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US Brand Names

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Description

Ziprasidone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia and mania or bipolar disorder. This medicine should NOT be used to treat behavioral problems in older adult patients who have dementia .

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Capsule

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Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ziprasidone in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ziprasidone in the elderly. However, this medicine should not be used for behavioral problems in older adults with dementia

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acecainide
• Ajmaline
• Amiodarone
• Amisulpride
• Aprindine
• Arsenic Trioxide
• Astemizole
• Azimilide
• Bepridil
• Bretylium
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cisapride
• Clarithromycin
• Disopyramide
• Dofetilide
• Dolasetron
• Droperidol
• Enflurane
• Erythromycin
• Flecainide
• Fluconazole
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Halofantrine
• Haloperidol
• Halothane
• Hydroquinidine
• Ibutilide
• Isoflurane
• Isradipine
• Levomethadyl
• Lidoflazine
• Lorcainide
• Mefloquine
• Mesoridazine
• Methadone
• Moxifloxacin
• Octreotide
• Pentamidine
• Pimozide
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Quinidine
• Ranolazine
• Sematilide
• Sertindole
• Sotalol
• Sparfloxacin
• Spiramycin
• Sultopride
• Tacrolimus
• Tedisamil
• Telithromycin
• Terfenadine
• Thioridazine
• Trifluoperazine
• Vasopressin
• Zolmitriptan
• Zotepine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer, prolactin-dependent or
• Diabetes mellitus (sugar diabetes) or
• High level of sugar in the blood or
• Hyperprolactinemia (high prolactin in the blood)—Use with caution. Ziprasidone may make these conditions worse .

• Heart attack (recent) or
• Heart disease or
• Heart failure or
• Irregular heartbeat—Should not be used in patients with these conditions .

• Low level of magnesium in your blood or
• Low level of potassium in your blood—These may increase the chance for heart problems.

• Neuroleptic Malignant Syndrome (NMS) or
• Tardive Dyskinesia—May appear or worsen with ziprasidone therapy.

• Seizures or
• Alzheimer's disease—Increased risk of seizures and aspiration pneumonia.

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Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more or less of it and do not take it more or less often than your doctor ordered .

Swallow the capsules whole. Do not split, crush, or chew it .

Dosing

The dose of this medicine 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 this medicine. 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 (capsules):
  • For treating bipolar disorder:
    • Adults— At first, 40 milligrams (mg) twice a day with food. The dose will be increased to either 60 or 80 mg on the second day. Your doctor may increase your dose if needed. However, the dose is usually not more than 80 mg twice a day.
    • Children—Use and dose must be determined by your doctor .
  • For treating schizophrenia:
    • Adults—At first, 20 mg twice a day with food. Your doctor may increase your dose if needed. However, the dose is usually not more than 80 mg twice a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

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.

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Precautions

It is very important that your doctor check you at regular visits to make sure your medicine is working for you. Your doctor will check your blood to make sure your potassium is normal.

Make sure your doctor knows if you are using sparfloxacin (Zagam®), gatifloxacin (Tequin®), moxifloxacin (Avelox®), mesoridazine (Serentil®), thioridazine (Mellaril®), chlorpromazine (Thorazine®), droperidol (Inapsine®), pimozide (Orap®), halofantrine (Halfan®), mefloquine (Lariam®), pentamidine (Nebupent®), arsenic trioxide (Trisenox®), levomethadyl acetate (Orlaam®), dolasetron mesylate (Anzemet®), probucol (Lorelco®), tacrolimus (Prograf®), or certain medicines for heart rhythm problems (e.g., quinidine [Cardioquin®, Quinaglute®], disopyramide [Norpace®], procainamide [Procanbid®], amiodarone [Cordarone®], dofetilide [Tikosyn®], or sotalol [Betapace®]). Using any of these medicines together with ziprasidone may cause serious side effects .

Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS) .

This medicine may cause a condition called tardive dyskinesia, which is a movement disorder. Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs while you are using this medicine .

This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor .

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. Avoid use of alcohol.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor .

Avoid activities involving high temperature or humidity. This medicine may reduce your body's ability to adjust to the heat.

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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:

• Cough
• Difficulty in speaking
• Drooling
• Fear or nervousness
• Fever
• Inability to sit still
• Loss of balance control
• Muscle trembling, jerking, or stiffness
• Need to keep moving
• Restlessness
• Shuffling walk
• Sneezing
• Sore throat
• Stiffness of limbs
• Twisting movements of the body
• Uncontrolled movements, especially of the face, neck, and back

• Blurred vision
• Body aches or pain
• Chest pain
• Congestion
• Dizziness
• Edema of tongue
• Fast, pounding, or irregular heartbeat or pulse
• Headache
• Hoarseness
• Nervousness
• Palpitations
• Pounding in the ears
• Runny nose
• Slow or fast heartbeat
• Tender, swollen glands in neck
• Trouble in swallowing
• Voice changes

• Fainting or feeling faint
• Feeling faint upon standing
• Persistent, painful erection
• Seizures

• Inability to move eyes
• Increased blinking or spasms of eyelid
• Sticking out of tongue
• Trouble in breathing, speaking, or swallowing
• Uncontrolled twisting movements of the neck, trunk, arms, or legs
• Unusual facial expressions

Get emergency help immediately if any of the following symptoms of overdose occur:

• Drowsiness
• Shakiness in legs, arms, hands, or feet
• Sleepiness
• Slurred speech
• Trembling or shaking of hands or feet

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:

• Acid or sour stomach
• Belching
• Constipation
• Diarrhea
• Heartburn
• Indigestion
• Lack or loss of strength
• Nausea
• Rash
• Stomach discomfort, upset, or pain
• Weakness
• Weight gain

• Blistering, crusting, irritation, itching, or reddening of skin
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Change in vision
• Cracked, dry, scaly skin
• Depression
• Difficulty in moving
• Dry mouth
• Increase in salivation
• Itching or reddening of skin
• Joint pain
• Loss of appetite
• Muscle ache
• Muscle pains or stiffness
• Muscle tightness
• Stuffy nose
• Swelling
• Swollen joints
• Vomiting
• Weakness of arms and legs
• Weight loss

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

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