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PRAMIPEXOLE DIHYDROCHLORIDE

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Overview

What is PRAMIPEXOLE DIHYDROCHLORIDE?

Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is ()-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate.

The structural formula is:

Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane.

Pramipexole dihydrochloride tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of corn starch, hydrogenated vegetable oil, mannitol, povidone and pregelatinized corn starch.



What does PRAMIPEXOLE DIHYDROCHLORIDE look like?



What are the available doses of PRAMIPEXOLE DIHYDROCHLORIDE?

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

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How should I use PRAMIPEXOLE DIHYDROCHLORIDE?

In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dosage should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.


What interacts with PRAMIPEXOLE DIHYDROCHLORIDE?

Pramipexole dihydrochloride tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.



What are the warnings of PRAMIPEXOLE DIHYDROCHLORIDE?

Falling Asleep During Activities of Daily Living

Patients treated with pramipexole dihydrochloride tablets have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on pramipexole dihydrochloride tablets, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as one year after the initiation of treatment.

Somnolence is a common occurrence in patients receiving pramipexole dihydrochloride tablets at doses above 1.5 mg/day (0.5 mg TID) for Parkinson’s disease. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with pramipexole dihydrochloride tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with pramipexole dihydrochloride tablets such as concomitant sedating medications, the presence of sleep disorders, and concomitant medications that increase pramipexole plasma levels (e.g., cimetidine - see PRECAUTIONS, ). If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.), pramipexole dihydrochloride tablets should ordinarily be discontinued. If a decision is made to continue pramipexole dihydrochloride tablets, patients should be advised to not drive and to avoid other potentially dangerous activities. While dose reduction clearly reduces the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

 Symptomatic Hypotension

Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting orthostatic hypotension, especially during dose escalation. Parkinson's disease patients, in addition, appear to have an impaired capacity to respond to an orthostatic challenge. For these reasons, both Parkinson's disease patients being treated with dopaminergic agonists ordinarily require careful monitoring for signs and symptoms of orthostatic hypotension, especially during dose escalation, and should be informed of this risk (see PRECAUTIONS, ).

In clinical trials of pramipexole, however, and despite clear orthostatic effects in normal volunteers, the reported incidence of clinically significant orthostatic hypotension was not greater among those assigned to pramipexole dihydrochloride tablets than among those assigned to placebo. This result, especially with the higher doses used in Parkinson’s disease, is clearly unexpected in light of the previous experience with the risks of dopamine agonist therapy.

While this finding could reflect a unique property of pramipexole, it might also be explained by the conditions of the study and the nature of the population enrolled in the clinical trials. Patients were very carefully titrated, and patients with active cardiovascular disease or significant orthostatic hypotension at baseline were excluded.

Hallucinations

In the three double-blind, placebo-controlled trials in early Parkinson's disease, hallucinations were observed in 9% (35 of 388) of patients receiving pramipexole dihydrochloride tablets, compared with 2.6% (6 of 235) of patients receiving placebo. In the four double-blind, placebo-controlled trials in advanced Parkinson's disease, where patients received pramipexole dihydrochloride tablets and concomitant levodopa, hallucinations were observed in 16.5% (43 of 260) of patients receiving pramipexole dihydrochloride tablets compared with 3.8% (10 of 264) of patients receiving placebo. Hallucinations were of sufficient severity to cause discontinuation of treatment in 3.1% of the early Parkinson's disease patients and 2.7% of the advanced Parkinson's disease patients compared with about 0.4% of placebo patients in both populations.

Age appears to increase the risk of hallucinations attributable to pramipexole. In the early Parkinson's disease patients, the risk of hallucinations was 1.9 times greater than placebo in patients younger than 65 years and 6.8 times greater than placebo in patients older than 65 years. In the advanced Parkinson's disease patients, the risk of hallucinations was 3.5 times greater than placebo in patients younger than 65 years and 5.2 times greater than placebo in patients older than 65 years.


What are the precautions of PRAMIPEXOLE DIHYDROCHLORIDE?

Rhabdomyolysis

A single case of rhabdomyolysis occurred in a 49 year-old male with advanced Parkinson's disease treated with pramipexole dihydrochloride tablets. The patient was hospitalized with an elevated CPK (10,631 IU/L). The symptoms resolved with discontinuation of the medication.

