellow no. 10.n
  • No data
  • Carcinogenesis
  • 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 (CHO) cells. Methylphenidate was negative in males and females in the mouse bone marrow micronucleus assay.
  • 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 basis.n
  • Methylphenidate hydrochloride extended-release capsules were 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.n
  • Figure 2: CADS-T Total Subscale - Mean Change From Baseline*n n n
  • Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5345 on the body, containing 10 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5345-01).
  • Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg are available as two-piece, hard gelatin capsules, with white opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5346 on the body, containing 20 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5346-01).n
  • Methylphenidate Hydrochloride Extended-Release Capsules, 30 mg are available as two-piece, hard gelatin capsules, with ivory opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5347 on the body, containing 30 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5347-01).n
  • Methylphenidate Hydrochloride Extended-Release Capsules, 40 mg are available as two-piece, hard gelatin capsules, with light brown opaque cap and light brown opaque body, filled with white to off-white pellets. Imprinted in black ink TEVA on the cap and 5348 on the body, containing 40 mg of methylphenidate hydrochloride, USP packaged in bottles of 100 capsules (NDC 0093-5348-01).n
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].n
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).n
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.n
  • Disposal
  • 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 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 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.n
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).u00a0n n n
  • Advise patients that methylphenidate hydrochloride extended-release capsules are a controlled substance, and they 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 .
  • 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 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
  • 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 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
  • 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.n
  • 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
  • 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 n n .
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to methylphenidate hydrochloride extended-release capsules during pregnancy .n
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454n n
  • Rev. F 12/2019
  • Methylphenidate Hydrochloride (methu2033 il fenu2032 i date hyeu2033 droe kloru2032 ide) Extended-Release Capsules LA CII
  • Whn- an- t is the most important information I should know about n- methylphenidate hydrochloride extended-release capsulesn- ?
  • Methylphenidate hydrochloride extended-release capsulesu00a0n- areu00a0n- a federal controlled substance (CII) because it can be abused or lead to dependence. Keep n- methylphenidate hydrochloride extended-release capsulesu00a0n- in a safe place to prevent misuse and abuse. Selling or giving away n- methylphenidate hydrochloride extended-release capsulesu00a0n- mn- an- y harm others, and is against the law.
  • Thn- e following have been reported with use of methylphenidate hydrochloride and other stimulant medicines:
  • Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.n
  • Your doctor should check you or your child carefully for heart problems before starting methylphenidate hydrochloride extended-release capsules.n
  • Your doctor should check you or your childu2019s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules.n
  • 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 n- methylphenidate hydrochloride extended-release capsulesn- .
  • Aln- l Patients
  • Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.n n n n n n n
  • Methylphenidate hydrochloride extended-release capsules are a central nervous system stimulant prescription medicine. Methylphenidate hydrochloride extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.n
  • Methylphenidate hydrochloride extended-release capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.n n n
  • Who should not take n- methylphenidate hydrochloride extended-release capsulesn- ?
  • Methylphenidate hydrochloride extended-release capsulesn- should not be taken if you or your child:
  • Methylphenidate hydrochloride extended-release capsulesn- may not be right for you or your child. Before starting n- methylphenidate hydrochloride extended-release capsules,n- 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 take including prescription and over- the-counter medicines, vitamins, and herbal supplements.
  • Your doctor will decide whether methylphenidate hydrochloride extended-release capsules can be taken with other medicines.n
  • Especialln- y 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.n n n n n n n
  • In case of poisoning, call your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.n
  • What are possible side effects of n- methylphenidate hydrochloride extended-release capsules?
  • Tell your doctor if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
  • Arrayn- methylphenidate hydrochloride extended-release capsules?
  • Genen- rn- al information about the safe and effective use n- methylphenidate hydrochloride extended-release capsules
  • 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 extended-release capsules that is written for healthcare professionals. Do not use methylphenidate hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give methylphenidate hydrochloride extended-release capsules to other people, even if they have the same symptoms. It may harm them and it is against the law.n
  • What are the ingredients in methylphenidate hydrochloride extended-release capsules?
  • Active Ingredient:
  • Inactin- vn- e Ingredients:
  • Teva Pharmaceuticals USA, Inc.
  • For more information about methylphenidate hydrochloride extended-release capsules call 1-888-838-2872.n n
  • This Medication Guide has been approved by the U.S. Food and Drug Administration. u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rev. E 12/2019
  • Arrayn- Array
  • NDCn- 5346
  • CII
  • Methylphenidate
  • Hydrochloride
  • Extended-Release
  • Capsules (LA), 20 mg
  • Once-Daily
  • PHARMACIST: Dispense the accompanying
  • Medication Guide to each patient.
  • Rx only
  • 100 CAPSULES
  • TEVA
  • NDCn- 5347
  • CII
  • Methylphenidate
  • Hydrochloride
  • Extended-Release
  • Capsules (LA), 30 mg
  • Once-Daily
  • PHARMACIST: Dispense the accompanying
  • Medication Guide to each patient.
  • Rx only
  • 100 CAPSULES
  • TEVA
  • Arrayn- Array
  • NDCn- 5348
  • CII
  • Methylphenidate
  • Hydrochloride
  • Extended-Release
  • Capsules (LA), 40 mg
  • Once-Daily
  • PHARMACIST: Dispense the accompanying
  • Medication Guide to each patient.
  • Rx only
  • 100 CAPSULES
  • TEVA

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