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Dronabinol Dosage

Applies to the following strength(s): 2.5 mg ; 5 mg ; 10 mg ; 5 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Nausea/Vomiting - Chemotherapy Induced

Oral solution:
-Initial dose: 4.2 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day.
-Maintenance dose: May escalate dose by 2.1 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects.
-Maximum dose: 12.6 mg/m2 per dose

Oral solution comments:
-The initial dose should be rounded to the nearest 0. 1 mg increment, and may need to be rounded to the nearest 0.1 mL increment (for dosing with an oral syringe).
-Patients should be given the initial dose on an empty stomach at least 30 minutes before eating; subsequent doses may be given without regard to meals.
-Healthcare providers should consider decreasing the dose to 2.1 mg orally once a day 1 to 3 hours prior to chemotherapy to decrease the risk of adverse reactions.

Oral tablets:
-Initial dose: 5 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day.
-Maintenance dose: May escalate dose by 2.5 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects.
-Maximum dose: 15 mg/m2 per dose

Oral tablet comments:
-Most patients respond to 5 mg given 3 or 4 times daily.
-Clinical trial data indicate escalating the dose above 7 mg/m2 increased the frequency of adverse effects with no additional antiemetic benefit.

Use: Treatment for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments

Usual Adult Dose for Anorexia

Oral solution:
-Initial dose: 2.1 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.1 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 4.2 mg/day.
-Maintenance dose: May increase dose to 2.1 mg/day or 4.2 mg/day orally (2.1 mg 1 hour before lunch and 4.2 mg 1 hour before dinner OR 4.2 mg 1 hour before lunch and 4.2 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired.
-Maximum dose: 16.8 mg/day (8.4 mg orally 2 times a day)

Oral tablets:
-Initial dose: 2.5 mg orally 2 times a day 1 hour before lunch and dinner; reduce dose to 2.5 mg orally once a day 1 hour before dinner or at bedtime for patients unable to tolerate 5 mg/day.
-Maintenance dose: May increase dose to 7.5 mg/day or 10 mg/day orally (2.5 mg before 1 hour before lunch and 5 mg 1 hour before dinner OR 5 mg 1 hour before lunch and 5 mg 1 hour before dinner) when adverse effects are absent/minimal or when further therapeutic effect is desired.
-Maximum dose: 20 mg/day (10 mg orally 2 times a day)

Comments:
-The majority of patients in clinical trials were treated with oral tablet formulations of 5 mg/day, although the dosages ranged from 2.5 to 20 mg/day.
-If CNS symptoms (e.g., feeling high, dizziness, confusion, somnolence) occur, they usually resolve in 1 to 3 days with continued dosage.
-Early morning administration has been associated with an increased frequency of adverse reactions as compared to dosing later in the day.

Use: Appetite stimulant for anorexia associated with weight loss in AIDS patients

Usual Pediatric Dose for Nausea/Vomiting - Chemotherapy Induced

Oral tablets:
-Initial Dose: 5 mg/m2 orally 1 to 3 hours prior to chemotherapy administration, then every 2 to 4 hours after chemotherapy for a total of 4 to 6 doses a day.
-Maintenance Dose: May escalate dose by 2.5 mg/m2 increments during a chemotherapy cycle or at subsequent cycles if the initial dose is ineffective and there are no significant side effects.
-Maximum Dose: 15 mg/m2 per dose

Comments:
-This drug should be used with caution in children because of its psychoactive effects.
-Most patients respond to 5 mg given 3 or 4 times daily.
-Clinical trial data indicate escalating the dose above 7 mg/m2 increased the frequency of adverse effects with no additional antiemetic benefit.

Use: Treatment for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Nausea/Vomiting-Chemotherapy Induced:
-Oral solution: Healthcare providers should consider initial doses of 2.1 mg/m2 orally once a day 1 to 3 hours before chemotherapy in geriatric patients to reduce the risk of CNS reactions.

Severe or Persistent CNS Symptoms (when treating anorexia in AIDS patients):
-Oral solution: 2.1 mg orally once a day 1 hour before dinner
-Oral tablets: 2.5 mg orally once a day 1 hour before dinner
-Doses should be given in the evening or at bedtime if symptoms continue to be a problem.

Precautions

Safety and efficacy in oral solution formulations and in the treatment of AIDS-related anorexia have not been established in pediatric patients; this drug is not recommended for use in these patients.

Consult WARNINGS section for additional precautions.

US Controlled Substance:
-Schedule II (oral solution formulations)
-Schedule III (oral capsule formulations)

Dialysis

Data not available

Other Comments

Administration advice:
-Caution is recommended in dose escalation due to the significant increase of disturbing psychiatric symptoms at the maximum dose.
-Coadministration with phenothiazines (e.g., prochlorperazine) may result in improved efficacy, as compared to either drug alone, without additional toxicity.
-Dose individualization is recommended to achieve maximum treatment benefit.
-Therapy should be initiated at the lowest recommended dose and titrated to clinical response.
-Patients should drink a full glass of water after taking a dose of the oral solution.

Storage requirements:
-This drug should be packaged in a well-closed container, with unopened bottles kept refrigerated at 2 to 8 degrees Celsius (36 to 46 Fahrenheit), and protected from freezing.
-Oral solution formulations may be stored at 20 to 25C once opened for up to 28 days.

Reconstitution/preparation techniques: The manufacturer product information should be consulted for further details regarding the oral solution.

General:
-This drug demonstrates reversible, dose-related effects on appetite, mood, cognition, memory, and perception; these phenomena increase in frequency with higher dosages and are subject to great interpatient variability.
-Tachyphylaxis and tolerance develop to some of the pharmacologic effects of this drug and other cannabinoids with chronic use; however, they do not appear to develop to the appetite stimulant effect of this drug.
-The estimated lethal human dose is 30 mg/kg (IV).
-Overdosage: Gut decontamination is recommended for recent serious oral ingestion; the manufacturer product information should be consulted for overdose management.

Monitoring:
-Cardiovascular: Blood pressure and heart rate (after dose adjustments)
-Nervous System: Signs/symptoms of syncope (after dose adjustments); seizures

Patient advice:
-This drug may cause side effects such as dizziness and drowsiness that can affect your ability to perform certain activities; avoid driving and tasks such as operating machinery until you know that you can perform these activities safely during treatment.
-Do not drink alcohol while taking this drug.

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