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edaravone
Overview
What is RADICAVA?
The active ingredient in RADICAVA is edaravone, which is a member of the substituted 2-pyrazolin-5-one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. The molecular formula is CHNO and the molecular weight is 174.20.
The chemical structure is:
Edaravone is a white crystalline powder with a melting point of 129.7°C. It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether.
RADICAVA injection is a clear, colorless liquid provided as a sterile solution.
RADICAVA injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further overwrapped with polyvinyl alcohol (PVA) secondary packaging. The overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4.
What does RADICAVA look like?
What are the available doses of RADICAVA?
RADICAVA is supplied for intravenous infusion in a single-dose polypropylene bag containing 30 mg of edaravone in 100 mL of clear, colorless aqueous solution.
What should I talk to my health care provider before I take RADICAVA?
How should I use RADICAVA?
RADICAVA is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
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What interacts with RADICAVA?
Sorry No Records found
What are the warnings of RADICAVA?
Sorry No Records found
What are the precautions of RADICAVA?
Sorry No Records found
What are the side effects of RADICAVA?
Sorry No records found
What should I look out for while using RADICAVA?
RADICAVA is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions and anaphylactic reactions have occurred .
What might happen if I take too much RADICAVA?
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How should I store and handle RADICAVA?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10 mg atorvastatin.10 mg tablets Bottles of 30 and 90 tablets.Storage Dispense in a tight container [see USP]. Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10 mg atorvastatin.10 mg tablets Bottles of 30 and 90 tablets.Storage Dispense in a tight container [see USP]. Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10 mg atorvastatin.10 mg tablets Bottles of 30 and 90 tablets.Storage Dispense in a tight container [see USP]. Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10 mg atorvastatin.10 mg tablets Bottles of 30 and 90 tablets.Storage Dispense in a tight container [see USP]. Atorvastatin calcium tablets are supplied as white, oval, biconvex film-coated tablets of atorvastatin calcium containing 10 mg atorvastatin.10 mg tablets Bottles of 30 and 90 tablets.Storage Dispense in a tight container [see USP].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism by which RADICAVA exerts its therapeutic effect in patients with ALS is unknown.
Non-Clinical Toxicology
RADICAVA is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions and anaphylactic reactions have occurred .No significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Rifampin, an inducer of drug metabolism, decreased the concentrations of losartan and its active metabolite. (See .) In humans, two inhibitors of P450 3A4 have been studied. Ketoconazole did not affect the conversion of losartan to the active metabolite after intravenous administration of losartan, and erythromycin had no clinically significant effect after oral administration. Fluconazole, an inhibitor of P450 2C9, decreased active metabolite concentration and increased losartan concentration. The pharmacodynamic consequences of concomitant use of losartan and inhibitors of P450 2C9 have not been examined. Subjects who do not metabolize losartan to active metabolite have been shown to have a specific, rare defect in cytochrome P450 2C9. These data suggest that the conversion of losartan to its active metabolite is mediated primarily by P450 2C9 and not P450 3A4. As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The Veterans Affairs Nephropathy in Diabetes (VANEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or Placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. Closely monitor blood pressure, renal function, and electrolytes in patients on losartan potassium and other agents that affect the RAS. Do not co-administer aliskiren with losartan potassium in patients with diabetes. Avoid use of aliskiren with losartan potassium in patients with renal impairment (GFR <60 mL/min).
Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA, treat per standard of care, and monitor until the condition resolves
The following serious adverse reactions are described elsewhere in the labeling:
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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