Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Prialt

Descriptions


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.

This product is available in the following dosage forms:

  • Solution

Before Using

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.

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.

Pregnancy

Information about this ziconotide-intrathecal-route
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.

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.

Drug Interactions

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

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

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

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

  1. Anxiety
  2. being forgetful
  3. change in walking and balance
  4. changes in patterns and rhythms of speech
  5. clumsiness or unsteadiness
  6. confusion
  7. decrease in the frequency of urination
  8. decrease in urine volume
  9. delusions
  10. dementia
  11. difficulty in passing urine (dribbling)
  12. difficulty with speaking
  13. feeling unusually cold
  14. painful urination
  15. problems with speech or speaking
  16. seeing, hearing, or feeling things that are not there
  17. shakiness and unsteady walk
  18. shakiness in the legs, arms, hands, or feet
  19. shivering
  20. slurred speech
  21. thoughts of killing oneself
  22. trembling or shaking of the hands or feet
  23. uncontrolled eye movements
  24. unsteadiness, trembling, or other problems with muscle control or coordination

Less common

  1. Aggressive or angry
  2. chest pain
  3. chills
  4. confusion as to time, place, or person
  5. convulsions
  6. cough
  7. dark-colored urine
  8. dizziness
  9. drowsiness
  10. fainting
  11. fast heartbeat
  12. fearfulness, suspiciousness, or other mental changes
  13. feeling that others are watching you or controlling your behavior
  14. feeling that others can hear your thoughts
  15. fever
  16. general feeling of illness
  17. holding false beliefs that cannot be changed by fact
  18. lightheadedness
  19. muscle spasm or jerking of all extremities
  20. muscle stiffness
  21. rapid, shallow breathing
  22. severe mood or mental changes
  23. shortness of breath
  24. sneezing
  25. sore throat
  26. stiff neck or back
  27. tightness in the chest
  28. troubled breathing
  29. trouble in concentration
  30. trouble in sleeping
  31. unusual behavior unusual excitement, nervousness, or restlessness
  32. unusual tiredness or weakness
  33. wheezing

Rare

  1. Actions that are out of control
  2. changes in behavior
  3. irritability
  4. talking, feeling, and acting with excitement

Incidence not known

  1. 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

  1. Decreased awareness or responsiveness
  2. 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

  1. Blurred vision
  2. crawling feelings
  3. diarrhea
  4. dizziness
  5. dizziness or lightheadedness
  6. excessive muscle tone, tension, or tightness
  7. feeling of constant movement of self or surroundings
  8. headache
  9. itching
  10. lack or loss of strength
  11. loss of appetite
  12. loss of memory
  13. nausea
  14. pain in the arms or legs
  15. problems with memory
  16. sensation of spinning
  17. sleepiness or unusual drowsiness
  18. vomiting
  19. weight loss

Less common

  1. Acid or sour stomach
  2. back pain
  3. bad, unusual, or unpleasant (after) taste
  4. belching
  5. bladder pain
  6. bloody or cloudy urine
  7. bruising
  8. change in taste
  9. congestion
  10. constipation
  11. continuing ringing or buzzing or other unexplained noise in the ears
  12. crying
  13. dehydration
  14. depersonalization
  15. depression
  16. difficulty seeing at night
  17. difficulty with moving
  18. double vision
  19. dry mouth
  20. dry skin
  21. dysphoria
  22. euphoria
  23. fainting
  24. frequent urge to urinate
  25. hearing loss
  26. heartburn
  27. hoarseness
  28. increased sensitivity of the eyes to sunlight
  29. increased sensitivity to pain or touch
  30. indigestion
  31. loss of bladder control
  32. loss of taste
  33. lung disorder
  34. nerve pain
  35. pain in the joints
  36. pain or tenderness around the eyes and cheekbones
  37. pale skin
  38. pounding in the ears
  39. quick to react or overreact emotionally
  40. rapidly changing moods
  41. red, scaly, swollen, or peeling areas of the skin
  42. redness or pain at the catheter site
  43. runny nose
  44. severe muscle stiffness
  45. shortness of breath or troubled breathing
  46. sleeplessness
  47. slow or fast heartbeat
  48. stomach discomfort, upset, or pain
  49. stuffy nose
  50. sweating
  51. swelling or redness in the joints
  52. tender, swollen glands in the neck
  53. tightness of the chest or wheezing
  54. trouble with swallowing
  55. unusual bleeding or bruising
  56. unusual tiredness or weakness
  57. voice changes
  58. warmth on the skin
  59. weakness or heaviness in the legs

Incidence not known

  1. Burning sensation on the skin
  2. flaking and falling off of skin
  3. skin blisters
  4. 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.