Abstral buccal / sublingual

Name: Abstral buccal / sublingual

What should I discuss with my healthcare provider before using fentanyl buccal/sublingual?

Do not use fentanyl unless you are already using an around-the-clock opioid medicine and are tolerant to it. You should not use fentanyl if you are allergic to it, or if you have:

  • severe asthma or other breathing problems; or

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • any type of breathing problem or lung disease;

  • a head injury, brain tumor, or seizures;

  • low blood pressure, slow heartbeats or other heart rhythm disorder;

  • drug or alcohol addiction, depression, schizophrenia, or hallucinations;

  • liver or kidney disease;

  • urination problems;

  • problems with your thyroid, gallbladder, or pancreas; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with fentanyl and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Tell your doctor if there are children living in the home where you will store this medicine. The amount of fentanyl in this medicine can be fatal to a child.

If you use fentanyl while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while you are using this medicine.

How should I use fentanyl buccal/sublingual?

Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

If you have been using another form of fentanyl (injection, skin patch, "lollipop" device), your buccal or sublingual dose may be different.

Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away fentanyl is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use only 1 tablet at a time. If your pain does not go away completely, use a second tablet only if your doctor has approved it.

You must wait at least 2 hours after your last dose of Abstral before you can treat a new pain episode. You must wait at least 4 hours after your last dose of Fentora or Subsys before you can treat a new pain episode.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine. Do not treat more than 4 pain episodes per day with this medicine.

Do not stop using fentanyl suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using fentanyl.

Never crush or break a fentanyl pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

Store at room temperature away from moisture and heat. Do not freeze. Keep track of your medicine. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each buccal or sublingual product can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Carefully follow disposal instructions when this medicine is no longer needed. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, throw away any unused fentanyl tablets by removing them from the blister pack and flushing them down a toilet. Dispose of used sublingual spray units in the disposal bags provided with the medicine. Empty any unused spray units into the disposal bottle provided.

What happens if I miss a dose?

Since fentanyl is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme weakness or drowsiness, weak pulse, cold and clammy skin, pinpoint pupils, and slow breathing (breathing may stop).

What should I avoid while using fentanyl buccal/sublingual?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death could occur.

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while taking fentanyl.

What other drugs will affect fentanyl buccal/sublingual?

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make fentanyl less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Fentanyl Levels and Effects while Breastfeeding

Summary of Use during Lactation

When used epidurally or intravenously during labor or for a short time immediately postpartum, amounts of fentanyl ingested by the neonate are usually small and are not expected to cause any adverse effects in breastfed infants. The results of studies on the effect of epidural fentanyl on breastfeeding initiation and duration are mixed and controversial, because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used and deficient designs of many of the studies. In infants placed skin-to-skin after a normal vaginal delivery, epidural fentanyl given during labor may delay the infant's first suckling in a dose-dependent manner,[1] perhaps because it can persist in the infant's serum for over 24 hours after discontinuation.[2] However, it appears that with good breastfeeding support, epidural fentanyl plus bupivacaine has little overall effect on breastfeeding success.[3][4][5][6][7]

No waiting period or discarding of milk is required before resuming breastfeeding after fentanyl is used for short procedures (e.g., for endoscopy).[8][9] After general anesthesia, breastfeeding can be resumed as soon as the mother has recovered sufficiently from anesthesia to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure. Limited information indicates that transdermal fentanyl in a dosage of 100 mcg/hour results in undetectable fentanyl concentrations in breastmilk.

Newborn infants seem to be particularly sensitive to the effects of even small dosages of narcotic analgesics. Once the mother's milk comes in, it is best to provide pain control with a nonnarcotic analgesic and limit maternal intake of fentanyl to a few days at a low dosage with close infant monitoring. If the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately.

Drug Levels

Plasma fentanyl levels of 0.2 to 1.2 mcg/L are required for analgesia via the nonepidural route and plasma levels over 1 to 2 mcg/L may cause respiratory depression. Plasma levels are markedly lower when the epidural route is used. The oral bioavailability of fentanyl is 33% in adults. The usual intravenous of fentanyl for an infant is 1 to 2 mcg/kg. Fentanyl is metabolized to norfentanyl and inactive metabolites.

