Indications and Important safety information1

Indication1

MARINOL (dronabinol capsules, USP) is indicated for the treatment of:
1. anorexia associated with weight loss in patients with AIDS; and
2. nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Important Safety Information1

Contraindications: MARINOL is contraindicated in any patient who has a known sensitivity to MARINOL or any of its ingredients, including cannabinoid and sesame oil.

Warnings: Patients receiving treatment with MARINOL should be specifically warned not to drive, operate machinery, or engage in any hazardous activity until it is established that they are able to tolerate the drug and to perform such tasks safely.

Precautions: The risk/benefit ratio of MARINOL use should be carefully evaluated in patients with the following medical conditions because of individual variation in response and tolerance to the effects of MARINOL.

MARINOL should be used with caution in patients:

  • With a history of seizure disorder, because MARINOL may lower the seizure threshold. Seizure and seizure-like activity have been reported in patients receiving MARINOL. MARINOL should be discontinued immediately in patients who develop seizures, and medical attention should be sought immediately.
  • With cardiac disorders because of occasional hypotension, possible hypertension, syncope or tachycardia.
  • With a history of substance abuse, including alcohol abuse or dependence, because they may be more prone to abuse MARINOL as well.
  • With mania, depression, or schizophrenia (along with careful psychiatric monitoring) because MARINOL may exacerbate these illnesses.
  • Receiving concomitant therapy with sedatives, hypnotics, or other psychoactive drugs, because of the potential for additive or synergistic CNS effects.
  • Who are elderly, because they may be more sensitive to the neurological, psychoactive, and postural hypotensive effects of the drug.
  • Who are pregnant, nursing mothers, or pediatric patients, because it has not been studied in these patient populations.

Adverse Reactions: Reported in clinical trials ≥1% were amnesia, anxiety/nervousness, ataxia, confusion, depersonalization, dizziness, euphoria, hallucination, paranoid reaction, somnolence, abnormal thinking, asthenia, palpitations, tachycardia, vasodilation/facial flush, abdominal pain, nausea, and vomiting.

Please click here for Full Prescribing Information for MARINOL Capsules.

Reference:
  1. MARINOL [package insert]. North Chicago, IL: AbbVie Inc.