Anzemet and night sweats

Anzemet has a tendency to cause sweating, flushing  and many other side effects that make it difficult to get a good nights sleep. Here you will find the warnings, precautions, and side effects attributed to this drug. If you are interested in this medication, this site should help you.

Prescribing Information as of October 2003

DESCRIPTION

ANZEMET (dolasetron mesylate) is an antinauseant and antiemetic agent. Chemically, dolasetron mesylate is (2(alpha),6(alpha),8(alpha),9a(beta))-octahydro-3-oxo-2,6-methano-2 H -quinolizin-8-yl-l H -indole-3-carboxylate monomethanesulfonate, mono-hydrate. It is a highly specific and selective serotonin subtype 3 (5-HT ₃ ) receptor antagonist both in vitro and in vivo. Dolasetron mesylate has the following structural formula:

WARNINGS

ANZEMET can cause ECG interval changes (PR, QT _C , JT prolongation and QRS widening). These changes are related in magnitude and frequency to blood levels of the active metabolite. These changes are self-limiting with declining blood levels. Some patients have interval prolongations for 24 hours or longer. Interval prolongation could lead to cardiovascular consequences, including heart block or cardiac arrhythmias. These have rarely been reported.

A cardiac conduction abnormality observed on an intra-operative cardiac rhythm monitor (interpreted as complete heart block) was reported in a 61-year-old woman who received 200 mg ANZEMET for the prevention of postoperative nausea and vomiting. This patient was also taking verapamil. A similar event also interpreted as complete heart block was reported in one patient receiving placebo.

A 66-year-old man with Stage IV non-Hodgkins lymphoma died suddenly 6 hours after receiving 1.8 mg/kg (119 mg) intravenous ANZEMET Injection. This patient had other potential risk factors including substantial exposure to doxorubicin and concomitant cyclophosphamide.

PRECAUTIONS

General

Dolasetron should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals, particularly QT _c . These include patients with hypokalemia or hypomagnesemia, patients taking diuretics with potential for inducing electrolyte abnormalities, patients with congenital QT syndrome, patients taking anti-arrhythmic drugs or other drugs which lead to QT prolongation, and cumulative high dose anthracycline therapy.

Cross hypersensitivity reactions have been reported in patients who received other selective 5-HT ₃ receptor antagonists. These reactions have not been seen with dolasetron mesylate.

ADVERSE REACTIONS

Chemotherapy Patients

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 4).

Postoperative Patients

In controlled clinical trials, 936 adult female patients have received oral ANZEMET for the prevention of postoperative nausea and vomiting. Following is a listing of all adverse events reported in >/=2% of patients receiving either placebo or ANZEMET for prevention of postoperative nausea and vomiting in controlled clinical trials (Table 5).

In clinical trials, the following infrequently reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of ANZEMET to adult patients receiving concomitant cancer chemotherapy or surgery:

Cardiovascular: Hypotension; rarely-edema, peripheral edema. The following events also occurred rarely 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. See PRECAUTIONS section for information on potential effects on ECG.

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.

Furthermore, severe hypotension, bradycardia and syncope have been reported immediately or closely following IV administration.

Dermatologic: Rash, increased sweating.

Gastrointestinal System: Constipation, dyspepsia, abdominal pain, anorexia; rarely—pancreatitis.

Hearing, Taste and Vision: Taste perversion, abnormal vision; rarely—tinnitus, photophobia.

Hematologic: Rarely—hematuria, epistaxis, prothrombin time prolonged, PTT increased, anemia, purpura/hematoma, thrombocytopenia.

Hypersensitivity: Rarely—anaphylactic reaction, facial edema, urticaria.

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. Rarely—hyperbilirubinemia, increased GGT.

Metabolic and Nutritional: Rarely—alkaline phosphatase increased.

Musculoskeletal: Rarely—myalgia, arthralgia.

Nervous System: Flushing, vertigo, paresthesia, tremor; rarely—ataxia, twitching.

Psychiatric: Agitation, sleep disorder, depersonalization; rarely—confusion, anxiety, abnormal dreaming.

Respiratory System: Rarely—dyspnea, bronchospasm.

Urinary System: Rarely—dysuria, polyuria, acute renal failure.

Vascular (Extracardiac): Local pain or burning on IV administration; rarely—peripheral ischemia, thrombophlebitis/phlebitis.