SYNDROS CII(dronabinol oral solution)
Generic Name and Formulations:
Dronabinol 5mg/mL; oral soln; contains 50% w/w dehydrated alcohol, 5.5%w/w propylene glycol.
Company:
Insys Therapeutics, Inc.
RECENT UPDATES Monograph added.
Indications for SYNDROS:
Anorexia associated with weight loss in patients with AIDS.
Adult:
Individualize. Take each dose with 6–8oz water. Initially 2.1mg twice daily 1hr before lunch and dinner. If elderly or severe or persistent CNS effects occur, reduce to 2.1mg once daily 1hr before dinner or bedtime. If tolerated, may gradually increase to 2.1mg 1hr before lunch and 4.2mg before dinner; may further titrate up to 4.2mg twice daily as tolerated; max 8.4mg twice daily.
Children:
Not established.
Contraindications:
Concomitant disulfiram- or metronidazole-containing products within the past 14 days. Alcohol hypersensitivity.
Warnings/Precautions:
Seizure disorders; monitor and discontinue if seizure occurs. Cardiac disorders; monitor changes in BP, HR, syncope after initiation or dose increase. Screen for psychiatric disorders prior to starting; avoid in those with a psychiatric history (eg, mania, depression, schizophrenia); if unavoidable, monitor for new or worsening symptoms. Substance abuse or dependence; monitor. Monitor for neurological and psychoactive effects (esp. children, elderly); reduce or discontinue dose if cognitive impairment or nausea/vomiting/abdominal pain worsens. Diminished CYP2C9 function; monitor for increased adverse effects. Avoid in preterm neonates in immediate postnatal period. Pregnancy, nursing mothers: not recommended.
Interactions:
See Contraindications. Do not give disulfiram- or metronidazole-containing products within 7 days of completing treatment. Highly protein bound drugs (eg, warfarin, cyclosporine, amphotericin B); monitor. CYP2C9 and CYP3A4 inducers may decrease systemic exposure; effects may be potentiated by inhibitors of CYP2C9 (eg, amiodarone, fluconazole) and CYP3A4 (eg. ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice); monitor. Additive CNS effects with other CNS depressants (eg, barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamine, TCAs, other anticholinergics, muscle relaxants). Caution with antiepileptics or factors that can lower seizure threshold. Avoid concomitant psychoactive drugs or drugs with cardiac effects (eg, amphetamines, other sympathomimetics, atropine, amoxapine, scopolamine, antihistamines, other anticholinergics, amitriptyline, desipramine, other TCAs). May potentiate propylene glycol.
Pharmacological Class:
Cannabinoid.
Adverse Reactions:
Dizziness, euphoria, paranoid reactions, somnolence, abnormal thinking, amnesia, feeling high, abdominal pain, nausea, vomiting, hemodynamic instability, preterm neonatal toxicity.
Generic Availability:
NO
How Supplied:
Oral soln—30mL (w. syringe and adapter)
