Dolasetron

Name: Dolasetron

Dolasetron Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of dolasetron there are no specific foods that you must exclude from your diet when receiving dolasetron.

 

What is dolasetron?

Dolasetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Dolasetron oral (taken by mouth) is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy).

Dolasetron may also be used for purposes not listed in this medication guide.

Proper Use of dolasetron

Take dolasetron only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If your child cannot swallow the tablets, the injection solution can be mixed with apple or apple-grape juice and taken by mouth. The mixture may be stored for up to 2 hours at room temperature before use.

Dosing

The dose of dolasetron will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dolasetron. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For prevention of nausea and vomiting after cancer medicines:
      • Adults—100 milligrams (mg) given within 1 hour before starting cancer treatment.
      • Children 2 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 1.8 milligrams (mg) per kilogram (kg) of body weight given within 1 hour before starting cancer treatment. However, the dose is usually not more than 100 mg.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of dolasetron, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of dolasetron, and you feel nauseated or you vomit, take the missed dose as soon as possible.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

dolasetron Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Chest pain or discomfort
  • lightheadedness, dizziness, or fainting
  • slow or irregular heartbeat
  • unusual tiredness or weakness
Less common
  • Chills
  • decrease in the amount of urine
  • fast, pounding, or irregular heartbeat or pulse
  • fever
Rare
  • Agitation
  • black, tarry stools
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • blurred vision
  • burning while urinating
  • changes in skin color
  • confusion
  • cough
  • delirium
  • depression
  • diarrhea
  • difficult or labored breathing
  • difficult or painful urination
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth
  • feeling uncoordinated
  • frequent urination
  • hallucinations
  • headache
  • hives or welts, itching, or skin rash
  • increased volume of pale, dilute urine
  • irritability
  • lethargy
  • muscle twitching
  • nausea
  • noisy breathing
  • numbness and tingling of the face, fingers, or toes
  • pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
  • pain, tenderness, or swelling of the foot or leg
  • pale skin
  • pale, bluish-colored, or cold hands or feet
  • pinpoint red or purple spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red skin
  • rigid muscles
  • seizures
  • sweating
  • swelling of the face, ankles, or hands
  • tightness in the chest
  • tingling of the hands or feet
  • tremor
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • vomiting
  • weak or absent pulses in the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Belching
  • heartburn
  • indigestion
  • pain
  • stomach discomfort, upset, or pain
Rare
  • Abnormal dreams
  • bad, unusual, or unpleasant (after) taste
  • bloating
  • bloody nose
  • change in taste
  • changes in vision
  • continuing ringing or buzzing or other unexplained noise in the ears
  • darkened urine
  • difficulty having a bowel movement (stool)
  • difficulty seeing at night
  • difficulty with moving
  • feeling of constant movement of self or surroundings
  • feeling of unreality
  • hearing loss
  • increased sensitivity of the eyes to sunlight
  • increased sweating
  • joint pain
  • loss of appetite
  • muscle aching or cramping
  • muscle pain or stiffness
  • pain or burning sensation at the injection site
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • redness of the face, neck, arms, and occasionally, upper chest
  • sensation of spinning
  • sense of detachment from self or body
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • swollen joints
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • weight loss
  • yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Index Terms

  • Dolasetron Mesylate
  • MDL 73,147EF

Brand Names U.S.

  • Anzemet

Pharmacologic Category

  • Antiemetic
  • Selective 5-HT3 Receptor Antagonist

Special Populations Hepatic Function Impairment

The apparent oral clearance of hydrodolasetron decreases 42% (oral) with severe hepatic impairment.

Adverse Reactions

Adverse events may vary according to indication and route of administration.

>10%: Central nervous system: Headache (oral: 18% to 23%; IV: 9%)

1% to 10%:

Cardiovascular: Bradycardia (4% to 5%; may be severe after IV administration), tachycardia (≤3%), edema (<2%), facial edema (<2%), flushing (<2%), hypotension (<2%; may be severe after IV administration), orthostatic hypotension (<2%), peripheral edema (<2%), peripheral ischemia (<2%), phlebitis (<2%), sinus arrhythmia (<2%), thrombophlebitis (<2%)

Central nervous system: Fatigue (oral: 3% to 6%), dizziness (1% to 6%), pain (≤3%), abnormal dreams (<2%), agitation (<2%), anxiety (<2%), ataxia (<2%), chills (≤2%), confusion (<2%), depersonalization (<2%), paresthesia (<2%), shivering (≤2%), sleep disorder (<2%), twitching (<2%), vertigo (<2%)

Dermatologic: Diaphoresis (<2%), skin rash (<2%), urticaria (<2%)

Endocrine & metabolic: Increased gamma-glutamyl transferase (<2%)

Gastrointestinal: Diarrhea (oral: 2% to 5%), dyspepsia (≤3%), abdominal pain (<2%), anorexia (<2%), constipation (<2%), dysgeusia (<2%), pancreatitis (<2%)

Genitourinary: Dysuria (<2%), hematuria (<2%)

Hematologic and oncologic: Anemia (<2%), hematoma (<2%), prolonged prothrombin time (<2%), prolonged partial thromboplastin time (<2%), purpura (<2%), thrombocytopenia (<2%)

Hepatic: Hyperbilirubinemia (<2%), increased serum alkaline phosphatase (<2%)

Hypersensitivity: Anaphylaxis (<2%)

Local: Burning sensation at injection site (IV: <2%), pain at injection site (IV: <2%)

Neuromuscular & skeletal: Arthralgia (<2%), myalgia (<2%), tremor (<2%)