Renal

Since pramipexole is eliminated through the kidneys, caution should be exercised when prescribing pramipexole dihydrochloride tablets to patients with renal insufficiency (see ).

Dyskinesia

Pramipexole dihydrochloride tablets may potentiate the dopaminergic side effects of levodopa and may cause or exacerbate preexisting dyskinesia. Decreasing the dose of levodopa may ameliorate this side effect.

Retinal Pathology in Albino Rats

Pathologic changes (degeneration and loss of photoreceptor cells) were observed in the retina of albino rats in the 2 year carcinogenicity study. While retinal degeneration was not diagnosed in pigmented rats treated for 2 years, a thinning in the outer nuclear layer of the retina was slightly greater in rats given drug compared with controls. Evaluation of the retinas of albino mice, monkeys, and minipigs did not reveal similar changes. The potential significance of this effect in humans has not been established, but cannot be disregarded because disruption of a mechanism that is universally present in vertebrates (i.e., disk shedding) may be involved (see ).

Events Reported with Dopaminergic Therapy

Although the events enumerated below may not have been reported in association with the use of pramipexole in its development program, they are associated with the use of other dopaminergic drugs. The expected incidence of these events, however, is so low that even if pramipexole caused these events at rates similar to those attributable to other dopaminergic therapies, it would be unlikely that even a single case would have occurred in a cohort of the size exposed to pramipexole in studies to date.

Withdrawal-Emergent Hyperpyrexia and Confusion

Although not reported with pramipexole in the clinical development program, a symptom complex resembling the neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy.

Fibrotic Complications

Although not reported with pramipexole in the clinical development program, cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, and pleural thickening, pericarditis, and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when the drug is discontinued, complete resolution does not always occur.

Although these adverse events are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.

A small number of reports have been received of possible fibrotic complications, including peritoneal fibrosis, pleural fibrosis, and pulmonary fibrosis in the postmarketing experience for pramipexole. While the evidence is not sufficient to establish a causal relationship between pramipexole and these fibrotic complications, a contribution of pramipexole cannot be completely ruled out in rare cases.

Melanoma

Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other factors, such as drugs used to treat Parkinson’s disease, is unclear.

For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using pramipexole dihydrochloride tablets for indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

Information for Patients (also see Patient Package Insert)

Patients should be instructed to take pramipexole dihydrochloride tablets only as prescribed.

Patients should be alerted to the potential sedating effects associated with pramipexole dihydrochloride tablets, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Since somnolence is a frequent adverse event with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with pramipexole dihydrochloride tablets to gauge whether or not it affects their mental and/or motor performance adversely. Patients should be advised that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Because of possible additive effects, caution should be advised when patients are taking other sedating medications or alcohol in combination with pramipexole dihydrochloride tablets and when taking concomitant medications that increase plasma levels of pramipexole (e.g., cimetidine).

Patients should be informed that hallucinations can occur and that the elderly are at a higher risk than younger patients with Parkinson's disease.

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease, including pramipexole dihydrochloride. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with pramipexole dihydrochloride. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking pramipexole dihydrochloride. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking pramipexole dihydrochloride.

Patients may develop postural (orthostatic) hypotension, with or without symptoms such as dizziness, nausea, fainting or blackouts, and sometimes, sweating. Hypotension may occur more frequently during initial therapy. Accordingly, patients should be cautioned against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with pramipexole dihydrochloride tablets.

Because the teratogenic potential of pramipexole has not been completely established in laboratory animals, and because experience in humans is limited, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy (see PRECAUTIONS, ).

Because of the possibility that pramipexole may be excreted in breast milk, patients should be advised to notify their physicians if they intend to breast-feed or are breast-feeding an infant.

If patients develop nausea, they should be advised that taking pramipexole with food may reduce the occurrence of nausea.

Laboratory Tests

During the development of pramipexole dihydrochloride tablets, no systematic abnormalities on routine laboratory testing were noted. Therefore, no specific guidance is offered regarding routine monitoring; the practitioner retains responsibility for determining how best to monitor the patient in his or her care.

Drug Interactions

Carbidopa/levodopa did not influence the pharmacokinetics of pramipexole in healthy volunteers (N=10). Pramipexole did not alter the extent of absorption (AUC) or the elimination of carbidopa/levodopa, although it caused an increase in levodopa C by about 40% and a decrease in T from 2.5 to 0.5 hours.

