DRONABINOL 5 mg/mL Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cannabinoid class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Dronabinol is specifically approved for situations where standard anti-nausea medications haven't worked well enough. It works differently from typical anti-nausea drugs — it acts...
- Why did my doctor prescribe this instead of a regular anti-nausea pill?
- Yes, that's a known and expected effect — the clinical trials even tracked it. You might feel euphoric, giggly, or have a heightened sense of awareness, especially early on. The go...
- Will this make me feel "high"? Is that normal?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dronabinol — tap one for details:
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dronabinol 5 mg/mL 62135-0033-43 | Chartwell | 1 bottle | — | — | FDA listed | — |
| Syndros 5 mg/mL 78613-0201-30 | Benuvia | 1 bottle | — | — | FDA listed | — |
| Syndros 5 mg/mL 85776-0201-30 | Wellhouse | 1 bottle | — | — | FDA listed | — |
| Dronabinol 5 mg/mLthis 85776-0202-30 | Wellhouse | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10265293 ↗ | Drug substance | — | Aug 6, 2028 |
| US 9345771 ↗ | Drug substance | — | Aug 6, 2028 |
| US 11253472 ↗ | Drug substance | — | Aug 6, 2028 |
| US 8222292 ↗ | Drug substance | — | Aug 6, 2028 |
Is there a generic version of this drug?
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Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 85776-0202-30 You're viewing this | 1 BOTTLE, GLASS in 1 CARTON (85776-202-30) / 30 mL in 1 BOTTLE, GLASS | 2026-02-11 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and 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 and 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 without regard to meals.
See the full prescribing information for dosage titration to manage adverse reactions and to achieve desired therapeutic effect.
2.1Important Administration Instructions Oral Administration Always use the enclosed calibrated oral dosing syringe when administering dronabinol oral solution to ensure the dose is measured and administered accurately. 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 each dose of dronabinol oral solution with a full glass of water (6 to 8 ounces). For information on dosing dronabinol with regard to meals, see Dosage and Administration 2.2 and 2.3 . Administration via Feeding Tube (silicone only, greater than or equal to 14 French) Dronabinol oral solution can be administered via enteral feeding tubes that are manufactured using silicone, size greater than or equal to 14 French, such as Naso-Gastric (NG), Gastrostomy Tube (G-tube), Percutaneous Endoscopic Gastrostomy tube (PEG-tube) and Gastro-Jejunostomy tube (GJ-tube).
Do not use tubes manufactured of polyurethane. Draw up the prescribed dose with the calibrated dosing syringe packaged with dronabinol oral solution. 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.
Using the calibrated dosing syringe, administer the dose via the feeding tube. Using a catheter-tip syringe, flush the feeding tube with 30 mL of water.
2.2Anorexia Associated with Weight Loss in Adult Patients with AIDS Starting Dosage The recommended adult starting dosage of dronabinol oral solution is 2.1 mg orally twice daily, one hour before lunch and one hour before dinner. In elderly patients, or patients unable to tolerate 2.1 mg twice daily, consider initiating dronabinol oral solution at 2.1 mg once daily one hour before dinner or at bedtime to reduce the risk of central nervous system (CNS) symptoms [see Use in Specific Populations ( 8.5 ) ] . Dosing later in the day may reduce the frequency of Central Nervous System (CNS) adverse reactions.
CNS adverse reactions are dose-related [see Warnings and Precautions ( 5.1 )] ; therefore, monitor patients and reduce the dosage as needed. If CNS adverse reactions of feeling high, dizziness, confusion, and somnolence occur, they usually resolve in 1 to 3 days and usually do not require dosage reduction. If CNS adverse reactions are severe or persistent, reduce the dosage to 2.1 mg once daily one hour before dinner or in the evening at bedtime.
Dosage Titration If tolerated and further therapeutic effect is desired, the dosage may be increased gradually to 2.1 mg…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Oral Solution: 5 mg/mL, a clear, pale yellow to brown solution. Oral Solution: 5 mg/ mL ( 3 )
⛔ 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 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 dronabinol oral solution does not affect them adversely. ( 5.1 ) 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 dronabinol oral solution.
