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Dronabinol
Overview
What is Dronabinol?
Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas:
CHO (molecular weight = 314.46)
Dronabinol, the active ingredient in dronabinol capsules, USP, is synthetic delta-9-tetrahydrocannabinol (delta-9-THC).
Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.
Each dronabinol capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.
What does Dronabinol look like?
What are the available doses of Dronabinol?
Dronabinol capsules are supplied as round, soft gelatin capsules for oral use as follows:
What should I talk to my health care provider before I take Dronabinol?
How should I use Dronabinol?
Dronabinol capsules are indicated in adults for the treatment of:
Starting Dosage
The recommended adult starting dosage of dronabinol capsules is 2.5 mg orally twice daily, one hour before lunch and dinner.
In elderly patients or patients unable to tolerate 2.5 mg twice daily, consider initiating dronabinol capsules at 2.5 mg once daily one hour before dinner or at bedtime to reduce the risk of central nervous system (CNS) symptoms .
Dosing later in the day may reduce the frequency of CNS adverse reactions. CNS adverse reactions are dose-related ; therefore monitor patients and reduce the dosage as needed. If CNS adverse reactions of feeling high, dizziness, confusion, and somnolence occur, they usually resolve in 1 to 3 days and usually do not require dosage reduction. If CNS adverse reactions are severe or persistent, reduce the dosage to 2.5 mg in the evening or at bedtime.
Dosage Titration
If tolerated and further therapeutic effect is desired, the dosage may be increased gradually to 2.5 mg one hour before lunch and 5 mg one hour before dinner. Increase the dose of dronabinol capsules gradually in order to reduce the frequency of dose-related adverse reactions .
Most patients respond to 2.5 mg twice daily, but the dose may be further increased to 5 mg one hour before lunch and 5 mg one hour before dinner, as tolerated to achieve a therapeutic effect.
Maximum Dosage: 10 mg twice daily.
What interacts with Dronabinol?
Sorry No Records found
What are the warnings of Dronabinol?
Sorry No Records found
What are the precautions of Dronabinol?
Sorry No Records found
What are the side effects of Dronabinol?
Sorry No records found
What should I look out for while using Dronabinol?
Dronabinol capsules are contraindicated in patients with a history of a hypersensitivity reaction to dronabinol or sesame oil. Reported hypersensitivity reactions to dronabinol capsules include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing and throat tightness .
What might happen if I take too much Dronabinol?
Signs and symptoms of dronabinol overdosage include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth, tachycardia, memory impairment, depersonalization, mood alteration, urinary retention, reduced bowel motility, decreased motor coordination, lethargy, slurred speech, and postural hypotension. Patients may also experience panic reactions if they have a prior history of nervousness or anxiety, and seizures may occur in patients with existing seizure disorders.
It is not known if dronabinol can be removed by dialysis in cases of overdose.
If over-exposure of dronabinol capsules occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
How should I store and handle Dronabinol?
Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. Dronabinol Capsules, USP2.5 mg white capsules (Identified UM).NDC 67877-568-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM).NDC 67877-569-60 (Bottle of 60 capsules).10 mg orange capsules (Identified UM).NDC 67877-570-60 (Bottle of 60 capsules).Storage ConditionsDronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.Dronabinol Capsules, USP2.5 mg white capsules (Identified UM).NDC 67877-568-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM).NDC 67877-569-60 (Bottle of 60 capsules).10 mg orange capsules (Identified UM).NDC 67877-570-60 (Bottle of 60 capsules).Storage ConditionsDronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.Dronabinol Capsules, USP2.5 mg white capsules (Identified UM).NDC 67877-568-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM).NDC 67877-569-60 (Bottle of 60 capsules).10 mg orange capsules (Identified UM).NDC 67877-570-60 (Bottle of 60 capsules).Storage ConditionsDronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.Dronabinol Capsules, USP2.5 mg white capsules (Identified UM).NDC 67877-568-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM).NDC 67877-569-60 (Bottle of 60 capsules).10 mg orange capsules (Identified UM).NDC 67877-570-60 (Bottle of 60 capsules).Storage ConditionsDronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.Dronabinol Capsules, USP2.5 mg white capsules (Identified UM).NDC 67877-568-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM).NDC 67877-569-60 (Bottle of 60 capsules).10 mg orange capsules (Identified UM).NDC 67877-570-60 (Bottle of 60 capsules).Storage ConditionsDronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.Dronabinol Capsules, USP2.5 mg white capsules (Identified UM).NDC 67877-568-60 (Bottle of 60 capsules). 5 mg dark brown capsules (Identified UM).NDC 67877-569-60 (Bottle of 60 capsules).10 mg orange capsules (Identified UM).NDC 67877-570-60 (Bottle of 60 capsules).Storage ConditionsDronabinol capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Dronabinol is an orally active cannabinoid which has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.
Non-Clinical Toxicology
Dronabinol capsules are contraindicated in patients with a history of a hypersensitivity reaction to dronabinol or sesame oil. Reported hypersensitivity reactions to dronabinol capsules include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing and throat tightness .Specific drug interaction studies have not been conducted. Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; therefore, it may impair intestinal absorption of doxercalciferol. Magnesium-containing antacids and doxercalciferol should not be used concomitantly because such use may lead to the development of hypermagnesemia (see ). The use of mineral oil or other substances that may affect absorption of fat may influence the absorption and availability of doxercalciferol. Although not examined specifically, enzyme inducers (such as glutethimide and phenobarbital) may affect the 25-hydroxylation of doxercalciferol and may necessitate dosage adjustments. Cytochrome P450 inhibitors (such as ketoconazole and erythromycin) may inhibit the 25-hydroxylation of doxercalciferol. Hence, formation of the active doxercalciferol moiety may be hindered.
Psychiatric Adverse Reactions
Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Significant CNS symptoms followed oral doses of 0.4 mg/kg (28 mg per 70 kg patient) of dronabinol capsules in antiemetic studies.
Prior to initiating treatment with dronabinol capsules, screen patients for a history of these illnesses. Avoid use in patients with a psychiatric history or, if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment. Also, avoid concomitant use with other drugs that are associated with similar psychiatric effects.
Cognitive Adverse Reactions
Use of dronabinol capsules has been associated with cognitive impairment and altered mental state. Reduce the dose of dronabinol capsules or discontinue use of dronabinol capsules if signs or symptoms of cognitive impairment develop. Elderly patients may be more sensitive to the neurological and psychoactive effects of dronabinol capsules .
Hazardous Activities
Dronabinol capsules can cause and may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle or operating machinery. Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants). Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol capsules do not affect them adversely.
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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