Top PLR Article Directory Grenada: fentanyl Nasal

FEN-ta-nil SIT-rate

Nasal route(Spray)

Due to the risk of fatal respiratory depression, immediate-release transmucosal fentanyl is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Keep out of reach of children. Use with CYP3A4 inhibitors may cause fatal respiratory depression. When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. When dispensing, do not substitute with any other fentanyl products. Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program .

Available Dosage Forms:

Spray

Chemical Class: Fentanyl

Uses For fentanyl

Fentanyl belongs to the group of medicines called narcotic analgesics, which are medicines used to relieve pain. Fentanyl nasal spray is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which “breaks through” the medication used to control the persistent pain. Nasal fentanyl is only used in patients who are already taking narcotic analgesics and who are tolerant to opioid medicines for cancer pain.

Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of nasal fentanyl you should receive.

fentanyl is available only under a restricted distribution program called Lazanda® REMS Program.

Before Using fentanyl

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 fentanyl, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fentanyl 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 nasal fentanyl 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 nasal fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of narcotic analgesics than younger adults and are more likely to have age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving nasal fentanyl.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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. When you are taking fentanyl, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fentanyl with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Using fentanyl with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam

Alfentanil

Alprazolam

Amiodarone

Amobarbital

Amprenavir

Anileridine

Aprepitant

Aprobarbital

Bromazepam

Brotizolam

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Citalopram

Clarithromycin

Clobazam

Clonazepam

Clorazepate

Clorgyline

Codeine

Crizotinib

Dantrolene

Dezocine

Diazepam

Diltiazem

Erythromycin

Estazolam

Ethchlorvynol

Fentanyl

Fluconazole

Flunitrazepam

Fluphenazine

Flurazepam

Fosamprenavir

Fospropofol

Furazolidone

Halazepam

Hydrocodone

Hydromorphone

Imatinib

Iproniazid

Isocarboxazid

Itraconazole

Ketazolam

Ketoconazole

Levorphanol

Linezolid

Lopinavir

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Moclobemide

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nefazodone

Nelfinavir

Nialamide

Nicardipine

Nifedipine

Nitrazepam

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pargyline

Paroxetine

Pazopanib

Pentazocine

Pentobarbital

Perphenazine

Phenelzine

Phenobarbital

Prazepam

Procarbazine

Prochlorperazine

Promazine

Promethazine

Propoxyphene

Quazepam

Ranolazine

Rasagiline

Remifentanil

Ritonavir

Secobarbital

Selegiline

Sertraline

Sibutramine

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiethylperazine

Thiopental

Thioridazine

Toloxatone

Tranylcypromine

Triazolam

Trifluoperazine

Troleandomycin

Vemurafenib

Using fentanyl with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atazanavir

Azithromycin

Carbamazepine

Clotrimazole

Dirithromycin

Econazole

Indinavir

Josamycin

Mepartricin

Miconazole

Miokamycin

Nevirapine

Phenytoin

Rifampin

Rokitamycin

Roxithromycin

Saquinavir

Spiramycin

Voriconazole

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fentanyl with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use fentanyl, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of fentanyl

Fentanyl nasal sprays are for use in opioid-tolerant patients only. If you are not sure whether or not you are opioid-tolerant, check with your doctor before using fentanyl.

It is very important that you understand the requirements of the Lazanda® REMS program, and become familiar with the Lazanda® Medication Guide. Ask your doctor or pharmacist before starting treatment with fentanyl.

fentanyl is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off with water right away.

Fentanyl nasal spray works differently than other fentanyl products, even at the same dose (number of milligrams). Do not substitute or convert it to other products containing fentanyl.

To use the nasal spray:

Keep the spray in the child-resistant container until ready to use.

If you are using the nasal spray for the first time, you will need to prime the spray. To do this, you should release four sprays into the pouch. Now it is ready to use.

Before using fentanyl, gently blow your nose to clear the nostrils.

Insert the tip of the Lazanda® bottle into the nose. Point towards the bridge of the nose and tilt the bottle slightly.

Press down firmly on the finger grips until you hear a "click" sound and the number in the dose counter window adds up. This confirms a spray has been taken.

Return the spray bottle to the child-resistant container after each use.

