Fentanyl (nasal)

Fentanyl (nasal)

What is fentanyl nasal?

Fentanyl nasal is administered with other non-fentanyl opioid pain medications used around the clock.

Fentanyl nasal may also be used for purposes not listed in this medication guide.

Side effects of fentanyl in the nose

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Opioid medications can slow or stop your breathing and cause death. A person caring for you should seek emergency medical attention if your breathing is slow and takes long pauses, your lips are blue, or you have difficulty waking up.

Fentanyl can cause serious side effects. Call your doctor immediately if you have:

• slow heartbeat, sighing, shallow breathing, stopping breathing during sleep;

• confusion, extreme anxiety, unusual thoughts or behavior;

• dizziness, the feeling of fainting; or

• increasing tiredness or weakness.

Seek immediate medical attention if you have symptoms of serotonin syndrome, such as:Restlessness, hallucinations, fever, sweating, shaking, fast heartbeat, muscle stiffness, twitching, loss of coordination, nausea, vomiting or diarrhea.

Serious side effects may be more likely in older adults and people who are malnourished or weakened.

Long-term use of opioid medications can affect fertility (ability to have children) in men and women. It is not known whether the effects of opioids on fertility are permanent.

Common side effects of fentanyl can include:

• dizziness, drowsiness, weakness;

• anxiety depression;

• sleep disorders;

• stomach pain, nausea, vomiting, constipation; or

• Swelling of the arms, hands, legs or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

Do not use nasal fentanyl as a substitute for another form of fentanyl.If you are switching from another form of fentanyl, you will not use the same dose.

Abusing opioids can lead to addiction, overdose or death.Store the medication in a place where others cannot reach it.

Taking opioids during pregnancy can cause life-threatening withdrawal symptoms in the newborn.

If you take opioid medicines with alcohol or other medicines that cause drowsiness or slow your breathing, fatal side effects may occur.

Before you take this medicine

You should not use fentanyl if you are allergic to it or if you have:

• severe asthma or breathing problems; or

• a stomach or intestinal obstruction (including paralytic ileus).

You should not use fentanyl nasal unless you are already using a similar opioid medicine and your body is tolerant to it.

Do not give this medication to anyone under 18 years of age.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;

• a head injury, brain tumor, or seizures;

• drug or alcohol addiction, mental illness;

• problems urinating;

• liver or kidney disease;

• a blockage in your stomach or intestines; or

• Problems with your gallbladder, pancreas, or thyroid.

If you take opioid medications during pregnancy, your baby could become dependent on the medication.This can lead to life-threatening withdrawal symptoms in the baby after birth. Babies born addicted to opioids may require medical treatment for several weeks.

Don't breastfeed.Fentanyl may cause drowsiness, breathing problems, or withdrawal symptoms in a breast-fed infant.

How should I use fentanyl nasally?

Follow the instructions on your prescription label and read all medication guides. Never use fentanyl in larger quantities or for longer than prescribed. Tell your doctor if you feel an increased urge to take more fentanyl.

Never share opioid medications with another person, especially someone with a history of drug abuse or addiction. Abuse can lead to addiction, overdose or death.Store the medication in a place where others cannot reach it. Selling or giving away opioid medications is against the law.

Never use nasal fentanyl with a second form of fentanyl or as a substitute for another form of fentanyl (injection, skin patch, dissolving film, or “lollipop” device).

If you are switching from another form of fentanyl to fentanyl nasal, you will not use the same dose. You must start with the lowest dose.

Carefully read and follow all instructions for use that come with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if you still have pain more than 30 minutes after using the nasal spray or if you have breakthrough pain more than four times in a day.

You must wait at least 2 hours after the last dose of nasal fentanyl before treating a new episode of pain.

Do not suddenly stop using fentanyl after long-term use or you may experience unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature, away from heat and moisture.Keep this medicine out of the reach of children.The amount of fentanyl in each bottle of Lazanda can be fatal to a child.

Do not keep leftover opioid medication.Even a single dose can cause death if this medication is used accidentally or improperly.Carefully read and follow the instructions included with this medicine for the safe disposal of unused parts.

What happens if I miss a dose?

Because fentanyl is used to relieve pain, you are unlikely to miss a dose. Skip the missed dose if it is almost time for the next dose. Do not use two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.A fentanyl overdose can be fatal, especially in children or others using the drug without a prescription.Symptoms of overdose may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid when taking fentanyl nasal?

Don't drink alcohol.Dangerous side effects or death could occur.

Avoid driving and dangerous activities until you know how fentanyl affects you. Dizziness or drowsiness can lead to falls, accidents or serious injury.

Grapefruit can interact with fentanyl and cause unwanted side effects. Avoid using grapefruit products.

What other drugs will affect fentanyl nasal?

When you start or stop taking certain other medicines, you may experience breathing problems or withdrawal symptoms. Tell your doctor if you are also taking an antibiotic, antifungal, anti-seizure medication, or medication to treat HIV or hepatitis C.

Opioid medications can interact with many other medications, causing dangerous side effects or death.Make sure your doctor knows if you are also using:

• other narcotic medications – opioid pain relievers or prescription cough medicines;

• a sedative such as Valium – Diazepam, Alprazolam, Lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax and others;

• medicines that make you sleepy or slow your breathing – a sleeping pill, a muscle relaxant, a sedative, an antidepressant, or an antipsychotic; or

• Medicines that affect the levels of serotonin in your body - a stimulant or medicine for depression, Parkinson's disease, migraines, serious infections or to prevent nausea and vomiting.

This list is not complete. Other medications can affect fentanyl, including prescription and over-the-counter medications, vitamins, and herbal products. Not all possible interactions are listed here.