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Focalin

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Overview

What is Focalin?

Focalin (dexmethylphenidate hydrochloride) is the -enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the and -enantiomers. Focalin is a central nervous system (CNS) stimulant, available in 3 tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5, 5, or 10 mg for oral administration. Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its empirical formula is CHNO•HCl. Its molecular weight is 269.77 and 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.

Focalin also contains the following inert ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye.



What does Focalin look like?



What are the available doses of Focalin?

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What should I talk to my health care provider before I take Focalin?

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How should I use Focalin?

Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Focalin in the treatment of ADHD was established in 2 controlled trials of patients aged 6 to 17 years of age who met DSM-IV criteria for ADHD (see Clinical Studies).

A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, ., in social, academic, or occupational functioning; and be present in 2 or more settings, ., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go,” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Focalin is administered twice daily, at least 4 hours apart. Focalin may be administered with or without food.

Dosage should be individualized according to the needs and responses of the patient.


What interacts with Focalin?

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What are the warnings of Focalin?

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What are the precautions of Focalin?

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What are the side effects of Focalin?

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What should I look out for while using Focalin?


What might happen if I take too much Focalin?


How should I store and handle Focalin?

Carton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49.Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30.Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49.Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30.Rx onlyCarton containing two epinephrine injection, USP auto-injectors 0.3 mg: NDC 0115-1694-49.Carton containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 0115-1694-30.Carton containing two epinephrine injection, USP auto-injectors 0.15 mg: NDC 0115-1695-49.Carton containing one epinephrine injection, USP auto-injector 0.15 mg: NDC 0115-1695-30.Rx onlyTablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.Tablets, D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face 2.5 mg Tablets - blue       Bottles of 100………………………………………………….NDC 0078-0380-055 mg Tablets - yellow       Bottles of 100………………………………………………….NDC 0078-0381-0510 mg Tablets - white       Bottles of 100………………………………………………….NDC 0078-0382-05Store at 25°C (77°F); excursions permitted 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature]Protect from light and moisture.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Because of possible effects on blood pressure, Focalin should be used cautiously with pressor agents.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and some antidepressants (tricyclics and selective serotonin reuptake inhibitors). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in the case of coumarin, coagulation times), when initiating or discontinuing concomitant methylphenidate.

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

The premarketing development program for Focalin included exposures in a total of 696 participants in clinical trials (684 patients, 12 healthy adult subjects). These participants received Focalin 5, 10, or 20 mg/day. The 684 ADHD patients (ages 6 to 17 years) were evaluated in 2 controlled clinical studies, 2 clinical pharmacology studies, and 2 uncontrolled long-term safety studies. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, and results of physical examinations, vital sign and body weight measurements, and laboratory analyses.

Adverse events during exposure were primarily obtained by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard COSTART dictionary terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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