( 5.2 ) 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 dronabinol oral solution. ( 4 , 5.3 , 7.1 ) Seizures and Seizure-like Activity : Weigh the potential risk versus benefits before prescribing dronabinol oral solution 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. ( 5.4 ) Multiple Substance Abuse : Assess risk for abuse or misuse in patients with a history of substance abuse or dependence, prior to prescribing dronabinol oral solution and monitor for the development of associated behaviors or conditions. ( 5.5 ) Paradoxical Nausea, Vomiting, or Abdominal Pain : Consider reduction or discontinuation, if worsening of symptoms while on treatment.
( 5.6 ) Toxicities Related to Propylene Glycol in Preterm Neonates : The safety and effectiveness of dronabinol oral solution have not been established in pediatric patients. Avoid use in preterm neonates in the immediate postnatal period. ( 5.7 )
5.1Neuropsychiatric Adverse Reactions Psychiatric Adverse Reactions Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Prior to initiating treatment with dronabinol oral solution, screen patients for a history of these illnesses. Avoid use in patients with a psychiatric history or, if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment.
Also, avoid concomitant use with other drugs that are associated with similar psychiatric effects. Cognitive Adverse Reactions Use of dronabinol oral solution has been associated with cognitive impairment and altered mental state. Reduce the dose of dronabinol oral solution or discontinue use of dronabinol oral solution if signs or symptoms of cognitive impairment develop.
Elderly and pediatric patients may be more sensitive to the neurological and psychoactive effects of dronabinol oral solution [see Use in Specific Populations ( 8.4 , 8.5 )] . Hazardous Activities Dronabinol oral solution can cause and may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle or operating machinery. Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, and muscle relaxants).
Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol oral solution does not affect them adversely.
5.2Hemodynamic Instability Patients may experience occasional hypotension, possible hypertension, syncope, or tachycardia while taking dronabinol oral solution [see Clinical Pharmacology ( 12.2 )] . Patients with cardiac disorders may be at higher risk. Avoid concomitant use of other drugs that are also associated with similar cardiac effects (e.g., ampheta…
🤒 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 Wellhouse Pharma, LLC at 1-844-558-8289 or FDA at MedWatch phone number 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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 included 157 patients receiving dronabinol capsules and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving dronabinol capsules and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to dronabinol capsules in studies.
Studies of different durations were combined by considering the first occurrence of adverse reactions during the first 28 days. A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving dronabinol capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving dronabinol capsules.
About 25% of patients reported a CNS adverse reaction during the first 2 weeks and about 4% reported such a reaction each week for the next 6 weeks thereafter. Common Adverse Reactions The following adverse reactions were reported in clinical trials of dronabinol capsules at an incidence greater than 1%. *Actual Incidence 3% to 10% System Organ Class Adverse Reactions General Asthenia Cardiovascular Palpitations, tachycardia, vasodilation/facial flush Gastrointestinal Abdominal pain*, nausea*, vomiting* Central Nervous System Dizziness*, euphoria*, paranoid reaction*, somnolence*, thinking abnormal*, amnesia, anxiety/nervousness, ataxia, confusion, depersonalization, hallucination Less Common Adverse Reactions The following adverse reactions were reported in clinical trials of dronabinol capsules at an incidence less than or equal to 1%.
System Organ Class Adverse Reactions General Chills, headache, malaise Cardiovascular Hypotension, conjunctival injection [see Clinical Pharmacology ( 12.2 )] Gastrointestinal Diarrhea, fecal incontinence, anorexia, hepatic enzyme elevation Musculoskeletal Myalgias Central Nervous System Depression, nightmares, speech difficulties, tinnitus Respiratory Cough, rhinitis, sinusitis Skin Flushing, sweating Sensory Vision difficulties
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of another oral formulation of dronabinol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions: fatigue.
Hypersensitivity reactions : lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see Contraindications ( 4 )] . Injury, poisoning and procedural complications :…
🔄 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 )
7.1Disulfiram 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 elevated concentrations of propylene glycol. However, the contribution of propylene glycol, if any, to the interaction between disulfiram and dronabinol oral solution is unknown.
7.2Effect of Other Drugs on Dronabinol Dronabinol is primarily metabolized by CYP2C9 and CYP3A4 enzymes. Inhibitors of these enzymes may increase, while inducers may decrease, the systemic exposure of dronabinol and/or its active metabolite resulting in an increase in dronabinol-related adverse reactions or loss of efficacy of dronabinol oral solution. Monitor for increased dronabinol-related adverse reactions when dronabinol oral solution is co-administered with inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) and inhibitors of CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).