In healthy volunteers (N=11), selegiline did not influence the pharmacokinetics of pramipexole.

Population pharmacokinetic analysis suggest that amantadine may slightly decrease the oral clearance of pramipexole.

Cimetidine, a known inhibitor of renal tubular secretion of organic bases via the cationic transport system, caused a 50% increase in pramipexole AUC and a 40% increase in half-life (N=12).

Probenecid, a known inhibitor of renal tubular secretion of organic acids via the anionic transporter, did not noticeably influence pramipexole pharmacokinetics (N=12).

Other Drugs Eliminated Via Renal Secretion

Population pharmacokinetic analysis suggests that coadministration of drugs that are secreted by the cationic transport system (e.g., cimetidine, ranitidine, diltiazem, triamterene, verapamil, quinidine, and quinine) decreases the oral clearance of pramipexole by about 20%, while those secreted by the anionic transport system (e.g., cephalosporins, penicillins, indomethacin, hydrochlorothiazide, and chlorpropamide) are likely to have little effect on the oral clearance of pramipexole.

CYP Interactions

Inhibitors of cytochrome P450 enzymes would not be expected to affect pramipexole elimination because pramipexole is not appreciably metabolized by these enzymes or . Pramipexole does not inhibit CYP enzymes CYP1A2, CYP2C9, CYP2C19, CYP2E1, and CYP3A4. Inhibition of CYP2D6 was observed with an apparent Ki of 30 µM, indicating that pramipexole will not inhibit CYP enzymes at plasma concentrations observed following the clinical dose of 4.5 mg/day (1.5 mg TID).

Dopamine Antagonists

Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride tablets.

Drug/Laboratory Test Interactions

There are no known interactions between pramipexole dihydrochloride tablets and laboratory tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two year carcinogenicity studies with pramipexole have been conducted in mice and rats. Pramipexole was administered in the diet to Chbb:NMRI mice at doses of 0.3, 2, and

10 mg/kg/day [0.3, 2.2, and 11 times the maximum recommended human dose [MRHD of 1.5 mg TID on a mg/m basis). Pramipexole was administered in the diet to Wistar rats at 0.3, 2, and 8 mg/kg/day (plasma AUCs were 0.3, 2.5, and 12.5 times the AUC in humans at the MRHD). No significant increases in tumors occurred in either species.

Pramipexole was not mutagenic or clastogenic in a battery of assays, including the Ames assay, V79 gene mutation assay for HGPRT mutants, chromosomal aberration assay in Chinese hamster ovary cells, and mouse micronucleus assay.

In rat fertility studies, pramipexole at a dose of 2.5 mg/kg/day (5 times the MRHD on a mg/mbasis), prolonged estrus cycles and inhibited implantation. These effects were associated with reductions in serum levels of prolactin, a hormone necessary for implantation and maintenance of early pregnancy in rats.

Pregnancy

When pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day (5 times the maximum recommended human dose (MRHD) on a mg/mbasis). Administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. The plasma AUC in rats at this dose was 4 times the AUC in humans at the MRHD. These findings are thought to be due to the prolactin lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance of early pregnancy in rats (but not rabbits or humans). Because of pregnancy disruption and early embryonic loss in these studies, the teratogenic potential of pramipexole could not be adequately evaluated. There was no evidence of adverse effects on embryo fetal development following administration of up to 10 mg/kg/day to pregnant rabbits during organogenesis (plasma AUC was 71 times that in humans at the MRHD). Postnatal growth was inhibited in the offspring of rats treated with 0.5 mg/kg/day (approximately equivalent to the MRHD on a mg/m basis) or greater during the latter part of pregnancy and throughout lactation.

There are no studies of pramipexole in human pregnancy. Because animal reproduction studies are not always predictive of human response, pramipexole should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Nursing Mothers

A single-dose, radio-labeled study showed that drug-related materials were excreted into the breast milk of lactating rats. Concentrations of radioactivity in milk were three to six times higher than concentrations in plasma at equivalent time points.

Other studies have shown that pramipexole treatment resulted in an inhibition of prolactin secretion in humans and rats.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from pramipexole, a decision should be made as to whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of pramipexole dihydrochloride tablets in pediatric patients has not been established.

