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Ziconotide (Intrathecal route)

Pronunciation:

zye-KON-oh-tide

Brand Names:

  • Prialt

Dosage Forms:

  • Solution

Warnings:

Intrathecal route(Solution)

Ziconotide is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue ziconotide therapy in the event of serious neurological or psychiatric signs or symptoms .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Calcium Channel Blocker

Uses of This Medicine:

Ziconotide injection is used to relieve severe chronic pain in patients who have already been treated with other medicines (e.g., morphine) and did not work well.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ziconotide injection in the elderly. However, elderly patients are more likely to have confusion and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving ziconotide injection.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

  • Bleeding problems, uncontrolled or
  • Infection at the microinfusion injection site or
  • Psychosis (mental illness), history of or
  • Spinal canal blockage—Should not be used in patients with these conditions.
  • Depression or
  • Mental illness—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle or catheter into your back using a special infusion pump.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Serious infection or meningitis can occur if the catheter of this medicine becomes disconnected. It is very important that you follow your doctor's instructions about the care of the catheter and the use of the infusion pump.

If you or your caregiver notice any signs of meningitis such as confusion, drowsiness, fever, headache, nausea or vomiting, seizures, or stiff neck, call your doctor right away.

This medicine may cause some people to become dizzy, drowsy, confused, disoriented, clumsy, 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 not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before you take any of the medicines listed above while you are using this medicine.

Tell your doctor right away if you have unexplained muscle pain or weakness, loss of strength or energy, and with or without a darkened urine. Your doctor may need to reduce the dose of your medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common
Anxiety
being forgetful
change in walking and balance
changes in patterns and rhythms of speech
clumsiness or unsteadiness
confusion
decrease in the frequency of urination
decrease in urine volume
delusions
dementia
difficulty in passing urine (dribbling)
difficulty with speaking
feeling unusually cold
painful urination
problems with speech or speaking
seeing, hearing, or feeling things that are not there
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
shivering
slurred speech
thoughts of killing oneself
trembling or shaking of the hands or feet
uncontrolled eye movements
unsteadiness, trembling, or other problems with muscle control or coordination
Less common
Aggressive or angry
chest pain
chills
confusion as to time, place, or person
convulsions
cough
dark-colored urine
dizziness
drowsiness
fainting
fast heartbeat
fearfulness, suspiciousness, or other mental changes
feeling that others are watching you or controlling your behavior
feeling that others can hear your thoughts
fever
general feeling of illness
holding false beliefs that cannot be changed by fact
lightheadedness
muscle spasm or jerking of all extremities
muscle stiffness
rapid, shallow breathing
severe mood or mental changes
shortness of breath
sneezing
sore throat
stiff neck or back
tightness in the chest
troubled breathing
trouble in concentration
trouble in sleeping
unusual behavior unusual excitement, nervousness, or restlessness
unusual tiredness or weakness
wheezing
Rare
Actions that are out of control
changes in behavior
irritability
talking, feeling, and acting with excitement
Incidence not known
Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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

Symptoms of overdose
Decreased awareness or responsiveness
severe sleepiness

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:

More common
Blurred vision
crawling feelings
diarrhea
dizziness
dizziness or lightheadedness
excessive muscle tone, tension, or tightness
feeling of constant movement of self or surroundings
headache
itching
lack or loss of strength
loss of appetite
loss of memory
nausea
pain in the arms or legs
problems with memory
sensation of spinning
sleepiness or unusual drowsiness
vomiting
weight loss
Less common
Acid or sour stomach
back pain
bad, unusual, or unpleasant (after) taste
belching
bladder pain
bloody or cloudy urine
bruising
change in taste
congestion
constipation
continuing ringing or buzzing or other unexplained noise in the ears
crying
dehydration
depersonalization
depression
difficulty seeing at night
difficulty with moving
double vision
dry mouth
dry skin
dysphoria
euphoria
fainting
frequent urge to urinate
hearing loss
heartburn
hoarseness
increased sensitivity of the eyes to sunlight
increased sensitivity to pain or touch
indigestion
loss of bladder control
loss of taste
lung disorder
nerve pain
pain in the joints
pain or tenderness around the eyes and cheekbones
pale skin
pounding in the ears
quick to react or overreact emotionally
rapidly changing moods
red, scaly, swollen, or peeling areas of the skin
redness or pain at the catheter site
runny nose
severe muscle stiffness
shortness of breath or troubled breathing
sleeplessness
slow or fast heartbeat
stomach discomfort, upset, or pain
stuffy nose
sweating
swelling or redness in the joints
tender, swollen glands in the neck
tightness of the chest or wheezing
trouble with swallowing
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
warmth on the skin
weakness or heaviness in the legs
Incidence not known
Burning sensation on the skin
flaking and falling off of skin
skin blisters
sores on the 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.


Last Updated: 4/4/2014

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