Marinol


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dronabinol

Marinol

Pharmacologic class: Cannabinoid

Therapeutic class: Antiemetic

Controlled substance III

Pregnancy risk category B

Action

Unknown. May exert antiemetic effect by inhibiting vomiting control mechanism in medulla oblongata.

Availability

Capsules: 2.5 mg, 5 mg, 10 mg

Indications and dosages

Prevention of nausea and vomiting caused by chemotherapy

Adults and children: Initially, 5 mg/m2 P.O. 1 to 3 hours before chemotherapy. Repeat dose q 2 to 4 hours after chemotherapy, up to four to six doses per day. If 5-mg/m2 dose is ineffective and patient has no significant adverse reactions, dosage may be increased in increments of 2.5 mg/m2 to a maximum dosage of 15 mg/m2.

Appetite stimulant

Adults and children: Initially, 2.5 mg P.O. b.i.d. May reduce dosage to 2.5 mg/day given as a single evening or bedtime dose. Maximum dosage is 10 mg P.O. b.i.d.

Contraindications

• Hypersensitivity to cannabinoids or sesame oil

• Breastfeeding

Precautions

Use cautiously in:

• hypertension, heart disease, bipolar disorder, schizophrenia, drug abuse, seizures

• pregnant patients.

Administration

• When used to stimulate appetite, give before lunch and dinner.

Adverse reactions

CNS: drowsiness, anxiety, impaired coordination, irritability, depression, headache, hallucinations, memory loss, paresthesia, ataxia, paranoia, disorientation, nightmares, speech difficulties, syncope, suicidal ideation

CV: tachycardia, hypotension, hypertension

EENT: visual disturbances, tinnitus

GI: dry mouth

Skin: facial flushing, diaphoresis

Interactions

Drug-drug. Anticholinergics, antihistamines, tricyclic antidepressants: increased tachycardia and hypertension

CNS depressants: increased CNS depression

Ritonavir: increased dronabinol blood level and risk of toxicity

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Monitor vital signs for hypotension and tachycardia.

Check for adverse CNS reactions. Report significant depression, paranoid reaction, or emotional lability.

• Monitor nutritional status and hydration.

Patient teaching

• Teach patient about drug's significant adverse CNS and cardiovascular effects. Emphasize that he should take it only as prescribed and needed.

Advise patient (and significant other) to immediately report depression, suicidal thoughts, paranoid reactions, seizures, and other serious CNS reactions.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

dronabinol

(droe-nab-i-nol) ,

delta-9-tetrahydrocannabinol

(trade name),

THC

(trade name),

Marinol

(trade name)

Classification

Therapeutic: antiemetics
Pharmacologic: cannabinoids
Pregnancy Category: C

Indications

Prevention of serious nausea and vomiting from cancer chemotherapy when other more conventional agents have failed.Management of anorexia associated with weight loss in patients with AIDS.

Action

Active ingredient in marijuana.
Has a wide variety of CNS effects, including inhibition of the vomiting control mechanism in the medulla oblongata.

Therapeutic effects

Suppression of nausea and vomiting.
Increased appetite in patients with AIDS.

Pharmacokinetics

Absorption: Extensively metabolized following absorption, resulting in poor bioavailability (10–20%).
Distribution: Enters breast milk in high concentrations. Highly lipid-soluble. Persists in tissues for prolonged period of time.
Protein Binding: 97%.
Metabolism and Excretion: Extensively metabolized; 50% excreted via biliary elimination. At least one metabolite is psychoactive.
Half-life: 25–36 hr.

Time/action profile (antiemetic effect)

ROUTEONSETPEAKDURATION
POunknown2–4 hr4–6 hr†
†Appetite stimulation lasts 24 hr or longer

Contraindications/Precautions

Contraindicated in: Hypersensitivity to dronabinol, marijuana, or sesame oil; Nausea and vomiting due to any other causes; Lactation: Lactation.
Use Cautiously in: Patients with history of substance abuse; Cardiovascular disease (due to potential adverse effects); Mania, depression, or schizophrenia (use may worsen these conditions); Patients taking sedatives, hypnotics, or other psychoactive drugs (increased risk of adverse effects); Geriatric: ↑ risk of adverse effects; Obstetric / Pediatric: Safety and efficacy not established.

