what is Abstral( Fentanyl sublingual)?
Abstral (Fentanyl) 30 pills per package. Tablet contains fentanyl,it has been confirmed in the treatment of breakthrough cancer pain in patients with chronic cancer pain and who have used opioids like morphine for treatment.
Important information on Abstral (Fentanyl Sublingual Tablets)
Do not use Abstral as a replacement for any other Fentanyl form such as Actiq, Duragesic or Fentanyl generic brands like skin patch, injection, etc. Abstral (Fentanyl Sublingual Tablets)
Avoid using Abstral to treat pain that is not cancer-related. Also, take note that when misuse it can cause addiction, overdose, and even death especially to other people using including kids without a prescription.Product should be well kept from kids and people not in need of .
Take quantity as prescribed and no excess. Abstral can interact with other medicines and cause severe breathing problems.
Keep product(Abstral) away from children because it is dengerous to them.
Report to your doctor before taking Abstral if you have the below:
Kidney or liver condition
Ulcers or mouth sores
Any breathing condition
A history of alcohol or substance abuse
Any history of brain tumor, head injury, or seizures
Slow heartbeats, low blood pressure, or any other heartbeat condition
Any mental state like hallucinations, depression
It is required of you to tell the doctor if you are pregnant or you are planning to be pregnant because if a pregnant woman is using Abstral, the baby may become dependent on Fentanyl, which can cause life-threatening withdrawal symptoms in the baby after birth. Babies involve might need medical treatment for a few weeks. You should also avoid breastfeeding while pregnant.
General Information
Abstral is a sublingual tablet formulation of fentanyl citrate, a potent opioid analgesic. The precise mechanism of the analgesic action is unknown.
Abstral is specifically indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain.
Abstral is supplied as a sublingual tablet designed for oral administration. The recommended initial dose of the drug is a single 100 mcg tablet. If adequate analgesia is obtained within 30 minutes of administration of the 100 mcg tablet, continue to treat subsequent episodes of breakthrough pain with this dose. If adequate analgesia is not obtained after the initial dose, the patient may use a second Abstral dose (after 30 minutes) as directed by their health care provider. No more than two doses of Abstral may be used to treat an episode of breakthrough pain. Patients must wait at least 2 hours before treating another episode of breakthrough pain. The Abstral dose should be escalated in a stepwise manner, increased by 100 mcg multiples up to 400 mcg, over consecutive breakthrough episodes until adequate analgesia with tolerable side effects is achieved.
Clinical Results
FDA Approvals
The FDA approval of Abstral was based on a double-blind, placebo-controlled, crossover study in 131 subjects experiencing breakthrough cancer pain. Breakthrough cancer pain was defined as a transient flare of moderate-to-severe pain occurring in patients experiencing persistent cancer pain otherwise controlled with maintenance doses of opioid medications. Of the 131 subjects who entered the titration phase of the study, 78 (60%) achieved a successful dose during the titration phase. Sixty-six patients entered the double-blind phase and 60 completed the study. The primary outcome measure, the mean sum of pain intensity difference at 30 minutes (SPID30) for Abstral-treated episodes was statistically significantly higher than for placebo-treated episodes. In a second open-label safety study using an identical titration regimen, 96 of 139 patients (69%) who entered the study titrated to a dose in which the patient obtained adequate analgesia with tolerable side effects during the titration phase.
Side Effects
Adverse events associated with the use of Abstral may include, but are not limited to, the following:
- nausea
- somnolence
- headache
- constipation
Mechanism of Action
Abstral is a sublingual tablet formulation of fentanyl citrate, a potent opioid analgesic. The precise mechanism of the analgesic action is unknown although fentanyl is known to be a µ-opioid receptor agonist. Specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.
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