Drugs Details

Drugs Info of Marinol
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Feb 2015 12:01 am
  • Brand Name : Marinol
  • Generic Name :  dronabinol (Pronunciation: droe NAH bih nol)
Descriptions


Dronabinol is a cannabinoid designated chemically as (6aR-trans)-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:

 

MARINOL (dronabinol) structural formula illustration

 

Dronabinol, the active ingredient in MARINOL® (dronabinol) Capsules, is synthetic delta-9- tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol is also a naturally occurring component of Cannabis sativa L. (Marijuana).

Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.

Capsules for oral administration: MARINOL (dronabinol) Capsules is supplied as round, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each MARINOL (dronabinol) Capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.

 

What are the possible side effects of dronabinol (Marinol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dronabinol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • paranoia, extreme fear;
  • fast heart rate;
  • feeling light-headed, fainting; or
  • unusual thoughts or behavior.

Continue using dronabinol and talk with your doctor if you have any of these less serious side effects:

  • mood...

Read All Potential Side Effects and See Pictures of Marinol »

What are the precautions when taking dronabinol (Marinol)?

Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood disorders (such as mania, depression, schizophrenia), seizures.

This drug may make you dizzy or drowsy or affect your judgment. Do not do any activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects you and...

Read All Potential Precautions of Marinol »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

MARINOL (dronabinol) Capsules 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.

Dosage Administration

Appetite Stimulation: Initially, 2.5 mg MARINOL (dronabinol) Capsules should be administered orally twice daily (b.i.d.), before lunch and supper. For patients unable to tolerate this 5 mg/day dosage of MARINOL (dronabinol) Capsules, the dosage can be reduced to 2.5 mg/day, administered as a single dose in the evening or at bedtime. If clinically indicated and in the absence of significant adverse effects, the dosage may be gradually increased to a maximum of 20 mg/day MARINOL (dronabinol) Capsules, administered in divided oral doses. Caution should be exercised in escalating the dosage of MARINOL (dronabinol) Capsules because of the increased frequency of dose-related adverse experiences at higher dosages. (See PRECAUTIONS.)

Antiemetic: MARINOL (dronabinol) Capsules is best administered at an initial dose of 5 mg/m2, given 1 to 3 hours prior to the administration of chemotherapy, then every 2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Should the 5 mg/m2 dose prove to be ineffective, and in the absence of significant side effects, the dose may be escalated by 2.5 mg/m2 increments to a maximum of 15 mg/m2 per dose. Caution should be exercised in dose escalation, however, as the incidence of disturbingpsychiatric symptoms increases significantly at maximum dose. (SeePRECAUTIONS.)

Storage Conditions

MARINOL (dronabinol) Capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could be stored in a refrigerator. Protect from freezing.

How Supplied

MARINOL Capsules (dronabinol solution in sesame oil in soft gelatin capsules)

2.5 mg white capsules (Identified UM).

NDC 0051-0021-21 (Bottle of 60 capsules).

5 mg dark brown capsules (Identified UM).

NDC 0051-0022-21 (Bottle of 60 capsules).

10 mg orange capsules (Identified UM).

NDC 0051-0023-21 (Bottle of 60 capsules).

MARINOL (dronabinol) is a registered trademark of Unimed Pharmaceuticals, Inc. and is Manufactured by Banner Pharmacaps, Inc. High Point, NC 27265. For: Unimed Pharmaceuticals, Inc. A Solvay Pharmaceuticals, Inc. Company, Marietta, GA 30062-2224, USA. Rev Jul 2006. FDA Rev date: 6/21/2006


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Adverse experiences information summarized in the tables below was derived from well-controlled clinical trials conducted in the US and US territories involving 474 patients exposed to MARINOL (dronabinol) Capsules. Studies of AIDS-related weight loss included 157 patients receiving dronabinol at a dose of 2.5 mg twice daily and 67 receivingplacebo. Studies of different durations were combined by considering the first occurrence of events during the first 28 days. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving dronabinol and 68 receiving placebo.

A cannabinoid dose-related "high" (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL (dronabinol) Capsules in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). (See Clinical Trials.)

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 MARINOL (dronabinol) Capsules. About 25% of patients reported a minor CNS adverse event during the first 2 weeks and about 4% reported such an event each week for the next 6 weeks thereafter.

PROBABLY CAUSALLY RELATED: Incidence greater than 1%.

Rates derived from clinical trials in AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317). Rates were generally higher in the anti-emetic use (given in parentheses).

Body as a whole: Asthenia.

Cardiovascular: Palpitations, tachycardia, vasodilation/facial flush.

Digestive: Abdominal pain*, nausea*, vomiting*.

Nervous system: (Amnesia), anxiety/nervousness, (ataxia), confusion, depersonalization, dizziness*, euphoria*, (hallucination), paranoid reaction*, somnolence*, thinking abnormal*.

*Incidence of events 3% to 10%

PROBABLY CAUSALLY RELATED: Incidence less than 1%.

Event rates derived from clinical trials in AIDS-related anorexia (N=157) and chemotherapy-related nausea (N=317).

Cardiovascular: Conjunctivitis*, hypotension*.

Digestive: Diarrhea*, fecal incontinence.

Musculoskeletal: Myalgias.

Nervous system: Depression, nightmares, speech difficulties, tinnitus.

Skin and Appendages: Flushing*.

Special senses: Vision difficulties.

*Incidence of events 0.3% to 1%

CAUSAL RELATIONSHIP UNKNOWN: Incidence less than 1%.

The clinical significance of the association of these events with MARINOL (dronabinol) Capsules treatment is unknown, but they are reported as alerting information for the clinician.

Body as a whole: Chills, headache, malaise.

Digestive: Anorexia, hepatic enzyme elevation.

Respiratory: Cough, rhinitis, sinusitis.

Skin and Appendages: Sweating.

Postmarketing Experience

Seizure and seizure-like activity have been reported in patients receiving MARINOL (dronabinol) Capsules during marketed use of the drug and in clinical trials. (See PRECAUTIONS and OVERDOSAGE.) Reports of fatigue have also been received. A causal relationship between MARINOL (dronabinol) Capsules and these events has not been established.

Drug Abuse And Dependence

MARINOL (dronabinol) Capsules is one of the psychoactive compounds present in cannabis, and is abusable and controlled [Schedule III (CIII)] under the Controlled Substances Act. Both psychological and physiological dependence have been noted in healthy individuals receiving dronabinol, but addiction is uncommon and has only been seen after prolonged high dose administration.

Chronic abuse of cannabis has been associated with decrements in motivation, cognition, judgement, and perception. The etiology of these impairments is unknown, but may be associated with the complex process of addiction rather than an isolated effect of the drug. No such decrements in psychological, social or neurological status have been associated with the administration of MARINOL (dronabinol) Capsules for therapeutic purposes.

In an open-label study in patients with AIDS who received MARINOL (dronabinol) Capsules for up to five months, no abuse, diversion or systematic change in personality or social functioning were observed despite the inclusion of a substantial number of patients with a past history of drug abuse.

An abstinence syndrome has been reported after the abrupt discontinuation of dronabinol in volunteers receiving dosages of 210 mg/day for 12 to 16 consecutive days. Within 12 hours after discontinuation, these volunteers manifested symptoms such as irritability, insomnia, and restlessness. By approximately 24 hours post-dronabinol discontinuation, withdrawal symptoms intensified to include "hot flashes", sweating, rhinorrhea, loose stools, hiccoughs and anorexia.

These withdrawal symptoms gradually dissipated over the next 48 hours. Electroencephalographic changes consistent with the effects of drug withdrawal (hyperexcitation) were recorded in patients after abrupt dechallenge. Patients also complained of disturbed sleep for several weeks after discontinuing therapy with high dosages of dronabinol.

Read the Marinol (dronabinol) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

In studies involving patients with AIDS and/or cancer, MARINOL (dronabinol) Capsules has been co-administered with a variety of medications (e.g.,cytotoxic agents, anti-infective agents, sedatives, or opioid analgesics) without resulting in any clinically significant drug/drug interactions. Although no drug/drug interactions were discovered during the clinical trials of MARINOL (dronabinol) Capsules, cannabinoids may interact with other medications through both metabolic and pharmacodynamic mechanisms. Dronabinol is highly protein bound to plasma proteins, and therefore, might displace other protein-bound drugs. Although this displacement has not been confirmed in vivo, practitioners should monitor patients for a change in dosage requirements when administering dronabinol to patients receiving other highly protein-bound drugs. Published reports of drug/drug interactions involving cannabinoids are summarized in the following table.

