Ziconotide

Generic name: ziconotide [ zye-KON-oh-tide ]
Brand name: Prialt
Dosage form: intrathecal solution (100 mcg/mL; 25 mcg/mL)
Drug class: Miscellaneous analgesics

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 30, 2023.

What is ziconotide?

Ziconotide is a non-narcotic pain reliever that works by blocking pain signals from the nerves to the brain.

Ziconotide injection is given by intrathecal administration for around-the-clock treatment of severe chronic pain in people who cannot use or do not respond to standard pain-relieving medications.

Ziconotide is not intended for IV (intravenous) use.

Warnings

Some people using ziconotide have had new or worsening mental problems. Tell your doctor right away if you have any unusual changes in mood or behavior.

You should not receive this medicine if you have an uncontrolled bleeding disorder, a problem affecting your spine, or a history of psychosis.

Ziconotide must be given only as an intrathecal injection through an infusion pump and should not be injected directly into a vein or other part of the body. Your doctor, nurse, or other healthcare provider will give you this injection.

Your doctor may occasionally change your dose or infusion pump flow rate to make sure you get the best results from this medicine.

Tell your doctor if the medicine seems to stop working as well in relieving your pain. Tell your doctor if you regularly use other medicines that make you sleepy. Ziconotide can add to sleepiness caused by these other medications.

Call your doctor at once if you have a serious side effect, especially fever, neck stiffness, seizure (convulsions), extreme drowsiness or tired feeling, confusion, disorientation, hallucinations, thoughts of hurting yourself, or decreased consciousness.

Before taking this medicine

You should not be treated with ziconotide if you are allergic to it, or if you have:

• an uncontrolled or untreated bleeding disorder; or

• a problem affecting your spine (such as arthritis, bone disorder, or narrowing of the spinal canal).

Some people using ziconotide have had new or worsening mental problems. You should not be treated with this medicine if you have a history of psychosis (delusions or loss of contact with reality).

Tell your doctor if you have recently used opioid medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using ziconotide.

How is ziconotide given?

Ziconotide is given around the clock using an infusion pump attached to a catheter placed into the space around your spinal cord (intrathecal injection). The infusion pump may be surgically implanted into your body or worn on the outside of your body. The pump controls how quickly the medicine is injected into your body.

Ziconotide may affect your thoughts, memory, speech, or daily activities. This effect may come on gradually after you''ve used this medicine for several weeks. Your doctor may occasionally change your dose or infusion pump flow rate.

Ziconotide doses are based on weight. Your dose needs may change if you gain or lose weight.

Tell your doctor if the medicine seems to stop relieving your pain, or if your infusion pump is not working properly.

If your catheter becomes contaminated, you may develop an infection. Call your doctor right away if you have symptoms such as fever, headache, confusion, neck stiffness, nausea, or vomiting.

If you also use opioid pain medicine, do not stop using it suddenly or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using opioid medicine.

You may need to use this medicine for a period of many years.

Your doctor will need to check your progress on a regular basis.

What happens if I miss a dose?

Since your infusion pump programming control your dosing, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or drowsiness, vision problems, speech problems, stiffness in your neck or back, nausea and vomiting, or loss of consciousness.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid drinking alcohol.

Ziconotide side effects

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

Ziconotide can affect your central nervous system and you may feel less alert. A person caring for you should seek emergency medical attention if you are hard to wake up.

Call your doctor at once if you have:

• new or worsening muscle pain, soreness, or weakness, and/or dark urine;

• a light-headed feeling (like you might pass out);

• strange sensations in your mouth;

• skin sores, itching, blisters, breakdown of the outer layer of skin;

• confusion (especially in older adults);

• problems with memory or thought;

• unusual changes in mood or behavior--anger, aggression, paranoia, hallucinations, racing thoughts, risk-taking behavior;

• symptoms of depression--feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself; or

• symptoms of meningitis--fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, or drowsiness.

Common ziconotide side effects may include:

• dizziness;

• confusion;

• nausea; or

• unusual or involuntary eye movements.

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.

Dosing information

Usual Adult Dose for Chronic Pain:

Initial dose: 0.1 mcg/hr (2.4 mcg/day) via intrathecal device
-Titrate dose in increments of up to 2.4 mcg/day at intervals of no more than 2 to 3 times per week based on analgesic response and adverse events; adjust pump infusion flow rate as required to achieve new dosing
Maximum dose: 19.2 mcg/day (0.8 mcg/hr)

Comments:
-Administration should be under the direction of a physician experienced in the technique of intrathecal administration and who is familiar with the drug and device labeling.
-This drug is intended for intrathecal delivery using the Medtronic SynchroMed(R) II Infusion System and CADD-Micro Ambulatory Infusion Pump; refer to manufacturer''s manual for specific instructions and precautions for programming the microinfusion device and/or refilling the reservoir.

Use: For the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of, or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.

What other drugs will affect ziconotide?

Using ziconotide with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill";

• seizure medicine; or

• medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia.

This list is not complete. Other drugs may interact with ziconotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use ziconotide only for the indication prescribed.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 2.01.

Ziconotide (Intrathecal)

Medically reviewed by Drugs.com. Last updated on Oct 27, 2022.

Commonly used brand name(s)

In the U.S.

• Prialt

Available Dosage Forms:

• Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Calcium Channel Blocker

Uses for ziconotide

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.

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

Before using ziconotide

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 ziconotide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ziconotide 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 ziconotide injection 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 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.

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.

Interactions with 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.

Interactions with food/tobacco/alcohol

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 ziconotide. 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 ziconotide

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

Precautions while using ziconotide

It is very important that your doctor check your progress closely while you are receiving ziconotide. 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.

Ziconotide 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 ziconotide 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.

Ziconotide 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 ziconotide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Ziconotide 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 ziconotide.

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.

Ziconotide 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 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer