dronabinol

Contraindicated in:

Hypersensitivity to dronabinol, marijuana, or sesame oil;
Hypersensitivity to alcohol (oral solution contains 50% dehydrated alcohol and 5.5% propylene glycol);
Received disulfiram- or metronidazole-containing products in previous 14 days (oral solution);
Nausea and vomiting due to any other causes;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

History of substance abuse;
Cardiovascular disease (due to potential adverse effects);
Mania, depression, or schizophrenia (may worsen these conditions);
History of seizures;
Patients taking sedatives, hypnotics, or other psychoactive drugs (increased risk of adverse effects);
Pedi: Safety and effectiveness not established in children; avoid use of oral solution in preterm neonates because of risk of propylene glycol toxicity;
Geri: risk of neurological, psychoactive, and cardiovascular adverse effects in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, hypotension, palpitations, syncope, tachycardia

Derm: facial flushing

EENT: dry mouth

GI: abdominal pain, nausea, vomiting

Neuro: anxiety, concentration difficulty, confusion, dizziness, drowsiness, mood change, abnormal thinking, amnesia, ataxia, depression, disorientation, euphoria, hallucinations, headache, impaired judgment, paranoia, paresthesia, SEIZURES

Misc: physical dependence, psychological dependence (high doses or prolonged therapy)

Interactions ⬆ ⬇

Drug-drug:

Additive CNS depression with alcohol, antihistamines,barbiturates, benzodiazepines, atropine, scopolamine,lithium, buspirone, muscle relaxants, opioid analgesics, tricyclic antidepressants, and sedative/hypnotics.
↑risk of tachycardia with amphetamine, atropine, scopolamine, cocaine, sympathomimetics, antihistamines, and tricyclicantidepressants.
Concurrent use of CYP2C9 inhibitors, including amiodarone or fluconazole may ↑ levels and risk of toxicity
Concurrent use of CYP3A4 inhibitors, including clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir may ↑ levels and risk of toxicity.
May ↑ levels of theophylline.
Oral solution may ↑ risk of disulfiram-like reaction with disulfiram or metronidazole; discontinue disulfiram or metronidazole within 14 days of starting dronabinol oral solution and do not initiate disulfiram or metronidazole within 7 days of discontinuing dronabinol oral solution
May ↑ protein displacement and toxicity of amphotericin B, cyclosporine, and warfarin.

Drug-Natural Products:

↑risk of tachycardia with caffeine-containing herbs (cola nut,guarana,mate,tea,coffee).
Concomitant use of kava, valerian, skullcap, chamomile, or hopscan increase CNS depression.

Grapefruit juice may ↑ levels and risk of toxicity.

Route/Dosage ⬆ ⬇

Nausea and Vomiting Associated with Cancer Chemotherapy

PO (Adults ): Capsules: 5 mg/m² 1–3 hr prior to chemotherapy; may repeat every 2–4 hr after chemotherapy to a total of 4–6 doses/day. If 5 mg/m² dose is ineffective and no significant adverse reactions have occurred, dosage may be ↑ by 2.5 mg/m² to a maximum of 15 mg/m²/dose;Oral solution: 4.2 mg/m² 1–3 hr prior to chemotherapy; may repeat every 2–4 hr after chemotherapy to a total of 4–6 doses/day. May ↑ dose by 2.1 mg/m² if initial dose ineffective to a maximum of 12.6 mg/m²/dose.
PO Geriatric Patients ): Oral solution: 2.1 mg/m² 1–3 hr prior to chemotherapy; may repeat every 2–4 hr after chemotherapy to a total of 4–6 doses/day. May ↑ dose by 2.1 mg/m² if initial dose ineffective to a maximum of 12.6 mg/m²/dose.

Anorexia Associated with Weight Loss in AIDS

PO (Adults ): Capsules: 2.5 mg twice daily initially; may be gradually ↑ as needed (up to 20 mg/day). ↓ dose to 2.5 mg/day in the evening or at bedtime if unable to tolerate 5 mg/day dose; Oral solution: 2.1 mg twice daily 1 hr before lunch and 1 hr before dinner; may be gradually ↑ as needed (up to 8.4 mg twice daily).
PO Geriatric Patients ): Oral solution: 2.1 mg 1 hr before dinner or at bedtime, may be gradually ↑ as needed (up to 8.4 mg twice daily).

Availability ⬆ ⬇

(Generic available)

Capsules: 2.5 mg; 5 mg; 10 mg
Oral solution (contains 50% dehydrated alcohol and 5.5% propylene glycol): 5 mg/mL

Assessment ⬆ ⬇

Assess nausea, vomiting, appetite, bowel sounds, and abdominal pain prior to and following the administration.
Monitor hydration, nutritional status, and intake and output. Patients with severe nausea and vomiting may require IV fluids in addition to antiemetics.
Monitor BP and heart rate periodically during therapy.
Monitor closely for side effects; effects of dronabinol vary with each patient. Monitor for new or worsening psychiatric symptoms, cognitive impairment and altered mental state during therapy.

