Dexmethylphenidate hydrochloride

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Overview

What is Dexmethylphenidate hydrochloride?

Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release 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 second delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release is available as 5 mg, 10 mg, 15 mg, 20 mg and 30 mg extended-release capsules. Dexmethylphenidate hydrochloride extended-release 5 mg, 10 mg, 15 mg, 20 mg and 30 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5 mg, 5 mg, 7.5 mg, 10 mg or 15 mg of dexmethylphenidate hydrochloride given twice a day as tablets.

Dexmethylphenidate hydrochloride, the enantiomer of racemic methylphenidate hydrochloride, is a central nervous system (CNS) stimulant.

Dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is CHNO•HCl. Its molecular weight is 269.77 and its structural formula is:

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.

Inactive ingredients:

What does Dexmethylphenidate hydrochloride look like?

What are the available doses of Dexmethylphenidate hydrochloride?

Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg and 30 mg ()

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

How should I use Dexmethylphenidate hydrochloride?

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.

The effectiveness of dexmethylphenidate hydrochloride extended-release in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., 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 Types requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

Dexmethylphenidate hydrochloride extended-release capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.

Long-Term Use

The effectiveness of dexmethylphenidate hydrochloride extended-release for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dexmethylphenidate hydrochloride extended-release for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient

Dexmethylphenidate hydrochloride extended-release is for oral administration once daily in the morning.

Dexmethylphenidate hydrochloride extended-release may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Dexmethylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.

The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.

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

What interacts with Dexmethylphenidate hydrochloride?

Sorry No Records found

What are the warnings of Dexmethylphenidate hydrochloride?

Sorry No Records found

What are the precautions of Dexmethylphenidate hydrochloride?

Sorry No Records found

What are the side effects of Dexmethylphenidate hydrochloride?

Sorry No records found

What should I look out for while using Dexmethylphenidate hydrochloride?

Agitation, marked anxiety, and tension ()

Known hypersensitivity to methylphenidate or product components ()

Glaucoma ()

History of motor tics or a family history or diagnosis of Tourette’s syndrome ()

During, or within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI) ()

Dexmethylphenidate hydrochloride extended-release should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

What might happen if I take too much Dexmethylphenidate hydrochloride?

How should I store and handle Dexmethylphenidate hydrochloride?

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 onlyDexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Dexmethylphenidate hydrochloride extended-release capsules contain white to off-white pellets and are available as follows:5 mg – Size 2 capsule with white opaque body and light purple opaque cap imprinted in black "IX" on the capsule cap and "682" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9918-01. 10 mg - Size 2 capsule with white opaque body and dark purple opaque cap imprinted in black "IX" on the capsule cap and "683" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9919-01.15 mg - Size 2 capsule with white opaque body and light pink opaque cap imprinted in black "IX" on the capsule cap and "684" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9920-01.20 mg - Size 0 capsule with white opaque body and dark pink opaque cap imprinted in black "IX" on the capsule cap and "685" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9921-01.30 mg - Size 00 capsule with white opaque cap and body imprinted in black "IX" on the capsule cap and "686" on the capsule body. Capsules are supplied in bottles of 100 NDC 0115-9922-01.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Dexmethylphenidate hydrochloride, the active ingredient in dexmethylphenidate hydrochloride extended-release, is a central nervous system stimulant. Dexmethylphenidate, the more pharmacologically active enantiomer of racemic methylphenidate, is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known.

Non-Clinical Toxicology

Agitation, marked anxiety, and tension ()

Known hypersensitivity to methylphenidate or product components ()

Glaucoma ()

History of motor tics or a family history or diagnosis of Tourette’s syndrome ()

During, or within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI) ()

Dexmethylphenidate hydrochloride extended-release should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Children and Adolescents

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

Adults

Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.

Dexmethylphenidate hydrochloride extended-release was administered to 46 children and 7 adolescents with ADHD for up to 7 weeks and 206 adults with ADHD in clinical studies. During the clinical studies, 101 adult patients were treated for at least 6 months.

Adverse events during exposure were obtained primarily 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 listings that follow, MedDRA 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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