Cesamet
nabilone
Pharmacologic class: Synthetic cannabinoid
Therapeutic class: Antiemetic
Controlled substance schedule II
Pregnancy risk category C
Action
Unclear. Drug has complex effects on CNS, including relaxation, drowsiness, and euphoria; antiemetic effect may result from interaction with cannabinoid receptor system in neural tissues.
Availability
Capsules: 1 mg
Indications and dosages
➣ Nausea and vomiting associated with cancer chemotherapy in patients who respond inadequately to conventional antiemetics
Adults: 1 to 2 mg P.O. twice daily; give initial dose 1 to 3 hours before chemotherapy. Maximum daily dose, 6 mg given in divided doses three times daily.
Contraindications
• Hypersensitivity to drug or other cannabinoids
Precautions
Use cautiously in:
• hepatic or renal impairment, hypertension, cardiac disease, QT interval prolongation, psychiatric disorders (current or previous)
• history of substance abuse
• concurrent use of sedatives, hypnotics, other psychoactive drugs, or CNS depressants
• concurrent alcohol use
• pregnant or breastfeeding patients
• elderly patients
• children (safety and efficacy not established).
Administration
• On day of chemotherapy, give 1 to 3 hours before chemotherapeutic drug is administered.
• To minimize adverse reactions, give recommended lower starting dosage and increase dosage as necessary.
• Know that drug may be given two or three times daily during entire course of each chemotherapy cycle and, if needed, for 48 hours after last dose of each chemotherapy cycle.
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Adverse reactions
CNS: drowsiness, euphoria, dysphoria, inebriated feeling, mood swings, irritability, fatigue, malaise, ataxia, headache, poor concentration, disorientation, anxiety, depersonalization, depersonalization syndrome, speech disorder or disturbance, insomnia, abnormal dreams, vertigo, light-headedness, dizziness, orthostatic dizziness, twitching, depression, confusion, asthenia, sedation, hallucinations, paresthesia, memory disturbance, perception disturbance, seizures, dystonia, numbness, akathisia, tremor, incoordination, toxic psychosis, paranoia, apathy, thought disorder, panic disorder, withdrawal, nervousness, phobic neurosis, emotional disorder, hyperactivity, hypotonia, sinus headache
CV: orthostatic hypotension
EENT: visual disturbances, pharyngitis, nasal congestion, dry throat, dry nose, nosebleed, voice change, thick tongue sensation
GI: nausea, dry mouth
GU: increased or decreased urination, urinary retention, urinary frequency
Metabolic: thirst
Musculoskeletal: muscle pain, back pain, neck pain, joint pain
Respiratory: dyspnea, wheezing, cough
Skin: excessive sweating, pruritus, rash, photosensitivity
Other: taste changes, increased appetite, fever, hot flashes, chills, unspecified pain, bacterial infection, chest pain, allergic reaction
Interactions
Drug-drug. Amitriptyline, amoxapine, desipramine, other tricyclics: additive tachycardia, hypertension, drowsiness
Amphetamines, cocaine, other sympathomimetics: additive hypertension, tachycardia, possible cardiotoxicity
Anticholinergics, antihistamines, tri-cyclic antidepressants: increased tachycardia and hypertension
Antihistamines, atropine, scopolamine, other anticholinergics: additive or superadditive tachycardia, drowsiness
Antihistamines, barbiturates, benzodiazepines, buspirone, lithium, muscle relaxants, opioids, other CNS depressants: additive drowsiness and CNS depression
Antipyrine, barbiturates: decreased clearance of these drugs
Disulfiram, fluoxetine: reversible hypomanic reaction
Opioids: cross-tolerance and mutual potentiation
Naltrexone: enhanced nabilone effects
Theophylline: increased theophylline metabolism
Drug-behaviors. Alcohol use: increased positive mood effects, increased CNS depression
Sun exposure: increased risk of skin reactions
Patient monitoring
• Ensure that patient remains under supervision of responsible adult, especially during initial use and dosage adjustments.
• Monitor vital signs for orthostatic hypotension and tachycardia.
