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Dexmethylphenidate Hydrochloride (Dexmethylphenidate Hydrochloride)

Trade Name : Dexmethylphenidate Hydrochloride

Teva Pharmaceuticals USA, Inc.

CAPSULE, EXTENDED RELEASE

Strength 25 mg/1

DEXMETHYLPHENIDATE 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 Dexmethylphenidate Hydrochloride (Dexmethylphenidate Hydrochloride) which is also known as Dexmethylphenidate Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Dexmethylphenidate Hydrochloride (Dexmethylphenidate 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
  • CNS stimulants, including dexmethylphenidate 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 .
  • WARNING: ABUSE AND DEPENDENCE
  • See full prescribing information for complete boxed warning.
  • CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence (, , ).u00a0u00a0
  • u00a0n- Array
  • Boxed Warning u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2019
  • Contraindications () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2019
  • Warnings and Precautions () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a01/2019
  • Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) .
  • Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)u00a0()
  • No data
  • Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ()u00a0u00a0
  • Patients currently on methylphenidate: Dexmethylphenidate hydrochloride extended-release capsules dosage is half the current total daily dosage of methylphenidate ()
  • Patients currently on dexmethylphenidate hydrochloride immediate-release tablets: Give the same daily dose of dexmethylphenidate hydrochloride extended-release capsules ()
  • Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients ()
  • Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults ()
  • Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ()
  • Extended-Release Capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg of dexmethylphenidate hydrochlorideu00a0()
  • No data
  • Known hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules ()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:
  • The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo):
  • 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.
  • Pediatric patients 6 to 17 years: dyspepsia, decreased appetite, headache, and anxiety ()
  • Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, and anxiety ()
  • Table 5 presents clinically important drug interactions with dexmethylphenidate hydrochloride extended-release capsules.
  • Table 5: Clinically Important Drug Interactions with Dexmethylphenidate Hydrochloride Extended-Release Capsules
  • Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ().
  • Halogenated Anesthetics: Avoid use of dexmethylphenidate hydrochloride extended-release capsules on the day of surgery if halogenated anesthetics will be used ().
  • No data
  • No data
  • Human Experience
  • Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: nausea, vomiting, diarrhea, restlessness, anxiety, agitation, tremors, hyperreflexia, muscle twitching, convulsions (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.
  • Dexmethylphenidate Hydrochloride Extended-Release Capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each Dexmethylphenidate Hydrochloride Extended-Release Capsule contains a single type multilayered beads having half the dose as immediate-release component and half as enteric-coated, delayed-release component, thus providing an immediate-release of dexmethylphenidate and a second delayed-release of dexmethylphenidate. Dexmethylphenidate Hydrochloride Extended-Release Capsules are available as 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths. Dexmethylphenidate Hydrochloride Extended-Release Capsules, 5, 10, 15, 20, 25, 30, 35 and 40 mg provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, 7.5, 10, 12.5, 15, 17.5 or 20 mg of dexmethylphenidate hydrochloride given b.i.d. as tablets.
  • Dexmethylphenidate hydrochloride, the enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant.
  • Dexmethylphenidate hydrochloride is (2R, 2u2019R)-(+)-threo-methyl u03b1-phenyl-2- piperidineacetate hydrochloride. Its structural formula is:
  • CHNOu2022HCl u00a0u00a0u00a0u00a0M.W. 269.77
  • Note* = asymmetric carbon center
  • Dexmethylphenidate hydrochloride is a white crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in chloroform, sparingly soluble in ethanol, and very slightly soluble in acetone.
  • Arrayn- Inactive ingredients:
  • No data
  • Carcinogenesis
  • Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas was seen at a daily dose of approximately 60 mg/kg/day. This dose is approximately 2 times the MRHD of 60 mg of racemic methylphenidate in children on a 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.
  • Racemic 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 of 60 mg of racemic methylphenidate in children on a mg/m basis.
  • In a 24-week carcinogenicity study with racemic methylphenidate 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 concentrations as in the lifetime carcinogenicity study; the high-dose group was exposed to 60 to 74 mg/kg/day of racemic methylphenidate.
  • Mutagenesis
  • Dexmethylphenidate was not mutagenic in the Ames reverse mutation assay, in the mouse lymphoma cell forward mutation assay, or in the mouse bone marrow micronucleus test. In an assay using cultured Chinese Hamster Ovary (CHO) cells treated with racemic methylphenidate, sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response.
  • Impairment of Fertility
  • No human data on the effect of methylphenidate on fertility are available.
  • Fertility studies have not been conducted with dexmethylphenidate. Racemic 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 of up to 160 mg/kg/day, approximately 10-fold the maximum recommended dose of 60 mg of racemic methylphenidate in adolescents on a mg/m basis.