Maternal Levels. Eight women who had undergone cesarean section received fentanyl 100 mcg epidurally immediately after delivery. Fentanyl was undetectable (<0.1 mcg/L) in colostrum at about 1 hour after the dose.[10]

Thirteen women were given a single fentanyl 2 mcg/kg intravenous dose during either cesarean section or postpartum tubal ligation. Colostrum was collected at 0.75, 2, 4, 6, 8, and 10 hours after the dose. The average peak fentanyl level was 0.40 mcg/L and occurred 45 minutes after the dose. Average levels declined to 0.22 mcg/L at 2 hours and to 0.15 mcg/L at 4 hours then to the lower limit of the assay (0.05 mcg/L) at 6, 8, and 10 hours after the dose.[11] Based on the peak milk fentanyl level reported in this study, an exclusively breastfed infant would receive a fentanyl dose of 0.06 mcg/kg daily.

Ten women were given 50 to 100 mcg of intravenous fentanyl every hour during labor. Their breastmilk was sampled 4 and 24 hours after delivery. The cumulative maternal fentanyl dosages ranged from 50 to 400 mcg and the longest time from last dose to delivery was 3.1 hours (range 0 to 3.1 hours). Fentanyl was undetectable (<0.05 mcg/L) in the milk of 8 of the women 4 hours after delivery and in 2 of the women 24 hours after delivery. Detectable milk levels of fentanyl ranged from 0.12 to 0.15 mcg/L at 4 hours after delivery and from 0.12 to 0.14 mcg/L at 24 hours after delivery.[12] Based on the highest milk level reported in this study, an exclusively breastfed infant would receive a fentanyl dosage of 0.02 mcg/kg daily.

Five women who were 6 to 15 weeks postpartum were given a single dose of 100 mcg of fentanyl intravenously before undergoing general anesthesia. Several milk samples were collected between 5 and 24 hours after the injection from each woman. The authors estimated that the infants would receive an average of 0.005 mcg/kg in the 24 hours after a single dose of fentanyl. This corresponds to about 0.38 % of the maternal weight-adjusted dosage. The women's milk output following the surgical procedure was less than half of the normal milk output of nursing mothers. The authors concluded that this amount of fentanyl in milk is unlikely to affect a healthy, term infant.[13] The infants of mothers not undergoing a surgical procedure might receive a greater dose of fentanyl in breastmilk, but it would be unlikely to be a large dose.

A randomized, prospective study measured colostrum fentanyl concentrations following epidural or intravenous fentanyl during delivery in 100 multiparous mothers undergoing cesarean section and delivering fullterm, healthy infants. Epidural fentanyl was given to 50 women in a dose of 100 to 150 mcg in divided doses followed by a continuous epidural infusion of 20 mcg/hour. Intravenous fentanyl was given to 50 women as a single dose of 50 mcg after delivery. Both groups received epidural or spinal bupivacaine in addition. Colostrum samples were obtained 45 minutes and 24 hours after the initial fentanyl dose. At 45 minutes, colostrum fentanyl concentrations were 0.4 mcg/L in the epidural group and 0.19 mcg/L in the intravenous group. At 24 hours, colostrum fentanyl concentrations were 80 ng/L in the epidural group and 0.05 mcg/L in the intravenous group. The authors estimated that in the worst-case scenario, a fully breastfed infant would absorb a fentanyl dose of 0.016 mcg/kg.[14]

A woman was using a transdermal fentanyl patch for chronic back pain during pregnancy and postpartum. The mother required additional analgesia during labor and the infant required treatment for neonatal abstinence syndrome. By 2 weeks postpartum, the mother was using a fentanyl patch in a dosage of 100 mcg/hour which was changed every other day. A sample of pumped breastmilk from one breast contained fentanyl 6.4 mcg/L and norfentanyl 6.2 mcg/L.[15]

Infant Levels. An infant whose mother was using a fentanyl patch in a dosage of 100 mcg/hour which was changed every other day was fed her mother's milk either by bottle or by the breast every 3 hours beginning about 2 weeks postpartum. On day 27 of life, the infant was fed 380 mL of maternal milk following several feedings during the prior 24 hours. The infant's serum fentanyl and norfentanyl concentrations were not detectable (<0.1 mcg/L).[15]

