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What is SYNDROS?
Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-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:
CHO (molecular weight=314.46)
Dronabinol is a clear colorless to amber oil. Dronabinol is insoluble in water. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.
SYNDROS (dronabinol) oral solution, 5 mg/mL is a clear, pale yellow to brown solution. Each mL of SYNDROS contains 5 mg of dronabinol as an active ingredient and the following inactive ingredients: 50 % (w/w) dehydrated alcohol, polyethylene glycol 400, propylene glycol, sucralose, methyl paraben, propyl paraben, butylated hydroxyanisole, and water.
What does SYNDROS look like?
What are the available doses of SYNDROS?
Oral Solution: 5 mg/ mL ()
What should I talk to my health care provider before I take SYNDROS?
How should I use SYNDROS?
SYNDROS is indicated in adults for the treatment of:
Always use the enclosed calibrated oral dosing syringe.
The calibrated oral syringe measures a maximum SYNDROS dose of 5 mg. If the prescribed dose is greater than 5 mg, the total dose will need to be divided and drawn up in two or more portions using the oral syringe.
Take SYNDROS with a full glass of water (6 to 8 ounces).
What interacts with SYNDROS?
Sorry No Records found
What are the warnings of SYNDROS?
Sorry No Records found
What are the precautions of SYNDROS?
Sorry No Records found
What are the side effects of SYNDROS?
Sorry No records found
What should I look out for while using SYNDROS?
SYNDROS is contraindicated in patients:
What might happen if I take too much SYNDROS?
SYNDROS contains 50% (w/w) dehydrated alcohol and 5.5% (w/w) propylene glycol. Ingestion of the product over the recommended dose could result in significant toxicity.
Signs and symptoms of dronabinol overdose include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth, tachycardia, memory impairment, depersonalization, mood alteration, urinary retention, reduced bowel motility, decreased motor coordination, lethargy, slurred speech, and postural hypotension. Patients may also experience panic reactions if they have a prior history of nervousness or anxiety and seizures may occur in patients with existing seizure disorders.
It is not known if dronabinol can be removed by dialysis in cases of overdose.
Signs and symptoms of alcohol overdose include changes in mood or behavior, impaired judgment or social functioning, and one or more physical signs such as slurred speech, unsteadiness, lack of coordination, increased or irregular heart rate, respiratory depression, impaired attention, or loss of consciousness.
Signs and symptoms of acute poisoning occur only in rare circumstances where patients ingest large amounts of propylene glycol over several days. These include hypoglycemia, severe metabolic acidosis (caused by the metabolism into lactic acid), and CNS depression including coma and seizures.
Management of Overdosage
If over-exposure of SYNDROS occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
How should I store and handle SYNDROS?
Lamivudine Tablets USP, 150 mg (Scored)Recommended Storage: 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION:Lamivudine Tablets USP, 150 mg (Scored)Recommended Storage: 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION:Lamivudine Tablets USP, 150 mg (Scored)Recommended Storage: 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION:
Chemical StructureNo Image found
Dronabinol is an orally active cannabinoid that has complex effects on the CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.
Non-Clinical ToxicologySYNDROS is contraindicated in patients:
Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema (see WARNINGS).
Psychiatric Adverse Reactions
Dronabinol has been reported to exacerbate mania, depression, or schizophrenia. Prior to initiating treatment with SYNDROS, screen patients for a history of these illnesses. Avoid use in patients with a psychiatric history or, if the drug cannot be avoided, monitor patients for new or worsening psychiatric symptoms during treatment. Also, avoid concomitant use with other drugs that are associated with similar psychiatric effects.
Cognitive Adverse Reactions
Use of SYNDROS has been associated with cognitive impairment and altered mental state. Reduce the dose of SYNDROS or discontinue use of SYNDROS if signs or symptoms of cognitive impairment develop. Elderly and pediatric patients may be more sensitive to the neurological and psychoactive effects of SYNDROS .
SYNDROS can cause and may impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle or operating machinery. Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants may increase this effect (e.g., barbiturates, benzodiazepines, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, and muscle relaxants). Inform patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that SYNDROS does not affect them adversely.
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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