Overview
11 DESCRIPTION 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: C 21 H 30 O 2 (molecular weight=314.46) Dronabinol is a clear colorless to amber oil. Dronabinol is insoluble in water. It has a pKa of 10.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Dronabinol is an orally active cannabinoid that 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. 12.2 Pharmacodynamics Effects on the Cardiovascular System Dronabinol-induced sympathomimetic activity may result in tachycardia and/or conjunctival injection. Its effects on blood pressure are inconsistent, but subjects have experienced orthostatic hypotension and/or syncope upon abrupt standing [see Warnings and Precautions ( 5.2 )] . Effects on the Central Nervous System Dronabinol also demonstrates reversible effects on appetite, mood, cognition, memory, and perception.
Indications
- 1 INDICATIONS AND USAGE SYNDROS is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. SYNDROS is a cannabinoid indicated in adults for the treatment of: anorexia associated with weight loss in patients with AIDS. ( 1 ) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
Common Doses
- 5 mg
- 2.1 mg
- 4.2 mg
- 30 mL
Dosage
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): Always use the enclosed calibrated oral dosing syringe. The calibrated oral syringe measures a maximum SYNDROS dose of 5 mg. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe. Take SYNDROS with a full glass of water (6 to 8 ounces). SYNDROS can be administered via silicone enteral feeding tubes. Anorexia Associated with Weight Loss in Adult Patients with AIDS ( 2.2 ): The recommended starting dosage is 2.
Contraindications
- 4 CONTRAINDICATIONS SYNDROS is contraindicated in patients: with a history of a hypersensitivity reaction to dronabinol. Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Adverse Reactions ( 6.2 )] . with a history of a hypersensitivity reaction to alcohol. who are receiving, or have recently received, disulfiram- or metronidazole-containing products within 14 days [see Warning and Precautions ( 5.3 )] . SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol.
Side Effects
- 6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, thinking abnormal, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wellhouse Pharma, LLC at 1-844-558-8289 or FDA at MedWatch phone number 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not...
Interactions
- 7 DRUG INTERACTIONS Inhibitors and Inducers of CYP2C9 and CYP3A4 : May alter dronabinol systemic exposure; monitor for dronabinol-related adverse reactions or loss of efficacy. ( 7.2 ) Highly Protein-Bound Drugs : Potential for displacement of other drugs from plasma proteins; monitor for adverse reactions to concomitant narrow therapeutic index drugs (e.g., warfarin, cyclosporine, or amphotericin B) when initiating or increasing the dosage of SYNDROS. ( 7.3 ) 7.1 Disulfiram and Metronidazole SYNDROS contains 50% (w/w) dehydrated alcohol and 5.