Check for adverse CNS reactions. Report significant depression, paranoid reaction, or emotional lability. Be aware that adverse psychiatric reactions can last for 48 to 72 hours after treatment ends.
• Monitor for excessive use, abuse, or misuse of drug.
• Monitor patient's nutritional and hydration status.
Patient teaching
• Instruct patient to take drug on day of chemotherapy 1 to 3 hours before chemotherapeutic drug is scheduled.
• Teach patient about significant CNS side effects (especially mood changes) and cardiovascular side effects. Stress importance of taking drug only as prescribed and needed.
• Inform patient that drug may cause additive CNS depression if used with alcohol or other CNS depressants (such as sleeping pills, tranquilizers, or anxiolytics).
Advise patient, family member, or caregiver to immediately report depression, suicidal thoughts, paranoid reactions, and other serious CNS reactions.
• Caution patient to avoid driving and other hazardous activities until drug effects are known.
• Instruct breastfeeding patient not to use drug while breastfeeding.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.
nabilone
(na-bi-lone) nabilone,Cesamet
(trade name)Classification
Therapeutic: antiemeticsPharmacologic: cannabinoids
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
PO | unknown | 1–3 hr | 8–12 hr* |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- concentration difficulty (most frequent)
- drowsiness (most frequent)
- euphoria (most frequent)
- sleep disturbance (most frequent)
- vertigo (most frequent)
- altered mental state
- anxiety
- depression
- detachment
- disorientation
- headache
- panic
- paranoia
- psychotomimetic reactions
Cardiovascular
- hypotension (most frequent)
- tachycardia
Gastrointestinal
- dry mouth (most frequent)
- increased appetite
- nausea
Neurologic
- ataxia (most frequent)
- physical dependence
- psychological dependence
Interactions
Drug-Drug interaction
↑ risk of CNS depression with other CNS depressants including alcohol, antihistamines, barbiturates, benzodiazepines, buspirone, lithium, muscle relaxants, opioids, sedative/hypnotics or other other CNS depressants .↑ risk of hypertension, tachycardia and cardiotoxicity with amphetamines, cocaine, and other sympathomimetic agents.↑ risk of tachycardia or drowsiness with atropine, scopolamine, antihistamines, or other anticholinergics.↑ risk of tachycardia, hypertension, drowsiness with tricyclic antidepressants.May displace, be displaced by or otherwise interfere with other highly protein-bound drugs.May cause reversible hypomanic reaction with disulfiram or fluoxetine.May ↓ clearance and ↑ effects of barbiturates..May ↑ clearance and ↓ effects of theophylline. Cross-tolerance and potentiation of effects may occur with opioids.Naltrexone may enhance effects.Alcohol may ↑ mood effects.Route/Dosage
Availability
Nursing implications
Nursing assessment
- Monitor patient closely for altered mental status. Patient should remain under the supervision of a responsible adult, especially during initiation of therapy and dose adjustments. Adverse psychiatric reactions may persist for 48–72 hrs following cessation of treatment.
- Monitor vital signs periodically during therapy. May cause tachycardia and orthostatic hypotension.
- Lab Test Considerations: May cause anemia.
Potential Nursing Diagnoses
Nausea (Indications)Risk for injury (Side Effects)
Implementation
- Start with lowest dose and increase as needed to minimize side effects.
- Oral: Administer 1–3 hr before chemotherapeutic regimen is administered. May also be administered the night before chemotherapy Administer 2 or 3 times daily during entire course of each cycle of chemotherapy and, if needed, for 48 hr after last dose of each cycle of chemotherapy.
Patient/Family Teaching
- Instruct patient to take nabilone as directed. Do not take more than recommended.
- Causes difficulty concentrating, drowsiness, euphoria and other mental changes. Caution patient to avoid driving and other activities requiring alertness until response to nabilone is known.
- Caution patient to avoid taking alcohol, sedatives, hypnotics, CNS depressants, and other psychoactive substances concurrently with nabilone.
- Advise patient to notify health care professional prior to taking any Rx, OTC, or herbal product.
Evaluation/Desired Outcomes
- Decrease in nausea and vomiting during emetogenic chemotherapy.