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Syndros Generic Name & Formulations
Legal Class
CII
General Description
Dronabinol 5mg/mL; oral soln; contains 50% w/w dehydrated alcohol, 5.5%w/w propylene glycol.
Pharmacological Class
Cannabinoid.
How Supplied
Oral soln—30mL (w. syringe and adapter)
Manufacturer
Generic Availability
NO
Syndros Indications
Indications
Anorexia associated with weight loss in patients with AIDS.
Syndros Dosage and Administration
Adult
Individualize. Use calibrated oral syringe. Take each dose with 6–8oz water. May also administer via enteral feeding tubes manufactured with silicone only, size ≥14 French (eg, NG, G-tube, PEG-tube, GJ-tube). 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.
Syndros Contraindications
Contraindications
Concomitant disulfiram- or metronidazole-containing products within the past 14 days. Alcohol hypersensitivity.
Syndros Boxed Warnings
Not Applicable
Syndros Warnings/Precautions
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.
Syndros Pharmacokinetics
See Literature
Syndros Interactions
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.
Syndros Adverse Reactions
Adverse Reactions
Dizziness, euphoria, paranoid reactions, somnolence, abnormal thinking, amnesia, feeling high, abdominal pain, nausea, vomiting, hemodynamic instability, preterm neonatal toxicity.
Syndros Clinical Trials
See Literature
Syndros Note
Not Applicable
Syndros Patient Counseling
See Literature
Syndros Generic Name & Formulations
Legal Class
CII
General Description
Dronabinol 5mg/mL; oral soln; contains 50% w/w dehydrated alcohol, 5.5%w/w propylene glycol.
Pharmacological Class
Cannabinoid.
How Supplied
Oral soln—30mL (w. syringe and adapter)
Manufacturer
Generic Availability
NO
Syndros Indications
Indications
Refractory nausea and vomiting associated with cancer chemotherapy.
Syndros Dosage and Administration
Adult
Individualize. Use calibrated oral syringe. Take with 6–8oz water. May also administer via enteral feeding tubes manufactured with silicone only, size ≥14 French (eg, NG, G-tube, PEG-tube, GJ-tube). Give 1st dose ≥30mins before eating. Initially 4.2mg/m2 1–3hrs before chemotherapy then every 2–4hrs after chemotherapy; total 4–6 doses daily. Elderly: 2.1mg/m2 once daily 1–3hrs before chemotherapy. May increase in increments of 2.1mg/m2; max 12.6mg/m2 per dose for 4–6 doses per day. May reduce to 2.1mg once daily 1–3hrs before chemotherapy if needed.
Children
Not established.
Syndros Contraindications
Contraindications
Concomitant disulfiram- or metronidazole-containing products within the past 14 days. Alcohol hypersensitivity.
Syndros Boxed Warnings
Not Applicable
Syndros Warnings/Precautions
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.
Syndros Pharmacokinetics
See Literature
Syndros Interactions
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.
Syndros Adverse Reactions
Adverse Reactions
Dizziness, euphoria, paranoid reactions, somnolence, abnormal thinking, amnesia, feeling high, abdominal pain, nausea, vomiting, hemodynamic instability, preterm neonatal toxicity.
Syndros Clinical Trials
See Literature
Syndros Note
Not Applicable
Syndros Patient Counseling
See Literature
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