Zeldox
(ziprasidone)
DIN (Drug Identification Number)
02298597
ZELDOX 20 MG CAPSULE
02298600 ZELDOX 40 MG CAPSULE
02298619 ZELDOX 60 MG CAPSULE
02298627 ZELDOX 80 MG CAPSULE
How does this
medication work? What will it do for me?
Ziprasidone belongs to the class
of medications called antipsychotics. It is used to control
the symptoms of schizophrenia and the manic phase of bipolar disorder. It
works by adjusting the balance of chemicals in the brain that are involved in
schizophrenia.
This medication may be available
under multiple brand names and/or in several different forms. Any specific brand name of
this medication may not be available in all of the forms or approved for all of
the conditions discussed here. As well, some forms of this medication may not
be used for all of the conditions discussed here.
Your doctor may have suggested
this medication for conditions other than those listed in these drug
information articles. If you have not discussed this with your doctor or are not sure
why you are taking this medication, speak to your doctor. Do not stop
taking this medication without consulting your doctor.
Do not give this medication to anyone
else, even if they have the same symptoms as you do. It can be harmful for people
to take this medication if their doctor has not prescribed it.
What form(s) does this medication
come in?
20 mg
Each size No. 4 blue or white opaque hard gelatin capsule, imprinted in black
with "Pfizer" and "ZDX 20", contains ziprasidone
hydrochloride, monohydrate equivalent to 20 mg of ziprasidone. Nonmedicinal
ingredients: lactose monohydrate, pregelatinized starch, and magnesium
stearate.
40 mg
Each size No. 4 blue or blue-opaque hard gelatin capsule, imprinted in black
with "Pfizer" and "ZDX 40", contains ziprasidone
hydrochloride, monohydrate equivalent to 40 mg of ziprasidone. Nonmedicinal
ingredients: lactose monohydrate, pregelatinized starch, and magnesium
stearate.
60 mg
Each size No. 3 white or white-opaque hard gelatin capsule, imprinted in black
with "Pfizer" and "ZDX 60", contains ziprasidone
hydrochloride, monohydrate equivalent to 60 mg of ziprasidone. Nonmedicinal
ingredients: lactose monohydrate, pregelatinized starch, and magnesium
stearate.
80 mg
Each size No. 2 blue or white-opaque hard
gelatin capsule, imprinted in black with "Pfizer" and "ZDX
80", contains ziprasidone hydrochloride, monohydrate equivalent to 80 mg
of ziprasidone. Nonmedicinal ingredients: lactose monohydrate,
pregelatinized starch, and magnesium stearate.
How should I use this medication?
For the treatment of
schizophrenia, the
usual adult starting dose of ziprasidone is 40 mg twice daily, although a lower
dose may be used. The dose can be increased gradually every 2 days up to 80 mg
twice daily, as recommended by the doctor.
For the treatment of the manic
phase of bipolar disorder, the recommended adult starting dose is 40 mg twice daily for 1
day, then increased to 60 mg or 80 mg twice daily.
For maintenance treatment, your
doctor will recommend an appropriate dose for you.
The capsules should be swallowed
whole with a glass of water. Take this medication with food at the same time
every day.
Many things can affect the dose of
a medication that a person needs, such as body weight, other medical
conditions, and other medications. If your doctor has recommended a
dose different from the ones listed here,do not change the way that you are
taking the medication without consulting your doctor.
It is important to take this
medication exactly as prescribed by your doctor. If you miss a dose by only a
few hours, take it as soon as possible and continue with your regular schedule.
If it is almost time for your next dose, skip the missed dose and continue with
your regular dosing schedule. Do not take a double dose to make up for
a missed one. If you are not sure what to do after missing a dose,
contact your doctor or pharmacist for advice.
Store this medication at room
temperature and keep it out of the reach of children.
Do not dispose of medications in
wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask
your pharmacist how to dispose of medications that are no longer needed or have
expired.
Who should NOT take this
medication?