Implementation ⬆ ⬇

Do not confuse dronabinol with droperidol.
Physical or psychological dependence may occur with high doses or prolonged therapy, causing a withdrawal syndrome (irritability, restlessness, insomnia, hot flashes, sweating, rhinorrhea, loose stools, hiccups, anorexia) when discontinued. This is unlikely to occur with therapeutic doses and short-term use of dronabinol.
PO: Store Marinol capsules in refrigerator; do not freeze.
- Use syringe provided to measure oral solution accurately. Solution is clear, pale yellow to brown. Take each dose with a full glass of water (6–8 oz).
- May be administered via silicone enteral feeding tubes, size ≥14 French (nasogastric tube, gastrostomy tube, percutaneous endoscopic gastrostomy tube and gastrojejunostomy tube. Do not use polyurethane tubes. Flush feeding tube with 30 mL of water.
Antiemetic: Administer 1st dose on an empty stomach at least 30 min before a meal. Subsequent doses can be taken without regard to meals. Keep timing of dose in relation to meal consistent for each chemotherapy cycle. May be administered prophylactically 1–3 hr prior to chemotherapy and repeated every 2–4 hr after chemotherapy up to 4–6 doses daily. Most patients respond to 5 mg three or four times daily.
Appetite Stimulant: Give 2.5 mg twice daily 1 hr before lunch and supper initially. Reduce dose to 2.5 mg/day in the evening or at bedtime for patients unable to tolerate 5 mg/day dose. May increase dose to 2.5 mg at lunch and 5 mg before supper or 5 mg at lunch and 5 mg after supper if further therapeutic effect is desired and adverse effects are minimal. Most patients respond to 2.5 mg twice daily dose, but up to 10 mg twice daily have been tolerated in about 50% of patients. Adverse effects are dose related.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take dronabinol as directed. Take missed doses as soon as possible but not if almost time for next dose; do not double doses. Signs of overdose (mood changes, confusion, hallucinations, depression, nervousness, fast or pounding heartbeat) may occur with increased doses. Advise patient to read Patient Information prior to starting therapy and with each Rx refill in case of changes.
May cause dizziness, drowsiness, and impaired judgment and coordination. Advise patient to call for assistance when ambulating. Avoid driving or other activities requiring alertness until response to drug is known.
Instruct patient to change positions slowly to minimize orthostatic hypotension.
Advise patient to notify health care professional if new or worsening mood symptoms (symptoms of mania, depression, or schizophrenia, trouble remembering things, concentrating, increased sleepiness, confusion, headaches, vision problems, dizziness, feeling lightheaded, fainting, fast heartbeat) or seizures occur.
Caution patient to avoid taking alcohol or other CNS depressants during dronabinol therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Advise patient and family to use general measures to decrease nausea (begin with sips of liquids and small, nongreasy meals; provide oral hygiene; remove noxious stimuli from environment). Advise patient to notify health care professional if worsening nausea, vomiting, or abdominal pain occur; may require dose reduction or discontinuation of therapy.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during therapy. Instruct patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during and for 9 days after last dose. Monitor weight in infants of women taking dronabinol and breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention of and decrease in nausea and vomiting associated with chemotherapy.
Increased or maintained weight in patients with AIDS.

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆ ⬇

Schedule II (C-II)oral solution
Schedule III (C-III)capsules

Code ⬆

NDC Code

0051- AbbVie Inc.
- 0051-0021- Marinol
  - 0051-0021-21- 1 BOTTLE in 1 CARTON (0051-0021-21) > 60 CAPSULE in 1 BOTTLE

0051- AbbVie Inc.
- 0051-0022- Marinol
  - 0051-0022-21- 1 BOTTLE in 1 CARTON (0051-0022-21) > 60 CAPSULE in 1 BOTTLE

0051- AbbVie Inc.
- 0051-0023- Marinol
  - 0051-0023-21- 1 BOTTLE in 1 CARTON (0051-0023-21) > 60 CAPSULE in 1 BOTTLE

0527- Lannett Company, Inc.
- 0527-1450- Dronabinol
  - 0527-1450-06- 60 CAPSULE in 1 BOTTLE, PLASTIC (0527-1450-06)

0527- Lannett Company, Inc.
- 0527-1451- Dronabinol
  - 0527-1451-06- 60 CAPSULE in 1 BOTTLE, PLASTIC (0527-1451-06)

0527- Lannett Company, Inc.
- 0527-1452- Dronabinol
  - 0527-1452-06- 60 CAPSULE in 1 BOTTLE, PLASTIC (0527-1452-06)

0904- Major Pharmaceuticals
- 0904-6597- Dronabinol
  - 0904-6597-61- 100 BLISTER PACK in 1 CARTON (0904-6597-61) > 1 CAPSULE in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6745- DRONABINOL
  - 0904-6745-61- 100 BLISTER PACK in 1 CARTON (0904-6745-61) > 1 CAPSULE in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6746- DRONABINOL
  - 0904-6746-04- 30 BLISTER PACK in 1 CARTON (0904-6746-04) > 1 CAPSULE in 1 BLISTER PACK

