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ERAXIS

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Overview

What is ERAXIS?

ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of . Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.

ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-dihydroxy-N-[[4"-(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol. In addition to the active ingredient, anidulafungin, ERAXIS for Injection contains the following inactive ingredients:

50 mg/vial

100 mg/vial

The empirical formula of anidulafungin is CHNO and the formula weight is 1140.3.

The structural formula is:

Prior to administration, ERAXIS for Injection requires reconstitution with sterile Water for Injection and subsequent dilution with either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (normal saline).

DO NOT dilute with other solutions or co-infuse with other medications or electrolytes []



What does ERAXIS look like?



What are the available doses of ERAXIS?

Lyophilized powder for injection: 50 mg per vial

Lyophilized powder for injection: 100 mg per vial

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

How should I use ERAXIS?

ERAXIS is indicated for use in adults for the treatment of the following fungal infections listed below. Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Candidemia and other forms of infections: 200 mg loading dose on Day 1, followed by 100 mg daily dose thereafter for at least 14 days after the last positive culture ()

Esophageal candidiasis: 100 mg loading dose on Day 1, followed by 50 mg daily dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms ()

The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions] (, )


What interacts with ERAXIS?

Sorry No Records found


What are the warnings of ERAXIS?

Sorry No Records found


What are the precautions of ERAXIS?

Sorry No Records found


What are the side effects of ERAXIS?

Sorry No records found


What should I look out for while using ERAXIS?

ERAXIS is contraindicated in persons with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins.


What might happen if I take too much ERAXIS?

During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily, ERAXIS was generally well tolerated; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x ULN) [].

Anidulafungin is not dialyzable.

The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other infections (100 mg/day), based on relative body surface area comparisons.


How should I store and handle ERAXIS?

Buspirone HCl Tablets USP are supplied as follows:5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000.10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000.15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F).Dispense in a tight, light-resistant container as defined in USP/NF.Buspirone HCl Tablets USP are supplied as follows:5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000.10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000.15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F).Dispense in a tight, light-resistant container as defined in USP/NF.Buspirone HCl Tablets USP are supplied as follows:5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000.10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000.15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F).Dispense in a tight, light-resistant container as defined in USP/NF.Buspirone HCl Tablets USP are supplied as follows:5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000.10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000.15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F).Dispense in a tight, light-resistant container as defined in USP/NF.Buspirone HCl Tablets USP are supplied as follows:5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000.10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000.15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F).Dispense in a tight, light-resistant container as defined in USP/NF.Buspirone HCl Tablets USP are supplied as follows:5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000.10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000.15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F).Dispense in a tight, light-resistant container as defined in USP/NF.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Anidulafungin is an anti-fungal drug []

Non-Clinical Toxicology
ERAXIS is contraindicated in persons with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins.

Psychotropic Agents





Amitriptyline

Diazepam

Haloperidol

Nefazodone

Trazodone

Triazolam/Flurazepam

Other Psychotropics

Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with ERAXIS. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with ERAXIS, clinically significant hepatic abnormalities have occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to ERAXIS has not been established. Patients who develop abnormal liver function tests during ERAXIS therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing ERAXIS therapy.

The most serious adverse reactions reported with ERAXIS are:

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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

Tips

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Interactions

Interactions

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