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MYOCARD-DX

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Overview

What is MYOCARD-DX?

Dopamine Hydrochloride in 5% Dextrose Injection USP is prepared from Dopamine Hydrochloride and Hydrous Dextrose USP in Water for Injection USP. These solutions are for intravenous use only.

These solutions are sterile, nonpyrogenic, isotonic, and contain no bacteriostatic or antimicrobial agents or added buffers. They are intended for single use only. When smaller doses are required, the unused portion should be discarded.

Each 100 mL contains dopamine hydrochloride 80 mg or 160 mg and dextrose, hydrous, 5 g in water for injection, with sodium metabisulfite added 50 mg as a stabilizer; osmolar concentration, respectively 270 and 275 mOsmol/liter, pH 3.3 (2.5 - 4.5). pH may be adjusted with Hydrochloric Acid NF or Sodium Hydroxide NF, as required.

Dopamine administered intravenously is a myocardial inotropic agent which also may increase mesenteric and renal blood flow plus urinary output.

Dopamine hydrochloride is designated chemically, as 3,4-dihydroxyphenethylamine hydrochloride, a white crystalline powder freely soluble in water. Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring biochemical catecholamine precursor of norepinephrine.

The formulas of the active ingredients are:



What does MYOCARD-DX look like?



What are the available doses of MYOCARD-DX?

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What should I talk to my health care provider before I take MYOCARD-DX?

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How should I use MYOCARD-DX?

Dopamine Hydrochloride in 5% Dextrose Injection USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure, and chronic cardiac decompensation as in congestive heart failure.

Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine.

Patients most likely to respond adequately to administration of dopamine are those in whom physiological parameters such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine, the better the prognosis.

Poor Perfusion of Vital Organs

Nevertheless, in a number of oliguric or anuric patients, administration of dopamine has resulted in an increase in urine flow which in some cases reached normal levels. Dopamine may also increase urine flow in patients whose output is within normal limits and thus may be of value in reducing the degree of pre-existing fluid accumulation. It should be noted that at doses above those optimal for the individual patient, urine flow may decrease, necessitating reduction of dosage. Concurrent administration of dopamine and diuretic agents may produce an additive or potentiating effect.

Low Cardiac Output

Hypotension

Dopamine Hydrochloride in 5% Dextrose Injection USP is for intravenous use only.

Dosage is to be directed by a physician.

The less concentrated 400 mcg/mL or 800 mcg/mL solutions may be preferred when fluid expansion is not a concern.

Rate of Administration

Administration at rates greater than 50 mcg/kg/min have safely been used in advanced circulatory decompensation states. If unnecessary fluid expansion is of concern, adjustment of drug concentration may be preferred over increasing the flow rate of a less concentrated dilution.


What interacts with MYOCARD-DX?

Dopamine hydrochloride should not be used in patients with pheochromocytoma.


Dopamine hydrochloride should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.


Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.



What are the warnings of MYOCARD-DX?

The occurrence of hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function receiving thiazides and allopurinol concurrently. Thus, in patients with decreased renal function, such combinations should be administered with caution.

Do not add any alkalinizing substance since dopamine is inactivated in alkaline solution.

Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of dopamine will require substantially reduced dosage. Seebelow.

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is: seen more frequently in asthmatic than in nonasthmatic people.

Evidence is inadequate for fully defining proper dosage and limitation for use in children. (See )

Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration of erythrocytes.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Excess administration of potassium-free solutions may result in significant hypokalemia.

Because dosages of this drug are titrated to response (see ), no additives should be mixed with Dopamine Hydrochloride in 5% Dextrose Injection USP.


What are the precautions of MYOCARD-DX?

General

Control of the rate of infusion is essential to avoid inadvertent administration of a bolus of the drug (see ).

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid-balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Use only if solution is clear and vacuum is present.