7.3Highly Protein-Bound Drugs Dronabinol is highly bound to plasma proteins, and therefore, might displace and increase the free fraction of other concomitantly administered protein-bound drugs. Although this displacement has not been confirmed in vivo, monitor patients for increased adverse reactions to narrow therapeutic index drugs (e.g., warfarin, cyclosporine, amphotericin B) when initiating treatment or increasing the dosage of dronabinol oral solution.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm. ( 8.1 ) Lactation : Advise HIV infected women not to breastfeed due to the potential for HIV transmission. ( 8.2 ) Geriatric Use: Elderly patients may be more sensitive to the neuropsychiatric and postural hypotensive effects. Consider a lower starting dose in elderly patients. ( 2.2 , 2.3 , 5.1 , 5.2 , 8.5 )
8.1Pregnancy Risk Summary Dronabinol oral solution, a synthetic cannabinoid containing alcohol, may cause fetal harm. Avoid use of dronabinol oral solution in pregnant women. Although there is little published data on the use of synthetic cannabinoids during pregnancy, use of cannabis (e.g., marijuana) and use of alcohol during pregnancy have been associated with adverse fetal/neonatal outcomes (see Clinical Considerations ) .
Cannabinoids have been found in the umbilical cord blood from pregnant women who smoke cannabis. In animal reproduction studies, no teratogenicity was reported in mice administered dronabinol (delta-9-THC) at up to 30 times the MRHD (maximum recommended human doses) and up to 5 times the MRHD for patients with AIDS and cancer, respectively. Similar findings were reported in pregnant rats administered dronabinol at up to 5 to 20 times the MRHD and 3 times the MRHD for patients with AIDS and cancer, respectively.
Decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions were observed in both species at doses which induced maternal toxicity. In rats, maternal administration of dronabinol from pregnancy (implantation) through weaning was associated with maternal toxicity, including mortality of pups, and adverse developmental and neurodevelopmental effects on the pups at 2 to 20 times the MRHD for patients with AIDS and less than and up to 3.3 times the MRHD for patients with cancer.
(see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Published studies suggest that during pregnancy, the use of cannabis, which includes THC, whether for recreational or medicinal purposes, may increase the risk of adverse fetal/neonatal outcomes including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to the neonatal intensive care unit, and stillbirth.
Therefore, use of cannabis during pregnancy should be avoided. Dronabinol oral solution contains alcohol. Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development.
Avoid use of Dronabinol oral solution in pregnant women. Data Human Data Delta-9-THC has been measured in the cord blood of some infants whose mothers reported prenatal use of cannabis, suggesting that dronabinol may cross the placenta to the fetus during pregnancy. The effects of delta-9-THC on the fetus are not known.
Animal Data The recommended dose ranges for dronabinol oral solution in patients with AIDS and patients with cancer are designed to achieve the same systemic exposure ranges to delta-9-THC as with the recommended dose ranges for dronabinol capsules. Therefore, animal to human dose multiples, as shown below, are based on the MRHDs (maximum recommended human doses) for dronabinol capsules, instead of the MRHDs for dronabinol oral solution, which are 15% lower. This approach for dose comparison between animals and humans is supported by the demonstrated difference in dronabinol bioavailability between dronabinol oral solution and dronabinol capsules.
Reproduction studies with dronabinol have been performed in mice at 15…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Dronabinol oral solution, a synthetic cannabinoid containing alcohol, may cause fetal harm. Avoid use of dronabinol oral solution in pregnant women. Although there is little published data on the use of synthetic cannabinoids during pregnancy, use of cannabis (e.g., marijuana) and use of alcohol during pregnancy have been associated with adverse fetal/neonatal outcomes (see Clinical Considerations ) .
Cannabinoids have been found in the umbilical cord blood from pregnant women who smoke cannabis. In animal reproduction studies, no teratogenicity was reported in mice administered dronabinol (delta-9-THC) at up to 30 times the MRHD (maximum recommended human doses) and up to 5 times the MRHD for patients with AIDS and cancer, respectively. Similar findings were reported in pregnant rats administered dronabinol at up to 5 to 20 times the MRHD and 3 times the MRHD for patients with AIDS and cancer, respectively.
