Syndros

SYNDROS is indicated in adults for the treatment of:

• anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS).
• nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

• Always use the enclosed calibrated oral dosing syringe.
• The calibrated oral syringe measures a maximum SYNDROS dose of 5 mg. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe.
• Take SYNDROS with a full glass of water (6 to 8 ounces).
• SYNDROS can be administered via silicone enteral feeding tubes.

• The recommended starting dosage is 2.1 mg orally twice daily, one hour before lunch and dinner.
• See the full prescribing information for dosage titration to manage adverse reactions and to achieve desired therapeutic effect.

• The recommended starting dosage is 4.2 mg/m², administered 1 to 3 hours prior to chemotherapy, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses per day. Administer the first dose on an empty stomach at least 30 minutes prior to eating; subsequent doses can be taken without regard to meals.
• See the full prescribing information for dosage titration to manage adverse reactions and to achieve desired therapeutic effect.

Oral Solution: 5 mg/mL, a clear, pale yellow to brown solution.

• Pregnancy
  : May cause fetal harm.
• Lactation
  : Advise HIV infected women not to breastfeed due to the potential for HIV transmission.
• Geriatric Use:
  Elderly patients may be more sensitive to the neuropsychiatric and postural hypotensive effects. Consider a lower starting dose in elderly patients.

• Neuropsychiatric Adverse Reactions
  : May cause psychiatric and cognitive effects and impair mental and/or physical abilities. Avoid use in patients with a psychiatric history. Monitor for symptoms and avoid concomitant use of drugs with similar effects. Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that SYNDROS does not affect them adversely.
• Hemodynamic Instability
  : Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Avoid concomitant use of drugs with similar effects and monitor for hemodynamic changes after initiating or increasing the dosage of SYNDROS.
• Interaction with Disulfiram and Metronidazole
  : May cause disulfiram-like reaction. Discontinue products containing disulfiram or metronidazole at least 14 days before and do not administer 7 days after treatment with SYNDROS.
• Seizures and Seizure-like Activity
  : Weigh the potential risk versus benefits before prescribing SYNDROS to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold. Monitor patients and discontinue if seizures occur.
• Multiple Substance Abuse
  : Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing SYNDROS and monitor for the development of associated behaviors or conditions.
• Paradoxical Nausea, Vomiting, or Abdominal Pain
  : Consider dose reduction or discontinuation, if worsening of symptoms while on treatment.
• Toxicities Related to Propylene Glycol in Preterm Neonates
  : The safety and effectiveness of SYNDROS have not been established in pediatric patients. Avoid use in preterm neonates in the immediate postnatal period.