Ziprasidone should not be taken by
anyone who:
is
allergic to ziprasidone or to any of the ingredients of the medicationis taking
medications such as dofetilide, sotalol, quinidine, mesoridazine,
thioridazine, chlorpromazine, droperidol, pimozide, moxifloxacin,
halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl
acetate, probucol, tacrolimus, or any other medication that can cause QT
prolongationhas or has
a history of QT prolongation (including congenital long QT syndrome)has
recently had a heart attackhas severe heart failure
What side effects are possible
with this medication?
Many medications can cause side
effects. A side
effect is an unwanted response to a medication when it is taken in normal
doses. Side effects can be mild or severe, temporary or permanent. The side
effects listed below are not experienced by everyone who takes this
medication. If you are concerned about side effects, discuss the risks
and benefits of this medication with your doctor.
The following side effects have
been reported by at least 1% of people taking this medication. Many of these
side effects can be managed, and some may go away on their own over time.
Contact your doctor if you
experience these side effects and they are severe or bothersome. Your
pharmacist may be able to advise you on managing side effects.
|
abdominal painagitationconstipationdiarrheadifficulty sleepingdizzinessdrowsinessdry mouthfatigueflu-like symptoms (e.g., fever, sore
throat, chills)headacheheartburnincreased coughincreased sun sensitivityleakage of fluid or milk from breasts
(women)
|
loss of appetitemenstrual changesmuscle achesnausea or upset stomachrashrespiratory tract infectionsrestlessnessrunny nosesensations that the room is spinningsexual difficultiesslowness of movementtremorvision changesvomitingweaknessweight gain
|
Although most of the side effects
listed below don't happen very often, they could lead to serious problems if
you do not check with your doctor or seek medical attention.
Check with your doctor as soon as
possible if any of the following side effects occur:
abnormal
movements of the face or tongueabnormal
walkingchanges in
body temperature, or feeling very hot and unable to cool downchest paindizziness,
especially when standing from a lying down or seated positionfainting,
losing consciousness, or feeling a change in the way your heart beatsfeeling
very hot and unable to cool down (usually after exercise, dehydration, or
being in a warm place)high blood
pressuremuscle
twitchingnew or
worsening constipationpainful
eye movementssigns of a
blood clot in the arm or leg (tenderness, pain, swelling, warmth, or
redness in the arm or leg) or lungs (difficulty breathing, sharp chest
pain that is worse when breathing in, coughing, coughing up blood,
sweating, or passing out)signs of
high blood sugar (e.g., frequent urination, increased thirst, excessive
eating, unexplained weight loss, poor wound healing, infections, fruity
breath odour)signs of infection (symptoms may include
fever or chills, severe diarrhea, shortness of breath, prolonged
dizziness, headache, stiff neck, weight loss, or listlessness)
Stop taking the medication and
seek immediate medical attention if any of the following
occur:
abnormal
heart rhythms (e.g., fast or slow heart rate, palpitations), fainting, or
seizurespainful
erection lasting longer than 4 hourspeeling or
blistering skinseizuressigns of
neuroleptic malignant syndrome (e.g., confusion, reduced consciousness,
high fever, or muscle stiffness)symptoms
of a severe allergic reaction (e.g., itching or skin rash; shortness of
breath; swelling of the face, lips, or tongue)symptoms of a stroke (e.g., sudden weakness
or numbness of the face, arms, or legs [especially on one side]; slurred
speech; vision problems)
Some people may
experience side effects other than those listed.Check with your
doctor if you notice any symptom that worries you while you are taking this
medication.
Are there any other precautions or
warnings for this medication?
Before you begin using a
medication, be sure to inform your doctor of any medical conditions or
allergies you may have, any medications you are taking, whether you are
pregnant or breast-feeding, and any other significant facts about your health.
These factors may affect how you should use this medication.
