ziconotide (Intrathecal route)

zye-KON-oh-tide

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 is a medicine that reduces chronic pain in the body.

Intrathecal ziconotide is given 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

Studies on ziconotide have been done only in adult patients, and there is no specific information comparing use of ziconotide in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Confusion may be especially likely to occur in older adults who are usually more sensitive than younger adults to the effects of ziconotide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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.

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:

• Infection at the microinfusion injection site or
• Spinal canal obstruction that impairs circulation of the CSF or
• Uncontrolled bleeding diathesis—Ziconotide should not be used if these conditions are present

• Psychosis—Ziconotide may make this condition worse

Proper Use of ziconotide

Dosing

The dose of ziconotide 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 ziconotide. 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.

Storage

Store in the refrigerator. Do not freeze.

Protect from light.

Precautions While Using ziconotide

It is very important that your doctor check your progress at regular visits.

Contact your doctor right away if you are confused, less alert, or unusually tired

Tell your doctor right away if you have changes in mood, hallucinations, or unusual sensations in your mouth.

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 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 signs of meningitis such as nausea, vomiting, seizures, fever, headache, and/or stiff neck, tell your doctor right away.

ziconotide may cause some people to become drowsy, dizzy, 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 are not alert.

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 immediately if any of the following side effects occur:

More common

• Seeing, hearing, or feeling things that are not there
• thoughts of killing oneself

Less common

• Chest pain
• chills
• confusion
• convulsions
• cough
• dark-colored urine
• dizziness
• drowsiness
• fainting
• fast heartbeat
• fever
• general feeling of illness
• lightheadedness
• muscle spasm or jerking of all extremities
• muscle stiffness
• rapid, shallow breathing
• shortness of breath
• sneezing
• sore throat
• stiff neck or back
• tightness in chest
• troubled breathing
• trouble concentration
• trouble sleeping
• unusual tiredness or weakness
• wheezing

Symptoms of overdose

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

• Decreased awareness or responsiveness
• severe sleepiness
• shakiness and unsteady walk
• trembling or other problems with muscle control or coordination
• uncontrolled eye movements
• unsteadiness

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

• Burning
• change in walking and balance
• clumsiness or unsteadiness
• confusion
• crawling feelings
• diarrhea
• dizziness
• excessive muscle tone, muscle tension or tightness
• fear
• feeling of constant movement of self or surroundings
• fever
• headache
• itching
• lack or loss of strength
• lightheadedness
• loss of appetite
• nausea
• nervousness
• numbness
• problems with speech or speaking
• sensation of spinning
• trembling, or other problems with muscle control or coordination
• uncontrolled eye movements
• urinary retention
• 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
• cerebrospinal fluid abnormal
• change in taste
• congestion
• constipation
• continuing ringing or buzzing or other unexplained noise in ears
• crying
• decreased awareness or responsiveness
• dehydration
• depersonalization
• depression
• difficult, burning or painful urination
• difficulty in moving
• difficulty seeing at night
• double vision
• dry mouth
• dry skin
• dryness or soreness of throat
• dysphoria
• euphoria
• fainting
• fast or irregular heartbeat
• feeling that others can hear your thoughts, are watching you, or can control your behavior
• frequent urge to urinate
• hearing loss
• heartburn
• hoarseness
• hostility
• increased sensitivity of eyes to sunlight
• increased sensitivity to pain or touch
• indigestion
• loss of bladder control
• loss of memory or problems with memory
• lung disorder
• neck pain
• nerve pain
• pain in joints
• pale skin
• pounding in ears
• quick to react or overreact emotionally
• rapidly changing moods
• red, scaly, swollen or peeling areas of skin
• redness or pain at catheter site
• runny nose
• severe muscle stiffness
• sleeplessness
• slow or fast heartbeat
• stomach discomfort, upset or pain
• sweating
• swelling or redness in joints
• tender, swollen glands in neck
• trouble in swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• warmth on skin
• weakness or heaviness in legs

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.

See also: ziconotide Intrathecal side effects (in more detail)

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