Products
The cannabis oral spray Sativex was approved in many countries in 2013. It is subject to narcotics legislation and requires an enhanced prescription. In Germany, Sativex has been available since 2011.
Structure and properties
The oral spray contains a thick extract of the hemp plant L., which is extracted from the leaves and flowers using liquid carbon dioxide. The active ingredients are tetrahydrocannabinol (THC, dronabinol) and cannabidiol.
Effects
Cannabis oral spray (ATC M03BX) has antispastic and psychotropic properties and improves motor function in MS patients. The effects are due to the binding of the active ingredients to CB1 and CB2 receptors of the endocannabinoid system. In buccal use, the active ingredients enter the bloodstream through the mucosa.
Indications
As a second-line agent for symptom improvement in patients with moderate-to-severe spasticity due to multiple sclerosis.
Dosage
According to the SmPC. The spray is administered to a different site of the oral mucosa each time it is used, preferably with a meal, because absorption is increased when this occurs.
Contraindications
- Hypersensitivity
- Suicidality, suicidal ideation
- History or family history of schizophrenia or other psychoses.
- History of severe personality disorder or other significant psychiatric disorder (exception: depression)
- Breastfeeding
Full precautions can be found in the drug label.
Interactions
Tetrahydrocannabinol is metabolized by CYP isozymes. Corresponding drug-drug interactions with CYP inducers and inhibitors are possible. Other interactions may occur with central depressant drugs, other antispastic agents, and alcohol.
Adverse effects
The most common possible adverse effects include fatigue and dizziness. Other common adverse effects include: Drowsiness, amnesia, impaired balance, impaired attention, impaired taste, poor appetite, impaired memory, depression, disorientation, dissociation, euphoria, pain at the application site, discomfort, feeling drunk, feeling sick, visual disturbances, constipation, diarrhea, dry mouth, burning tongue, aphthae, nausea, and vomiting.