Effects in Breastfed Infants

Fentanyl was possibly the cause of statistically significant, but clinically unimportant, lower neurobehavioral scores in a group of 32 newborns who were less than 24 hours old and whose mothers had received epidural fentanyl during labor.[16]

An epidural fentanyl dosage greater than 150 mcg during labor was associated with slightly lower neurobehavioral scores in the newborns of 177 breastfeeding mothers on postpartum day 1 compared to a lower total dosage or to no fentanyl;[17] however, this might have been a chance association[18] and was probably due to placental transfer of fentanyl prior to delivery and not from breastmilk after delivery. All women also received epidural bupivacaine.

A woman was using a transdermal fentanyl patch for chronic back pain during pregnancy and postpartum. The mother required additional analgesia during labor and the infant required treatment for neonatal abstinence syndrome. By 2 weeks postpartum, the mother was using a fentanyl patch in a dosage of 100 mcg/hour which was changed every other day and the infant was being fed the mother's milk every 3 hours. The infant had no additional medical problems and fed well until discharge after day 27 of life, gaining 500 g.[15]

Effects on Lactation and Breastmilk

Fentanyl can increase serum prolactin.[19][20] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

In 58 breastfeeding mothers who received an epidural fentanyl dosage greater than 150 mcg during labor, 21% reported more difficulty in establishing breastfeeding at 24 hours after delivery compared to 10% of mothers who received to a lower dosage or to no fentanyl. There was no difference in breastfeeding difficulty noted between the groups 24 hours after delivery when the assessment was performed by a lactation consultant. Women in the high-dose group who could be contacted were more likely to discontinue breastfeeding by 6 weeks after delivery and there was a higher rate of breastfeeding discontinuation at 6 weeks among mothers who reported breastfeeding difficulty 24 hours after delivery.[17] A relatively high dropout rate from the study at 6 weeks clouds the results.[18]

A retrospective study of a random sample of 425 mothers delivering in a maternity unit found a dose-related increased risk of bottle feeding at hospital discharge associated with fentanyl administered during labor.[21]

A prospective cohort study compared women who received continuous epidural analgesia with fentanyl and either bupivacaine or ropivacaine during labor and delivery (n = 52) to women who received no analgesia (n = 63). The average total fentanyl dosage was 124 mcg and the average total infusion time from start to delivery was 219 minutes. The study found no differences between the groups in breastfeeding effectiveness or infant neurobehavioral status at 8 to 12 hours postpartum or the number exclusively or partially breastfeeding at 4 weeks postpartum.[22]

A randomized, prospective study measured infant breastfeeding behavior following epidural or intravenous fentanyl during delivery in 100 multiparous mothers undergoing cesarean section and delivering fullterm, healthy infants. Epidural fentanyl was given to 50 women in a dose of 100 to 150 mcg in divided doses followed by a continuous epidural infusion of 20 mcg/hour. Intravenous fentanyl was given to 50 women as a single dose of 50 mcg after delivery. Both groups received epidural or spinal bupivacaine in addition. A slight difference was seen in breastfeeding behavior between the groups, with the infants in the intravenous fentanyl group performing slightly worse than those in the epidural group. However, all mothers were able to breastfeed their infants at 24 hours. None had severe breastfeeding problems; 10 women in the epidural group reported mild or moderate problems and 7 women in the intravenous group reported breastfeeding problems. Twenty mothers in the epidural group and 14 in the intravenous group used supplemental bottle feeding, with the difference not statistically significant.[14]

A randomized, multicenter trial compared the initiation rate and duration of breastfeeding in women who received high-dose epidural bupivacaine alone, or one of two low-dose combinations of bupivacaine plus fentanyl. The average fentanyl dosages in the two groups were 97 and 151 mcg in the first stage of labor and 10 and 12 mcg of fentanyl during the second stage of labor, respectively, with great variability. A nonepidural matched control group was also compared. No differences in breastfeeding initiation rates or duration were found among the epidural and nonmedicated groups, but women in the nonepidural group who received systemic meperidine had a lower breastfeeding initiation rate than in the other groups.[23]

A nonrandomized study in low-risk mother-infant pairs found that there was no difference overall in the amount of sucking by newborns, whether their mothers received bupivacaine plus fentanyl, or fentanyl alone by epidural infusion in various dosages, or received no analgesia for childbirth. In a subanalysis by sex and number of sucks, female infants were affected by high-dose bupivacaine and high-dose fentanyl, but male infant were not.[24] However, the imbalances of many factors between the study groups makes this study difficult to interpret.

