Abstral buccal / sublingual

Name: Abstral buccal / sublingual

What is fentanyl buccal/sublingual?

Fentanyl is an opioid pain medication. An opioid is sometimes called a narcotic. Fentanyl buccal or sublingual products are used in the mouth but not swallowed whole. Fentanyl buccal is placed inside the mouth between the cheek and gum. Fentanyl sublingual is placed under the tongue.

Fentanyl buccal/sublingual is used to treat "breakthrough" cancer pain that is not controlled by other medicines. This medicine is not for treating pain that is not cancer-related.

Fentanyl buccal/sublingual may also be used for purposes not listed in this medication guide.

Fentanyl buccal/sublingual side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • slow heart rate, weak or shallow breathing, sighing, severe drowsiness, feeling like you might pass out;

  • confusion, extreme fear, unusual thoughts or behavior; or

  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

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

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

  • headache, dizziness, drowsiness, pale skin, feeling weak or tired;

  • constipation, nausea, vomiting; or

  • swelling in your hands 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 may report side effects to FDA at 1-800-FDA-1088.

What happens if I miss a dose?

Since Abstral 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 Abstral?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how Abstral 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 Abstral.

For Healthcare Professionals

Applies to fentanyl: buccal film, buccal tablet, compounding powder, injectable solution, intravenous solution, nasal spray, oral lozenge, oral transmucosal lozenge, sublingual spray, sublingual tablet, transdermal device, transdermal film extended release

General

The most commonly reported adverse reactions included headache, nausea, vomiting, ,dizziness, and constipation.[Ref]

Nervous system

Very common (10% or more): Somnolence, dizziness
Common (1% to 10%): Sedation, pyrexia, fatigue, lethargy, tremor, headache, chills, irritability, malaise, confusion, abnormal thinking, anxiety, dysphoria
Uncommon (0.1% to 1%): Hyperesthesia
Very rare (less than 0.01%): Severe hemiplegic migraine
Frequency not reported: Slurred speech, paresthesia, hypesthesia, tremor
Postmarketing reports: Loss of consciousness, vertigo, coma, shock, convulsion[Ref]

Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.[Ref]

Cardiovascular

One report has suggested that epidural fentanyl (the active ingredient contained in Abstral) may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.

Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.[Ref]

Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Sinus tachycardia, chest pain, hypertension, hypotension, palpitations
Rare (less than 0.1%): Arrhythmias, cardiac arrest
Frequency not reported: Syncope, vasodilation, bradycardia, bigeminy, myocardial infarct
Postmarketing reports: Circulatory depression[Ref]

Gastrointestinal

Very common (10% or more): Nausea (18%), vomiting (10%), constipation
Common (1% to 10%): Dry mouth, abdominal distension, gastritis, dysphagia, dyspepsia, gastroesophageal reflux disease, ascites, hematemesis, taste perversion, abdominal pain, dehydration, anorexia, cachexia, vomiting, dry mouth, mouth ulcers/stomatitis, tongue edema
Uncommon (0.1% to 1%): Abdomen enlarged, flatulence
Rare (less than 0.1%): Choledochoduodenal sphincter spasm
Frequency not reported: Diarrhea
Postmarketing reports: Ileus, dental caries, tooth loss, gingival recession, gingivitis, gingival bleeding, lip edema, pharyngeal edema, gum bleeding, ulcer[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention
Very rare (less than 0.01%): Priapism
Frequency not reported: Urinary tract infection, urination impaired, hematuria, urinary urgency, dysuria[Ref]

Dermatologic

Approximately 60% of patients had some redness at the skin site 24-hours after removal of the iontophoretic transdermal system. The majority of skin events were categorized as mild, erythema and papules were observed; 2 patients had hyperpigmentation at the application site lasting 2 to 3 weeks; 3 patients had a rectangular mark at the application site which persisted for up to 3 months.[Ref]

Very common(10% or more): Iontophoretic transdermal system: Application site reaction-Erythema (14%)
Common (1% to 10%): Application site irritation, pruritus
Uncommon (0.1% to 1%): Hyperhidrosis, rash
Rare (less than 0.1%): Systemic rashes
Frequency not reported: vesicles, papules/pustules, dry and flaky skin, vesiculobullous rash wound site oozing/bleeding, wound site inflammation/erythema
Postmarketing reports: Application site discharge, application site bleeding, application site infection, rash and scab, erosion, hyperesthesia, application site necrosis[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis[Ref]

