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Abstral
Overview
What is Abstral?
ABSTRAL (fentanyl) sublingual tablet is a solid formulation of fentanyl citrate, an opioid agonist, intended for oral sublingual administration. ABSTRAL is formulated as a white tablet available in six strengths (100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg), distinguishable by the shape of the tablet and by debossing on the tablet surface.
Active Ingredient:
All tablet strengths are expressed as the amount of fentanyl free base, e.g., the 100 mcg strength tablet contains 100 mcg of fentanyl free base.
Inactive Ingredients:
What does Abstral look like?
What are the available doses of Abstral?
Sublingual tablets: All tablets are white and available in six strengths, distinguishable by the shape of the tablet and by debossing on the tablet surface:
100 microgram tablet: round tablet marked with the number "1"
200 microgram tablet: oval-shaped tablet marked with the number "2"
300 microgram tablet: triangle-shaped tablet marked with the number "3"
400 microgram tablet: diamond-shaped tablet marked with the number "4"
600 microgram tablet: "D"-shaped tablet marked with the number "6"
800 microgram tablet: capsule-shaped tablet marked with the number "8" .
What should I talk to my health care provider before I take Abstral?
How should I use Abstral?
ABSTRAL is 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, around-the-clock opioid therapy for their underlying persistent cancer pain.
Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine per day, or at least 25 mcg per hour of transdermal fentanyl, or at least 30 mg of oral oxycodone per day, or at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the-clock opioids when taking ABSTRAL.
Patients must require and use around-the-clock opioids when taking ABSTRAL ().
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse ().
Administer on the floor of the mouth directly under the tongue and allow to completely dissolve ().
Initial dose of ABSTRAL: 100 mcg ().
No more than two doses can be taken per breakthrough pain episode ().
Individually titrate to a tolerable dose that provides adequate analgesia ().
Wait at least 2 hours before treating another episode of breakthrough pain with ABSTRAL ().
Limit consumption to treat four or fewer breakthrough pain episodes per day once a successful dose is found ().
When opioid therapy is no longer required, consider discontinuing ABSTRAL along with a gradual downward titration of other opioids to minimize possible withdrawal effects ().
What interacts with Abstral?
Sorry No Records found
What are the warnings of Abstral?
Sorry No Records found
What are the precautions of Abstral?
Sorry No Records found
What are the side effects of Abstral?
Sorry No records found
What should I look out for while using Abstral?
ABSTRAL is contraindicated in:
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What might happen if I take too much Abstral?
Clinical Presentation
Acute overdose with ABSTRAL can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
How should I store and handle Abstral?
Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. ABSTRAL is supplied in six dosage strengths. Tablets are supplied in child-resistant, protective blister cards with peelable foil. Each blister card contains 4 tablets, in pack sizes of 32 (all strengths) tablets. Each tablet is white in color, with the strength distinguishable by the shape of the dosage unit and by debossing on the tablet surface: Note: Colors and shapes are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing. Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. ABSTRAL is supplied in six dosage strengths. Tablets are supplied in child-resistant, protective blister cards with peelable foil. Each blister card contains 4 tablets, in pack sizes of 32 (all strengths) tablets. Each tablet is white in color, with the strength distinguishable by the shape of the dosage unit and by debossing on the tablet surface: Note: Colors and shapes are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing. Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture. ABSTRAL is supplied in six dosage strengths. Tablets are supplied in child-resistant, protective blister cards with peelable foil. Each blister card contains 4 tablets, in pack sizes of 32 (all strengths) tablets. Each tablet is white in color, with the strength distinguishable by the shape of the dosage unit and by debossing on the tablet surface: Note: Colors and shapes are a secondary aid in product identification. Please be sure to confirm the printed dosage before dispensing. Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Fentanyl is an opioid agonist whose principal therapeutic action is analgesia.
Non-Clinical Toxicology
ABSTRAL is contraindicated in:CYP2D6 Inhibitors
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CYP3A4 Inhibitors
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower dihydrocodeine plasma levels, greater dihydronorcodeine levels, and less metabolism via 2D6 with resultant lower dihyromorphine levels, resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to dihydrocodeine. If concomitant use with CYP3A4 inhibitor is necessary, consider dosage reduction of TREZIX™ until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals.
If a CYP3A4 inhibitor is discontinued, consider increasing the TREZIX™ dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
CYP3A4 Inducers
After stopping a CYP3A4 inducer, as the effects of the inhibitor decline, the dihydrocodeine plasma concentration may increase with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater dihyromorphine levels, which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use with CYP3A4 inducer is necessary, follow the patient for reduced efficacy and signs of opioid withdrawal and consider increasing the TREZIX™ dosage as needed.
If a CYP3A4 inducer is discontinued, consider TREZIX™ dosage reduction and monitor for signs of respiratory depression and sedation at frequent intervals.
Benzodiazepines and Other Central Nervous System (CNS) Depressants
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergic Drugs
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue TREZIX™ immediately if serotonin syndrome is suspected.
Dihydrocodeine with Monoamine Oxidase Inhibitors
Dihydrocodeine with Mixed Agonist/Antagonist Opioid Analgesics
Acetaminophen Drug Interactions
Caffeine Drug Interactions
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status . Carbon dioxide (CO) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of ABSTRAL, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with, and following dosage increases of, ABSTRAL.
To reduce the risk of respiratory depression, proper dosing and titration of ABSTRAL are essential . Overestimating the ABSTRAL dosage can result in a fatal overdose with the first dose. The substitution of ABSTRAL for any other fentanyl product may result in fatal overdose
ABSTRAL could be fatal to individuals for whom it is not prescribed and for those who are not opioidtolerant.
Accidental ingestion of even one dose of ABSTRAL, especially by children, can result in respiratory depression and death due to an overdose of fentanyl.
The following serious adverse reactions are described, or described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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