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Dexmethylphenidate Hydrochloride - Xr (Focalin)

Trade Name : Focalin

Novartis Pharmaceuticals Corporation

CAPSULE, EXTENDED RELEASE

Strength 5 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 - Xr (Focalin) which is also known as Focalin and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5 mg/1 per ml. Read more

Dexmethylphenidate Hydrochloride - Xr (Focalin) 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

Packaging and Delivery

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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.

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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 Focalin XR, 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 (, ).
  • No data
  • Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) .
  • Focalin XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ().
  • 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 ().
  • Patients currently on methylphenidate: Focalin XR dosage is half (1/2) the current total daily dosage of methylphenidate ().
  • Patients currently on Focalin (dexmethylphenidate) immediate-release tablets: Give the same daily dose of Focalin XR ().
  • 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 hydrochloride ()
  • No data
  • Known hypersensitivity to methylphenidate or other components of Focalin XR ().
  • 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 Novartis Pharmaceuticals Corporation at 1-888-669-6682, or FDA at 1-800-FDA-1088 or .
  • 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 Focalin XR.
  • Antihypertensive Drugs:
  • Halogenated Anesthetics:
  • 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.
  • Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules.
  • Chemically, dexmethylphenidate hydrochloride is methyl u03b1-phenyl-2-piperidineacetate hydrochloride, (R,Ru2019)-(+)-. Its molecular formula is CHNOu2022HCl. Its structural formula is:
  • u00a0n
  • Note* = asymmetric carbon center
  • Dexmethylphenidate hydrochloride 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.
  • Inactive ingredients:
  • Each strength capsule also contains colorant ingredients in the capsule shell as follows:
  • 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/day of racemic methylphenidate given to children on a mg/m2 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 (children) of 60 mg/day 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 to74 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 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 times the MRHD of 60 mg/day of racemic methylphenidate given to adolescents on a mg/m basis.
  • No data
  • Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules are available as follows:
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), with excursions permitted between 15u00b0C and 30u00b0C (59u00b0F to 86u00b0F) [See USP Controlled Room Temperature].
  • Dispense in tight container (USP).
  • Disposal
  • Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Focalin XR 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 Focalin XR 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 Focalin XR 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 Focalin XR is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give Focalin XR to anyone else. Advise patients to store Focalin XR 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 Focalin XR 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 Focalin XR 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 .
  • Blood Pressure and Heart Rate Increases
  • Instruct patients that Focalin XR can cause elevations of their blood pressure and pulse rate .
  • Psychiatric Risks
  • Advise patients that Focalin XR, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania .
  • 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 Focalin XR 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 Focalin XR. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients .
  • Suppression of Growth
  • Advise patients that Focalin XR may cause slowing of growth and weight loss .
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Focalin XR, during pregnancy .
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • T2019-133
  • No data
  • NDC 0078-0430-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 5 mg
  • 100 capsules
  • Dispense with MedicationGuide attached or providedseparately.
  • NOVARTIS
  • NDC 0078-0431-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 10 mg
  • 100 capsules
  • Dispense with MedicationGuide attached or providedseparately.
  • NOVARTIS
  • NDC 0078-0493-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 15 mg
  • 100 capsules
  • Dispense with MedicationGuide attached or providedseparately.
  • NOVARTIS
  • NDC 0078-0432-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 20 mg
  • 100 capsules
  • Dispense with MedicationGuide attached or providedseparately.
  • NOVARTIS
  • NDC 0078-0608-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 25 mg
  • 100 capsules
  • Dispense in tight container (USP).
  • Dispense with Medication Guideattached or provided separately.
  • NOVARTIS
  • NDC 0078-0433-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 30 mg
  • 100 capsules
  • Dispense in tight container (USP).
  • Dispense withMedication Guide attachedor provided separately.
  • NOVARTIS
  • NDC 0078-0609-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 35 mg
  • 100 capsules
  • Dispense in tight container (USP).
  • Dispense withMedication Guide attachedor provided separately.
  • NOVARTIS
  • NDC 0078-0434-05nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntRx only
  • Focalin XRn
  • (dexmethylphenidate HCl)
  • extended-release capsules
  • 40 mg
  • 100 capsules
  • Dispense in tight container (USP).
  • Dispense withMedication Guide attachedor provided separately.
  • NOVARTIS

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