Syndros (dronabinol)

The manufacturer of dronabinol oral solution states that a 4.2-mg dose of the oral solution appears to provide comparable systemic exposure to dronabinol as a 5-mg dose of the dronabinol oral capsule, under fasted conditions.

Dronabinol is administered orally as capsules (e.g., Marinol(R)) or oral solution (Syndros(R)).

When used for the management of anorexia in adults with acquired immunodeficiency syndrome (AIDS), administer dronabinol capsules and oral solution initially twice daily, 1 hour before lunch and dinner. In geriatric patients or patients unable to tolerate the recommended twice-daily dosage, administer dronabinol capsules and oral solution once daily, 1 hour before dinner or at bedtime to reduce the risk of CNS symptoms. Dosing dronabinol later in the day may help reduce the frequency of adverse CNS effects.

When used for the treatment of cancer chemotherapy-induced nausea and vomiting in adults who have failed conventional antiemetics, administer dronabinol capsules and oral solution 1-3 hours prior to chemotherapy and then every 2-4 hours after chemotherapy totaling 4-6 doses per day. In geriatric patients, consider initiating dronabinol capsules or oral solution at a lower dosage 1-3 hours prior to chemotherapy once daily to reduce the risk of CNS symptoms.

Because food delays absorption and can substantially affect systemic exposure, administer the first dose of dronabinol capsules or oral solution on an empty stomach, >=30 minutes before eating. Subsequent doses may be administered without regard to meals; however, administer dronabinol in a consistent manner relative to meals for each chemotherapy cycle once the dosage has been determined from the titration process.

When administering dronabinol oral solution, use the calibrated oral dosing syringe supplied by the manufacturer to ensure accurate measurement and administration of the drug. The oral syringe measures a maximum dose of 5 mg (i.e., 1 mL of the oral solution); if the prescribed dose is greater than 5 mg, divide the total dose into 2 or more portions and administer using the oral syringe. When preparing the oral solution, firmly insert the adapter provided by the manufacturer into the neck of the bottle before first use; the adapter should remain in place as long as the bottle is in use. A dose is dispensed by firmly inserting the oral dosing syringe tip into the adapter, and then carefully inverting the bottle and slowly withdrawing the appropriate dose into the syringe. Lastly, while the oral syringe and adaptor are connected, turn the bottle upright and remove the oral syringe from the adapter by gently pulling up. Slowly administer the dose into the back of the patient's mouth on top of the tongue. Administer a full glass of water (180-240 mL (6-8 ounces)) after each dose of dronabinol oral solution. For complete instructions on how to prepare and administer dronabinol oral solution, refer to the full prescribing information.

Dronabinol oral solution can be administered via enteral feeding tubes that are manufactured with silicone and of a size greater than or equal to 14 French, such as nasogastric, gastrostomy, percutaneous endoscopic gastrostomy, and gastro-jejunostomy tubes. Do not use with tubes manufactured of polyurethane. To prepare and administer the oral solution via feeding tube, first draw up the prescribed dose with the calibrated dosing syringe. If the prescribed dose is greater than 5 mg, divide the total dose and draw up in 2 or more portions using the oral syringe. Administer the dose via the feeding tube using the calibrated dosing syringe. Flush the feeding tube with 30 mL of water using a catheter-tip syringe. For complete instructions on how to prepare and administer dronabinol solution via a feeding tube, refer to the full prescribing information.

Store dronabinol capsules in a well-closed container in a cool environment between 8-15degreesC or alternatively in a refrigerator. Protect from freezing.

Store dronabinol oral solution in a refrigerator between 2-8degreesC (excursions permitted up to 25degreesC); the opened bottle can be stored at 25degreesC. Discard unused portion 42 days after first opening. Keep the oral solution and the oral syringe in the supplied carton.

No dosing information is available for this tab.

No dosing information is available for this tab.

No formal drug interaction studies have been performed with dronabinol to date. The enzyme inhibition and induction potential of dronabinol and its active metabolite have not been fully elucidated. Dronabinol is metabolized principally by cytochrome P-450 (CYP) isoenzymes 2C9 and 3A4.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*History of hypersensitivity to dronabinol or any ingredient in the formulation. Hypersensitivity reactions reported with dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, and throat tightness.

*History of hypersensitivity to sesame oil (for dronabinol capsules (e.g., Marinol(R)) as it contains sesame oil).

*History of hypersensitivity to alcohol, or in patients who are receiving or have recently received (i.e., within 14 days) preparations containing disulfiram or metronidazole (for dronabinol oral solution (Syndros(R)) as it contains 50% dehydrated alcohol and 5.5% propylene glycol).