Avoid Hypovolemia

Hypoxia, Hypercapnia, Acidosis

Ventricular Arrhythmias

Decreased Pulse Pressure

Hypotension

Extravasation

Occlusive Vascular Disease

Important – Antidote for Peripheral Ischemia: To prevent sloughing and necrosis in ischemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of 0.9% Sodium Chloride Injection USP containing 5 to 10 mg of Regitine™ (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used and the solution liberally infiltrated throughout the ischemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area Is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Weaning

Drug Interactions

Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as dopamine. This interaction appears to be related both to pressor activity and to the beta adrenergic stimulating properties of these catecholamines, and may produce ventricular arrhythmias. Therefore, EXTREME CAUTION should be exercised when administering dopamine HCI to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine-induced ventricular arrhythmias during anesthesia can be reversed by propranolol.

Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who ave been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine should receive an initial dose of Dopamine HCl no greater than one-tenth (1/10) of the usual dose.

Concurrent administration of low-dose dopamine HCI and diuretic agents may produce an additive or potentiating effect on urine flow.

Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents.

Cardiac effects of dopamine are antagonized by beta-adrenergic blocking agents, such as propranolol and metoprolol. The peripheral vasoconstriction caused by high doses of dopamine HCI is antagonized by alpha-adrenergic blocking agents. Dopamine-induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.

Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopaminergic renal and mesenteric vasodilation induced with low-dose dopamine infusion.

The concomitant use of vasopressors, vasoconstrictor agents (such as ergonovine) and some oxytocic drug may result in severe hypertension.

Administration of phenytoin to patients receiving dopamine HCI has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine HCI, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of dopamine HCl.

Dopamine HCI at doses approaching maximal solubility showed no clear genotoxic potential in the Ames test. Although there was a reproducible dose-dependent increase in the number of revertant colonies with strains TA100 and TA98, both with and without metabolic activation, the small increase was considered inconclusive evidence of mutagenicity. In the L5178Y TK+/- mouse lymphoma assay, dopamine HCl at the highest concentrations used of 750 µg/mL without metabolic activation, and 3000 µg/mL with activation, was toxic and associated with increases in mutant frequencies when compared to untreated and solvent controls; at the lower concentrations no increases over controls were noted.

No clear evidence of clastogenic potential was reported in themouse or male rat bone marrow micronucleus test when the animals were treated intravenously with up to 224 mg/kg and 30 mg/kg of dopamine HCl, respectively.

Pregnancy



Labor and Delivery

In obstetrics, if vasopressor drugs are used to correct hypotension or are added to a local anesthetic solution the interaction with some oxytocic drugs may cause severe hypertension.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dopamine is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Dopamine HCI has been used in a limited number of pediatric patients, but such use has been inadequate to fully define proper dosage and limitations for use. Peripheral gangrene has been reported in neonates and children.


What are the side effects of MYOCARD-DX?

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Cardiovascular System

Respiratory System

Gastrointestinal System

Metabolic/Nutritional System

Central Nervous System

Dermatological System

Other

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.


What should I look out for while using MYOCARD-DX?

Dopamine hydrochloride should not be used in patients with pheochromocytoma.

Dopamine hydrochloride should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Do not add any alkalinizing substance since dopamine is inactivated in alkaline solution.

Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of dopamine will require substantially reduced dosage. Seebelow.

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is: seen more frequently in asthmatic than in nonasthmatic people.

Evidence is inadequate for fully defining proper dosage and limitation for use in children. (See )

Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration of erythrocytes.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Excess administration of potassium-free solutions may result in significant hypokalemia.

Because dosages of this drug are titrated to response (see ), no additives should be mixed with Dopamine Hydrochloride in 5% Dextrose Injection USP.


What might happen if I take too much MYOCARD-DX?

In case of accidental overdosage, as evidenced by excessive blood pressure elevation, reduce rate of administration or temporarily discontinue dopamine until patients condition stabilizes. Since the duration of action of dopamine is quite short, no additional remedial measures are usually necessary. If these measures fail to stabilize the patients condition, use of the short acting alpha adrenergic blocking agent, phentolamine, should be considered.


