Geodon

DRUG DESCRIPTION

GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:

GEODON (ziprasidone HCl) Structural Formula Illustration

GEODON (ziprasidone) Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate. The empirical formula is C21H21ClN4OS HCl H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder.

GEODON (ziprasidone) Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON Capsules contain ziprasidone hydrochloride monohydrate, lactose, pregelatinized starch, and magnesium stearate.

GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C21H21ClN4OS CH3SO3H 3H2O and its molecular weight is 563.09.

GEODON (ziprasidone) for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [See DOSAGE AND ADMINISTRATION]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether ?-cyclodextrin sodium (SBECD).

What are the possible side effects of ziprasidone (Geodon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ziprasidone and call your doctor at once if you have any of these serious side effects:

  • dizziness, feeling light-headed, fainting, fast or pounding heartbeat;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your...

Read All Potential Side Effects and See Pictures of Geodon

What are the precautions when taking ziprasidone (Geodon)?

Before taking ziprasidone, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., recent heart attack, untreated heart failure).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: Alzheimer's disease, heart problems (e.g., coronary artery disease, irregular heartbeat, low blood pressure), severe dizziness/fainting, diabetes (including family history), liver disease,...

Read All Potential Precautions of Geodon


Geodon Consumer (continued)

SIDE EFFECTS: Dizziness, drowsiness, weakness, nausea, vomiting, runny nose, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist 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: severe/persistent dizziness, mental/mood changes (e.g., agitation, anxiety, depression, suicidal thoughts), feelings of restlessness, mask-like facial expression (pseudoparkinsonism), shakiness (tremors), muscle spasm/stiffness, numbness/tingling, trouble swallowing, vision problems, difficulty walking, signs of infection (such as fever, persistent sore throat).

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

This drug may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs).

This medication may rarely cause a very serious condition called serotonin syndrome. The risk may increase when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, paroxetine) and SNRIs (e.g., duloxetine, venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

Medications used for a similar purpose to ziprasidone may infrequently cause a serious (rarely fatal) nervous system disorder called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you notice any of the following rare but very serious side effects: confusion, fever, fast heartbeat, muscle stiffness, increased sweating.

In rare instances, this medication may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missing/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop these symptoms, tell your doctor immediately.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may 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 ziprasidone, tell your doctor or pharmacist if you are allergic to it; 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., recent heart attack, untreated heart failure).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: Alzheimer's disease, heart problems (e.g., coronary artery disease, irregular heartbeat, low blood pressure), severe dizziness/fainting, diabetes (including family history), liver disease, nervous system problems (e.g., stroke, seizures, NMS), obesity, swallowing problems, aspiration pneumonia, low white blood cell count.

Ziprasidone 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 ziprasidone, 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 ziprasidone 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. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst or urination. If you already have diabetes, be sure to check your blood sugar regularly.

This drug may rarely cause weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, (especially if you have diabetes), may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

This medication can make you prone to heat stroke. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using a hot tub).

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially involuntary movements and dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

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


Geodon Patient Information Including Side Effects

Brand Names: Geodon

Generic Name: ziprasidone (Pronunciation: zi PRAY si done)

  • What is ziprasidone (Geodon)?
  • What are the possible side effects of ziprasidone (Geodon)?
  • What is the most important information I should know about ziprasidone (Geodon)?
  • What should I discuss with my healthcare provider before taking ziprasidone (Geodon)?
  • How should I take ziprasidone (Geodon)?
  • What happens if I miss a dose (Geodon)?
  • What happens if I overdose (Geodon)?
  • What should I avoid while taking ziprasidone (Geodon)?
  • What other drugs will affect ziprasidone (Geodon)?
  • Where can I get more information?

What is ziprasidone (Geodon)?

Ziprasidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Ziprasidone is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

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

What are the possible side effects of ziprasidone (Geodon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ziprasidone and call your doctor at once if you have any of these serious side effects:

  • dizziness, feeling light-headed, fainting, fast or pounding heartbeat;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • tremor (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;
  • agitation, hostility, confusion;
  • increased thirst or urination, weakness, extreme hunger; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild skin rash;
  • anxiety, headache, depressed mood;
  • dizziness, drowsiness;
  • muscle pain or twitching;
  • nausea, vomiting, loss of appetite;
  • runny or stuffy nose, cough, sore throat; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ziprasidone (Geodon)?

Ziprasidone is not for use in psychotic conditions related to dementia. Ziprasidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not use this medication if you have a personal or family history of "Long QT syndrome," if you have recently had a heart attack, or if you have uncontrolled heart failure.

Stop taking ziprasidone and call your doctor right away if you feel dizzy or light-headed, have a fast or pounding heartbeat, or if you faint. This could be signs of a serious heart rhythm problem.

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with ziprasidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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