Contrave

The usual starting dose of Contrave is one tablet taken by mouth once daily, in the morning for the first week. For the second week, the dose is one tablet twice a day, once in the morning and one with the evening meal. The dose is increased by 1 tablet daily each week until the recommended maximum daily dose of two tablets taken twice daily.

Naltrexone-bupropion may be taken with meals. High-fat meals should be avoided, as this increases the amount of medication in the body and can increase the side effects. Swallow the tablets whole and do not cut, crush, or chew them.

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 taking the medication without consulting your doctor.

It is important to take Contrave exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Contrave at room temperature, protect it from light and moisture, and keep it out of the reach of children.

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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause dryness of the mouth; it may cause headaches; it may cause constipation - to prevent this, drink plenty of water or juice, and eat more dietary fibre; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea or, rarely, vomiting; it may cause difficulty falling or staying asleep. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each round, biconvex, blue, film-coated, extended-release tablet, debossed with NB-890 on one side, contains 8 mg of naltrexone hydrochloride and 90 mg of bupropion hydrochloride. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, edetate disodium, FD&C Blue No. 2 indigo carmine aluminum lake, hydroxypropyl cellulose, ypromellose, lactose anhydrous, lactose monohydrate, L-cysteine hydrochloride, macrogol/peg, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.

Do not take Contrave if you:

• are allergic to naltrexone, bupropion, or any ingredients of Contrave
• are pregnant
• are taking another medication that contains bupropion (e.g., Wellbutrin XL®, Wellbutrin® SR, or Zyban®)
• are currently taking thioridazine (an antipsychotic medication)
• are receiving opiate analgesics (e.g., narcotics medications such as oxycodone and codeine) or opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine)
• are abruptly discontinuing alcohol, benzodiazepines (e.g., diazepam, clonazepam, lorazepam), other sedatives (e.g., phenobarbital), or seizure medications
• are experiencing opiate withdrawal
• have uncontrolled high blood pressure
• have or have had an eating disorder (bulimia or anorexia nervosa)
• have severely decreased liver function
• have end-stage kidney failure
• have a seizure disorder or history of seizures
• have taken a monoamine oxidase inhibitor (MAO inhibitor; e.g., phenelzine, tranylcypromine) within the past 2 weeks

There may be an interaction between naltrexone – bupropion and any of the following:

• alcohol
• amantadine
• amphetamines (dextroamphetamine, lisdexamfetamine)
• antipsychotics (e.g., amoxapine, chlorpromazine, haloperidol, pimozide, risperidone, thioridazine)
• apomorphine
• atomoxetine
• bromocriptine
• caffeine
• carbamazepine
• carvedilol
• clopidogrel
• dexmethylphenidate
• dextromethorphan
• digoxin
• doxorubicin
• eliglustat
• fesoterodine
• flecainide
• glyburide
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, nevirapine)
• levodopa
• linezolid
• lithium
• lopinavir
• lumacaftor and ivacaftor
• metoclopramide
• methadone
• metoprolol
• methylene blue
• methylphenidate
• methylnaltrexone
• mexiletine
• mifepristone
• mirtazapine
• monoamine oxidase inhibitors (MAO inhibitors; e.g., phenelzine, tranylcypromine, moclobemide, selegilene) - bupropion should not be started until at least 14 days after MAO inhibitors are stopped
• naloxegol
• narcotic pain relievers (e.g., codeine, fentanyl, hydrocodone, morphine, oxycodone, tramadol)
• ozanimod
• pitolisant
• phenytoin
• phenobarbital
• pramipexole
• prochlorperazine
• propafenone
• propranolol
• rifampin
• ritonavir
• ropinirole
• rotigotine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• tamoxifen
• tamsulosin
• tetrabenazine
• theophylline
• tolterodine
• tricyclic antidepressants (e.g., nortriptyline, imipramine, 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 Contrave. 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.

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 Contrave.

Accidental ingestion: If you are dependent on narcotics and you ingest Contrave, you could experience severe symptoms of withdrawal including confusion, nausea, shakiness, sweating, anxiety, visual hallucinations, vomiting, or diarrhea. Avoid taking narcotic medications while you are taking naltrexone-bupropion.