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most common adverse reactions (>=3%) are abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, abnormal thinking, and vomiting.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and effectiveness of dronabinol have not been established in pediatric patients. Pediatric patients may be more sensitive to the neurological and psychoactive effects of the drug.

Avoid dronabinol oral solution in preterm neonates in the immediate postnatal period because of reduced metabolism of propylene glycol leading to accumulation and increased risk of possible propylene glycol-associated toxicities.

Dronabinol may cause fetal harm. Although there are limited data regarding the use of synthetic cannabinoids during pregnancy, use of cannabis during pregnancy has been associated with adverse fetal/neonatal outcomes, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to neonatal intensive care unit, and stillbirth.

Cannabinoids (delta-9-THC) have been found in umbilical cord blood from pregnant women who reported prenatal use of cannabis (e.g., marijuana), suggesting that dronabinol may cross the placenta. In addition, dronabinol oral solution (Syndros(R)) contains alcohol, which also is associated with fetal harm (e.g., CNS abnormalities, behavioral disorders, impaired intellectual development).

In reproduction studies in mice, dronabinol (delta-9-THC) was not teratogenic; however, decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions were observed at the dosages studied, which caused maternal toxicity. Maternal administration of dronabinol in rats from implantation through weaning was associated with maternal toxicity. Prenatal exposure to delta-9-THC has resulted in neurotoxicity with adverse effects on brain development in rats, including abnormal neuronal connectivity and impairments in cognitive and motor function.

Avoid use of cannabis and dronabinol in pregnant women.

The Centers for Disease Control and Prevention recommends that mothers infected with human immunodeficiency virus (HIV) not breast-feed their infants to avoid risking postnatal transmission of HIV. Because of the potential for HIV transmission (in HIV-negative infants) and serious adverse reactions in breast-fed infants, instruct mothers not to breast-feed if they are receiving dronabinol.

For mothers with nausea and vomiting associated with cancer chemotherapy, limited data are available on the presence of dronabinol in human milk, the effects of the drug on the breast-fed infant, or its effects on milk production. The reported effects of inhaled cannabis on breast-fed infants have been inconsistent and insufficient to establish causality. Reduced bodyweight has been observed during the preweaning stage in rat offspring exposed to dronabinol in utero and during lactation. Monitor weight in breast-feeding infants of mothers with nausea and vomiting associated with chemotherapy who are receiving dronabinol capsules and in whom breast-feeding is appropriate.

Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for dronabinol and any potential adverse effects on the breast-fed infant from dronabinol or from the underlying maternal condition.

In geriatric patients, exercise caution in dosage selection of dronabinol, usually starting at the low end of the recommended dosage range because these patients have a greater frequency of falls; decreased hepatic, renal, or cardiac function; increased sensitivity to psychoactive effects; and of concomitant illnesses and medication.

For the management of anorexia in geriatric patients with AIDS with dronabinol capsules (e.g., Marinol(R)), consider an initial dosage of 2.5 mg once daily 1 hour before dinner or at bedtime to reduce the risk of CNS symptoms. For the management of cancer chemotherapy-induced nausea and vomiting in geriatric patients, consider an initial dosage of 2.5 mg/m2once daily, administered 1-3 hours before chemotherapy to reduce the risk of CNS symptoms.

For the management of anorexia in geriatric patients with AIDS with dronabinol oral solution (Syndros(R)), consider an initial dosage of 2.1 mg once daily 1 hour before dinner or at bedtime to reduce the risk of CNS symptoms. For the management of cancer chemotherapy-induced nausea and vomiting in geriatric patients, consider an initial dosage of 2.1 mg/m2 once daily, administered 1-3 hours before chemotherapy to reduce the risk of CNS symptoms.

Clinical studies of dronabinol capsules in patients with AIDS and cancer >=65 years of age are insufficient to determine whether they respond differently from younger patients. Elderly patients may be more sensitive to the neuropsychiatric and postural hypotensive effects of dronabinol. Elderly patients with dementia are at increased risk for falls as a result of their underlying disease state, which may be exacerbated by the CNS effects (e.g., somnolence, dizziness) associated with dronabinol. Monitor these patients closely and place them on fall precautions before starting dronabinol. In antiemetic studies, no difference in efficacy was apparent in patients >55 years of age compared to younger patients.

Dosage selection for geriatric patients should be cautious, usually starting at the lower end of the dosage range, reflecting the greater frequency of falls and of decreased hepatic, renal, and cardiac function; increased sensitivity to psychoactive effects; and concomitant illness and other drug therapy in this population.