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delta-9-tetrahydrocannabinol (THC) - cannabidiol (CBD)
This medication contains two ingredients: tetrahydrocannabinol (THC) and cannabidiol (CBD). These ingredients belong to the family of medications known as cannabinoids and are extracted from the Cannabis sativa (hemp) plant. This medication is used to treat pain. Although it is not known exactly how THC and CBD work to relieve nerve pain, it is thought to work by mimicking natural pain relievers called cannabinoids that are released in the body.
Tetrahydrocannabinol - cannabidiol is used, along with other medications, to relieve the muscle spasms that occur with multiple sclerosis (MS), when other medications do not provide enough relief. MS is a chronic disease that affects the brain. It is caused by the destruction of myelin, a fatty tissue that allows the nerves to conduct signals to and from the brain.
Delta-9-tetrahydrocannabinol (THC) - cannabidiol (CBD) has also been granted a notice of compliance with conditions (NOC/c) by Health Canada to reduce the nerve pain that is also associated with MS and to treat moderate-to-severe pain in advanced cancer, when the highest doses of other pain relievers do not provide adequate pain relief. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.
Each spray (100 µL) contains 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Nonmedicinal ingredients: ethanol, propylene glycol, and peppermint oil.
Tetrahydrocannabinol - cannabidiol is available as a spray for the mouth. It is sprayed under the tongue or on the inside of the cheeks. The usual starting adult dose of tetrahydrocannabinol - cannabidiol is one spray 2 times a day on the first day. You should start to feel its effects in about 30 minutes. Do not spray the back of the throat or into the nose. After the first day, you may be advised to increase the dose by 1 spray every 24 hours, spacing the doses evenly. No more than 12 doses should be used over a 24 hour period.
The maintenance dose depends on each person's medical condition and individual response to the medication. The right dose is reached when you achieve acceptable pain relief with tolerable side effects. Most people require between 4 and 8 doses daily.
Space out your doses evenly throughout the day, or adjust the timing of the dose depending on how you feel. If you experience side effects that you cannot tolerate, try reducing your dose or increasing the time between each dose.
How to prime your spray: Before using a pump spray device for the first time, it must be primed. Shake the vial gently and remove the protective cap. Hold the vial in an upright position and press firmly and quickly on the actuator 2 or 3 times, until a fine spray appears. Point the spray into a tissue, away from yourself, children, and pets when priming.
Normal use: Shake the vial gently and remove the protective cap before using. Holding the vial upright and directing it into your mouth, press firmly and quickly to release the spray under the tongue or towards the inside of the cheek. Regularly change the site that the spray is directed at to reduce irritation.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important to use this medication exactly as prescribed by your doctor. If you miss a dose of the medication, do not worry. Tetrahydrocannabinol - cannabidiol is a medication that is taken as needed; take another dose as soon as you feel you need to for the pain. Store unopened bottles in the refrigerator. Do not freeze. Keep away from sources of heat such as direct sunlight or flames (as the product is flammable). Opened bottles may be stored at room temperature. Keep it out of the reach of children.
Any unused contents should be discarded after 28 days for the small vial and 42 days for the larger vial.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not use tetrahydrocannabinol - cannabidiol if you:
- are allergic to cannabinoids or any ingredients of the medication
- are a woman of child-bearing age and not using reliable contraception
- are pregnant or breast-feeding
- are less than 18 years old
- have a history of schizophrenia or other psychotic disorders
- have serious heart disease, such as ischemic heart disease, irregular heartbeat or rhythm, poorly controlled blood pressure, or severe heart failure
- intend to start a family while on treatment (applies to both men and women)
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal (stomach) pain
- appetite changes (increase or decrease)
- balance problems
- burning sensation in the mouth
- dry mouth
- forgetfulness or poor concentration
- mood changes
- panic attacks
- sore throat
- soreness or stinging sensation in mouth
- spinning sensation
- trouble sleeping
- trouble urinating
- unusual taste in the mouth
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- blood pressure changes
- blurred vision
- difficulty passing urine
- falls, or difficulty with balance
- hallucinations (seeing, hearing, or feeling things that are not there) or strange ideas
- intoxication (a feeling of being drunk; e.g., difficulty paying attention, dizziness, sleepiness, disorientation, changes in mood, a feeling of unreality, or a feeling of general happiness or a "high," such as easy laughter or heightened awareness)
- mouth sores
- rapid heartbeat
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- slurred speech
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a severe allergic reactions (e.g., hives; difficulty breathing; or swelling of the tongue, face, mouth, or throat)
- thoughts of self-harm or suicide
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Alcohol: This medication contains alcohol and may be harmful to people who have an alcohol use disorder. It may also become a problem for people with liver disease. If you have a history of alcohol abuse or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Bladder outflow obstruction: This medication can cause the inability to urinate in people who have medical problems that obstruct the flow of urine from the bladder (e.g., enlarged prostate, prostate cancer). If you have a history of bladder outflow obstruction, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Depression: THC is known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or you notice them in a family member who is taking this medication, contact your doctor as soon as possible.
