Abstral (Fentanyl) is a sublingual tablet formulation of fentanyl citrate, a potent opioid analgesic. The precise mechanism of the analgesic action is unknown. Abstral - fentanyl 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-Fentanyl 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 achieved 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-Fentanyl 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-Fentanyl 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.
Adverse events associated with the use of Abstral - fentanyl may include, but are not limited to, the following:
• a headache
• Eye disorders: vision blurred
• Gastrointestinal disorders
• Liver/Kidney disorders
• Do not substitute with other fentanyl products; not equivalent to other fentanyl products on an mcg to mcg basis.
• Do not chew, suck, swallow tablets. Allow tablets to dissolve in the sublingual cavity.
• Do not eat or drink until the pill completely dissolves.
• Overdose can be fatal.
• Tell your doctor if you are pregnant or breastfeeding before using this medication.
• Before using this medication, tell your doctor your medical history, especially of: breathing problems (such as asthma, emphysema), heart problems, high blood pressure, and liver disease.
Before taking Abstral-Fentanyl, keep your doctor informed about the other drugs/supplements you are taking, especially:
• Benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids);
• reserve concomitant use in those for whom alternative options are inadequate;
• 5-HT3 antagonists
• mirtazapine, trazodone, tramadol, MAOIs, linezolid
• Other steroid hormones (eg., oral contraceptives)
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