When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to ziconotide. You should not receive this medicine if you have an infection at the injection site, blockage in your spine, uncontrolled bleeding problems, or a history of psychosis (mental illness). Your doctor will decide if there is any reason you should not receive this medicine.

How to Use This Medicine:
Injectable

• 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.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using medicines to treat depression (such as amitriptyline, doxepin, nortriptyline, Celexa®, Pamelor®, Prozac®, Serzone®, Sinequan®, or Zoloft®), sleeping medicine (such as alprazolam, diazepam, midazolam, Halcion®, Librium®, Valium®, Versed®, or Xanax®), medicines for seizures (such as phenytoin, primidone, Dilantin®, or Tegretol®), or a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, depression, or mental illness.
• 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.
• This medicine may make you dizzy, drowsy, confused, disoriented, or clumsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Serious infection or meningitis can occur if the catheter of this medicine becomes disconnected. It is very important that you or your caregiver must follow 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.
• Call your doctor right away if you have unexplained muscle pain or weakness, loss of strength or energy, and with or without darkened urine. Your doctor may need to reduce the dose of your medicine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, depression, restlessness, or changes in mood or behavior.
• Dark-colored urine.
• Decrease in how much or how often you urinate, or painful urination.
• Feeling unusually cold.
• Fever, headache, nausea or vomiting, seizures, or stiff neck.
• Lightheadedness or fainting.
• Muscle pain, soreness, or weakness.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Problems with speech, balance, or walking.
• Seeing, hearing, or feeling things that are not there.
• Seizures or tremors.
• Uncontrolled eye movements.
• Unusual thoughts or behavior, or thoughts of killing oneself or others.

If you notice these less serious side effects, talk with your doctor:

• Abnormal thinking, anxiety, or memory loss or being forgetful.
• Blurred vision.
• Diarrhea or loss of appetite.
• Dizziness or headache.
• Dry skin.
• Lack or loss of strength.
• Pain, swelling, itching, or burning where the catheter is placed.
• Rash or itching skin.
• Sensation of spinning.
• Sleepiness or unusual drowsiness.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088