Adverse Reactions/Side Effects

Central nervous system

  • anxiety (most frequent)
  • concentration difficulty (most frequent)
  • confusion (most frequent)
  • dizziness (most frequent)
  • drowsiness (most frequent)
  • mood change (most frequent)
  • abnormal thinking
  • depression
  • disorientation
  • hallucinations
  • headache
  • impaired judgment
  • memory lapse
  • paranoia

Ear, Eye, Nose, Throat

  • dry mouth (most frequent)

Cardiovascular

  • palpitations
  • syncope
  • tachycardia

Gastrointestinal

  • abdominal pain
  • nausea
  • vomiting

Dermatologic

  • facial flushing

Neurologic

  • ataxia
  • paresthesia

Miscellaneous

  • physical dependence
  • psychological dependence (high doses or prolonged therapy)

Interactions

Drug-Drug interaction

Additive CNS depression with alcohol, antihistamines,barbiturates, benzodiazepines, atropine, scopolamine,lithium, buspirone, muscle relaxants, opioid analgesics, tricyclicantidepressants, and sedative/hypnotics.Increased risk of tachycardia with amphetamine, atropine, scopolamine, cocaine, sympathomimetics, antihistamines, and tricyclicantidepressants.May increase blood levels of theophylline.Increased risk of tachycardia with caffeine -containing herbs (cola nut, guarana, mate, tea, coffee).Concomitant use of kava, valerian, skullcap, chamomile, or hopscan increase CNS depression.

Route/Dosage

Oral (Adults) Antiemetic—5 mg/m2 1–3 hr prior to chemotherapy; may repeat every 2–4 hr after chemotherapy to a total of 4–6 doses/day. If 5 mg/m2 dose is ineffective and no significant adverse reactions have occurred, dosage may be increased by 2.5 mg/m2 to a maximum of 15 mg/m2/dose. Appetite stimulant—2.5 mg twice daily initially; may be gradually increased as needed (up to 20 mg/day). Reduce dose to 2.5 mg/day in the evening or at bedtime if unable to tolerate 5 mg/day dose.

Availability (generic available)

Gelatin capsules: 2.5 mg, 5 mg, 10 mg

Nursing implications

Nursing assessment

  • Assess nausea, vomiting, appetite, bowel sounds, and abdominal pain prior to and following the administration of this drug.
  • Monitor hydration, nutritional status, and intake and output. Patients with severe nausea and vomiting may require IV fluids in addition to antiemetics.
  • Monitor BP and heart rate periodically throughout therapy.
  • Patients on dronabinol therapy should be monitored closely for side effects because the effects of dronabinol vary with each patient.

Potential Nursing Diagnoses

Risk for deficient fluid volume (Indications)
Imbalanced nutrition: less than body requirements (Indications)
Risk for injury (Side Effects)

Implementation

  • Dronabinol capsules should be refrigerated (not frozen).
    • Physical or psychological dependence may occur with high doses or prolonged therapy, causing a withdrawal syndrome (irritability, restlessness, insomnia, hot flashes, sweating, rhinorrhea, loose stools, hiccups, anorexia) when discontinued. This is unlikely to occur with therapeutic doses and short-term use of dronabinol.
  • Antiemetic: This drug may be administered prophylactically 1–3 hr prior to chemotherapy and repeated every 2–4 hr after chemotherapy up to 4–6 doses daily. Most patients respond to 5 mg three or four times daily.
  • Appetite Stimulant: Give 2.5 mg twice daily before lunch and supper initially. Reduce dose to 2.5 mg/day in the evening or at bedtime for patients unable to tolerate 5 mg/day dose. May increase dose to 2.5 mg at lunch and 5 mg before supper or 5 mg at lunch and 5 mg after supper if further therapeutic effect is desired and adverse effects are minimal. Most patients respond to 2.5 mg twice daily dose, but up to 10 mg bid have been tolerated in about 50% of patients. Adverse effects are dose related.