Geriatric Use

Pramipexole total oral clearance was approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. This resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. In clinical studies with Parkinson’s disease patients, 38.7% of patients were older than 65 years. There were no apparent differences in efficacy or safety between older and younger patients, except that the relative risk of hallucination associated with the use of pramipexole dihydrochloride tablets was increased in the elderly.


What are the side effects of PRAMIPEXOLE DIHYDROCHLORIDE?

Parkinson's Disease

During the premarketing development of pramipexole, patients with either early or advanced Parkinson's disease were enrolled in clinical trials. Apart from the severity and duration of their disease, the two populations differed in their use of concomitant levodopa therapy. Patients with early disease did not receive concomitant levodopa therapy during treatment with pramipexole; those with advanced Parkinson's disease all received concomitant levodopa treatment. Because these two populations may have differential risks for various adverse events, this section will, in general, present adverse event data for these two populations separately.

Because the controlled trials performed during premarketing development all used a titration design, with a resultant confounding of time and dose, it was impossible to adequately evaluate the effects of dose on the incidence of adverse events.

Early Parkinson's Disease

In the three double-blind, placebo-controlled trials of patients with early Parkinson's disease, the most commonly observed adverse events (>5%) that were numerically more frequent in the group treated with pramipexole dihydrochloride tablets were nausea, dizziness, somnolence, insomnia, constipation, asthenia, and hallucinations.

Approximately 12% of 388 patients with early Parkinson's disease and treated with pramipexole dihydrochloride tablets who participated in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared with 11% of 235 patients who received placebo. The adverse events most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [3.1% on pramipexole dihydrochloride tablets vs. 0.4% on placebo]; dizziness [2.1% on pramipexole dihydrochloride tablets vs. 1% on placebo]; somnolence [1.6% on pramipexole dihydrochloride tablets vs. 0% on placebo]; extrapyramidal syndrome [1.6% on pramipexole dihydrochloride tablets vs. 6.4% on placebo]; headache and confusion [1.3% and 1.0%, respectively, on pramipexole dihydrochloride tablets vs. 0% on placebo]); and gastrointestinal system (nausea [2.1% on pramipexole dihydrochloride tablets vs. 0.4% on placebo]).

Table 1 lists treatment-emergent adverse events that occurred in the double-blind, placebo-controlled studies in early Parkinson's disease that were reported by ≥1% of patients treated with pramipexole dihydrochloride tablets and were numerically more frequent than in the placebo group. In these studies, patients did not receive concomitant levodopa. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-event incidence rate in the population studied.

Other events reported by 1% or more of patients with early Parkinson's disease and treated with pramipexole dihydrochloride tablets but reported equally or more frequently in the placebo group were infection, accidental injury, headache, pain, tremor, back pain, syncope, postural hypotension, hypertonia, depression, abdominal pain, anxiety, dyspepsia, flatulence, diarrhea, rash, ataxia, dry mouth, extrapyramidal syndrome, leg cramps, twitching, pharyngitis, sinusitis, sweating, rhinitis, urinary tract infection, vasodilation, flu syndrome, increased saliva, tooth disease, dyspnea, increased cough, gait abnormalities, urinary frequency, vomiting, allergic reaction, hypertension, pruritis, hypokinesia, increased creatine PK, nervousness, dream abnormalities, chest pain, neck pain, paresthesia, tachycardia, vertigo, voice alteration, conjunctivitis, paralysis, accommodation abnormalities, tinnitus, diplopia, and taste perversions.

In a fixed-dose study in early Parkinson's disease, occurrence of the following events increased in frequency as the dose increased over the range from 1.5 mg/day to 6 mg/day: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence with pramipexole at a dose of 1.5 mg/day was comparable to that reported for placebo.

