E-DRUG: Cannabis interactions (2)
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Dear Beverley Snell,
The following is extracted the package insert for Elevat, recently
registered in South Africa:
Each ELEVAT 2,5=A0mg capsule contains 2,5=A0mg dronabinol
Each ELEVAT 5,0=A0mg capsule contains 5,0=A0mg dronabinol
Dronabinol (delta-9-Tetrahydrocannabinol D9-THC), is
naturally-occurring and has been extracted from Cannabis sativa L.
(marijuana). It is also chemically synthesized and formulated in
sesame oil and encapsulated in round soft gelatin capsules for oral
administration.
INTERACTIONS:
In studies involving patients with AIDS and/or cancer, ELEVAT
(dronabinol) has been co-administered with a variety of medications
(e.g. cytotoxic agents, anti-infective agents, sedatives or opioid
analgesics) without resulting in any clinically significant drug/drug
interactions. Although no drug/drug interactions were discovered
during the clinical trials of ELEVAT, cannabinoids may interact with
other medications through both metabolic and pharmacodynamic
mechanisms.
Dronabinol is highly protein-bound to plasma proteins, and therefore
might displace other protein-bound drugs. Although this displacement
has been confirmed in vivo, practitioners should monitor patients for
a change in dosage requirements when administering dronabinol to
patients receiving other highly protein-bound drugs. Published
reports of drug/drug interactions involving cannabinoids are
summarised below: {displayed as a table}
CONCOMITANT DRUG CLINICAL EFFECTS
Amphetamines, cocaine, other sympathomimetic agents Additive
hypertension, tachycardia, possibly cardiotoxicity.
Atropine, scopolamine, antihistamines, other anti cholinergic agents
Additive or super-additive tachycardia, drowsiness
Amitriptyline, amoxapine, desipramine, other tricyclic antidepressants
Additive tachycardia, hypertension, drowsiness
Barbiturates, benzodiazepines, ethanol, lithium, opoids, buspirone,
antihistamines, muscle relaxants, other CNS depressants
Additive drowsiness and CNS depression
Disulfiram A reversible hypomanic reaction was reported in a
28=A0year old man who smoked marijuana; confirmed by dechallenge and
rechallenge
Fluoxetine A 21=A0year old female with depression and bulimia
receiving 20=A0mg/day fluoxetine for 4=A0weeks became hypomanic after
smoking marijuana; symptoms resolved after 4=A0days
Antipyrine, barbiturates Decreased clearance of these agents,
presumably via competitive inhibition of metabolism
Theophylline Increased theophylline metabolism reported with smoking
marijuana; effect similar to that following smoking tobacco.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Lagamed (Pty) Ltd
17 Eastern Service Road,
Eastgate Ext 8,
Sandton, Johannesburg
South Africa
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1996
Full text of the package insert may be found on the Internet site
<http://home.intekom.com/pharm/>
Hope this helps
Marland Holderness
Email: marland@intekom.co.za
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