Patient/Family Teaching

  • Instruct patient to take dronabinol exactly as directed. Take missed doses as soon as possible but not if almost time for next dose; do not double doses. Signs of overdose (mood changes, confusion, hallucinations, depression, nervousness, fast or pounding heartbeat) may occur with increased doses.
  • Advise patient to call for assistance when ambulating, because this drug may cause dizziness, drowsiness, and impaired judgment and coordination. Avoid driving or other activities requiring alertness until response to the drug is known.
  • Instruct patient to change positions slowly to minimize orthostatic hypotension.
  • Caution patient to avoid taking alcohol or other CNS depressants during dronabinol therapy.
  • Advise patient and family to use general measures to decrease nausea (begin with sips of liquids and small, nongreasy meals; provide oral hygiene; remove noxious stimuli from environment).

Evaluation/Desired Outcomes

  • Prevention of and decrease in nausea and vomiting associated with chemotherapy.
  • Increased or maintained weight in patients with AIDS.

Marinol

(măr′ĭ-nôl′)
A trademark for the drug dronabinol.
References in periodicals archive ?
[[DELTA].sup.9]-Tetrahydrocannabivarin as a marker for the ingestion of marijuana versus Marinol: Results of a clinical study.J Anal Toxicol2001; 25:565-71.
Connolly) (noting that Marinol is a Schedule III drug that is a form of THC); Cesamet, Leaf Science, http:// www.leafscience.com/pharmaceuticals/cesamet/[http://perma.cc/NS24-VTQP].
Oleo de um milk-shake contendo 95 palma (Acido g de gordura, o qual foi graxos dividido em ingestao de saturado) acido graxo saturado, Marinol D- acido graxo 40 (Acido monoinsaturado ou acido graxo graxo poliinsaturado.
While chronic pain and loss of appetite and/or weight are specifically targeted indications of pharmaceutical products such as Marinol and Sativex, anxiety, depression, and insomnia have not yet been targeted as indications for pharmaceutical drug development.
(B) Marinol [R], an FDA-approved medication, is a synthetic (i.e., human-made) version of THC.
Stepan Specialty Products, a subsidiary of Stepan Company (NYSE: SCL), has acquired the Clarinol, Marinol and Pinnothin product ranges of Lipid Nutrition BV, a subsidiary of Loders Croklaan BV.
(8) Cannabis (under the trade name Marinol) is currently available for medical use in the USA to relieve nausea and vomiting associated with chemotherapy in cancer patients, as well as to prevent loss of appetite associated with AIDS.
Oral forms of THC, the active ingredient in the plant, such as Marinol, are available by prescription.
My recommendations: 1) use pharmaceutical products (Marinol, Cesamet, Sativex) for those few patients who may benefit from cannabinoids; 2) repeal the Montana Medical Marijuana act; 3) if the act is not repealed, then growers, product preparers, distributors, sellers, and users should all be regulated and taxed in a similar way as all other controlled substances, foods, alcohol, and tobacco; 4) designate tax and license revenues from marijuana production, distribution, and sales for prevention and treatment of marijuana abuse disorders; 5) enact and enforce laws to protect the public, especially our children.
The impact of ethanol and Marinol /marijuana usage on HIV+/AIDS patients undergoing azidothymidine, azidothymidine/ dideoxycytidine, or dideoxyinosine therapy.
They want to replace it with a taxpayer-financed, multimillion dollar boondoggle program under which the state's Department of Human Services would provide Marinol (an expensive pharmaceutical synthetic form of the active ingredient in marijuana) to patients who would be forced to requalify their medical conditions with a DHS-provided doctor, not their own physician.
One called Marinol has been approved in the United States since 1985, and another called Cesamet was cleared more recently.