Ziconotide Solution for injection

What is this medicine?

ZICONOTIDE(zye KON oh tide)is a non-narcotic pain reliever. It is used to treat severe chronic pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood disease, bleeding disorders or problems, hemophilia or aneurysm

• depression, psychosis, thoughts of suicide or past suicide attempts, or other mental health problems

• infection

• spinal canal blockage

• an unusual or allergic reaction to ziconotide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into the space around the spinal cord. It is given by a special implanted pump under the supervision of a doctor or health care professional. You will be taught how to use your pump.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. Your healthcare professional will schedule refills of your medication pump as needed. It is important not to miss your appointments. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• alcohol

• other medicines that cause drowsiness

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may need blood work done while you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• confusion, agitation, changes in mental ability

• dark urine

• feeling faint or lightheaded, falls

• fever, headache and/or stiff neck

• hallucinations

• memory problems

• muscle pain or weakness

• nausea, vomiting

• problems with balance, talking, walking

• seizures

• suicidal thoughts or other mood changes

• trouble passing urine or change in the amount of urine

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• clumsiness, unsteadiness

• diarrhea

• dizziness, drowsiness

• headache

• loss of appetite

• nervous or restless

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.