 

CONCOMITANT DRUG CLINICAL EFFECT(S)
Amphetamines, cocaine, other sympathomimetic agents Additive hypertension, tachycardia, possibly cardiotoxicity
Atropine, scopolamine, antihistamines, other anticholinergic agents Additive or super-additive tachycardia, drowsiness
Amitriptyline, amoxapine, desipramine, other tricyclic antidepressants Additive tachycardia, hypertension, drowsiness
Barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants Additive drowsiness and CNS depression
Disulfiram A reversible hypomanic reaction was reported in a 28 y/o man who smoked marijuana; confirmed by dechallenge and rechallenge
Fluoxetine A 21 y/o female with depression and bulimia receiving 20 mg/day fluoxetine X 4 wks became hypomanic after smoking marijuana; symptoms resolved after 4 days
Antipyrine, barbiturates Decreased clearance of these agents, presumably via competitive inhibition of metabolism
Theophylline Increased theophylline metabolism reported with smoking of marijuana; effect similar to that following smoking tobacco

 

Read the Marinol Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

 
 

Warnings

Patients receiving treatment with MARINOL (dronabinol) Capsules 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

General: The risk/benefit ratio of MARINOL (dronabinol) Capsules 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 (dronabinol) Capsules.

Seizure and seizure-like activity have been reported in patients receiving MARINOL (dronabinol) Capsules during marketed use of the drug and inclinical trials. (See ADVERSE REACTIONS and OVERDOSAGE.) MARINOL (dronabinol) Capsules should be used with caution in patients with a history of seizure disorder because MARINOL (dronabinol) Capsules may lower the seizure threshold. A causal relationship between MARINOL (dronabinol) Capsules and these events has not been established. MARINOL (dronabinol) Capsules should be discontinued immediately in patients who develop seizures and medical attention should be sought immediately.

MARINOL (dronabinol) Capsules should be used with caution in patients withcardiac disorders because of occasional hypotension, possible hypertension,syncope, or tachycardia. (See CLINICAL PHARMACOLOGY.)

MARINOL (dronabinol) Capsules should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence, because they may be more prone to abuse MARINOL (dronabinol) Capsules as well. Multiple substance abuse is common and marijuana, which contains the same active compound, is a frequently abused substance.

MARINOL (dronabinol) Capsules should be used with caution and carefulpsychiatric monitoring in patients with mania, depression, or schizophreniabecause MARINOL (dronabinol) Capsules may exacerbate these illnesses.

MARINOL (dronabinol) Capsules should be used with caution in patients receiving concomitant therapy with sedatives, hypnotics or other psychoactive drugs because of the potential for additive or synergistic CNSeffects.

MARINOL (dronabinol) Capsules should be used with caution in elderly patients because they may be more sensitive to the neurological, psychoactive, and postural hypotensive effects of the drug.(SeeIndividualization Of Dosages)

MARINOL (dronabinol) Capsules should be used with caution in pregnantpatients, nursing mothers, or pediatric patients because it has not been studied in these patient populations.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies in mice and rats have been conducted under the US NationalToxicology Program (NTP). In the 2-year carcinogenicity study in rats, there was no evidence of carcinogenicity at doses up to 50 mg/kg/day, about 20 times the maximum recommended human dose on a body surface areabasis. In the 2-year carcinogenicity study in mice, treatment with dronabinol at 125 mg/kg/day, about 25 times the maximum recommended human dose on a body surface area basis, produced thyroid follicular cell adenoma in both male and female mice but not at 250 or 500 mg/kg/day.

Dronabinol was not genotoxic in the Ames tests, the in vitro chromosomalaberration test in Chinese hamster ovary cells, and the in vivo mouse micronucleus test. It, however, produced a weak positive response in a sister chromatid exchange test in Chinese hamster ovary cells.

In a long-term study (77 days) in rats, oral administration of dronabinol at doses of 30 to 150 mg/m2, equivalent to 0.3 to 1.5 times maximum recommended human dose (MRHD) of 90 mg/m2/day in cancer patients or 2 to 10 times MRHD of 15 mg/m2/day in AIDS patients, reduced ventralprostate, seminal vesicle and epididymal weights and caused a decrease in seminal fluid volume. Decreases in spermatogenesis, number of developinggerm cells, and number of Leydig cells in the testis were also observed. However, sperm count, mating success and testosterone levels were not affected. The significance of these animal findings in humans is not known.

