Prialt

Injectable Prialt mitigates severe chronic pain unresponsive to other pain relievers such as morphine.

Only a doctor or a health professional in the presence of a doctor can inject this medicine. It is available as the solution.

Before using Prialt, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will provide you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

• Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.
• Pediatric: Pediatric: Not enough pediatric studies have been carried out till date. So, safety and efficacy of ziconotide injection in children are not clear.
• Geriatric: It may be used in elderly after adjusting doses.
• Pregnancy: It falls under category C for all trimesters, meaning that due to lack of sufficient studies, it’s not clear if this medication is safe for use in pregnancy.
• Breastfeeding: It may be used cautiously in a nursing mother after assessing both risks and benefits of the use.
• Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions. In case you are currently on treatment with any other prescription or nonprescription (over-the-counter: OTC) medicine, inform your doctor.
• Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.
• Medical Problems: Certain medical conditions might influence the effects (both positive and adverse) and action of this medicine. DO NOT forget to inform your doctor about the following conditions:

        o Bleeding disorders
        o Infection at the place where the drip is given
        o Past occurrence of psychosis
        o Obstructed spinal canal (Do not use ziconotide)
        o Depression (Use cautiously)

Proper usage of Prialt requires strict adherence to your doctor’s orders. This medicine is injected into your back by a doctor or other health personnel. S/he can use a needle or a special infusion pump to deliver the drug into your spine.

If you take Prialt, your doctor should perform routine checkups and advise you in taking precautions. Your doctor may order blood tests to look for undesirable effects. Remember:

• You may develop irritation, restlessness or other abnormal behavior while taking this medicine.
• It aggravates depressive symptoms and may induce suicidal thoughts in some patients, both of which require immediate medical attention.
• Using the catheter or infusion pump can expose your spine to microorganisms which in some cases leads to meningitis. So use these devices properly and ask your doctor if you have any query. If you develop any of the following symptoms indicative of meningitis, immediately consult your doctor

        o Confusion
        o Drowsiness
        o Fever
        o Headache
        o Nausea or vomiting
        o Convulsions
        o Neck rigidity

• Take special care while doing activities that require you to be alert such as driving or using machines.
• Using this medicine with alcohol and other CNS depressing agents such as allergy medicines, sleeping pills, prescription pain relievers, seizure medicines, and muscle relaxants can cause marked reduction in brain activities. Make sure you do not take these medicines together with ziconotide.
• Your dose may be adjusted if you develop symptoms like:

        o Muscle pain or weakness with no obvious reason
        o Lack of energy

• Consult your doctor about using other prescription or nonprescription medicines and herbal or vitamin supplements while taking this medicine.

Consult your doctor immediately if you experience any of the following side effects in using Prialt:

More common:

• Anxiety
• Memory, speech or balance problems
• Confusion
• Reduced frequency or volume of urination
• Painful urination
• Tremors
• Suicidal thoughts

Less common:

• Chest pain
• Chills
• Disorientation
• Seizures
• Cough
• Dark urine
• Dizziness
• Sleepiness
• Fainting
• Rapid heartbeat
• Paranoia
• Abnormal muscle contractions
• Breathing problems
• Neck rigidity
• Noisy breathing

Rare:

• Loss of control over activities
• Irritability
• Euphoria

Seek emergency medical care if you notice any of the following symptoms of overdose:

• Inability or reduced ability to respond
• Excessive sleepiness

Mild and non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common:

• Vision difficulties
• Abnormal skin sensations
• Dizziness
• Increased muscle contraction
• Weakness
• Reduced hunger
• Memory problems

Less common:

• Increased stomach acid
• Altered taste
• Blood in urine
• Bruising
• Hearing unusual sounds
• Depersonalization
• Depression
• Vision problems
• Abnormal moods
• Pain or wound at the site where the injection is given
• Breathing problems
• Pain in joint
• Noisy breathing
• Tendency to bleed or bruise

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.