Abnormal heart rhythms: This medication can cause
abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine,
thioridazine, chlorpromazine, droperidol, pimozide, moxifloxacin, mefloquine,
pentamidine, arsenic trioxide, probucol, tacrolimus) can increase the risk of a
type of abnormal heart rhythm called QT prolongation, and
should not be used in combination with ziprasidone. You are more at risk for
this type of abnormal heart rhythm and its complications if you:
are femaleare older
than 65 years of agehave a
family history of sudden cardiac deathhave a
history of heart disease or abnormal heart rhythmshave a
slow heart ratehave
congenital prolongation of the QT intervalhave
diabeteshave had a
strokehave low
potassium, magnesium, or calcium levelshave nutritional deficiencies
People with any of these risk
factors should discuss with their doctor how this medication may affect their
medical condition, how their medical condition may affect the dosing and
effectiveness of this medication, and whether any special monitoring is needed.
Blood clots: Ziprasidone may increase the risk
of blood clots, especially in the lower leg. Talk to your doctor or pharmacist
if you have risk factors for developing blood clots (e.g., a family history of
blood clots, recent major surgery, immobility due to air travel, or other
reason).
Blood sugar: This medication may cause
high blood sugar levels. People with diabetes should discuss with their doctor
how this medication may affect their medical condition, how their medical
condition may affect the dosing and effectiveness of this medication, and
whether any special monitoring is needed. If you experience weakness, increased
thirst, increased urination, and increased appetite while taking this
medication, contact your doctor.
Body temperature: This medication, like other
antipsychotic medications, can disrupt the body's ability to control body
temperature. People who exercise vigorously, who are exposed to extreme heat,
are dehydrated, or are taking anticholinergic medications (e.g., benztropine,
oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel
very hot and are unable to cool down while taking this medication.
Drowsiness/reduced alertness: Ziprasidone may interfere
with activities requiring mental alertness. People taking this medication
should not drive or operate machinery until they know how this medication
affects them.
Low blood pressure: Ziprasidone may cause low
blood pressure when rising from a sitting or lying down position. If you feel
dizzy, lightheaded, feel your pulse racing, or if you faint, call your doctor.
While you are taking this medication, get up slowly after you have been sitting
or lying down.
Neuroleptic malignant syndrome
(NMS): Ziprasidone,
like other antipsychotic medications, can cause a potentially fatal syndrome
known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of
NMS such as high fever, muscle stiffness, confusion or loss of consciousness,
sweating, racing or irregular heartbeat, or fainting, get immediate medical
attention.
Seizures: Ziprasidone may increase the
risk of seizures, especially in people who have had seizures in the past.
People with seizure disorders or a history of seizures should discuss with
their doctor how this medication may affect their medical condition, how their
medical condition may affect the dosing and effectiveness of this medication,
and whether any special monitoring is needed.
Tardive dyskinesia (TD): Ziprasidone, like some other
antipsychotic medications may cause tardive dyskinesia (TD) to develop. TD is a
potentially irreversible syndrome of involuntary, repetitive movements of the
face and tongue muscles. Although TD appears most commonly in seniors,
especially women, it is impossible to predict who will develop TD. The risk of
developing TD increases with higher doses and long-term treatment. If you experience
muscle twitching or abnormal movements of the face or tongue, contact your
doctor as soon as possible.
White blood cells: As with other
antipsychotics, ziprasidone can lower the number of infection-fighting white
blood cells in your blood. This can increase your risk of infections. If you
experience frequent colds or other infections, contact your doctor. Your doctor
will monitor your white blood cell levels with blood tests during treatment
with ziprasidone.
Pregnancy: This medication should not
be used during pregnancy unless the benefits outweigh the risks. If you become
pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if
ziprasidone passes into breast milk. If you are a breast-feeding mother and are
taking this medication, it may affect your baby. Talk to your doctor about
whether you should continue breast-feeding.
Children: The safety and effectiveness
of using this medication have not been established for children under 18 years
of age.