  • No data
  • Dexmethylphenidate Hydrochloride Extended-Release Capsules are available as follows:
  • 5 mg: Two-piece hard-gelatin capsule with aqua-blue-opaque cap and aqua-blue-opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5550u201d on body in bottles of 100 (NDC 0093-5550-01).
  • 10 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and ivory-opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5551u201d on body in bottles of 100 (NDC 0093-5551-01).
  • 15 mg: Two-piece hard-gelatin capsule with blue-green-opaque cap and blue-green-opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5552u201d on body in bottles of 100 (NDC 0093-5552-01).
  • 20 mg: Two-piece hard-gelatin capsule with white-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5553u201d on body in bottles of 100 (NDC 0093-5553-01).
  • 25 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and white opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5045u201d on body in bottles of 100 (NDC 0093-5045-01).
  • 30 mg: Two-piece hard-gelatin capsule with ivory-opaque cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5554u201d on body in bottles of 100 (NDC 0093-5554-01).
  • 35 mg: Two-piece hard-gelatin capsule with aqua blue opaque cap and ivory opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5046u201d on body in bottles of 100 (NDC 0093-5046-01).
  • 40 mg: Two-piece hard-gelatin capsule with blue-green cap and white-opaque body, filled with white to off-white pellets. Imprinted in black ink with u201cTEVAu201d on cap and u201c5562u201d on body in bottles of 100 (NDC 0093-5562-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Disposal
  • Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Dexmethylphenidate Hydrochloride Extended-Release Capsules by a medicine takeback program or 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 Dexmethylphenidate Hydrochloride Extended-Release Capsules with an undesirable, non-toxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard Dexmethylphenidate Hydrochloride Extended-Release Capsules in the household trash.
  • Advise patients to read the FDA-approved patient labeling (Medication Guide).
  • Controlled Substance Status/High Potential for Abuse and Dependence
  • Advise patients that dexmethylphenidate hydrochloride extended-release capsules is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give dexmethylphenidate hydrochloride extended-release capsules to anyone else. Advise patients to store dexmethylphenidate 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 dexmethylphenidate 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 dexmethylphenidate 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
  • Blood Pressure and Heart Rate Increases
  • Instruct patients that dexmethylphenidate hydrochloride extended-release capsules can cause elevations of their blood pressure and pulse rate .
  • Psychiatric Risks
  • Advise patients that dexmethylphenidate 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
  • 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 beginning treatment with dexmethylphenidate 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 dexmethylphenidate hydrochloride extended-release capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients .
  • Suppression of Growth
  • Advise patients that dexmethylphenidate hydrochloride extended-release capsules may cause slowing of growth and weight loss n
  • Teva Pharmaceuticals USA, Inc.n
  • Rev. J 1/2019
  • Dexmethylphenidate (dex meth ill FEN i date) Hydrochloride Extended-Release Capsules CII
  • What are dexmethylphenidate hydrochloride extended-release capsules?
  • Dexmethylphenidate hydrochloride extended-release capsules may not be right for you or your child. Before starting dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules 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 dexmethylphenidate hydrochloride extended-release capsules without talking to your doctor first.
  • How should dexmethylphenidate hydrochloride extended-release capsules be taken?
  • What are the possible side effects of dexmethylphenidate hydrochloride extended-release capsules?
  • Dexmethylphenidate hydrochloride extended-release capsules 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:
  • Children (6 to 17 years)
  • u25cf dyspepsiau00a0u00a0u00a0u00a0u00a0u00a0u00a0 u25cf decreased appetiteu00a0u00a0u00a0u00a0u00a0u00a0u00a0 u25cf headacheu00a0u00a0u00a0u00a0u00a0u00a0u00a0 u25cf anxiety
  • Adults
  • u25cf dry mouthu00a0u00a0u00a0u00a0u00a0u00a0 u25cf dyspepsiau00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u25cf headacheu00a0u00a0u00a0u00a0u00a0u00a0u00a0 u25cf anxietyu00a0u00a0u00a0u00a0u00a0u00a0u00a0 u25cf pharyngolaryngeal pain Call your doctor for medical advice about side effects. n
  • How should I store dexmethylphenidate hydrochloride extended-release capsules?
  • General information about the safe and effective use of dexmethylphenidate 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 dexmethylphenidate hydrochloride extended-release capsules that is written for healthcare professionals. Do not use dexmethylphenidate hydrochloride extended-release capsules for a condition for which they were not prescribed. Do not give dexmethylphenidate hydrochloride extended-release capsules to other people, even if they have the same symptoms that you have. They may harm them and it is against the law.
  • What are the ingredients in dexmethylphenidate hydrochloride extended-release capsules?
  • Active ingredient:
  • Inactive ingredients:
  • For more information, call 1-888-838-2872.n n n
  • North Wales, PA 19454
  • This Medication Guide has been approved by the U.S. Food and Drug Administrationu00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rev. F 1/2019
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