Abstral

Name: Abstral

US Brand Name

  1. Abstral
  2. Actiq
  3. Fentora
  4. Onsolis
  5. Subsys

Commonly used brand name(s)

In the U.S.

  • Abstral
  • Actiq
  • Fentora
  • Onsolis
  • Subsys

Available Dosage Forms:

  • Spray
  • Tablet
  • Lozenge/Troche
  • Film

Therapeutic Class: Analgesic

Chemical Class: Opioid

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Very upset stomach or throwing up.
  • Very hard stools (constipation).
  • Very bad belly pain.
  • Feeling very tired or weak.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Noisy breathing.
  • Shortness of breath.
  • Chest pain.
  • Fast or slow heartbeat.
  • Feeling very sleepy.
  • Seizures.
  • Very bad irritation where Abstral (fentanyl sublingual tablet) is used.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Taking an opioid drug like Abstral may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
  • Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

What side effects can this medication cause?

Fentanyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • drowsiness
  • stomach pain
  • gas
  • heartburn
  • weight loss
  • difficulty urinating
  • changes in vision
  • anxiety
  • depression
  • unusual thinking
  • unusual dreams
  • difficulty falling asleep or staying asleep
  • dry mouth
  • sudden reddening of the face, neck, or upper chest
  • uncontrollable shaking of a part of the body
  • back pain
  • chest pain
  • pain, sores, or irritation in the mouth in the area where you placed the medication
  • swelling of the hands, arms, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • changes in heartbeat
  • agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
  • nausea, vomiting, loss of appetite, weakness, or dizziness
  • inability to get or keep an erection
  • irregular menstruation
  • decreased sexual desire
  • seizures
  • hives
  • rash
  • itching

If you experience any of these symptoms, stop using fentanyl and call your doctor immediately or get emergency medical treatment:

  • slow, shallow breathing
  • decreased urge to breathe
  • difficulty breathing or swallowing
  • extreme drowsiness
  • dizziness
  • confusion
  • fainting

Fentanyl may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, remove the fentanyl from the victim's mouth and call local emergency services at 911.

Symptoms of overdose may include the following:

  • drowsiness
  • dizziness
  • confusion
  • slow, shallow breathing or stopped breathing
  • smaller pupils (black circles in the middle of the eyes)

Manufacturer

  • Galena BioPharma, Inc.

  • ProStrakan, Inc.

Side Effects of Abstral

Serious side effects have been reported with Abstral. See the “Abstral Precautions” section.

Common side effects of Abstral include the following:

  • nausea
  • sleepiness
  • headache
  • dry mouth
  • sweating
  • drowsiness
  • constipation
  • stomach pain

This is not a complete list of Abstral side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

 

Inform MD

Before taking Abstral, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Abstral or to any of its ingredients
  • have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
  • have or had a head injury or brain problem
  • have liver or kidney problems
  • have seizures
  • have a slow heart rate or other heart problems
  • have low blood pressure
  • have mental health problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)
  • have a past or present drinking problem (alcoholism), or a family history of drinking problems
  • have a past or present drug abuse problem or addiction problem, or a family history of a drug abuse problem or addiction problem
  • have any other medical conditions
  • have more than 4 episodes of breakthrough cancer pain per day.
  • are pregnant or plan to become pregnant. Abstral may cause serious harm to your unborn baby.
  • are breastfeeding or plan to breastfeed. Abstral can pass into your breast milk. It can cause serious harm to your baby. You should not use Abstral while breastfeeding.

Tell your doctor if your dose of Abstral does not relieve your breakthrough cancer pain.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Other Requirements

  • Always keep Abstral in a safe place away from children and from anyone for whom it has not been prescribed. Protect Abstral from theft.
  • Store Abstral at room temperature, 59°F to 86°F (15°C to 30°C) until ready to use.
  • Keep Abstral in the original blister unit. Do not remove Abstral tablets from their blister packaging for storage in a temporary container, such as a pillbox.
  • Keep this and all medicines out of the reach of children.

Dosing

The dose of this medicine 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 this medicine. 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 cancer pain:
    • For buccal dosage form (film):
      • Adults—At first, one 200 microgram (mcg) film for each pain episode. Your doctor may adjust your dose as needed. However, the maximum number of pain episodes that can be treated each day is 4.
      • Children—Use and dose must be determined by your doctor.
    • For buccal dosage form (tablets):
      • Adults—At first, 100 micrograms (mcg) for each pain episode. If instructed by your doctor, this dose may be repeated after waiting 30 minutes between doses. Your doctor may adjust your dose as needed. However, the maximum number of pain episodes that can be treated each day is 4.
      • Children—Use and dose must be determined by your doctor.
    • For transmucosal dosage form (lozenges):
      • Adults—At first, 200 micrograms (mcg) for each pain episode. If instructed by your doctor, this dose may be repeated after waiting 15 minutes between doses. Your doctor may adjust your dose as needed. However, the maximum number of units that can be used each day is 4.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (spray):
      • Adults—At first, 100 micrograms (mcg) or 1 spray for each pain episode. If instructed by your doctor, this dose may be repeated once after waiting 30 minutes. Additional pain episodes may be treated after a minimum of 4 hours.
      • Children—Use and dose must be determined by your doctor.
    • For sublingual dosage form (tablets):
      • Adults—At first, 100 micrograms (mcg) for each pain episode. If instructed by your doctor, this dose may be repeated after waiting 30 minutes between doses. Your doctor may adjust your dose as needed. However, the maximum number of pain episodes that can be treated each day is 4.
      • Children—Use and dose must be determined by your doctor.
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