Description
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.
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
- Anxiety
- being forgetful
- change in walking and balance
- changes in patterns and rhythms of speech
- clumsiness or unsteadiness
- confusion
- decrease in the frequency of urination
- decrease in urine volume
- delusions
- dementia
- difficulty in passing urine (dribbling)
- difficulty with speaking
- feeling unusually cold
- painful urination
- problems with speech or speaking
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- shivering
- slurred speech
- thoughts of killing oneself
- trembling or shaking of the hands or feet
- uncontrolled eye movements
- unsteadiness, trembling, or other problems with muscle control or coordination
Less common
- Aggressive or angry
- chest pain
- chills
- confusion as to time, place, or person
- convulsions
- cough
- dark-colored urine
- dizziness
- drowsiness
- fainting
- fast heartbeat
- fearfulness, suspiciousness, or other mental changes
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- fever
- general feeling of illness
- holding false beliefs that cannot be changed by fact
- lightheadedness
- muscle spasm or jerking of all extremities
- muscle stiffness
- rapid, shallow breathing
- severe mood or mental changes
- shortness of breath
- sneezing
- sore throat
- stiff neck or back
- tightness in the chest
- troubled breathing
- trouble in concentration
- trouble in sleeping
- unusual behavior unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- wheezing
Rare
- Actions that are out of control
- changes in behavior
- irritability
- talking, feeling, and acting with excitement
Incidence not known
- 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
- Decreased awareness or responsiveness
- 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
- Blurred vision
- crawling feelings
- diarrhea
- dizziness
- dizziness or lightheadedness
- excessive muscle tone, tension, or tightness
- feeling of constant movement of self or surroundings
- headache
- itching
- lack or loss of strength
- loss of appetite
- loss of memory
- nausea
- pain in the arms or legs
- problems with memory
- sensation of spinning
- sleepiness or unusual drowsiness
- 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
- change in taste
- congestion
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- crying
- dehydration
- depersonalization
- depression
- difficulty seeing at night
- difficulty with moving
- double vision
- dry mouth
- dry skin
- dysphoria
- euphoria
- fainting
- frequent urge to urinate
- hearing loss
- heartburn
- hoarseness
- increased sensitivity of the eyes to sunlight
- increased sensitivity to pain or touch
- indigestion
- loss of bladder control
- loss of taste
- lung disorder
- nerve pain
- pain in the joints
- pain or tenderness around the eyes and cheekbones
- pale skin
- pounding in the ears
- quick to react or overreact emotionally
- rapidly changing moods
- red, scaly, swollen, or peeling areas of the skin
- redness or pain at the catheter site
- runny nose
- severe muscle stiffness
- shortness of breath or troubled breathing
- sleeplessness
- slow or fast heartbeat
- stomach discomfort, upset, or pain
- stuffy nose
- sweating
- swelling or redness in the joints
- tender, swollen glands in the neck
- tightness of the chest or wheezing
- trouble with swallowing
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- warmth on the skin
- weakness or heaviness in the legs
Incidence not known
- Burning sensation on the skin
- flaking and falling off of skin
- skin blisters
- 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.
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