Pregnancy: Pregnancy Category C. Reproduction studies with dronabinol have been performed in mice at 15 to 450 mg/m2, equivalent to 0.2 to 5 times maximum recommended human dose (MRHD) of 90 mg/m2/day in cancer patients or 1 to 30 times MRHD of 15 mg/m2/day in AIDS patients, and in rats at 74 to 295 mg/m2 (equivalent to 0.8 to 3 times MRHD of 90 mg/m2 in cancer patients or 5 to 20 times MRHD of 15 mg/m2/day in AIDS patients). These studies have revealed no evidence of teratogenicity due to dronabinol. At these dosages in mice and rats, dronabinol decreasedmaternal weight gain and number of viable pups and increased fetalmortality and early resorptions. Such effects were dose dependent and less apparent at lower doses which produced less maternal toxicity. There are no adequate and well-controlled studies in pregnant women. Dronabinol should be used only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Use of MARINOL (dronabinol) Capsules is not recommended in nursing mothers since, in addition to the secretion of HIVvirus in breast milk, dronabinol is concentrated in and secreted in human breast milk and is absorbed by the nursing baby.

Geriatric Use: Clinical studies of MARINOL (dronabinol) Capsules in AIDS and cancer patients did not include the sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and 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, decreasedhepatic, renal, or cardiac function, increased sensitivity to psychoactive effects and of concomitant disease or other drug therapy.

This monograph has been modified to include the generic and brand name in many instances.

 
 

OverDose

Signs and symptoms following MILD MARINOL (dronabinol) Capsules intoxication include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth and tachycardia; following MODERATE intoxication include memory impairment, depersonalization, mood alteration, urinary retention, and reduced bowelmotility; and following SEVERE intoxication include decreased motorcoordination, lethargy, slurred speech, and postural hypotension. Apprehensive patients may experience panic reactions and seizures may occur in patients with existing seizure disorders.

The estimated lethal human dose of intravenous dronabinol is 30 mg/kg (2100 mg/ 70 kg). Significant CNS symptoms in antiemetic studies followed oral doses of 0.4 mg/kg (28 mg/70 kg) of MARINOL (dronabinol) Capsules.

Management: A potentially serious oral ingestion, if recent, should be managed with gut decontamination. In unconscious patients with a secureairway, instill activated charcoal (30 to 100 g in adults, 1 to 2 g/kg in infants) via a nasogastric tube. A saline cathartic or sorbitol may be added to the first dose of activated charcoal. Patients experiencing depressive, hallucinatory or psychotic reactions should be placed in a quiet area and offered reassurance. Benzodiazepines (5 to 10 mg diazepam po) may be used for treatment of extreme agitation. Hypotension usually responds to Trendelenburg position and IV fluids. Pressors are rarely required.

ContrainDications

MARINOL (dronabinol) Capsules is contraindicated in any patient who has a known sensitivity to MARINOL (dronabinol) Capsules or any of its ingredients. It contains cannabinoid and sesame oil and should never be used by patients allergic to these substances.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Dronabinol is an orally active cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS), including central sympathomimetic activity. Cannabinoid receptors have been discovered inneural tissues. These receptors may play a role in mediating the effects of dronabinol and other cannabinoids.

Pharmacodynamics

Dronabinol-induced sympathomimetic activity may result in tachycardiaand/or conjunctival injection. Its effects on blood pressure are inconsistent, but occasional subjects have experienced orthostatic hypotension and/orsyncope upon abrupt standing.

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 interpatient variability.

After oral administration, dronabinol has 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 pharmacologic effects of dronabinol and other cannabinoids with chronic use, suggesting an indirect effect on sympathetic neurons. In a study of the pharmacodynamics of chronic dronabinol exposure, healthy male volunteers (N = 12) received 210 mg/day dronabinol, administered orally 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 volunteers developed tolerance to the cardiovascular and subjective adverse CNS effects of dronabinol within 12 days of treatment initiation.

Tachyphylaxis and tolerance do not, however, appear to develop to the appetite stimulant effect of MARINOL (dronabinol) Capsules. In studies involving patients with Acquired Immune Deficiency Syndrome (AIDS), the appetite stimulant effect of MARINOL (dronabinol) Capsules has been sustained for up to five months in clinical trials, at dosages ranging from 2.5 mg/day to 20 mg/day.

Pharmacokinetics

Absorption and Distribution: MARINOL (dronabinol) Capsules is almost completely absorbed (90 to 95%) after single oral doses. 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. Dronabinol has a large apparent volume of distribution, approximately 10 L/kg, because of its lipid solubility. The plasma protein binding of dronabinol and its metabolites is approximately 97%.