Decreased maternal weight gain and number of viable pups and increased fetal mortality and early resorptions were observed in both species at doses which induced maternal toxicity. In rats, maternal administration of dronabinol from pregnancy (implantation) through weaning was associated with maternal toxicity, including mortality of pups, and adverse developmental and neurodevelopmental effects on the pups at 2 to 20 times the MRHD for patients with AIDS and less than and up to 3.3 times the MRHD for patients with cancer.
(see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Published studies suggest that during pregnancy, the use of cannabis, which includes THC, whether for recreational or medicinal purposes, may increase the risk of adverse fetal/neonatal outcomes including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, admission to the neonatal intensive care unit, and stillbirth.
Therefore, use of cannabis during pregnancy should be avoided. Dronabinol oral solution contains alcohol. Published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development.
Avoid use of Dronabinol oral solution in pregnant women. Data Human Data Delta-9-THC has been measured in the cord blood of some infants whose mothers reported prenatal use of cannabis, suggesting that dronabinol may cross the placenta to the fetus during pregnancy. The effects of delta-9-THC on the fetus are not known.
Animal Data The recommended dose ranges for dronabinol oral solution in patients with AIDS and patients with cancer are designed to achieve the same systemic exposure ranges to delta-9-THC as with the recommended dose ranges for dronabinol capsules. Therefore, animal to human dose multiples, as shown below, are based on the MRHDs (maximum recommended human doses) for dronabinol capsules, instead of the MRHDs for dronabinol oral solution, which are 15% lower. This approach for dose comparison between animals and humans is supported by the demonstrated difference in dronabinol bioavailability between dronabinol oral solution and dronabinol capsules.
Reproduction studies with dronabinol have been performed in mice at 15 to 450 mg/m 2 , equivalent to 1 to 30 times the MRHD of 15 mg/m 2 /day (dronabinol capsules) in patients with AIDS or 0.2 to 5 times the MRHD of 90 mg/m 2 /day (dronabinol capsules) in patients with cancer, and in rats at 74 to 295 mg/m 2 (equivalent to 5 to 20 times the MRHD of 15 mg/m 2 /day in patients with AIDS or 0.8 to 3 times the MRHD of 90 mg/m 2 /day in patients w…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dronabinol oral solution have not been established in pediatric patients. Pediatric patients may be more sensitive to neurological and psychoactive effects of dronabinol oral solution [see Warnings and Precautions ( 5.1 )] . Dronabinol oral solution contains the excipients 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol.
Ethanol competitively inhibits the metabolism of propylene glycol, which may lead to elevated concentrations of propylene glycol. Preterm neonates may be at increased risk of propylene glycol-associated adverse events due to diminished ability to metabolize propylene glycol, thereby, leading to accumulation [see Warnings and Precautions ( 5.7 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of dronabinol capsules in AIDS and cancer patients did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be more sensitive to the neuropsychiatric and postural hypotensive effects of dronabinol oral solution [see Warnings and Precautions ( 5.1 , 5.2 )] . 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 of somnolence and dizziness associated with dronabinol oral solution [see Warnings and Precautions ( 5.1 )] .
These patients should be monitored closely and placed on fall precautions prior to initiating dronabinol oral solution therapy . In antiemetic studies, no difference in efficacy was apparent in patients greater than 55 years of age compared to younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of falls, decreased hepatic, renal, or cardiac function, increased sensitivity to psychoactive effects, and of concomitant disease or other drug therapy [see Dosage and Administration ( 2.2 , 2.3 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Dronabinol oral solution contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. Ingestion of the product over the recommended dose could result in significant toxicity. Dronabinol Signs and symptoms of dronabinol overdose include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth, tachycardia, memory impairment, depersonalization, mood alteration, urinary retention, reduced bowel motility, decreased motor coordination, lethargy, slurred speech, and postural hypotension.
Patients may also experience panic reactions if they have a prior history of nervousness or anxiety and seizures may occur in patients with existing seizure disorders. It is not known if dronabinol can be removed by dialysis in cases of overdose. Alcohol Signs and symptoms of alcohol overdose include changes in mood or behavior, impaired judgment or social functioning and one or more physical signs such as slurred speech, unsteadiness, lack of coordination, increased or irregular heart rate, respiratory depression, impaired attention or loss of consciousness.
