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| {{DrugProjectFormSinglePage
| | #REDIRECT[[Dolasetron]] |
| |authorTag={{KS}}
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| |aOrAn=a
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| |indicationType=treatment
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| |adverseReactions=<!--Black Box Warning-->
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| |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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| * Content
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| <!--Adult Indications and Dosage-->
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| <!--FDA-Labeled Indications and Dosage (Adult)-->
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| |fdaLIADAdult===Indications==
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| ANZEMET Tablets are indicated for the prevention of [[nausea]] and [[vomiting]] associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older.
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| ==Dosage==
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| The recommended doses of ANZEMET Tablets should not be exceeded.
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| '''Adults'''
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| * The recommended oral dosage of ANZEMET (dolasetron mesylate) is 100 mg given within one hour before chemotherapy.
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| '''Use in the Elderly, Renal Failure Patients, or Hepatically Impaired Patients'''
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| * No dosage adjustment is recommended, however; ECG monitoring is recommended for elderly and renally impaired patients.
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| |offLabelAdultGuideSupport======Condition1=====
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| * Developed by:
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| * Class of Recommendation:
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| * Strength of Evidence:
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| * Dosing Information
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| :* Dosage
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| =====Condition2=====
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| There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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| <!--Non–Guideline-Supported Use (Adult)-->
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| |offLabelAdultNoGuideSupport======Condition1=====
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| * Dosing Information
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| :* Dosage
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| =====Condition2=====
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| There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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| <!--Pediatric Indications and Dosage-->
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| <!--FDA-Labeled Indications and Dosage (Pediatric)-->
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| |fdaLIADPed======Condition1=====
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| * Dosing Information
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| :* Dosage
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| =====Condition2=====
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| There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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| <!--Off-Label Use and Dosage (Pediatric)-->
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| <!--Guideline-Supported Use (Pediatric)-->
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| |offLabelPedGuideSupport======Condition1=====
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| * Developed by:
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| * Class of Recommendation:
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| * Strength of Evidence:
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| * Dosing Information
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| :* Dosage
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| =====Condition2=====
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| There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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| <!--Non–Guideline-Supported Use (Pediatric)-->
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| |offLabelPedNoGuideSupport======Condition1=====
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| * Dosing Information
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| :* Dosage
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| =====Condition2=====
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| There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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| <!--Contraindications-->
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| |contraindications=* Condition1
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| <!--Warnings-->
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| |warnings=* Description
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| ====Precautions====
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| * Description
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| <!--Adverse Reactions-->
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| <!--Clinical Trials Experience-->
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| |clinicalTrials=* In controlled clinical trials, 943 adult cancer patients received ANZEMET Tablets. These patients were receiving concurrent chemotherapy, predominantly cyclophosphamide and doxorubicin regimens. The following adverse events were reported in ≥2% of patients receiving either ANZEMET 25 mg or ANZEMET 100 mg tablets for prevention of cancer chemotherapy induced nausea and vomiting in controlled clinical trials (Table 3).
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| [[File:Dolasetron table3.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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| * In clinical trials, the following reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of ANZEMET in < 2% of adult patients receiving concomitant cancer chemotherapy:
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| '''Cardiovascular''':
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| * [[Hypotension]]; [[edema]], [[peripheral edema]]. The following events also occurred and with a similar frequency as placebo and/or active comparator: Mobitz I AV block, [[chest pain]], orthostatic hypotension, [[myocardial ischemia]], [[syncope]], severe [[bradycardia]], and palpitations.
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| * In addition, the following asymptomatic treatment-emergent ECG changes were seen at rates less than or equal to those for active or placebo controls: bradycardia, T wave change, ST-T wave change, sinus arrhythmia, extrasystole (APCs or VPCs), poor R-wave progression, bundle branch block (left and right), nodal arrhythmia, U wave change, atrial flutter/fibrillation.
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| * Furthermore, severe [[hypotension]], [[bradycardia]] and [[syncope]] have been reported immediately or closely following IV administration.
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| '''Dermatologic''': [[Rash]], increased sweating.
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| '''Gastrointestinal System''': [[Constipation]], [[dyspepsia]], [[abdominal pain]], [[anorexia]]; [[pancreatitis]].
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| '''Hearing, Taste and Vision''': Taste perversion, abnormal vision, [[tinnitus]], [[photophobia]].
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| '''Hematologic''': [[Hematuria]], [[epistaxis]], prothrombin time prolonged, PTT increased, [[anemia]], [[purpura]]/hematoma, [[thrombocytopenia]].
