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Nabilone

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Overview

What is Cesamet?

Cesamet® (nabilone) is a synthetic cannabinoid for oral administration. Nabilone as a raw material occurs as a white to off-white polymorphic crystalline powder. In aqueous media, the solubility of nabilone is less than 0.5 mg/L, with pH values ranging from 1.2 to 7.0.

Chemically, nabilone is similar to the active ingredient found in naturally occurring [Marijuana; delta-9-tetrahydrocannabinol (delta-9-THC)]. Nabilone is (±)--3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6-6-dimethyl-9H-dibenzo[b,d]pyran-9-one and has the empirical formula C24H36O3. It has a molecular weight of 372.55. The structural formula is as follows:

Each 1 mg Cesamet capsule contains 1 mg of nabilone and the following inactive ingredients: povidone and corn starch. The capsule shells contain the following inactive ingredients: FD&C Blue No. 2 (indigo carmine), red iron oxide, gelatin, and titanium dioxide.



What does Cesamet look like?



What are the available doses of Cesamet?

Sorry No records found.

What should I talk to my health care provider before I take Cesamet?

Sorry No records found

How should I use Cesamet?

Cesamet capsules are indicated for the treatment of the nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. This restriction is required because a substantial proportion of any group of patients treated with Cesamet can be expected to experience disturbing psychotomimetic reactions not observed with other antiemetic agents.

Because of its potential to alter the mental state, Cesamet is intended for use under circumstances that permit close supervision of the patient by a responsible individual particularly during initial use of Cesamet and during dose adjustments.

Cesamet contains nabilone, which is controlled in Schedule II of the Controlled Substances Act. Schedule II substances have a high potential for abuse. Prescriptions for Cesamet should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days).

Cesamet capsules are not intended to be used on as needed basis or as a first antiemetic product prescribed for a patient.

As with all controlled drugs, prescribers should monitor patients receiving nabilone for signs of excessive use, abuse and misuse. Patients who may be at increased risk for substance abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness.

The usual adult dosage is 1 or 2 mg 2 times a day. On the day of chemotherapy, the initial dose should be given 1 to 3 hours before the chemotherapeutic agent is administered. To minimize side effects, it is recommended that the lower starting dose be used and that the dose be increased as necessary. A dose of 1 or 2 mg the night before may be useful. The maximum recommended daily dose is 6 mg given in divided doses 3 times a day.

Cesamet may be administered 2 or 3 times a day during the entire course of each cycle of chemotherapy and, if needed, for 48 hours after the last dose of each cycle of chemotherapy.


What interacts with Cesamet?

Sorry No Records found


What are the warnings of Cesamet?

Sorry No Records found


What are the precautions of Cesamet?

Sorry No Records found


What are the side effects of Cesamet?

Sorry No records found


What should I look out for while using Cesamet?

Cesamet is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.


What might happen if I take too much Cesamet?

Signs and Symptoms

Treatment

Overdosage may be considered to have occurred, even at prescribed dosages, if disturbing psychiatric symptoms are present. In these cases, the patient should be observed in a quiet environment and supportive measures, including reassurance, should be used. Subsequent doses should be withheld until patients have returned to their baseline mental status; routine dosing may then be resumed if clinically indicated. In such instances, a lower initiating dose is suggested. In controlled clinical trials, alterations in mental status related to the use of Cesamet resolved within 72 hours without specific medical therapy.

In overdose settings, attention should be paid to vital signs, since both hypertension and hypotension have been known to occur; tachycardia and orthostatic hypotension were most commonly reported.

No cases of overdosage with more than 10 mg/day of nabilone were reported during clinical trials. Signs and symptoms that would be expected to occur in large overdose situations are psychotic episodes, including hallucinations, anxiety reactions, respiratory depression, and coma.

If psychotic episodes occur, the patient should be managed conservatively, if possible. For moderate psychotic episodes and anxiety reactions, verbal support and comforting may be sufficient. In more severe cases, antipsychotic drugs may be useful; however, the utility of antipsychotic drugs in cannabinoid psychosis has not been systematically evaluated. Support for their use is drawn from limited experience using antipsychotic agents to manage cannabis overdoses. Because of the potential for drug-drug interactions (e.g., additive CNS depressant effects due to nabilone and chlorpromazine), such patients should be closely monitored.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, as well as other laboratory values and physical assessments. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

The use of forced diuresis, peritoneal dialysis, hemodialysis, charcoal hemoperfusion, or cholestyramine has not been reported. In the presence of normal renal function, most of a dose of nabilone is eliminated through the biliary system.

Treatment for respiratory depression and comatose state consists in symptomatic and supportive therapy. Particular attention should be paid to the occurrence of hypothermia. If the patient becomes hypotensive, consider fluids, inotropes, and/or vasopressors.

The estimated oral median lethal dose in female mice is between 1,000 and 2,000 mg/kg; in the female rat, it is greater than 2,000 mg/kg, (See ).