Propylene Glycol Signs and symptoms of acute poisoning occur only in rare circumstances where patients ingest large amounts of propylene glycol over several days. These include hypoglycemia, severe metabolic acidosis (caused by the metabolism into lactic acid), and CNS depression including coma and seizures. Management of Overdosage If over-exposure of dronabinol oral solution occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Dronabinol is an orally active cannabinoid that has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.
12.2Pharmacodynamics Effects on the Cardiovascular System Dronabinol-induced sympathomimetic activity may result in tachycardia and/or conjunctival injection. Its effects on blood pressure are inconsistent, but subjects have experienced orthostatic hypotension and/or syncope upon abrupt standing [see Warnings and Precautions ( 5.2 )] . Effects on the Central Nervous System Dronabinol also demonstrates reversible effects on appetite, mood, cognition, memory, and perception.
These phenomena appear to be dose-related, increasing in frequency with higher dosages, and subject to great inter-patient variability. After oral administration, dronabinol capsules have an onset of action of approximately 0.5 to 1 hours and peak effect at 2 to 4 hours. Duration of action for psychoactive effects is 4 to 6 hours, but the appetite stimulant effect of dronabinol may continue for 24 hours or longer after administration.
Tachyphylaxis and tolerance develop to some of the cardiovascular and CNS pharmacologic effects of dronabinol with chronic use, suggesting an indirect effect on sympathetic neurons. In a study of the pharmacodynamics of chronic dronabinol exposure, healthy male subjects (N = 12) received 12 times the maximum dose for anorexia associated with weight loss in patients with AIDS of dronabinol capsules in divided doses for 16 days. An initial tachycardia induced by dronabinol was replaced successively by normal sinus rhythm and then bradycardia.
A decrease in supine blood pressure, made worse by standing, was also observed initially. These subjects developed tolerance to the cardiovascular and subjective adverse CNS effects of dronabinol within 12 days of treatment initiation. Tachyphylaxis and tolerance do not appear to develop to the appetite stimulant effect of dronabinol.
In clinical studies of dronabinol capsules in AIDS patients, at the recommended dosage, the appetite stimulant effect was sustained for up to five months.
12.3Pharmacokinetics Absorption Dronabinol (delta-9-THC) is almost completely absorbed (90 to 95%) after a single oral dose. Due to the combined effects of first pass hepatic metabolism and high lipid solubility, only 10 to 20% of the administered dose reaches the systemic circulation. Relative bioavailability data from healthy male and female subjects suggest that a dose of 4.2 mg of dronabinol oral solution provides comparable systemic exposure (C max and AUC) to a 5 mg dronabinol capsule, under fasted conditions [see Dosage and Administration ( 2.1 )] .
The concentrations of both dronabinol and its major active metabolite (11-hydroxy-delta-9-THC) peak at approximately 0.5 to 4 hours after oral dosing with dronabinol oral solution and decline over several days. The mean inter- and intra-subject variability in dronabinol pharmacokinetics (C max and AUC inf ) was approximately 66% and 47% and 67% and 14%, respectively, following administration of dronabinol oral solution to healthy subjects. Table 1: Summary of Single-Dose Pharmacokinetic Parameters of Dronabinol After Replicated Oral Administration of Dronabinol (4.2 mg to Healthy Subjects under Fasted Conditions) * Arithmetic mean ± standard deviation except T max for which the median [range] is reported Parameter* Dronabinol C max (ng/mL) 1.9 ±
1.3T max (h) 1.0 [0.5 to 4.0] AUC (inf) (ng.h/mL) 3.8 ± 1.8 t ½ (h) 5.6 ±
2.7Food Effect The effect of food on the pharmacokinetics of dronabinol oral solution was studied by concomitant dosing of dronabinol oral solution with a high-fat (59 grams of fat, approximately 50% of total caloric content of the meal), high calorie meal (approximately 950 calories). An appreciable food effect was observed: food result…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Dronabinol is an orally active cannabinoid that has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dronabinol oral solution (dronabinol) oral solution, 5 mg/mL is a clear, pale yellow to brown solution. Dronabinol oral solution is supplied in a multi-dose, clear, amber-colored 30 mL glass bottle. It is closed with a 20 mm child-resistant, white polypropylene screw cap with a Teflon coated liner.