 Table 1: Treatment-Emergent Adverse-Event Incidence in Double-Blind, Placebo-Controlled Trials in Early Parkinson's Disease (Events ≥1% of Patients Treated With Pramipexole Dihydrochloride Tablets and Numerically More Frequent Than in the Placebo Group)
Body System/Adverse EventPramipexole dihydrochloride N=388N=235
Body as a Whole
Asthenia 1412
General edema 53
Malaise 21
Reaction unevaluable 21
Fever 10
Digestive System
Nausea 2818
Constipation 146
Anorexia 42
Dysphagia 20
Metabolic & Nutritional System
Peripheral edema 54
Decreased weight 20
Nervous System
Dizziness 2524
Somnolence 229
Insomnia 1712
Hallucinations 93
Confusion 41
Amnesia 42
Hypesthesia 31
Dystonia 21
Akathisia 20
Thinking abnormalities 20
Decreased libido 10
Myoclonus 10
Special Senses
Vision abnormalities 30
Urogenital System
Impotence 21


Advanced Parkinson's Disease

In the four double-blind, placebo-controlled trials of patients with advanced Parkinson's disease, the most commonly observed adverse events (>5%) that were numerically more frequent in the group treated with pramipexole dihydrochloride tablets and concomitant levodopa were postural (orthostatic) hypotension, dyskinesia, extrapyramidal syndrome, insomnia, dizziness, hallucinations, accidental injury, dream abnormalities, confusion, constipation, asthenia, somnolence, dystonia, gait abnormality, hypertonia, dry mouth, amnesia, and urinary frequency.

Approximately 12% of 260 patients with advanced Parkinson's disease who received pramipexole dihydrochloride tablets and concomitant levodopa in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared with 16% of 264 patients who received placebo and concomitant levodopa. The events most commonly causing discontinuation of treatment were related to the nervous system (hallucinations [2.7% on pramipexole dihydrochloride tablets vs 0.4% on placebo]; dyskinesia [1.9% on pramipexole dihydrochloride tablets vs 0.8% on placebo]; extrapyramidal syndrome [1.5% on pramipexole dihydrochloride tablets vs 4.9% on placebo]; dizziness [1.2% on pramipexole dihydrochloride tablets vs 1.5% on placebo]; confusion [1.2% on pramipexole dihydrochloride tablets vs 2.3% on placebo]); and cardiovascular system (postural [orthostatic] hypotension [2.3% on pramipexole dihydrochloride tablets vs 1.1% on placebo]).

Table 2 lists treatment-emergent adverse events that occurred in the double-blind, placebo-controlled studies in advanced Parkinson's disease that were reported by ≥1% of patients treated with pramipexole dihydrochloride tablets and were numerically more frequent than in the placebo group. In these studies, pramipexole dihydrochloride tablets or placebo was administered to patients who were also receiving concomitant levodopa. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the adverse-events incidence rate in the population studied.

Other events reported by 1% or more of patients with advanced Parkinson's disease and treated with pramipexole dihydrochloride tablets but reported equally or more frequently in the placebo group were nausea, pain, infection, headache, depression, tremor, hypokinesia, anorexia, back pain, dyspepsia, flatulence, ataxia, flu syndrome, sinusitis, diarrhea, myalgia, abdominal pain, anxiety, rash, paresthesia, hypertension, increased saliva, tooth disorder, apathy, hypotension, sweating, vasodilation, vomiting, increased cough, nervousness, pruritus, hypesthesia, neck pain, syncope, arthralgia, dysphagia, palpitations, pharyngitis, vertigo, leg cramps, conjunctivitis, and lacrimation disorders.

Table 2: Treatment-Emergent Adverse-Event Incidence in Double-Blind, Placebo-Controlled Trials in Advanced Parkinson's Disease (Events ≥1% of Patients Treated with Pramipexole Dihydrochloride Tablets and Numerically More Frequent Than in the Placebo Group)
Body System/ Adverse Event N=260 N=264
Body as a Whole
Accidental injury 17 15
Asthenia 10 8
General edema 4 3
Chest pain 3 2
Malaise 3 2
Cardiovascular System
Postural hypotension 53 48
Digestive System
Constipation 10 9
Dry mouth 7 3
Metabolic & Nutritional System
Peripheral edema 2 1
Increased creatine PK 1 0
Musculoskeletal System
Arthritis 3 1
Twitching 2 0
Bursitis 2 0
Myasthenia 1 0
Nervous System
Dyskinesia 47 31
Extrapyramidal syndrome 28 26
Insomnia 27 22
Dizziness 26 25
Hallucinations 17 4
Dream abnormalities 11 10
Confusion 10 7
Somnolence 9 6
Dystonia 8 7
Gait abnormalities 7 5
Hypertonia 7 6
Amnesia 6 4
Akathisia 3 2
Thinking abnormalities 3 2
Paranoid reaction 2 0
Delusions 1 0
Sleep disorders 1 0
Respiratory System
Dyspnea 4 3
Rhinitis 3 1
Pneumonia 2 0
Skin & Appendages
Skin disorders 2 1
Special Senses
Accommodation abnormalities 4 2
Vision abnormalities 3 1
Diplopia 1 0
Urogenital System
Urinary frequency 6 3
Urinary tract infection 4 3
Urinary incontinence 2 1