Dosing

The dose of fentanyl will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fentanyl. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nasal dosage form (spray):
- For cancer pain:
  - Adults—At first, 100 micrograms (mcg) or 1 spray in one nostril during an episode of breakthrough cancer pain. Your doctor may increase your dose as needed and tolerated, up to a maximum of 800 mcg or 1 spray containing 400 mcg of fentanyl in each nostril. However, patients should not use more than 4 doses per 24 hours. Wait at least 2 hours before treating another episode of breakthrough cancer pain. If pain relief is not achieved within 30 minutes, a rescue medicine may be used as directed by your doctor. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their doctor to determine if a dosage adjustment is warranted.
  - Chidlren—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of fentanyl, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused spray bottle and start using a new one after 5 days or more since it has been used or 14 days or more since it has been primed. Dispose any used, partially used, or unneeded spray bottles by emptying and spraying the remaining solution into the pouch. The sealed pouch and the empty bottle should be placed in a child-resistant container before discarding it in the trash can. Wash your hands with soap and water right away after handling the pouch. If additional assistance is required, call 1-866-435-6775.

Precautions While Using fentanyl

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure that fentanyl is working properly and to check you for any problems or unwanted effects that may be caused by fentanyl.

Do not use Lazanda® if you need pain medicine for just a short time, such as during a headache or migraine attack, tooth pain, or when recovering from surgery or an injury.

After you have been using fentanyl for awhile, "breakthrough" pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of nasal fentanyl or other narcotic that you are using without first checking with your doctor.

Using too much nasal fentanyl, or taking too much of another narcotic while using nasal fentanyl, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin; low blood pressure; pinpoint pupils of the eyes; and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

Lazanda® contains an amount of fentanyl which can be fatal to a child. Patients and their caregivers should keep fentanyl out of the reach of children, and discard used and unused bottle sprays in its child-resistant container properly.

fentanyl 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 taking any of the other medicines listed above while you are using fentanyl.

Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to fentanyl before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

fentanyl may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Using narcotics for a long time may cause severe constipation. To prevent this, your doctor may tell you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

For pregnant women: Do not use fentanyl during labor and delivery (including caesarean section).

Do not use fentanyl if you have taken a monoamine oxidase (MAOI) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not eat grapefruit or drink grapefruit juice while you are using fentanyl. Grapefruit and grapefruit juice may change the amount of fentanyl that is absorbed in the body.

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 (e.g., St. John's wort) or vitamin supplements.

fentanyl 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 immediately if any of the following side effects occur:

More common

Fever

Less common

Abdominal or stomach pain

anxiety

black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody nose

bloody or cloudy urine

blurred vision

body aches or pain

chest pain

chills

clay-colored stools

confusion

cough

cough producing mucus

dark urine

decreased urination

decreased weight

difficult or labored breathing

difficult, burning, or painful urination

difficulty with breathing

dizziness or lightheadedness

dry mouth

ear congestion

fainting

frequent urge to urinate

headache

hives

hoarseness

increase in heart rate

increased sweating

irritation

itching

joint pain, stiffness, or swelling

loss of appetite

loss of voice

lower back or side pain

nausea

nervousness

pain, redness, or swelling in the arm or leg

pale skin

pounding in the ears

rapid breathing

rapid weight gain

rash

redness of the skin

runny or stuffy nose

shortness of breath

slow or fast heartbeat

sneezing

sore throat

sudden shortness of breath or troubled breathing

sunken eyes

swelling of the eyelids, face, lips, hands, or feet

thirst

tightness in the chest

tingling of the hands or feet

troubled breathing or swallowing

troubled breathing with exertion

ulcers, sores, or white spots in the mouth

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting of blood

wheezing

wrinkled skin

yellow eyes or skin

Incidence not known

Irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

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

Difficulty having a bowel movement (stool)

sleepiness or unusual drowsiness

vomiting

Less common

Acid or sour stomach

back pain

belching

burning feeling in the chest or stomach

change in taste

confusion about identity, place, and time

decreased appetite

depression

diarrhea

difficulty with moving

drooping upper eyelids

dry eyes

flushed, dry skin

fruit-like breath odor

heartburn

hyperventilation

increased hunger

increased thirst

increased urination

indigestion

irregular heartbeats

irritability

irritation or soreness of the mouth

lack or loss of strength

loss of taste

muscle aches

muscle pain or stiffness

pain in the arms or legs

pain in the rectum

restlessness

shaking

sleeplessness

stomach discomfort or upset

stomach bloating

sweating

tenderness in the stomach area

trouble with sleeping

troubled breathing

unable to sleep

unexplained weight loss

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.

See also: fentanyl Nasal side effects (in more detail)

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Top PLR Article Directory Grenada

Monday 9 July 2012

fentanyl Nasal