Ophthalmic: Photophobia (<2%), visual disturbance (<2%)

Otic: Tinnitus (<2%)

Renal: Acute renal failure (<2%), polyuria (<2%)

Respiratory: Bronchospasm (<2%), dyspnea (<2%), epistaxis (<2%)

<1% (Limited to important or life-threatening): Abnormal T waves on ECG, appearance of U waves on ECG, atrial fibrillation, atrioventricular block, bundle branch block (left and right), chest pain, extrasystoles (APCs or VPCs), increased serum ALT (transient), increased serum AST (transient), ischemic heart disease, nodal arrhythmia, prolongation P-R interval on ECG (dose-dependent), prolonged Q-T interval on ECG, serotonin syndrome, slow R wave progression, ST segment changes on ECG, supraventricular cardiac arrhythmia, syncope (may be severe after IV administration), torsades de pointes, ventricular arrhythmia (may be serious), ventricular fibrillation cardiac arrest (intravenous), wide complex tachycardia (intravenous), widened QRS complex on ECG (dose-dependent)

For Healthcare Professionals

Applies to dolasetron: intravenous solution, oral tablet

General

The most common side effects include headache, constipation, sleep disorders, and dizziness.[Ref]

Nervous system

Loss of consciousness may occur immediately/closely after an IV bolus in patients receiving treatment for prophylaxis of chemotherapy induced nausea and vomiting.

Headache and dizziness occurred more frequently at higher doses.[Ref]

Very common (10% or more): Headache (up to 41.1%), dizziness (up to 12.5%), drowsiness (up to 10.5%)
Rare (0.01% to 0.1%): Seizure, syncope
Frequency not reported: Taste perversion, vertigo, paresthesia, tremor, ataxia
Postmarketing reports: Loss of consciousness[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 28.6%), dyspepsia (up to 12.8%), diarrhea (up to 11.1%), abdominal pain (up to 10.2%)
Rare (0.01% to 0.1%): Intestinal obstruction, pancreatitis[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (up to 12.8%)
Frequency not reported: Agitation, depersonalization, confusion, anxiety, abnormal dreaming[Ref]

Other

Very common (10% or more): Fatigue (up to 12.2%)
Common (1% to 10%): Pain, fever, chills/shivering
Frequency not reported: Tinnitus
Postmarketing reports: Facial edema[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia (mostly sinus), hypotension, tachycardia (mostly sinus)
Uncommon (0.1% to 1%): Chest pain, orthostatic hypotension, hypertension
Rare (0.01% to 0.1%): Myocardial ischemia, edema
Frequency not reported: T wave change, ST-T wave change, sinus arrhythmia, extrasystole (atrial/ventricular premature contractions), poor R wave progression, left and right bundle branch block, nodal arrhythmias, U wave change, atrial flutter/fibrillation, peripheral edema, Mobitz I AV block, palpitations, peripheral ischemia, thrombophlebitis/phlebitis
Postmarketing reports: Severe hypotension, wide complex tachycardia, ventricular tachycardia, ventricular fibrillation/cardiac arrest, shock[Ref]

Severe hypotension and bradycardia occurred immediately/closely after an IV bolus in patients receiving treatment for prophylaxis of chemotherapy induced nausea and vomiting.

Wide complex tachycardia, ventricular tachycardia, and ventricular fibrillation/cardiac arrest were rarely reported after IV administration.[Ref]

Hepatic

Common (1% to 10%): Increased serum transaminases (AST, ALT)
Rare (0.01% to 0.1%): Jaundice
Frequency not reported: Hyperbilirubinemia, increased GGT[Ref]

Increased serum transaminases occurred more frequently in patients treated during IV chemotherapy/radiotherapy than those treated during postoperative therapy/IV surgery; however, the increases did not appear to be related to dose/duration of therapy, and were not associated with symptomatic hepatic disease.[Ref]

Respiratory

Respiratory side effects have rarely included dyspnea and bronchospasm.[Ref]

Hematologic

Frequency not reported: Prothrombin time prolonged, partial thromboplastin time (PTT) increased, anemia, purpura/hematoma, thrombocytopenia[Ref]

Genitourinary

Frequency not reported: Hematuria, dysuria, urinary retention, polyuria[Ref]

Dermatologic

Frequency not reported: Increased sweating, flushing, rash
Postmarketing reports: Urticaria[Ref]

Musculoskeletal

Frequency not reported: Myalgia, arthralgia, twitching[Ref]

Metabolic

Frequency not reported: Anorexia, increased alkaline phosphatase[Ref]

Ocular

Frequency not reported: Abnormal vision, photophobia[Ref]

Renal

Frequency not reported: Acute renal failure[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic/anaphylactoid reactions, angioedema[Ref]

Local

Postmarketing reports: Local pain/burning (IV formulation)[Ref]

Some side effects of dolasetron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Nausea/Vomiting - Postoperative

2 to 16 years:
-Recommended dose: 0.35 mg/kg IV approximately 15 minutes before the cessation of anesthesia or as soon as nausea and vomiting presents
-Maximum dose: 12.5 mg
-Alternative dose: 1.2 mg/kg (of the IV injection solution) given orally within 2 hours before surgery, up to a maximum dose of 100 mg

Comments:
-The injection solution may be mixed with apple or apple-grape juice and administered orally; the mixed product may be kept up to 2 hours at room temperature before use.
-This drug should be given as a single dose, and may be given as an IV infusion over at least 30 seconds or diluted and infused over 15 minutes.

Uses:
-For the prevention of postoperative nausea and vomiting
-For the treatment of postoperative nausea and/or vomiting

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

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