How should I store and handle MYOCARD-DX?

Store refrigerated between 2° and 8°C (36° and 46°F). Protect from light.Store refrigerated between 2° and 8°C (36° and 46°F). Protect from light.Dopamine Hydrochloride in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.NOTE - Do not use solution if it is darker than slightly yellow or discolored in any other way.Dopamine Hydrochloride in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.NOTE - Do not use solution if it is darker than slightly yellow or discolored in any other way.Dopamine Hydrochloride in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.NOTE - Do not use solution if it is darker than slightly yellow or discolored in any other way.Dopamine Hydrochloride in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts.NOTE - Do not use solution if it is darker than slightly yellow or discolored in any other way.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Dopamine is a natural catecholamine formed by the decarboxylation of 3,4-ihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in noradrenergic nerves and is also a neurotransmitter in certain areas of the central nervous system, especially in the nigrostriatal tract, and in a few peripheral sympathetic nerves.

Dopamine produces positive chronotropic and inotropic effects on the myocardium, resulting in increased heart rate and cardiac contractility. This is accomplished directly by exerting an agonist action on beta-adrenoceptors and indirectly by causing release of norepinephrine from storage sites in sympathetic nerve ending.

Dopamine’s onset of action occurs within five minutes of intravenous administration, and with dopamine’s plasma half-life of about two minutes, the duration of action is less than ten minutes. If monoamine oxidase (MAO) inhibitors are present, however, the duration may increase to one hour. The drug is widely distributed in the body but does not cross the blood-brain barrier to a significant extent. Dopamine is metabolized in the liver, kidney, and plasma by MAO and catechol-O-methyltransferase to the inactive compounds homovanillic acid (HVA) and 3,4-dihydroxyphenylacetic acid. About 25% of the dose is taken up into specialized neurosecretory vesicles (the adrenergic nerve terminals), where it is hydroxylated to form norepinephrine. It has been reported that about 80% of the drug is excreted in the urine within 24 hours, primarily as HVA and its sulfate and glucuronide conjugates and as 3,4-dihydroxyphenylacetic acid. A very small portion is excreted unchanged.

The predominant effects of dopamine are dose-related, although actual response of an individual patient will largely depend on the clinical status of the patient at the time the drug is administered. At low rates of infusion (0.5-2 mcg/kg/min) dopamine causes vasodilation that is presumed to be due to a specific agonist action on dopamine receptors (distinct from alpha- and beta-adrenoceptors) In the renal, mesenteric, coronary, and intracerebral vascular beds. At these dopamine receptors, haloperidol is an antagonist. The vasodilation in these vascular beds is accompanied by increased glomerular filtration rate, renal blood flow, sodium excretion, and urine flow. Hypotension sometimes occurs. An increase in urinary output produced by dopamine is usually not associated with a decrease in osmolarity of the urine.

At intermediate rates of infusion (2-10 mcg/kg/min) dopamine acts to stimulate the beta-adrenoceptors, resulting In improved myocardial contractility, increased SA rate and enhanced impulse conduction in the heart. There is little, if any, stimulation of the beta-adrenoceptors (peripheral vasodilation). Dopamine causes less increase in myocardial oxygen consumption than isoproterenol, and its use is not usually associated with a tachyarrhythmia. Clinical studies indicate that it usually increases systolic and pulse pressure with either no effect or a slight increase in diastolic pressure. Blood flow to the peripheral vascular beds may decrease while mesenteric flow increased due to increased cardiac output. At low and intermediate doses, total peripheral resistance (which would be raised by alpha activity) is usually unchanged.

At higher rates of infusion (10-20 mcg/kg/min) there is some effect on alpha-adrenoceptors, with consequent vasoconstrictor effects and a rise in blood pressure. The vasoconstrictor effects are first seen in the skeletal muscle vascular beds, but with increasing doses they are also evident in the renal and mesenteric vessels. At very high rates of infusion (above 20 mcg/kg/min), stimulation of alpha-adrenoceptors predominates and vasoconstriction may compromise the circulation of the limbs and override the dopaminergic effects of dopamine, reversing renal dilation and natriuresis.

Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

Non-Clinical Toxicology
Dopamine hydrochloride should not be used in patients with pheochromocytoma.

Dopamine hydrochloride should not be administered in the presence of uncorrected tachyarrhythmias or ventricular fibrillation.

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Do not add any alkalinizing substance since dopamine is inactivated in alkaline solution.

Patients who have been treated with monoamine oxidase (MAO) inhibitors prior to the administration of dopamine will require substantially reduced dosage. Seebelow.

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is: seen more frequently in asthmatic than in nonasthmatic people.

Evidence is inadequate for fully defining proper dosage and limitation for use in children. (See )

Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration of erythrocytes.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

Excess administration of potassium-free solutions may result in significant hypokalemia.

Because dosages of this drug are titrated to response (see ), no additives should be mixed with Dopamine Hydrochloride in 5% Dextrose Injection USP.

Cyclopropane or halogenated hydrocarbon anesthetics increase cardiac autonomic irritability and may sensitize the myocardium to the action of certain intravenously administered catecholamines, such as dopamine. This interaction appears to be related both to pressor activity and to the beta adrenergic stimulating properties of these catecholamines, and may produce ventricular arrhythmias. Therefore, EXTREME CAUTION should be exercised when administering dopamine HCI to patients receiving cyclopropane or halogenated hydrocarbon anesthetics. Results of studies in animals indicate that dopamine-induced ventricular arrhythmias during anesthesia can be reversed by propranolol.

Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine. Patients who ave been treated with MAO inhibitors within two to three weeks prior to the administration of dopamine should receive an initial dose of Dopamine HCl no greater than one-tenth (1/10) of the usual dose.

Concurrent administration of low-dose dopamine HCI and diuretic agents may produce an additive or potentiating effect on urine flow.

Tricyclic antidepressants may potentiate the cardiovascular effects of adrenergic agents.

Cardiac effects of dopamine are antagonized by beta-adrenergic blocking agents, such as propranolol and metoprolol. The peripheral vasoconstriction caused by high doses of dopamine HCI is antagonized by alpha-adrenergic blocking agents. Dopamine-induced renal and mesenteric vasodilation is not antagonized by either alpha- or beta-adrenergic blocking agents.

Butyrophenones (such as haloperidol) and phenothiazines can suppress the dopaminergic renal and mesenteric vasodilation induced with low-dose dopamine infusion.

The concomitant use of vasopressors, vasoconstrictor agents (such as ergonovine) and some oxytocic drug may result in severe hypertension.

Administration of phenytoin to patients receiving dopamine HCI has been reported to lead to hypotension and bradycardia. It is suggested that in patients receiving dopamine HCI, alternatives to phenytoin should be considered if anticonvulsant therapy is needed.

Control of the rate of infusion is essential to avoid inadvertent administration of a bolus of the drug (see ).

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid-balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Use only if solution is clear and vacuum is present.

Avoid Hypovolemia

Hypoxia, Hypercapnia, Acidosis

Ventricular Arrhythmias

Decreased Pulse Pressure

Hypotension

Extravasation

Occlusive Vascular Disease

Important – Antidote for Peripheral Ischemia: To prevent sloughing and necrosis in ischemic areas, the area should be infiltrated as soon as possible with 10 to 15 mL of 0.9% Sodium Chloride Injection USP containing 5 to 10 mg of Regitine™ (brand of phentolamine), an adrenergic blocking agent. A syringe with a fine hypodermic needle should be used and the solution liberally infiltrated throughout the ischemic area. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area Is infiltrated within 12 hours. Therefore, phentolamine should be given as soon as possible after the extravasation is noted.

Weaning

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

Cardiovascular System

Respiratory System

Gastrointestinal System

Metabolic/Nutritional System

Central Nervous System

Dermatological System

Other

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

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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).