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FocalinXR

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Overview

What is FocalinXR?

Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Focalin XR uses the proprietary SODAS (Spheroidal Oral Drug Absorption System) technology. 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 second delayed release of dexmethylphenidate. Focalin XR is available as 5, 10, 15, 20, 30, and 40 mg extended-release capsules. Focalin XR 5, 10, 15, 20, 30, and 40 mg extended-release capsules provide in a single dose the same amount of dexmethylphenidate as dosages of 2.5, 5, 7.5, 10, 15 or 20 mg of Focalin given b.i.d. 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 empirical 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 FocalinXR look like?



What are the available doses of FocalinXR?

Extended-release capsules: 5, 10, 15, 20, 30, and 40 mg

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

How should I use FocalinXR?

Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.

The effectiveness of Focalin XR in the treatment of ADHD in patients aged 6 years and older was established in two 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 two 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 six 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 six 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

Focalin XR is 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 Focalin XR 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 Focalin XR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [ ].

Focalin XR is for oral administration once daily in the morning.

Focalin XR 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). Focalin XR 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 FocalinXR?

Sorry No Records found


What are the warnings of FocalinXR?

Sorry No Records found


What are the precautions of FocalinXR?

Sorry No Records found


What are the side effects of FocalinXR?

Sorry No records found


What should I look out for while using FocalinXR?

Agitation, marked anxiety, and tension (4.1)

Known hypersensitivity to methylphenidate or product components (4.2)

Glaucoma (4.3)

History of motor tics or a family history or diagnosis of Tourette’s syndrome (4.4)

During, or within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI) (4.5)

Focalin XR 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 FocalinXR?


How should I store and handle FocalinXR?

LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:ArrayLANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.Unopened Vial/Cartridge system/SoloStar disposable insulin device:Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date. Open (In-Use) Vial:Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C). Open (In-Use) Cartridge system:The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.Open (In-Use) SoloStar disposable insulin device:The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.These storage conditions are summarized in the following table:Array5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]Dispense in tight container (USP).5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]Dispense in tight container (USP).5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]Dispense in tight container (USP).5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]Dispense in tight container (USP).5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]Dispense in tight container (USP).5 mg Extended-Release Capsules, light-blue, (imprinted NVR D5) supplied in 10 mg Extended-Release Capsules, light caramel (imprinted NVR D10) supplied in 15 mg Extended-Release Capsules, green (imprinted NVR D15) supplied in 20 mg Extended-Release Capsules, white (imprinted NVR D20) supplied in Store FOCALIN XR at 25°C (77°F), excursions permitted 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]Dispense in tight container (USP).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology
Agitation, marked anxiety, and tension (4.1)

Known hypersensitivity to methylphenidate or product components (4.2)

Glaucoma (4.3)

History of motor tics or a family history or diagnosis of Tourette’s syndrome (4.4)

During, or within a minimum of 14 days following discontinuation of treatment with a monoamine oxidase inhibitor (MAOI) (4.5)

Focalin XR 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.

Because of possible effects on blood pressure, METADATE CD should be used cautiously with pressor agents.

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

In theory, there is a possibility that the clearance of methylphenidate might be affected by urinary pH, either being increased with acidifying agents or decreased with alkalizing agents. This should be considered when methylphenidate is given in combination with agents that alter urinary pH.

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.

Focalin XR 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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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).