The elimination phase of dronabinol can be described using a two compartment model with an initial (alpha) half-life of about 4 hours and a terminal (beta) half-life of 25 to 36 hours. Because of its large volume of distribution, dronabinol and its metabolites may be excreted at low levels for prolonged periods of time.

The pharmacokinetics of dronabinol after single doses (2.5, 5, and 10 mg) and multiple doses (2.5, 5, and 10 mg given twice a day; BID) have been studied in healthy women and men.

Summary of Multiple-Dose Pharmacokinetic Parameters of Dronabinol in Healthy Volunteers (n=34; 20-45 years) under Fasted Conditions

  MEAN (SD) PK PARAMETER VALUES
BID DOSE CMAX NG/ML MEDIAN TMAX (RANGE), HR AUC(0-12)NG•HR/ML
2.5 mg 1.32 (0.62) 1.00 (0.50-4.00) 2.88 (1.57)
5 mg 2.96 (1.81) 2.50 (0.50-4.00) 6.16 (1.85)
10 mg 7.88 (4.54) 1.50 (0.50-3.50) 15.2 (5.52)

 

A slight increase in dose proportionality on mean Cmax and AUC(0-12) of dronabinol was observed with increasing dose over the dose range studied.

Metabolism: Dronabinol undergoes extensive first-pass hepatic metabolism, primarily by microsomal hydroxylation, yielding both active and inactive metabolites. Dronabinol and its principal active metabolite, 11-OH-delta-9-THC, are present in approximately equal concentrations in plasma. Concentrations of both parent drug and metabolite peak at approximately 0.5 to 4 hours after oral dosing and decline over several days. Values for clearance average about 0.2 L/kg-hr, but are highly variable due to the complexity of cannabinoid distribution.

Elimination: Dronabinol and its biotransformation products are excreted in both feces and urine. Biliary excretion is the major route of elimination with about half of a radio-labeled oral dose being recovered from the feces within 72 hours as contrasted with 10 to 15% recovered from urine. Less than 5% of an oral dose is recovered unchanged in the feces.

Following single dose administration, low levels of dronabinol metabolites have been detected for more than 5 weeks in the urine and feces.

In a study of MARINOL (dronabinol) Capsules involving AIDS patients,urinary cannabinoid/creatinine concentration ratios were studied bi-weekly over a six week period. The urinary cannabinoid/creatinine ratio was closely correlated with dose. No increase in the cannabinoid/creatinine ratio was observed after the first two weeks of treatment, indicating that steady-state cannabinoid levels had been reached. This conclusion is consistent with predictions based on the observed terminal half-life of dronabinol.

Special Populations: The pharmacokinetic profile of MARINOL (dronabinol) Capsules has not been investigated in either pediatric or geriatric patients.

Clinical Trials

Appetite Stimulation: The appetite stimulant effect of MARINOL (dronabinol) Capsules in the treatment of AIDS-related anorexia associated with weight loss was studied in a randomized, double-blind, placebo-controlled study involving 139 patients. The initial dosage of MARINOL (dronabinol) Capsules in all patients was 5 mg/day, administered in doses of 2.5 mg one hour before lunch and one hour before supper. In pilot studies, early morning administration of MARINOL (dronabinol) Capsules appeared to have been associated with an increased frequency of adverse experiences, as compared to dosing later in the day. The effect of MARINOL (dronabinol) Capsules on appetite, weight, mood, and nausea was measured at scheduled intervals during the six-week treatment period. Side effects (feeling high, dizziness, confusion, somnolence) occurred in 13 of 72 patients (18%) at this dosage level and the dosage was reduced to 2.5 mg/day, administered as a single dose at supper or bedtime.

Of the 112 patients that completed at least 2 visits in the randomized, double-blind, placebo- controlled study, 99 patients had appetite data at 4-weeks (50 received MARINOL (dronabinol) and 49 received placebo) and 91 patients had appetite data at 6-weeks (46 received MARINOL (dronabinol) and 45 received placebo). A statistically significant difference between MARINOL (dronabinol) Capsules and placebo was seen in appetite as measured by the visual analog scale at weeks 4 and 6 (see figure). Trends toward improved body weight and mood, and decreases in nausea were also seen.

After completing the 6-week study, patients were allowed to continue treatment with MARINOL (dronabinol) Capsules in an open-label study, in which there was a sustained improvement in appetite.

