Anzemet Tablets

DRUG DESCRIPTION

ANZEMET (dolasetron mesylate) is an antinauseant and antiemetic agent. Chemically, dolasetron mesylate is (2?,6?,8?,9a?)-octahydro-3-oxo-2,6-methano-2H-quinolizin-8-yl-1Hindole-3-carboxylate monomethanesulfonate, monohydrate. It is a highly specific and selective serotonin subtype 3 (5-HT3) receptor antagonist both in vitro and in vivo. Dolasetron mesylate has the following structural formula:

ANZEMET® (dolasetron mesylate) Structural Formula Illustration

The empirical formula is C19H20N2O3•CH3SO3H•H2O, with a molecular weight of 438.50. Approximately 74% of dolasetron mesylate monohydrate is dolasetron base.

Dolasetron mesylate monohydrate is a white to off-white powder that is freely soluble in water and propylene glycol, slightly soluble in ethanol, and slightly soluble in normal saline.

Each ANZEMET Tablet for oral administration contains dolasetron mesylate (as the monohydrate) and also contains the inactive ingredients: carnauba wax, croscarmellose sodium, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, synthetic red iron oxide, titanium dioxide, and white wax. The tablets are printed with black ink, which contains lecithin, pharmaceutical glaze, propylene glycol, and synthetic black iron oxide.

What are the possible side effects of dolasetron (Anzemet)?

If you experience any of the following uncommon but serious side effects, stop taking dolasetron and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • irregular heartbeats; or
  • muscle cramps or uncontrollable movements.

Other, less serious side effects may be more likely to occur. Continue to take dolasetron and talk to your doctor if you experience

    ...

Read All Potential Side Effects and See Pictures of Anzemet Tablets »

What are the precautions when taking dolasetron (Anzemet Tablets)?

Before taking dolasetron, tell your doctor or pharmacist if you are allergic to it; or to other 5-HT3 blockers (e.g., granisetron, ondansetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat), stomach/intestinal problems (e.g., recent surgery, ileus, swelling), kidney disease.

Dolasetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting)...

Read All Potential Precautions of Anzemet Tablets »


Anzemet Tablets Consumer (continued)

SIDE EFFECTS: Headache, constipation, tiredness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach/abdominal pain, change in amount of urine, vision changes.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting, slow/fast/irregular heartbeat.

A very serious allergic reaction to this drug is unlikely, but stop taking this medication and seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking dolasetron, tell your doctor or pharmacist if you are allergic to it; or to other 5-HT3 blockers (e.g., granisetron, ondansetron); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat), stomach/intestinal problems (e.g., recent surgery, ileus, swelling), kidney disease.

Dolasetron may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using dolasetron, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dolasetron safely.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and light-headedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in children with heart problems because they may be more sensitive to the heart effects (e.g., irregular heartbeat) of the drug.

Older adults may be at greater risk for heart effects (e.g., irregular heartbeat) while using this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Anzemet Tablets Patient Information Including Side Effects

Brand Names: Anzemet

Generic Name: dolasetron (Pronunciation: doe LAH seh tron)

  • What is dolasetron (Anzemet Tablets)?
  • What are the possible side effects of dolasetron (Anzemet Tablets)?
  • What is the most important information I should know about dolasetron (Anzemet Tablets)?
  • Who should not take dolasetron (Anzemet Tablets)?
  • How should I take dolasetron (Anzemet Tablets)?
  • What happens if I miss a dose (Anzemet Tablets)?
  • What happens if I overdose (Anzemet Tablets)?
  • What should I avoid while taking dolasetron (Anzemet Tablets)?
  • What other drugs will affect dolasetron (Anzemet Tablets)?
  • Where can I get more information?

What is dolasetron (Anzemet Tablets)?

Dolasetron blocks the actions of chemicals in the body that may cause nausea and vomiting.

Dolasetron is used to prevent nausea and vomiting associated with cancer chemotherapy or surgery.

Dolasetron may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dolasetron (Anzemet Tablets)?

If you experience any of the following uncommon but serious side effects, stop taking dolasetron and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • irregular heartbeats; or
  • muscle cramps or uncontrollable movements.

Other, less serious side effects may be more likely to occur. Continue to take dolasetron and talk to your doctor if you experience

  • headache;
  • fatigue, drowsiness, or dizziness; or
  • diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dolasetron (Anzemet Tablets)?

Do not take dolasetron without first talking to your doctor if you have heart problems or if you take other medicines. Dolasetron can affect the way that your heart beats, which can be dangerous.

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