Pronunciation:

zye-KON-oh-tide

Brand Names:

• Prialt

Dosage Forms:

• Solution

Warnings:

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.

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.