Mean Appetite Change from Baseline

Mean Appetite Change from Baseline - illustration

 

Antiemetic: MARINOL (dronabinol) Capsules treatment of chemotherapy-induced emesis was evaluated in 454 patients with cancer, who received a total of 750 courses of treatment of various malignancies. The antiemetic efficacy of MARINOL (dronabinol) Capsules was greatest in patients receiving cytotoxic therapy with MOPP for Hodgkin's and non-Hodgkin's lymphomas. MARINOL (dronabinol) Capsules dosages ranged from 2.5 mg/day to 40 mg/day, administered in equally divided doses every four to six hours (four times daily). As indicated in the following table, escalating the MARINOL (dronabinol) Capsules dose above 7 mg/m2 increased the frequency of adverse experiences, with no additional antiemetic benefit.

MARINOL (dronabinol) Capsules Dose: Response Frequency and Adverse Experiences* (N = 750 treatment courses)

View Enlarged Table

 

Combination antiemetic therapy with MARINOL (dronabinol) Capsules and aphenothiazine (prochlorperazine) may result in synergistic or additive antiemetic effects and attenuate the toxicities associated with each of the agents.

Individualization Of Dosages

The pharmacologic effects of MARINOL (dronabinol) Capsules are dose-related and subject to considerable interpatient variability. Therefore, dosage individualization is critical in achieving the maximum benefit of MARINOL (dronabinol) Capsules treatment.

Appetite Stimulation: In the clinical trials, the majority of patients were treated with 5 mg/day MARINOL (dronabinol) Capsules, although the dosages ranged from 2.5 to 20 mg/day. For an adult:

  1. Begin with 2.5 mg before lunch and 2.5 mg before supper. If CNS symptoms (feeling high, dizziness, confusion, somnolence) do occur, they usually resolve in 1 to 3 days with continued dosage.
  2. If CNS symptoms are severe or persistent, reduce the dose to 2.5 mg before supper. If symptoms continue to be a problem, taking the single dose in the evening or at bedtime may reduce their severity.
  3. When adverse effects are absent or minimal and further therapeuticeffect is desired, increase the dose to 2.5 mg before lunch and 5 mg before supper or 5 and 5 mg. Although most patients respond to 2.5 mg twice daily, 10 mg twice daily has been tolerated in about half of the patients in appetite stimulation studies.

The pharmacologic effects of MARINOL (dronabinol) Capsules are reversible upon treatment cessation.

Antiemetic: Most patients respond to 5 mg three or four times daily. Dosage may be escalated during a chemotherapy cycle or at subsequent cycles, based upon initial results. Therapy should be initiated at the lowest recommended dosage and titrated to clinical response. Administration of MARINOL (dronabinol) Capsules with phenothiazines, such as prochlorperazine, has resulted in improved efficacy as compared to either drug alone, without additional toxicity.

Pediatrics: MARINOL (dronabinol) Capsules is not recommended for AIDS-related anorexia in pediatric patients because it has not been studied in this population. The pediatric dosage for the treatment of chemotherapy-induced emesis is the same as in adults. Caution is recommended in prescribing MARINOL (dronabinol) Capsules for children because of the psychoactive effects.

Geriatrics: Caution is advised in prescribing MARINOL (dronabinol) Capsules in elderly patients because they may be more sensitive to theneurological, psychoactive and postural hypotensive effects of the drug. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (See PRECAUTIONS.)

MARINOL (dronabinol) Capsules should be used with caution when administered to elderly patients with dementia, who are at increased risk for falls as a result of their underlying disease state which may be exacerbated by the central nervous system effects of somnolence and dizziness associated with MARINOL (dronabinol) Capsules. These patients should be monitored closely and placed on fall precautions prior to initiating MARINOL (dronabinol) therapy. In antiemetic studies, no difference in efficacy was apparent in patients > 55 years old.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients receiving treatment with MARINOL (dronabinol) Capsules should be alerted to the potential for additive central nervous system depression if MARINOL (dronabinol) Capsules is used concomitantly with alcohol or otherCNS depressants such as benzodiazepines and barbiturates.

Patients receiving treatment with MARINOL (dronabinol) Capsules 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.

