Ziconotide ( Zi-KOE-noe-tide) is a medicine that reduces chronic pain in the body.

Intrathecal ziconotide is given by or under the direct supervision of a doctor. It is available in the following dosage forms:

Intrathecal
• Injection (U.S.)

In deciding to use a medicine, the risks of using 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. Also tell your doctor and pharmacist if you are allergic to any other substances.

Pregnancy: Ziconotide has not been studied in pregnant women. However, studies in animals have shown that ziconotide can cause bone problems or death in the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding: It is not known whether ziconotide passes into the breast milk. However, ziconotide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children: Studies on this medicine 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.

Older adults: 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.

Other medicines: 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. When you are taking ziconotide, it is especially important that your health care professional knows if you are taking any of the following:

• Opioids, intrathecal

• 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

Dosing:

The dose of ziconotide will be different for different patients. The dose that is used may depend on a number of things.

Storage:

To store this medicine:

• Store in the refrigerator. However, keep the medicine from freezing.
• Protect from light

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.

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

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 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• 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 above may also occur in some patients. If you notice any other effects, check with your doctor.

In the U.S.:

• Analgesic