17478- Akorn, Inc.
- 17478-761- Dronabinol
  - 17478-761-06- 1 BOTTLE in 1 CARTON (17478-761-06) > 60 CAPSULE in 1 BOTTLE

17478- Akorn, Inc.
- 17478-762- Dronabinol
  - 17478-762-06- 1 BOTTLE in 1 CARTON (17478-762-06) > 60 CAPSULE in 1 BOTTLE

17478- Akorn, Inc.
- 17478-763- Dronabinol
  - 17478-763-06- 1 BOTTLE in 1 CARTON (17478-763-06) > 60 CAPSULE in 1 BOTTLE

20482- Insys Therapeutics, Inc.
- 20482-335- SYNDROS
  - 20482-335-30- 1 BOTTLE, GLASS in 1 CARTON (20482-335-30) > 30 mL in 1 BOTTLE, GLASS

42858- Rhodes Pharmaceuticals L.P.
- 42858-867- DRONABINOL
  - 42858-867-06- 60 CAPSULE in 1 BOTTLE (42858-867-06)

42858- Rhodes Pharmaceuticals L.P.
- 42858-868- DRONABINOL
  - 42858-868-06- 60 CAPSULE in 1 BOTTLE (42858-868-06)

42858- Rhodes Pharmaceuticals L.P.
- 42858-869- DRONABINOL
  - 42858-869-06- 60 CAPSULE in 1 BOTTLE (42858-869-06)

49884- Par Pharmaceutical, Inc.
- 49884-867- Dronabinol
  - 49884-867-01- 100 CAPSULE in 1 BOTTLE (49884-867-01)

49884- Par Pharmaceutical, Inc.
- 49884-867- Dronabinol
  - 49884-867-02- 60 CAPSULE in 1 BOTTLE (49884-867-02)

49884- Par Pharmaceutical, Inc.
- 49884-867- Dronabinol
  - 49884-867-05- 500 CAPSULE in 1 BOTTLE (49884-867-05)

49884- Par Pharmaceutical, Inc.
- 49884-867- Dronabinol
  - 49884-867-15- 25 CAPSULE in 1 BOTTLE (49884-867-15)

49884- Par Pharmaceutical, Inc.
- 49884-868- Dronabinol
  - 49884-868-01- 100 CAPSULE in 1 BOTTLE (49884-868-01)

49884- Par Pharmaceutical, Inc.
- 49884-868- Dronabinol
  - 49884-868-02- 60 CAPSULE in 1 BOTTLE (49884-868-02)

49884- Par Pharmaceutical, Inc.
- 49884-868- Dronabinol
  - 49884-868-05- 500 CAPSULE in 1 BOTTLE (49884-868-05)

49884- Par Pharmaceutical, Inc.
- 49884-868- Dronabinol
  - 49884-868-15- 25 CAPSULE in 1 BOTTLE (49884-868-15)

49884- Par Pharmaceutical, Inc.
- 49884-869- Dronabinol
  - 49884-869-01- 100 CAPSULE in 1 BOTTLE (49884-869-01)

49884- Par Pharmaceutical, Inc.
- 49884-869- Dronabinol
  - 49884-869-02- 60 CAPSULE in 1 BOTTLE (49884-869-02)

49884- Par Pharmaceutical, Inc.
- 49884-869- Dronabinol
  - 49884-869-05- 500 CAPSULE in 1 BOTTLE (49884-869-05)

49884- Par Pharmaceutical, Inc.
- 49884-869- Dronabinol
  - 49884-869-15- 25 CAPSULE in 1 BOTTLE (49884-869-15)

60687- American Health Packaging
- 60687-375- DRONABINOL
  - 60687-375-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-375-01) > 1 CAPSULE in 1 BLISTER PACK (60687-375-11)

60687- American Health Packaging
- 60687-386- DRONABINOL
  - 60687-386-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-386-21) > 1 CAPSULE in 1 BLISTER PACK (60687-386-11)

67877- Ascend Laboratories, LLC
- 67877-568- Dronabinol
  - 67877-568-60- 1 BOTTLE in 1 CARTON (67877-568-60) > 60 CAPSULE in 1 BOTTLE

67877- Ascend Laboratories, LLC
- 67877-569- Dronabinol
  - 67877-569-60- 1 BOTTLE in 1 CARTON (67877-569-60) > 60 CAPSULE in 1 BOTTLE

67877- Ascend Laboratories, LLC
- 67877-570- Dronabinol
  - 67877-570-60- 1 BOTTLE in 1 CARTON (67877-570-60) > 60 CAPSULE in 1 BOTTLE

68084- American Health Packaging
- 68084-174- Dronabinol
  - 68084-174-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-174-01) > 1 CAPSULE in 1 BLISTER PACK (68084-174-11)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2–4 hr	4–6 hr‡

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