Patients using MARINOL (dronabinol) Capsules should be advised of possible changes in mood and other adverse behavioral effects of the drug so as to avoid panic in the event of such manifestations. Patients should remain under the supervision of a responsible adult during initial use of MARINOL (dronabinol) Capsules and following dosage adjustments.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DRONABINOL - ORAL

 

(dro-NAB-in-all)

 

COMMON BRAND NAME(S): Marinol

 

USES: Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is usually used when other drugs to control nausea and vomiting have not been successful. Dronabinol is also used to treat loss of appetite and weight loss in patients with HIV infection. Dronabinol (also called THC) is a man-made form of the active natural substance in marijuana.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking dronabinol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 3 to 4 times daily if you are taking it to control nausea and vomiting or twice daily (before lunch and before dinner) if you are taking it to treat appetite loss. Follow your doctor's instructions carefully.

The dosage is based on your medical condition and response to treatment. If you are taking this medication to control nausea and vomiting, your dosage may also be based on your body size.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as irritability, trouble sleeping, restlessness, hot flashes, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists or worsens.

 

 

 

Consumer Overview Side Effect

SIDE EFFECTS: Dizziness, drowsiness, confusion, feeling "high", an exaggerated sense of well-being, lightheadedness, nausea, vomiting, or stomach/abdominal pain may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, fast/pounding heartbeat, mental/mood changes (such as anxiety, nervousness, hallucinations, abnormal thoughts, paranoia).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Marinol (dronabinol) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before taking dronabinol, tell your doctor or pharmacist if you are allergic to it; or to marijuana; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: regular use/abuse of drugs/alcohol/other substances, heart disease, high blood pressure, mental/mood disorders (such as mania, depression, schizophrenia), seizures.

This drug may make you dizzy or drowsy or affect your judgment. Do not do any activities requiring alertness and clear thinking, such as driving or using machinery, until you know how this medication affects you and until you are sure you can perform such activities safely. Alcohol can worsen these side effects. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and mental/mood changes.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, fast heartbeat, mental/mood changes, seizures.

 

NOTES: Do not share this medication with others. It is against the law.

Keep all medical appointments so your doctor can monitor your response to treatment (such as your weight) and check for side effects.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store this medication according to the directions on the product package, away from light and moisture. Some brands must be refrigerated, and others may be stored at room temperature. Consult your pharmacist for more details. Do not freeze this medication or store it in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Marinol

Generic Name: dronabinol (Pronunciation: droe NAH bih nol)

  • What is dronabinol (Marinol)?
  • What are the possible side effects of dronabinol (Marinol)?
  • What is the most important information I should know about dronabinol (Marinol)?
  • What should I discuss with my health care provider before taking dronabinol (Marinol)?
  • How should I take dronabinol (Marinol)?
  • What happens if I miss a dose (Marinol)?
  • What happens if I overdose (Marinol)?
  • What should I avoid while taking dronabinol (Marinol)?
  • What other drugs will affect dronabinol (Marinol)?
  • Where can I get more information?

What is dronabinol (Marinol)?

 

Dronabinol is a man-made form of cannabis (marijuana is an herbal form of cannabis). Dronabinol causes many effects on your central nervous system.

Dronabinol is used to treat loss of appetite in people with AIDS. It is also used to treat severe nausea and vomiting that is caused by cancer chemotherapy. Dronabinol is for use only when other medications have been unable to control the nausea and vomiting.

Dronabinol may also be used for purposes other than those listed in this medication guide.

Marinol 5 mg

spherical, maroon, imprinted with RL

What are the possible side effects of dronabinol (Marinol)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dronabinol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • paranoia, extreme fear;
  • fast heart rate;
  • feeling light-headed, fainting; or
  • unusual thoughts or behavior.

Continue using dronabinol and talk with your doctor if you have any of these less serious side effects:

  • mood changes;
  • dizziness, trouble concentrating;
  • feeling "high";
  • weakness, lack of coordination;
  • anxiety, confusion;
  • stomach pain, nausea, vomiting, diarrhea;
  • warmth or tingly feeling; or
  • sleep problems (insomnia).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Marinol (dronabinol) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about dronabinol (Marinol)?

 

Dronabinol may be habit-forming and should be used only by the person it was prescribed for. Dronabinol should never be given to another person, especially someone who has a history of drug addiction or habitual marijuana use. Keep the medication in a secure place where others cannot get to it.

Do not use dronabinol if you have ever had an allergic reaction to natural or man-made marijuana.