Seniors: The safety of using this
medication has not been established for adults 65 years of age or older. The
increased risk of liver, kidney, and heart conditions increases the risk of
side effects with the use of ziprasidone.
There may be a higher risk of strokes,
heart attacks, and deaths associated with the use of ziprasidone by seniors
with dementia. Seek medical attention immediately if you notice the signs and
symptoms of a stroke (e.g., sudden weakness or numbness, speech problems,
vision problems, dizziness, confusion, sudden severe headache) or a heart
attack (e.g., discomfort or pain in the chest, back, neck, jaw, arms; sweating;
shortness of breath; nausea; lightheadedness) or infection (e.g.,
pneumonia). Ziprasidone should not be used by seniors with dementia.
What other drugs could interact
with this medication?
There may be an interaction
between ziprasidone and any of the following:
|
alcoholalfuzosinamantadineamiodaroneantiseizure medications (e.g.,
carbamazepine, clobazam, ethosuximide, levetiracetam, phenytoin,
primidone, topiramate, valproic acid, zonisamide)antipsychotic medications (e.g.,
haloperidol, risperidone, quetiapine)arsenic trioxideazelastine“azole” antifungals (e.g., fluconazole,
ketoconazole, voriconazole)barbiturates (e.g., butalbital,
pentobarbital, phenobarbital)benzodiazepines (e.g., alprazolam,
diazepam, lorazepam)brimonidinebromocriptinebuprenorphinebuserelinchloral hydratechloroquinecisapridedegarelixdesvenlafaxinedextromethorphandiphenhydraminedisopyramidedofetilidedomperidonedopamine agonists (e.g., pramipexole,
ropinirole)droperidolfamotidinefingolimodflecainidefluconazolefluoxetinegalantamineHIV protease inhibitors (e.g., indinavir,
atazanavir, lopinavir, nelfinavir, ritonavir)indacaterolindapamidelevodopalithiummacrolide antibiotics (e.g.,
azithromycin, clarithromycin, erythromycin)mefloquinemethadonemethylphenidatemetoclopramidemetronidazolemirabegron
|
monoamine oxidase inhibitors (MAOIs;
e.g., moclobemide, rasagiline, phenelzine, selegiline, tranylcypromine)muscle relaxants (e.g., cyclobenzaprine,
methocarbamol, orphenadrine)narcotic pain relievers (e.g., codeine,
fentanyl, morphine, oxycodone)octreotidepentamidinepimozideprobucolprocainamidepropafenonequetiapinequinidinequininequinolone antibiotics (e.g.,
ciprofloxacin, moxifloxacin, norfloxacin)rilpivirinromidepsinSt. John’s wortsalmeterolscopolamineselective serotonin reuptake inhibitors
(SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine,
sertraline)serotonin antagonists (antinausea
medications; e.g., granisetron, ondansetron)solifenacinsotalolsulfamethoxazoletacrolimustamoxifentapentadoltetrabenazinethioridazinetramadoltrazodonetricyclic antidepressants (e.g.,
amitriptyline, desipramine)trimethoprimtyrosine kinase inhibitors (e.g.,
dasatinib, imatinib, nilotinib, sunitinib)"triptan" migraine medications
(e.g., eletriptan, sumatriptan)triptorelintryptophanvardenafilvenlafaxinevorinostatzolpidemzopiclone
|
If you are taking any of these
medications, speak with your doctor or pharmacist. Depending on your specific
circumstances, your doctor may want you to:
stop
taking one of the medications,change one
of the medications to another,change how
you are taking one or both of the medications, orleave everything as is.
An interaction between two
medications does not always mean that you must stop taking one of them. Speak to your doctor about
how any drug interactions are being managed or should be managed.
Medications other than those
listed above may interact with this medication. Tell your doctor or prescriber
about all prescription, over-the-counter (non-prescription), and herbal
medications you are taking. Also tell them about any supplements you take.
Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can
affect the action of many medications, you should let your prescriber know if
you use them.