General

Among the treatment-emergent adverse events in patients treated with pramipexole dihydrochloride tablets, hallucination appeared to exhibit a positive relationship to age in patients with Parkinson’s disease. Although no gender-related differences were observed in Parkinson’s disease patients. Less than 4% of patients enrolled were noncaucasian, therefore, an evaluation of adverse events related to race is not possible.

Pramipexole dihydrochloride tablets have been administered to 1,620 Parkinson’s disease patients in Phase 2 and 3 clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing; similar types of events were grouped into a smaller number of standardized categories using MedDRA dictionary terminology. These categories are used in the listing below. Adverse events which are not listed above but occurred on at least two occasions (one occasion if the event was serious) in the 2,509 individuals exposed to pramipexole dihydrochloride tablets are listed below. The reported events below are included without regard to determination of a causal relationship to pramipexole dihydrochloride tablets.

Falling Asleep During Activities of Daily Living 

Patients treated with pramipexole dihydrochloride tablets have reported falling asleep while engaged in activities of daily living, including operation of a motor vehicle which sometimes resulted in accidents (see bolded ).

Post-Marketing Experience 

In addition to the adverse events reported during clinical trials, the following adverse reactions have been identified during post-approval use of pramipexole dihydrochloride tablets, primarily in Parkinson’s disease patients. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to pramipexole tablets. Similar types of events were grouped into a smaller number of standardized categories using the MedDRA dictionary: abnormal behavior, abnormal dreams, accidents (including fall), blackouts, fatigue, hallucinations (all kinds), headache, hypotension (including postural hypotension), increased eating (including binge eating, compulsive eating, and hyperphagia), libido disorders (including increased and decreased libido, and hypersexuality), pathological gambling, syncope, and weight increase.


What should I look out for while using PRAMIPEXOLE DIHYDROCHLORIDE?

Pramipexole dihydrochloride tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.


What might happen if I take too much PRAMIPEXOLE DIHYDROCHLORIDE?

There is no clinical experience with massive overdosage. One patient, with a 10 year history of schizophrenia, took 11 mg/day of pramipexole for 2 days in a clinical trial to evaluate the effect of pramipexole in schizophrenic patients. No adverse events were reported related to the increased dose. Blood pressure remained stable although pulse rate increased to between 100 and 120 beats/minute. The patient withdrew from the study at the end of week 2 due to lack of efficacy.

There is no known antidote for overdosage of a dopamine agonist. If signs of central nervous system stimulation are present, a phenothiazine or other butyrophenone neuroleptic agent may be indicated; the efficacy of such drugs in reversing the effects of overdosage has not been assessed. Management of overdose may require general supportive measures along with gastric lavage, intravenous fluids, and electrocardiogram monitoring.


How should I store and handle PRAMIPEXOLE DIHYDROCHLORIDE?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Pramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLETPramipexole Dihydrochloride tablets are available as follows:0.125 mg: White, round unscored tablet. Debossed with stylized b on one side and C2 on the other side. Available in bottles of:0.25 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|3 on the other side.Available in bottles of:0.5 mg: White, oval tablet scored on both sides. Debossed with stylized b on one side and C|4 on the other side. Available in bottles of:1 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|5 on the other side.Available in bottles of:1.5 mg: White, round tablet scored on both sides. Debossed with stylized b on one side and C|6 on the other side.Available in bottles of:KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].Protect from light.PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pramipexole is a nonergot dopamine agonist with high relative specificity and full intrinsic activity at the D subfamily of dopamine receptors, binding with higher affinity to D than to D or D receptor subtypes.

Parkinson’s Disease:

Non-Clinical Toxicology
Pramipexole dihydrochloride tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

A single case of rhabdomyolysis occurred in a 49 year-old male with advanced Parkinson's disease treated with pramipexole dihydrochloride tablets. The patient was hospitalized with an elevated CPK (10,631 IU/L). The symptoms resolved with discontinuation of the medication.

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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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Tips

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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).