Before taking dronabinol, tell your doctor if you have a seizure disorder, high blood pressure, heart disease, a history of mental illness or drug addiction, or if you are also using other medicines that can affect your central nervous system, such as a tranquilizer, sleep medicine, or anti-psychotic medications.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Avoid using other medicines that affect the central nervous system (such as stimulants, diet pills, cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression, anxiety, mental illness, or Parkinson's disease). These other drugs can add to the effects of dronabinol.

Dronabinol causes effects that will impair your thinking or reactions. Do not drive or do anything that requires you to be awake and alert until the effects of dronabinol wear off.

There are many other medicines that can add to the side effects of dronabinol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Side Effects Centers
  • Marinol

Patient Detailed How Take

What should I discuss with my health care provider before taking dronabinol (Marinol)?

 

Do not use this medication if you are allergic to sesame oil, or if you have ever had an allergic reaction to natural or man-made marijuana such as dronabinol or nabilone (Cesamet).

Before using dronabinol, tell your doctor if you are allergic to any drugs, or if you have:

  • epilepsy or other seizure disorder;
  • high blood pressure (hypertension);
  • heart disease;
  • past or present mental illness such as depression, schizophrenia, or other psychotic disorders;
  • a history of drug or alcohol addiction; or
  • if you are also using other medicines that can affect your central nervous system, such as a tranquilizer, sleep medicine, or anti-psychotic medications.

If you have any of these conditions, you may not be able to use dronabinol, or you may need a dosage adjustment or special tests during treatment.

Dronabinol may be habit-forming and should be used only by the person it was prescribed for. Dronabinol should never be given to another person, especially someone who has a history of drug abuse or habitual marijuana use. Keep the medication in a secure place where others cannot get to it.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Dronabinol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be especially sensitive to the side effects of dronabinol.

Dronabinol is not for use in patients younger than 18 years old.

How should I take dronabinol (Marinol)?

 

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

As an appetite stimulant, dronabinol is usually taken before lunch and dinner.

To prevent nausea and vomiting, dronabinol is usually given 1 to 3 hours before you receive your chemotherapy treatment, and every 2 to 4 hours afterward. Follow your doctor's instructions.

Store dronabinol at cool room temperature. You may store the medicine in the refrigerator, but do not allow it to freeze.

Side Effects Centers
  • Marinol

Patient Detailed Avoid Taking

What happens if I miss a dose (Marinol)?

 

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Marinol)?

 

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a dronabinol overdose may include dry mouth, extreme drowsiness, feeling extremely happy or sad, fast heartbeat, memory problems, urinating less than usual or not at all, disorientation, unusual thoughts or behaviors, problems with speech or coordination, panic, fainting, or seizure (convulsions).

What should I avoid while taking dronabinol (Marinol)?

 

Avoid using other medicines that affect the central nervous system (such as stimulants, diet pills, cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression, anxiety, mental illness, or Parkinson's disease). These other drugs can add to the effects of dronabinol.

Dronabinol causes effects that will impair your thinking or reactions. Do not drive or do anything that requires you to be awake and alert until the effects of dronabinol wear off.

What other drugs will affect dronabinol (Marinol)?

 

Before taking dronabinol, tell your doctor if you are using any of the following drugs:

  • sedatives such as Ativan, Dalmane, Halcion, Klonopin, Librium, ProSom, Restoril, Tranxene, Valium, Xanax;
  • barbiturates such as butalbital (Fiorinal), phenobarbital (Luminal, Solfoton), secobarbital (Seconal);
  • amphetamines, including stimulants and medicine to treat attention deficit hyperactivity disorder (ADHD);
  • prescription or over-the-counter weight loss aids (Dexatrim, Meridia);
  • antidepressants such as amitriptyline (Elavil), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), or nortriptyline (Pamelor);
  • lithium;
  • theophylline (Respbid, Slo-Bid, Theo-24, Theo-Dur, Uniphyl);
  • buspirone (BuSpar);
  • atropine (Donnatal, and others);
  • belladonna, dicyclomine (Bentyl);
  • clidinium (Quarzan);
  • glycopyrrolate (Robinul);
  • hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);
  • mepenzolate (Cantil);
  • methscopolamine (Pamine), and scopolamine (Transderm-Scop);
  • methantheline (Provocholine), propantheline (Pro-Banthine); or
  • street drugs such as cocaine or Ectasy.

If you are using any of these drugs, you may not be able to use dronabinol, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect dronabinol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist has more information about dronabinol written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers
  • Marinol

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