Dronabinol 5 mg/1
Dronabinol · CAPSULE · Major Pharmaceuticals
Dronabinol is a prescription cannabinoid medication taken by mouth that is used to treat nausea and vomiting caused by cancer chemotherapy, as well as to stimulate appetite in patients with HIV/AIDS-related weight loss. It comes as a 5 mg oral capsule.
Key Facts
- Brand Name
- Dronabinol
- Generic Name
- Dronabinol
- NDC Code (Product)
0904-7145- Manufacturer
- Major Pharmaceuticals
- Strength
- 5 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA018651
- Drug Class
- Cannabinoid [EPC]
- Marketing Start
- 03/03/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dronabinol oral solution 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. Dronabinol oral solution is a cannabinoid indicated in adults for the treatment of: anorexia associated with weight loss in patients with AIDS. ( 1 ) nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administration ( 2.1 ): Always use the enclosed calibrated oral dosing syringe. The calibrated oral syringe measures a maximum dronabinol oral solution 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 dronabinol oral solution with a full glass of water (6 to 8 ounces). Dronabinol oral solution can be administered via silicone enteral feeding tubes. Anorexia Associated with Weight Loss in Adult Patients with AIDS ( 2.2 ): 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. Nausea and Vomiting Associated with Chemotherapy in Adult Patients Who Failed Conventional Antiemetics ( 2.3 ): The recommended starting dosage is 4.2 mg/m 2 , 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 witho…
Contraindications
4 CONTRAINDICATIONS Dronabinol oral solution is contraindicated in patients: with a history of a hypersensitivity reaction to dronabinol. Reported hypersensitivity reactions to dronabinol include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Adverse Reactions (6.2) ] . with a history of a hypersensitivity reaction to alcohol. who are receiving, or have recently received, disulfiram- or metronidazole-containing products within 14 days [see Warning and Precautions (5.3) ] . Dronabinol oral solution contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. Sensitivity to dronabinol or alcohol. ( 4 ) History of hypersensitivity reaction to alcohol. ( 4 ) Patients receiving, or have received, disulfiram- or metronidazole-containing products within the past 14 days. ( 4 , 5.3 , 7.1 )
Drug Interactions
7 DRUG INTERACTIONS Inhibitors and Inducers of CYP2C9 and CYP3A4 : May alter dronabinol systemic exposure; monitor for dronabinol-related adverse reactions or loss of efficacy. ( 7.2 ) Highly Protein-Bound Drugs : Potential for displacement of other drugs from plasma proteins; monitor for adverse reactions to concomitant narrow therapeutic index drugs (e.g., warfarin, cyclosporine, or amphotericin B) when initiating or increasing the dosage of dronabinol oral solution. ( 7.3 ) 7.1 Disulfiram and Metronidazole Dronabinol oral solution contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol, which can produce disulfiram-like reactions when co-administered with disulfiram or other drugs that produce this reaction (e.g., metronidazole). Discontinue products containing disulfiram or metronidazole at least 14 days before starting treatment with dronabinol oral solution and do not administer these products within 7 days of completing treatment with dronabinol oral solution [see Contraindications (4) , Warnings and Precautions (5.3) ] . When administered concomitantly with propylene glycol, ethanol competitively inhibits the metabolism of propylene glycol, which may lead to e…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, thinking abnormal, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC at 1-845-232-1683 or FDA at MedWatch phone number 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are described below and elsewhere in the labeling. Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.1) ] Hemodynamic Instability [see Warnings and Precautions (5.2) ] Seizures [see Warnings and Precautions (5.4) ] Paradoxical Nausea, Vomiting, and Abdominal Pain [see Warnings and Precautions (5.6) ] Toxicity in Preterm Neonates [see Warnings and Precautions (5.7) ] The safety of dronabinol oral solution has been established based on studies of dronabinol capsules. Studies of AIDS-related weight loss include…
Frequently Asked Questions
What is Dronabinol used for?
Dronabinol is a prescription cannabinoid medication taken by mouth that is used to treat nausea and vomiting caused by cancer chemotherapy, as well as to stimulate appetite in patients with HIV/AIDS-related weight loss. It comes as a 5 mg oral capsule.
Is Dronabinol a controlled substance?
Yes, Dronabinol is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Dronabinol?
The generic name for Dronabinol is Dronabinol. There are 6 other brand versions of Dronabinol.
What is the NDC code for Dronabinol 5 mg/1?
The NDC (National Drug Code) for Dronabinol 5 mg/1 is 0904-7145, listed by Major Pharmaceuticals.