The bottle is wrapped with a polyvinyl chloride body band to provide tamper evidence and packaged in a carton with an oral syringe, and a push-in bottle adapter. NDC 85776-202-30 (30 mL multi-dose bottle, an oral syringe and a push-in bottle adapter) Store in a refrigerator between 2°C and 8°C (36°F and 46°F); excursions permitted up to 25°C (77°F). The opened bottle can be stored at 25°C (77°F).
Discard unused portion 42 days after first opening [see USP Controlled Room Temperature]. Keep Dronabinol oral solution and the oral syringe in the supplied carton.
📋 Description ▾
11 DESCRIPTION Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas: C 21 H 30 O 2 (molecular weight=314.46) Dronabinol is a clear colorless to amber oil. Dronabinol is insoluble in water.
It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7. Dronabinol oral solution, 5 mg/mL is a clear, pale yellow to brown solution. Each mL of dronabinol oral solution contains 5 mg of dronabinol as an active ingredient and the following inactive ingredients: 50 % (w/w) dehydrated alcohol, polyethylene glycol 400, propylene glycol, sucralose, methyl paraben, propyl paraben, butylated hydroxyanisole, and water.
Dronabinol Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Accidental Ingestion Inform patients that accidental ingestion of dronabinol oral solution, which contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol, may result in toxicity [see Overdosage ( 10 )] . Instruct patients to seek immediate medical attention in case of accidental ingestion.
Also, instruct patients to store dronabinol oral solution securely. Administration Instructions Counsel patients on proper dosing and administration techniques. Advise patients to read the Instructions for Use.
Instruct patients to take each dronabinol oral solution dose with a full glass of water (6 to 8 ounces). Neuropsychiatric Adverse Reactions [see Warnings and Precautions ( 5.1 )] Advise patients that psychiatric adverse reactions may occur, especially in patients with a past psychiatric history or in those receiving other drugs also associated with psychiatric effects, and to report to their healthcare provider any new or worsening psychiatric symptoms. Advise patients, especially elderly patients, that cognitive impairment or an altered mental state may also occur during treatment with dronabinol oral solution and to report to their healthcare provider if they develop signs or symptoms of cognitive impairment.
Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that dronabinol oral solution does not affect them adversely. Hemodynamic Instability Advise patients, especially those with cardiac disorders, to report to their healthcare provider if they experience any signs or symptoms of hemodynamic instability, including hypotension, hypertension, syncope or tachycardia, especially after initiating or increasing the dosage of dronabinol oral solution [see Warnings and Precautions ( 5.2 )] .
Interaction with Disulfiram and Metronidazole Inform patients that taking dronabinol oral solution with products containing disulfiram or metronidazole may cause a disulfiram-like reaction due to the alcohol content of dronabinol oral solution. Advise patients not to take products containing disulfiram or metronidazole during treatment with dronabinol oral solution and for up to 7 days of completing treatment with dronabinol oral solution [see Warnings and Precautions ( 5.3 )] . Seizures Advise patients to discontinue dronabinol oral solution and contact a healthcare provider immediately if they experience a seizure [see Warnings and Precautions ( 5.4 )].
Multiple Substance Abuse Inform patients with a history of substance abuse or dependence, including marijuana or alcohol, that they may be more likely to abuse dronabinol oral solution. Advise patients to report to their healthcare provider if they develop abuse behaviors or conditions [see Warnings and Precautions ( 5.5 )] . Paradoxical Nausea, Vomiting, or Abdominal Pain Advise patients to report worsening nausea, vomiting, or abdominal pain to their healthcare provider [see Warnings and Precautions ( 5.6 )] .
Pregnancy Advise a pregnant woman of the potential risk to a fetus and to avoid use of dronabinol oral solution during pregnancy. [see Use in Specific Populations ( 8.1 )]. Lactation Advise HIV infected women with anorexia associated with weight loss, not to breastfeed because HIV can be passed to the baby through the breast milk [see Use in Specific Populations ( 8.2 )]. Manufactured for: Wellhouse Pharma, LLC Round Rock, TX 78665 01/2026