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| '''Hypersensitivity''': [[Anaphylactic reaction]], facial [[edema]], [[urticaria]].
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| '''Liver and Biliary System''': Transient increases in AST (SGOT) and/or ALT (SGPT) values have been reported as adverse events in less than 1% of adult patients receiving ANZEMET in clinical trials. The increases did not appear to be related to dose or duration of therapy and were not associated with symptomatic hepatic disease. Similar increases were seen with patients receiving active comparator. [[Hyperbilirubinemia]], increased GGT.
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| '''Metabolic and Nutritional''': Alkaline phosphatase increased.
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| '''Musculoskeletal''': [[Myalgia]], [[arthralgia]].
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| '''Nervous System: Flushing''', [[vertigo]], [[paresthesia]], [[tremor]]; [[ataxia]], twitching.
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| '''Psychiatric''': Agitation, sleep disorder, depersonalization; confusion, [[anxiety]], abnormal dreaming.
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| '''Respiratory System''': [[Dyspnea]], bronchospasm.
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| Urinary System: Dysuria, polyuria, acute renal failure.
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| Vascular (Extracardiac): Local pain or burning on IV administration; peripheral ischemia, thrombophlebitis/phlebitis.
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| |postmarketing=* There are reports of wide complex [[tachycardia]] or [[ventricular tachycardia]] and of [[ventricular fibrillation]] cardiac arrest following intravenous administration
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| |drugInteractions=* Drug
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| :* Description
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| <!--Use in Specific Populations-->
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| |useInPregnancyFDA=* '''Pregnancy Category'''
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| |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
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| |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
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| |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
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| |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
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| |useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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| |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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| |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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| |useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
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| |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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| |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
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| |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
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| <!--Administration and Monitoring-->
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| |administration=* Oral
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| * Intravenous
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| |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
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| * Description
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| <!--IV Compatibility-->
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| |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
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| <!--Overdosage-->
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| |overdose=* There is no known specific antidote for dolasetron mesylate, and patients with suspected overdose should be managed with supportive therapy. Individual doses as large as 5 mg/kg intravenously or 400 mg orally have been safely given to healthy volunteers or cancer patients.
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| * Following a suspected overdose of ANZEMET Injection, a patient found to have second-degree or higher AV conduction block with ECG should undergo cardiac telemetry monitoring.
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| * It is not known if dolasetron mesylate is removed by hemodialysis or peritoneal dialysis.
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| * Single intravenous doses of dolasetron mesylate at 160 mg/kg in male mice and 140 mg/kg in female mice and rats of both sexes (6.3 to 12.6 times the recommended human dose based on body surface area) were lethal. Symptoms of acute toxicity were tremors, depression and convulsions.
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| * A 59-year-old man with metastatic melanoma and no known pre-existing cardiac conditions developed severe hypotension and dizziness 40 minutes after receiving a 15 minute intravenous infusion of 1000 mg (13 mg/kg) of dolasetron mesylate. Treatment for the overdose consisted of infusion of 500 mL of a plasma expander, dopamine, and atropine. The patient had normal sinus rhythm and prolongation of PR, QRS and QTc intervals on an ECG recorded 2 hours after the infusion. The patient's blood pressure was normal 3 hours after the event and the ECG intervals returned to baseline on follow-up. The patient was released from the hospital 6 hours after the event.
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| |drugBox=<!--Mechanism of Action-->
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| |mechAction=*
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| <!--Structure-->
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| |structure=*
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| : [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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| <!--Pharmacodynamics-->
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| |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacokinetics-->
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| |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
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| <!--Nonclinical Toxicology-->
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| |nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
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| <!--Clinical Studies-->
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| |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
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| <!--How Supplied-->
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| |howSupplied=* [[File:Dolasetron supply.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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| |storage=* Store at controlled room temperature 20–25°C (68–77°F). Protect from light.
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| |packLabel=<!--Patient Counseling Information-->
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| |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
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| <!--Precautions with Alcohol-->
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| |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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| <!--Brand Names-->
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| |brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
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| <!--Look-Alike Drug Names-->
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| |lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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| <!--Drug Shortage Status-->
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| |drugShortage=
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| }}
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| {{PillImage
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| |fileName=No image.jpg
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| }}
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| <!--Pill Image-->
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| <!--Label Display Image-->
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| <!--Category-->
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| [[Category:Drug]]
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