Dexmethylphenidate Hydrochloride (Focalin)

Trade Name : Focalin

Novartis Pharmaceuticals Corporation

TABLET

Strength 2.5 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 (Focalin) which is also known as Focalin and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 2.5 mg/1 per ml. Read more

Dexmethylphenidate Hydrochloride (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

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WARNING: ABUSE AND DEPENDENCE
See full prescribing information for complete boxed warning.

CNS stimulants, including Focalin, 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 is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) .
Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ().

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Administer orally twice daily, 4 hours apart with or without food ().n
For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily) ().n
For patients currently taking methylphenidate: Initiate Focalin therapy with half (1/2) the current total daily dose of methylphenidate ().n
Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) ().

Focalin (dexmethylphenidate hydrochloride) tablets are D-shaped, embossed u201cDu201d on upper convex face and dosage strength on lower convex face in the following colors:
Tablets: 2.5 mg, 5 mg, and 10 mg ()

No data

Known hypersensitivity to methylphenidate or other components of Focalin ().
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
Psychotic 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) in pediatric patients 6 to 17 years were abdominal pain, fever, nausea, and anorexia ().

Table 2 presents clinically important drug interactions with Focalin.

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: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes, and rhabdomyolysis.
Overdose Management
Consult with a Certified Poison Control Center (1-800-222-1222) for latest recommendations.

Focalin contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the enantiomer of racemic methylphenidate hydrochloride. Focalin is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration.
Chemically, dexmethylphenidate hydrochloride is methyl u03b1-phenyl-2-piperidineacetate hydrochloride, (R,Ru2019)-(+)-. Its molecular formula is CHNOu2022HCl. Its structural formula is:
Note: * = asymmetric carbon centers
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:

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/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 (children) of 60 mg/day of racemic methylphenidate 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 60-74 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 in vivo mouse bone marrow micronucleus test. In an in vitro 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 adolescents on a mg/m basis.

The efficacy of Focalin for the treatment of ADHD was established in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients (ages 6 to 17 years old) who met DSM-IV criteria for ADHD inattentive, hyperactive-impulsive, or combined inattentive/hyperactive-impulsive subtypes. The sample was predominantly younger (ages 6 to 12 years); thus, the findings are most pertinent to this age group.
In Study 1, patients were randomized to receive either Focalin (5, 10, or 20 mg/day total dose), racemic methylphenidate HCl (10, 20, or 40 mg/day total dose), or placebo in a multicenter, 4-week, parallel group study in 132 pediatric patients. Patients received study medication twice daily separated by a 3.5 to 5.5 hours interval. Treatment was initiated with the lowest dose, and doses could be doubled at weekly intervals, depending on clinical response and tolerability, up to the maximum dose. The primary outcome was change from baseline to week 4 of the average score (an average of 2 ratings during the week) of the teacheru2019s version of the SNAP-ADHD Rating Scale. This 18 item scale measures ADHD symptoms of inattention and hyperactivity/impulsivity, rated on a scale of 0 (Not at All) to 3 (Very Much). Patients treated with Focalin showed a statistically significant improvement in symptom scores from baseline over patients who received placebo (Table 3).
Study 2 was a multicenter, placebo-controlled, double-blind, 2-week treatment withdrawal study in 75 children (ages 6 to 12 years) who were responders during a 6-week, open-label initial treatment period. Children took study medication twice a day separated by a 3.5 to 5.5 hour interval. The primary outcome was proportion of treatment failures at the end of the 2-week withdrawal phase, where treatment failure was defined as a rating of 6 (much worse) or 7 (very much worse) on the Investigator Clinical Global Impression - Improvement (CGI-I). Patients continued on Focalin showed a statistically significant lower rate of failure over patients who received placebo (Table 4).

Focalin (dexmethylphenidate hydrochloride) tablets (D-shaped, embossed u201cDu201d on upper convex face and dosage strength on lower convex face) 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, light-resistant container (USP).
Disposal
Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired Focalin 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 Focalin 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 Focalin 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 Focalin is a controlled substance, and it can be abused and lead to dependence. Instruct patients that they should not give Focalin to anyone else. Advise patients to store Focalin 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 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 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 can cause elevations of their blood pressure and pulse rate .
Psychiatric Risks
Advise patients that Focalin, 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 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. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients .
Suppression of Growth
Advise patients that Focalin 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, during pregnancy .
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
T2019-131

No data

NOVARTISnttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0380-05
Focalinn
dexmethylphenidatehydrochloride
2.5 mg
100 Tablets
Rx only
Dispense with Medication Guideattached or provided separately.

NOVARTISnttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0381-05
Focalinn
dexmethylphenidatehydrochloride
5 mg
100 Tablets
Rx only
Dispense with Medication Guideattached or provided separately.

NOVARTISnttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0382-05
Focalinn
dexmethylphenidatehydrochloride
10 mg
100 Tablets
Rx only
Dispense with Medication Guideattached or provided separately.

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Dexmethylphenidate Hydrochloride (Focalin)

Trade Name : Focalin

TABLET

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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Dexmethylphenidate Hydrochloride (Focalin)

Trade Name : Focalin

TABLET

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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