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AMIFOSTINE

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Overview

What is AMIFOSTINE?

Amifostine for injection is an organic thiophosphate cytoprotective agent known chemically as 2-[(3-aminopropyl) amino] ethanethiol dihydrogen phosphate (ester) and has the following structural formula:

Amifostine is a white crystalline powder, which is freely soluble in water. Its molecular formula is CHNOPS and it has a molecular weight of 214.22. Amifostine for Injection is the trihydrate form of amifostine and is supplied as a sterile powder requiring reconstitution for intravenous infusion. Each single-use 10 mL vial contains 500 mg of amifostine on the anhydrous basis.



What does AMIFOSTINE look like?



What are the available doses of AMIFOSTINE?

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

Sorry No records found

How should I use AMIFOSTINE?

For Reduction of Cumulative Renal Toxicity with Chemotherapy: The recommended starting dose of Amifostine for injection is 910 mg/m administered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy. The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated. Patients should be adequately hydrated prior to Amifostine for injection infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated. The infusion of Amifostine for injection should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below: If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of Amifostine for injection may be administered. If the full dose of Amifostine for injection cannot be administered, the dose of Amifostine for injection for subsequent chemotherapy cycles should be 740 mg/m. It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HT receptor antagonist, be administered prior to and in conjunction with Amifostine for injection. Additional antiemetics may be required based on the chemotherapy drugs administered. ReconstitutionAmifostine for Injection is supplied as a sterile powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of amifostine on the anhydrous basis. Prior to intravenous injection, Amifostine for injection is reconstituted with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution (500 mg amifostine/10 mL) is chemically stable for up to 5 hours at room temperature (approximately 25°C) or up to 24 hours under refrigeration (2°C to 8°C). Amifostine for injection prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL is chemically stable for up to 5 hours when stored at room temperature (approximately 25°C) or up to 24 hours when stored under refrigeration (2°C to 8°C). CAUTION: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed. IncompatibilitiesThe compatibility of Amifostine for injection with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.


What interacts with AMIFOSTINE?

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What are the warnings of AMIFOSTINE?

Array


What are the precautions of AMIFOSTINE?

General

Drug Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Nursing Mothers

Pediatric Use

Geriatric Use


What are the side effects of AMIFOSTINE?

Sorry No records found


What should I look out for while using AMIFOSTINE?

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What might happen if I take too much AMIFOSTINE?

In clinical trials, the maximum single dose of Amifostine was 1300 mg/m. No information is available on single doses higher than this in adults. In the setting of a clinical trial, pediatric patients have received single Amifostine doses of up to 2700 mg/m. At the higher doses, anxiety and reversible urinary retention occurred. Administration of Amifostine at 2 and 4 hours after the initial dose has not led to increased nausea and vomiting or hypotension. The most likely symptom of overdosage is hypotension, which should be managed by infusion of normal saline and other supportive measures, as clinically indicated.


How should I store and handle AMIFOSTINE?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Amifostine for Injection USP is supplied as a sterile powder in 10 mL single-use vials (NDC 62756-581-40). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:1 pack - 1 vial per carton (NDC 62756-581-40).3 pack - 3 vials per carton (NDC 62756-581-42).Store the powder dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].Distributed by: 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Acme Plaza, Andheri-Kurla Road,Andheri (East), Mumbai -400 059, India. PJPI0131AISS. 11/2009 Amifostine for Injection USP is supplied as a sterile powder in 10 mL single-use vials (NDC 62756-581-40). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:1 pack - 1 vial per carton (NDC 62756-581-40).3 pack - 3 vials per carton (NDC 62756-581-42).Store the powder dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].Distributed by: 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Acme Plaza, Andheri-Kurla Road,Andheri (East), Mumbai -400 059, India. PJPI0131AISS. 11/2009 Amifostine for Injection USP is supplied as a sterile powder in 10 mL single-use vials (NDC 62756-581-40). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:1 pack - 1 vial per carton (NDC 62756-581-40).3 pack - 3 vials per carton (NDC 62756-581-42).Store the powder dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].Distributed by: 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Acme Plaza, Andheri-Kurla Road,Andheri (East), Mumbai -400 059, India. PJPI0131AISS. 11/2009 Amifostine for Injection USP is supplied as a sterile powder in 10 mL single-use vials (NDC 62756-581-40). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:1 pack - 1 vial per carton (NDC 62756-581-40).3 pack - 3 vials per carton (NDC 62756-581-42).Store the powder dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].Distributed by: 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Acme Plaza, Andheri-Kurla Road,Andheri (East), Mumbai -400 059, India. PJPI0131AISS. 11/2009 Amifostine for Injection USP is supplied as a sterile powder in 10 mL single-use vials (NDC 62756-581-40). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:1 pack - 1 vial per carton (NDC 62756-581-40).3 pack - 3 vials per carton (NDC 62756-581-42).Store the powder dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].Distributed by: 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Acme Plaza, Andheri-Kurla Road,Andheri (East), Mumbai -400 059, India. PJPI0131AISS. 11/2009


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Clinical pharmacokinetic studies show that Amifostine is rapidly cleared from the plasma with a distribution half-life of <1 minute and an elimination half-life of approximately 8 minutes. Less than 10% of Amifostine remains in the plasma 6 minutes after drug administration. Amifostine is rapidly metabolized to an active free thiol metabolite. A disulfide metabolite is produced subsequently and is less active than the free thiol. After a 10-second bolus dose of 150 mg/m of Amifostine, renal excretion of the parent drug and its two metabolites was low during the hour following drug administration, averaging 0.69%, 2.64% and 2.22% of the administered dose for the parent, thiol and disulfide, respectively. Measurable levels of the free thiol metabolite have been found in bone marrow cells 5 to 8 minutes after intravenous infusion of Amifostine. Pretreatment with dexamethasone or metoclopramide has no effect on Amifostine pharmacokinetics.

Non-Clinical Toxicology
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S

Controlled Trials

Clinical Trials and Pharmacovigilance Reports

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TABLE 4

WARNINGS

PRECAUTIONS

WARNINGS

PRECAUTIONS

TABLE 4 Incidence of Common Adverse Events in Patients Receiving Amifostine

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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).