Dronabinol

Dronabinol is a synthetically produced delta-9-tetrahydrocannabinol (THC), the main active ingredient of the cannabis plant. It is used as a prescription-only medicine to treat various conditions.

Since March 2017, physicians in Germany have been able to prescribe cannabis-based medicines on a statutory health insurance prescription. Dronabinol is administered as an oily solution or in capsules and allows precise dosing.

It is used primarily for chronic pain, nausea caused by chemotherapy, and loss of appetite.

Dronabinol works via the body's own endocannabinoid system:

Mechanism of action:

• Binds to CB1 receptors in the central nervous system
• Binds to CB2 receptors in the immune system
• Modulates pain perception, appetite, nausea, and mood

Effects:

• Pain-relieving (analgesic)
• Antiemetic (against nausea)
• Appetite-stimulating
• Muscle-relaxing
• Anxiety-relieving (at low doses)

Pharmacokinetics:

• Onset of action when taken orally: 30-90 minutes
• Duration of action: 4-8 hours
• Metabolized in the liver

Dronabinol may be used for:

• Chronic pain (when other therapies are not sufficient)
• Nausea and vomiting caused by chemotherapy
• Loss of appetite in HIV/AIDS or cancer
• Spasticity in multiple sclerosis
• Chronic inflammatory bowel diseases

Requirements for a prescription:

• Serious illness
• Standard therapies exhausted or not tolerated
• Prospect of improvement in symptoms

Not suitable:

• In psychoses or severe mental illnesses
• In addictive disorders
• Under 18 years of age (relative contraindication)

Dronabinol drops (oily solution):

• 2.5% solution (25 mg/ml)
• Starting dose: 2.5 mg (1-2x daily)
• Slow increase over weeks
• Target dose: individual, usually 5-20 mg/day

Dronabinol capsules:

• 2.5 mg capsules
• 5 mg capsules
• 10 mg capsules

Important: Always start with the lowest dose and increase slowly ("start low, go slow").

How to take:

• Oily solution: drops under the tongue or onto a spoon
• Capsules: swallow with a little water
• With or after a meal (better absorption)

Dose adjustment:

• First week: 2.5 mg in the evening
• From week 2: 2.5 mg in the morning + 2.5 mg in the evening
• Further increase depending on tolerability

Important notes:

• Do not take part in road traffic at the start of therapy
• Fitness to drive only possible after stable dose adjustment
• No alcohol during treatment
• BtM prescription required

Contraindications:

• Hypersensitivity to dronabinol or cannabinoids
• Severe psychiatric disorders (psychoses, schizophrenia)
• Severe cardiovascular diseases
• Pregnancy and breastfeeding

Use with caution in:

• History of addictive disorders
• Depression or anxiety disorders
• Liver diseases
• Older patients
• Adolescents

Common (1-10%):

• Dizziness
• Fatigue, drowsiness
• Dry mouth
• Euphoria or dysphoria
• Changes in appetite

Uncommon (0.1-1%):

• Racing heart (tachycardia)
• Drop in blood pressure
• Headache
• Nausea
• Difficulty concentrating

Rare:

• Anxiety, paranoia
• Hallucinations
• Confusion
• Depressed mood

Note: Most side effects are dose-dependent and improve with a slow dose increase.

Interactions with:

• Sedatives (benzodiazepines) – increased sedation
• Alcohol – increased CNS depression
• Opioids – additive effect
• CYP inhibitors – increased dronabinol levels

Use with caution with:

• Antidepressants
• Antiepileptics
• Blood pressure medications

Fitness to drive:

• At the start of therapy: NO driving
• After stable dose adjustment: individual assessment
• THC detectable in the blood – observe the legal situation