Diabetes: Weight loss often causes decreased blood glucose. As a result, using naltrexone-bupropion may cause episodes of low blood sugar when taken by people with diabetes who are taking certain oral medications to control blood sugar. You may find it necessary to monitor your blood sugar more frequently while using Contrave.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Bupropion may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Contrave affects you.

Heart disease: Bupropion can increase blood pressure and heart rate. It is not known whether it is safe for use by people with a recent history of Heart Attack or unstable heart disease. If you have had a heart attack within the past 6 months, have an irregular heartbeat, high blood pressure, Congestive Heart Failure or a recent Stroke, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed.

Galactose intolerance/glucose malabsorption: Contrave contains lactose. If you have lactose or galactose intolerance you should not take Contrave.

Glaucoma: Contrave may cause the symptoms of glaucoma (increased pressure in the eye) to become worse. If you have glaucoma, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed. Report any changes in vision to your doctor as soon as possible while you are taking Contrave.

Identical medications: Wellbutrin®, Zyban® and several other medications contain bupropion. Revia® and Relistor® contain naltrexone. If you are taking naltrexone-bupropion, do not take any other product containing bupropion or naltrexone, as the risk of side effects increases with an increased dosage.

Interference with opiate-containing mediations: Because Contrave works by blocking the effects of opiates, it will reduce the effectiveness of narcotic pain relievers. It may also interfere with other medications that contain opiates such as certain cough and cold medications, antidiarrheal medications, and some analgesics (pain medications). Trying to overcome the blocking effects of naltrexone by taking larger doses of narcotics may result in severe side effects of the narcotic. Talk to your doctor or pharmacist about non-opiate containing alternatives.

Kidney function: Kidney Disease or reduced kidney function may cause Contrave to build up in the body, causing side effects. If you have kidney problems, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed. Contrave is not recommended for people with end-stage kidney disease.

Liver function: Liver disease or reduced liver function may cause Contrave to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed. Naltrexone-bupropion is not recommended for people with severely decreased liver function.

Naltrexone-bupropion has been reported to cause decreased liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lupus: There may be an association between taking naltrexone – bupropion and the autoimmune conditions systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). If you develop any skin rash (particularly on the face), fatigue, joint pain, or swelling, contact your doctor as soon as possible.

Mental health: Bupropion may trigger mania and make behaviour and thought disturbances worse for people who have mental health conditions. It may also cause symptoms of psychosis and mania to develop for people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking Contrave, contact your doctor as soon as possible. If you have mental health concerns, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed.

Seizure risk: Bupropion may increase the risk of seizures. If you are at risk of seizures, discuss with your doctor how Contrave may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Contrave, and whether any special monitoring is needed.

Things that increase the risk of seizures include:

• addiction to cocaine, stimulants, or opiates (such as morphine)
• diabetes treated with oral medications or insulin
• excessive alcohol use
• history of head trauma or seizures (including Epilepsy)
• severe liver problems
• tumours of the brain or spinal cord
• use of other medications that make seizures more likely (e.g., antipsychotics, antidepressants, lithium, theophylline, steroids)
• use of over-the-counter stimulants or appetite suppressants

Serotonin toxicity: Severe reactions are possible when naltrexone - bupropion is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors, medications used to treat depression. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are possible.

Suicidal or agitated behaviour, or other behaviour changes: People taking Contrave may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after people start taking Contrave. If you experience these side effects or notice them in a family member who is taking Contrave, contact your doctor immediately. Your doctor will monitor you for emotional and behavioural changes while you are taking bupropion.

Pregnancy: Weight loss does not benefit a woman during pregnancy and may cause harm to the developing baby. Use of either of these medications may also cause harm to the developing baby. For these reasons, Contrave should not be used during pregnancy. If you become pregnant while taking Contrave, contact your doctor immediately.

Breast-feeding: Both naltrexone and bupropion pass into breast milk. If you are breast-feeding and are taking Contrave, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Contrave have not been established for children.

Seniors: Seniors may be at an increased risk of side effects due to age-related decreased kidney or liver function.

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. This medication should be swallowed whole. It should not be split, crushed or chewed. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication should be taken after a light (low-fat) meal. Consuming alcohol may intensify the effect of this product. If you choose to drink alcohol, do so in moderation. Talk to your health care professional to find out exactly how much alcohol you can drink.