Hematologic

The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl (the active ingredient contained in Abstral) solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.[Ref]

Common (1% to 10%): Anemia, neutropenia, lymphadenopathy, thrombocytopenia, leukopenia, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose increased, blood lactate increased, hypoalbuminemia, vasodilation[Ref]

Immunologic

Uncommon (0.1% to 1%): Oral candidiasis, cellulitis, pneumonia, urinary tract infection, oral herpes, gastroenteritis, laryngitis
Very rare (less than 0.01%): Recurrent herpes simplex infection following epidural administration[Ref]

Metabolic

Common (1% to 10%): Asthenia, peripheral edema, weight decreased, hypokalemia, hyponatremia, hypocalcemia
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone
Frequency not reported: abnormal healing, dehydration[Ref]

Endocrine

Uncommon (0.1% to 1%): Hot flush[Ref]

Musculoskeletal

Common (1% to 10%): Fall/accidental injury, back pain, arthralgia, joint swelling, muscular weakness, myoclonus, involuntary muscle contractions, muscle rigidity (involving the respiratory musculature including the glottis)
Frequency not reported: Leg cramps, myalgia
Postmarketing reports: Abnormal gait/incoordination[Ref]

Ocular

Uncommon (0.1% to 1%): Vision blurred, dry eye
Rare (less than 0.1%): Abnormal vision[Ref]

Psychiatric

Common (1% to 10%): Depression, confusional state, hallucination, insomnia
Uncommon (0.1% to 1%): Anxiety, agitation, restlessness, agitation, disorientation, abnormal dreams, depersonalization, depression, emotional lability, euphoria, delirium
Frequency not reported: Nervousness[Ref]

Respiratory

Common (1% to 10%): Dyspnea, rhinitis, yawning, respiratory distress, apnea, bradypnea, hypoventilation, respiratory depression
Uncommon (0.1% to 1%): Cough, increased bronchial secretion, dysphonia, pharyngolaryngeal pain, wheezing, hypoxia, exertional dyspnea
Very rare (less than 0.01%): Acute noncardiogenic pulmonary edema
Frequency not reported: Asthma, hiccup, atelectasis, hyperventilation
Postmarketing reports: Respiratory arrest[Ref]

Some side effects of Abstral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Fentanyl Pregnancy Warnings

Use of this drug is not recommended unless the benefit outweighs the risk to the developing fetus. Comments: -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available. -There is insufficient data to support use of this during and labor and delivery; if this drug is administered, an antidote for the child should be readily available. AU TGA pregnancy category: C US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity; however, some reproductive toxicity has been reported. Maternal use of fentanyl may cause withdrawal symptoms and respiratory depression in the newborn infant. There are no controlled data in human pregnancy. In women treated acutely with IV or epidural fentanyl during labor, symptoms of neonatal respiratory or neurological depression were no more frequent than would be expected in infants of untreated mothers. Transient neonatal muscular rigidity has been reported in infants whose mothers were treated with IV fentanyl. Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures in newborn infants characteristic of neonatal abstinence syndrome. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Fentanyl Breastfeeding Warnings

This drug is excreted into human milk and achieves levels in colostrum which are greater than maternal serum levels. No adverse effects have been reported in nursing infants. Symptoms of opioid withdrawal may occur in infants at the cessation of nursing. One small study has reported the pharmacokinetic data of five lactating women who underwent induction of anesthesia with this drug. In 24 hours of milk collection, an average of 0.033% (0.006% to 0.073%) of the maternal fentanyl was collected in the milk representing an average of 0.039% of the elimination clearance of the drug. The author of the study concluded that the amount of fentanyl excreted into the milk within 24 hours of induction of anesthesia provided insufficient justification to interrupt breast-feeding.

This drug should not be used unless there are no safer alternatives. Excreted into human milk: Yes Comments: -General manufacturer recommendations: 1) Lozenge: Breast-feeding is not recommended for at least 48 hours after the last dose. 2) IV or IM: Breast-feeding is not recommended for at least 24 hours after the last dose. 3) Transdermal patch: Breast-feeding is not recommended for at least 72 hours after the last dose. -This drug considered compatible with breastfeeding by the American Academy of Pediatrics. -This drug may cause sedation and respiratory depression in the breastfed child.

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