Drowsiness/reduced alertness: This medication can impair mental and physical abilities. You should avoid driving, operating heavy machinery, or engaging in activities that require mental alertness when using this medication.
Heart problems: This medication may cause low blood pressure and can increase your heart rate. You may experience lightheadedness when getting up from a sitting or lying down position (postural hypotension). People with severe heart problems, such as an irregular heart rate or rhythm, ischemic heart disease (caused by restricted blood-flow to the heart), poorly controlled high blood pressure, or heart failure, should not use this medication. If you have a history of heart disease or blood pressure problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Intoxication: One of the active ingredients in this medication is tetrahydrocannabinol (THC). THC can have many effects on the central nervous system. It can impair memory, mental performance, and the ability to control behaviour. It can also change a person's mood and alter their sense of reality and time. THC can interfere with physical ability to carry out tasks and can cause fainting. These reactions tend to occur with larger doses or when the medication is used more frequently in the day. They may improve when the dose is lowered, when the medication is used less frequently, or when it is stopped. Talk to your doctor if you have any concerns about using this medication.
Kidney disease: If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. While taking this medication, your doctor may order blood tests to check how well your kidneys are working.
Mental health: THC may make behavior and thought disturbances worse for people who have psychotic conditions. This medication may also cause symptoms of psychosis and mania to develop in people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually overexcited or uninhibited), or delusional thinking, or other psychiatric changes (mood swings, hallucinations, anxiety), or notice them in a family member who is taking this medication, contact your doctor as soon as possible.
Seizure disorders: This medication may cause seizures, especially when higher doses are used or when taken with other medications such as:
- neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
- opioids (e.g., morphine, codeine, oxycodone)
- selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
- tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)
The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma). If you have a history of seizure disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Substance abuse disorders: This medication is not recommended for people with addictions, as it can cause physical and psychological dependence and has the potential to be abused. If you have a history of substance abuse disorders, including alcohol abuse or dependence, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Suicidal or agitated behaviour: Thoughts of self-harm have been reported by people taking this medication. This may be related to the use of the medication or it may be due to the medical conditions being treated. If you feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves) or want to hurt yourself or others, or notice these symptoms in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Pregnancy: This medication should not be used by women who are pregnant or intend to start a family. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking tetrahydrocannabinol - cannabidiol, it may affect your baby. Breast-feeding is not recommended while using this medication.
Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used in children under 18 years of age.
Seniors: The safety and effectiveness of this medication have not been established for seniors. Seniors using this medication should be monitored closely by their doctor.
There may be an interaction between tetrahydrocannabinol - cannabidiol and any of the following:
- abiraterone acetate
- amphetamines (e.g., dexamphetamine, lisdexamfetamine)
- antihistamines (e.g., cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine)
- antipsychotic medications (e.g., olanzepine, quetiapine, risperidone)
- “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- barbiturates (e.g., phenobarbital, butalbital)
- benzodiazepines (e.g., clonazepam, diazepam, lorazepam)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- chloral hydrate
- decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
- decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
- fast-acting bronchodilators (e.g., salbutamol, terbutaline)
- general anesthetics (medications used to put people to sleep before surgery)
- grapefruit juice
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
- long-acting bronchodilators (e.g., formoterol, salmeterol)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- marijuana or smoked cannabis
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
- narcotic medications (e.g., morphine, codeine, fentanyl)
- St. John's wort
- seizure medications (e.g., carbamazepine, clobazam, ethosuximide, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
- theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
- tricyclic antidepressants (e.g., amitriptyline, desipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sativex
All material © 1996-2020 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.