Ziconotide, Intrathecal

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KEY POINTS

• This medicine is given by drug pump to manage severe chronic pain. Use it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: analgesic (pain medicine)

Generic and brand names: ziconotide, intrathecal; Prialt Intrathecal

What is this medicine used for?

This medicine is used to manage severe chronic pain.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA), or other brain disease
• Kidney or liver problems
• Mental or emotional problems

Also tell your provider if you have recently had any kind of infection, especially an infection that affected your spine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

This medicine is given by a drug pump. The pump is a small, battery operated disk and catheter that is implanted under your skin. Check the label on the medicine for directions about your specific dose. Make sure that you understand how to fill and use the pump, and how much medicine to use. Make sure that you refill the pump so that you do not run out of medicine.

Use this medicine exactly as your healthcare provider prescribes. Your provider may adjust your dosage depending on how the medicine works for you.

Check with your healthcare provider before using this medicine in children under age 18.

What should I watch out for?

Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Worsening depression
• Suicidal thoughts

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

This medicine may make you feel dizzy or faint, especially when you get up from sitting or lying down. Getting up slowly may help.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe confusion, hallucinations (seeing or hearing things that are not there), fainting, thoughts of suicide, vomiting, seizures, fever, blurred vision, headache, stiff neck, trouble walking, memory problems, speech problems, severe muscle pain, severe weakness, dark urine, trouble urinating.

Other: Constipation, trouble sleeping, drowsiness, dizziness, dry mouth, nausea, vomiting, diarrhea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antihistamines such as azelastine (Astelin, Astepro), brompheniramine, chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), and diphenhydramine (Benadryl)
• Antipsychotic medicines such as chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), prochlorperazine (Compro), risperidone (Risperdal), and thioridazine
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Buprenorphine (Buprenex, Butrans)
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), and torsemide (Demadex)
• Doxepin (Silenor)
• Muscle relaxants such as carisoprodol (Soma), chlorzoxazone (Parafon Forte), cyclobenzaprine (Amrix), metaxalone (Skelaxin), methocarbamol (Robaxin), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as pramipexole (Mirapex), ropinirole (Requip), and rotigotine (Neupro)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as doxylamine (Unisom), eszopiclone (Lunesta), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Thalidomide (Thalomid)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator but do not let it freeze. Protect it from heat and light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.