How should I store and handle Cesamet?

Store VIREAD tablets and oral powder at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.Store VIREAD tablets and oral powder at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) Keep the bottle tightly closed. Dispense only in original container. Do not use if seal over bottle opening is broken or missing.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.Cesamet® capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0037-1221-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body. Store at controlled room temperature, 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Rx OnlyIN-012250-02     Rev 5/2015To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Manufactured by: Valeant Pharmaceuticals International, Inc., Quebec, CanadaDistributed by: Meda Pharmaceuticals Inc., Somerset, New Jersey 08873-4120MEDA is a registered trademark of Meda AB.©2015 Meda Pharmaceuticals Inc.Made in CanadaCESAMET is a registered trademark of Valeant Pharmaceuticals North America LLC.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Cesamet (nabilone) is an orally active synthetic cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS). It has been suggested that the antiemetic effect of nabilone is caused by interaction with the cannabinoid receptor system, i.e., the CB (1) receptor, which has been discovered in neural tissues.

Nontherapeutic Effects:

Data on the chronic use of Cesamet are not available; experience with cannabis suggests that chronic use of cannabinoids may be associated with a variety of untoward effects on motivation, cognition, judgment, as well as other mental status changes. Whether these phenomena reflect the underlying character of individuals chronically abusing cannabis or are a result of the use of cannabis is not known.

The simultaneous use of Cesamet and alcohol or barbiturates may produce additive depressive effects on central nervous system function. Possible changes in mood and other adverse behavioral effects may occur in patients receiving Cesamet. Patients should remain under supervision of a responsible adult while using Cesamet.

Cesamet has central nervous system activity. It produces relaxation, drowsiness, and euphoria in the recommended dosage range. Tolerance to these effects develops rapidly and is readily reversible.

In addition to effects on the mental state, Cesamet has several systemic actions; most prominent are dry mouth and hypotension. Cesamet has been observed to elevate supine and standing heart rates and to cause supine and orthostatic hypotension. In clinical studies, oral administration of 2 mg of Cesamet did produce some decrease in airway resistance in normal controls but had no effect in patients with asthma. No other nontherapeutic effects of clinical significance due to Cesamet have been reported.

Non-Clinical Toxicology
Cesamet is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid.

Potential interactions between Cesamet 2 mg, and diazepam 5 mg; sodium secobarbital 100 mg; alcohol 45 mL (absolute laboratory alcohol); or codeine 65 mg, were evaluated in 15 subjects. Only a single combination was utilized at any one time. The subjects were evaluated according to physiologic (i.e., heart rate and blood pressure), psychometric, psychomotor, and subjective parameters. In this study, as expected, the depressant effects of the combinations were additive. Psychomotor function was particularly impaired with concurrent use of diazepam. Caution must thus be used when administering nabilone in combination with any CNS depressant.

Nabilone is purportedly highly bound to plasma proteins, and therefore, might displace other protein-bound drugs. Therefore, practitioners should monitor patients for a change in dosage requirements when administering nabilone to patients receiving other highly protein-bound drugs. Published reports of drug-drug interactions involving cannabinoids are summarized in the following table.

Animal Pharmacology and/or Toxicology

Monkeys treated with Cesamet at doses as high as 2 mg/kg/day for a year experienced no significant adverse events. This result contrasts with the findings in a planned 1-year dog study that was prematurely terminated because of deaths associated with convulsions in dogs receiving as little as 0.5 mg/kg/day. The earliest deaths, however, occurred at 56 days in dogs receiving 2 mg/kg/day. The unusual vulnerability of the dog to Cesamet is not understood; it is hypothesized, however, that the explanation lies in the fact that the dog differs markedly from other species in its metabolism of Cesamet.

The benefit/risk ratio of Cesamet use should be carefully evaluated in patients with the following medical conditions because of individual variation in response and tolerance to the effects of Cesamet.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-723-1400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Commonly Encountered Reactions:

Comparative Incidence of Reactions:

Finally, it is important to emphasize that these tabulations do not reflect the relative severity and/or clinical importance of the adverse events. A better perspective on the serious adverse events associated with the use of Cesamet is provided in the and sections.

The following tables list in order of decreasing frequency the adverse reactions encountered by a substantial proportion of patients treated with Cesamet participating in representative controlled clinical trials.

Adverse Reactions by Body System

Blood and Hematopoietic

Cardiovascular

Eye and Ear

Gastrointestinal

Genitourinary

Infection

Metabolic and Endocrine

Musculoskeletal

Nervous System

Psychiatric

Respiratory

Skin and Appendages

Miscellaneous and Ill-Defined Conditions

Postmarketing Adverse Reactions

Blood and Hematopoietic

Cardiovascular

Eye and Ear

Gastrointestinal

Nervous System

Psychiatric

Miscellaneous and Ill-Defined Conditions

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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