In a prospective cohort study, 87 multiparous women who received epidural bupivacaine and fentanyl for pain control during labor and vaginal delivery. A loading dose of 0.125% bupivacaine with fentanyl 50-100 mcg. Epidural analgesia is maintained using 0.0625% bupivacaine and fentanyl 0.2 mcg/mL. The median dose of fentanyl received by the women was 151 mcg (range 30 to 570 mcg). The women completed questionnaires at 1 and 6 weeks postpartum regarding breastfeeding. Most women had prior experience with breastfeeding, support at home and ample time off from work. All women were breastfeeding at 1 week postpartum and 95.4% of women were breastfeeding at 6 weeks postpartum.[25]

A nonrandomized study at one Italian hospital compared primaparous mothers undergoing vaginal delivery who received epidural analgesia (n = 64) to those who did not (n = 64). Mothers who requested the epidural analgesia received an initial dose of 100 mcg of fentanyl diluted to 10 mL with saline. After the initial fentanyl, doses of 15 to 20 mL of 0.1% ropivacaine were administered if needed. The only difference between the groups of mothers was a longer duration of labor among the treated mothers. The quality of infant nursing was equal between the 2 groups of infants on several measures; however, more infants in the treated group breastfed for less than 30 minutes at the first feeding.[26]

A national survey of women and their infants from late pregnancy through 12 months postpartum compared the time of lactogenesis II in mothers who did and did not receive pain medication during labor. Categories of medication were spinal or epidural only, spinal or epidural plus another medication, and other pain medication only. Women who received medications from any of the categories had about twice the risk of having delayed lactogenesis II (>72 hours) compared to women who received no labor pain medication.[27]

A randomized study compared the effects of cesarean section using general anesthesia, spinal anesthesia, or epidural anesthesia, to normal vaginal delivery on serum prolactin and oxytocin as well as time to initiation of lactation. General anesthesia was performed using propofol 2 mg/kg and rocuronium 0.6 mg/kg for induction, followed by sevoflurane and rocuronium 0.15 mg/kg as needed. After delivery, patients in all groups received an infusion of oxytocin 30 international units in 1 L of saline, and 0.2 mg of methylergonovine if they were not hypertensive. Fentanyl 1 to 1.5 mcg/kg was administered after delivery to the general anesthesia group. Patients in the general anesthesia group (n = 21) had higher post-procedure prolactin levels and a longer mean time to lactation initiation (25 hours) than in the other groups (10.8 to 11.8 hours). Postpartum oxytocin levels in the nonmedicated vaginal delivery group were higher than in the general and spinal anesthesia groups.[28]

A randomized, nonblinded study compared the use of intramuscular meperidine 100 mg to intranasal (mean dose 486 mcg) or subcutaneous (mean dose 300 mcg) fentanyl for labor analgesia. More women in the meperidine group had difficulty establishing lactation (79%) than in the intranasal (39%) or subcutaneous (44%) fentanyl groups. Mothers who received meperidine reported more sedation, had longer labors, and their infants were more likely to be admitted to the nursery.[29][30]

A retrospective study in a Spanish public hospital compared the infants of mothers who received an epidural during labor that contained fentanyl and either bupivacaine or ropivacaine. Infants of mothers who received an epidural had a lower frequency of early breastfeeding.[31]

A small prospective study in California compared women who received an epidural infusion of fentanyl and ropivacaine to mothers who did not receive an epidermal during labor. All mothers had normal vaginal deliveries and their infants had 1 uninterrupted hour of skin-to-skin contact immediately postpartum. The study found inverse relationships between the amount of fentanyl and the amount of oxytocin received during labor and the time of the first suckling. Because women who received more fentanyl also tended to receive more oxytocin, the study could not clearly separate the effects of the two drugs.[1]

Alternate Drugs to Consider

Acetaminophen, Butorphanol, Hydromorphone, Ibuprofen, Morphine


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