methylphenidate hydrochloride CD

×

Overview

What is methylphenidate hydrochloride CD?

Methylphenidate HCl Extended-Release Capsules CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate HCl Extended-Release Capsules CD is available in six capsule strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride for oral administration.

Chemically, methylphenidate HCl is , (racemic)--methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is CHNO•HCl. Its structural formula is:

Methylphenidate HCl USP is a white, odorless, crystalline 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.

Methylphenidate HCl Extended-Release Capsules CD also contains the following inert ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethylcellulose aqueous dispersion, dibutyl sebacate, gelatin, and titanium dioxide.

The individual capsules contain the following color agents:

10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide20 mg capsules: FD&C Blue No. 230 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide40 mg capsules: FDA/E172 Yellow Iron Oxide50 mg capsules: FD&C Blue No. 2, FDA/E172 Red Iron Oxide

What does methylphenidate hydrochloride CD look like?

What are the available doses of methylphenidate hydrochloride CD?

Sorry No records found.

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

Sorry No records found

How should I use methylphenidate hydrochloride CD?

Methylphenidate HCl Extended-Release Capsules CD are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of Methylphenidate HCl Extended-Release Capsules CD in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who met DSM-IV criteria for ADHD (see ).

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.

Methylphenidate HCl Extended-Release Capsules CD is administered once daily in the morning, before breakfast.

Methylphenidate HCl Extended-Release Capsules CD may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g. water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed (see ). Patients should be advised to avoid alcohol while taking Methylphenidate HCl Extended-Release Capsules CD.

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

What interacts with methylphenidate hydrochloride CD?

Sorry No Records found

What are the warnings of methylphenidate hydrochloride CD?

Serious Cardiovascular Events

Sudden Death And Pre-existing Structural Cardiac Abnormalities Or Other Serious Heart Problems

Hypertension And Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see ).

Assessing Cardiovascular Status In Patients Being Treated With Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence Of New Psychotic Or Manic Symptoms

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Suppression Of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's phenomenon

Stimulants, including Methylphenidate HCl Extended-Release Capsules CD, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Use In Children Under Six Years Of Age

Methylphenidate HCl Extended-Release Capsules CD should not be used in children under six years, since safety and efficacy in this age group have not been established.

Drug Dependence

What are the precautions of methylphenidate hydrochloride CD?

Hematologic Monitoring

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

Drug Testing

Methylphenidate HCl Extended-Release Capsules CD contains methylphenidate which may result in a positive result during drug testing.

Information For Patients

Array

Instruct patients beginning treatment with Methylphenidate HCl Extended-Release Capsules CD about the risk of peripheral vasculopathy, including Raynaud's 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.
Array
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). .

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Methylphenidate HCl Extended-Release Capsules CD. The prescriber or healthcare professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. The Medication Guide may also be obtained by calling 1-866-822-0068.

Drug Interactions

Array

There is a risk of sudden blood pressure increase during surgery. If surgery is planned, Methylphenidate HCl Extended-Release Capsules CD should not be taken the day of the surgery.

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Array

Pregnancy

Nursing Mothers

It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Methylphenidate HCl Extended-Release Capsules CD is administered to a nursing woman.

Pediatric Use

The safety and efficacy of Methylphenidate HCl Extended-Release Capsules CD in children under 6 years old have not been established. Long-term effects of methylphenidate in children have not been well established (see ).

What are the side effects of methylphenidate hydrochloride CD?

The premarketing development program for Methylphenidate HCl Extended-Release Capsules CD included exposures in a total of 228 participants in clinical trials (188 pediatric patients with ADHD, 40 healthy adult subjects). These participants received Methylphenidate HCl Extended-Release Capsules CD 20, 40, and/or 60 mg/day. The 188 patients (ages 6 to 15) were evaluated in one controlled clinical study, one controlled, crossover clinical study, and one uncontrolled clinical study. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

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, COSTART 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.

Adverse Findings In Clinical Trials With Methylphenidate HCl Extended-Release Capsules CD

In the 3-week placebo-controlled, parallel-group trial, two Methylphenidate HCl Extended-Release Capsules CD-treated patients (1%) and no placebo-treated patients discontinued due to an adverse event (rash and pruritus; and headache, abdominal pain, and dizziness, respectively).

Adverse Events Occurring At An Incidence Of 5% Or More Among Methylphenidate HCl Extended-Release Capsules CD-Treated Patients

Array

**TABLE 1 Incidence of Treatment-Emergent Eventsin a Pool of 3-4 Week Clinical Trials of Methylphenidate HCl Extended-Release Capsules CD**
	Methylphenidate HCl Extended-Release	Placebo
	Capsules CD
General	Headache	12%	8%
	Abdominal pain (stomach ache)	7%	4%
Digestive System	Anorexia (loss of appetite)	9%	2%
Nervous System	Insomnia	5%	2%

Adverse Events With Other Marketed Methylphenidate HCl Products

Array

Postmarketing Experience

In addition to the adverse events listed above, the following have been reported in patients receiving Methylphenidate HCl Extended-Release Capsules CD worldwide. The list is alphabetized: abnormal behavior, aggression, anxiety, bruxism, cardiac arrest, depression, fixed drug eruption, hyperactivity, irritability, libido changes, migraine, obsessive-compulsive disorder, peripheral coldness, Raynaud's phenomenon, reversible ischaemic neurological deficit, rhabdomyolysis, serotonin syndrome in combination with serotonergic drugs, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.

What should I look out for while using methylphenidate hydrochloride CD?

What might happen if I take too much methylphenidate hydrochloride CD?

How should I store and handle methylphenidate hydrochloride CD?

Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at or below 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat. Protect from freezing. Protect from light. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free.The container closure is not made with natural rubber latex.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.Methylphenidate HCl Extended-Release Capsules CD are available in six strengths:10 mg, green/white capsules, imprinted with "UCB 579" in white letters on the green cap, and "10 mg" in black letters on the white body of the capsule.20 mg, blue/white capsules, imprinted with "UCB 580" in white letters on the blue cap, and "20 mg" in black letters on the white body of the capsule.30 mg, reddish-brown/white capsules, imprinted with "UCB 581" in white letters on the reddish-brown cap, and "30 mg" in black letters on the white body of the capsule.40 mg, yellow ivory/white capsules, imprinted with "UCB 582" in black letters on the yellow ivory cap, and "40 mg" in black letters on the white body of the capsule.50 mg, purple/white capsules, imprinted with "UCB 583" in white letters on the purple cap, and "50 mg" in black letters on the white body of the capsule.60 mg, white/white capsules, imprinted with "UCB 584" in black letters on the white cap, and "60 mg" in black letters on the white body of the capsule.

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. 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. Methylphenidate is a racemic mixture comprised of the and enantiomers. The enantiomer is more pharmacologically active than the enantiomer.

Non-Clinical Toxicology

Because of possible effects on blood pressure, Methylphenidate HCl Extended-Release Capsules 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.

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

The premarketing development program for Methylphenidate HCl Extended-Release Capsules CD included exposures in a total of 228 participants in clinical trials (188 pediatric patients with ADHD, 40 healthy adult subjects). These participants received Methylphenidate HCl Extended-Release Capsules CD 20, 40, and/or 60 mg/day. The 188 patients (ages 6 to 15) were evaluated in one controlled clinical study, one controlled, crossover clinical study, and one uncontrolled clinical study. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

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, COSTART 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.

×

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.

×

Review

×

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

×

Tips

×

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).

Disclaimer: