Naltrexone and bupropion (Oral route)
nal-TREX-one hye-droe-KLOR-ide, bue-PROE-pee-on hye-droe-KLOR-ide
- Tablet, Extended Release
Warnings:Oral route(Tablet, Extended Release)
Naltrexone hydrochloride/buPROPion hydrochloride is not approved for use in the treatment of major depressant disorder or other psychiatric disorders. Naltrexone hydrochloride/buPROPion hydrochloride contains buPROPion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on naltrexone hydrochloride/buPROPion hydrochloride, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Naltrexone hydrochloride/buPROPion hydrochloride is not approved for use in pediatric patients .
Uses of This Medicine:
Naltrexone and bupropion combination is used together with a reduced-calorie diet and proper exercise to help lose weight and keep it off. This medicine is used in people who are overweight or very overweight and who also have weight-related medical problems.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of naltrexone and bupropion combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naltrexone and bupropion combination in the elderly. However, elderly patients may be more sensitive to the effects of this medicine and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
- Morphine Sulfate Liposome
- Opium Alkaloids
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amdinocillin Pivoxil
- Belladonna Alkaloids
- Conjugated Estrogens
- Doxorubicin Hydrochloride Liposome
- Esterified Estrogens
- Ethinyl Estradiol
- Iobenguane I 123
- Iobenguane I 131
- Nalidixic Acid
- Penicillin G
- Penicillin V
- Polyestradiol Phosphate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aripiprazole Lauroxil
- Isavuconazonium Sulfate
- St John's Wort
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol use, if stopped suddenly, or
- Eating disorders (eg, anorexia, bulimia), history of or
- Hypertension (high blood pressure), uncontrolled or
- Seizure medicine use, if stopped suddenly (eg, carbamazepine (Tegretol®), phenobarbital, phenytoin (Dilantin®)), or
- Seizures, or history of or
- Sleeping or anxiety medicine use, if stopped suddenly (eg, alprazolam (Xanax®), lorazepam (Ativan®), temazepam (Restoril®), triazolam (Halcion®))—Should not be used in patients with these conditions.
- Arteriovenous malformation (circulation problem) or
- Brain tumor or infection or
- Diabetes or
- Drug or alcohol abuse or
- Head injury or
- Hypoglycemia (low blood sugar) or
- Hyponatremia (low sodium in the blood) or
- Hypoxia (low oxygen in the blood) or
- Liver disease, severe or
- Stroke, severe or history of—May increase risk for seizures.
- Bipolar disorder (type of depression), or risk of or
- Glaucoma, angle closure or
- Hypertension (high blood pressure) or
- Mania or hypomania (type of mental disease), history of or
- Psychosis (type of mental disease)—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Follow your doctor's instructions carefully on a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.
Swallow the tablet whole. Do not crush, break, or chew it.
Take this medicine with food. However, do not take it with high-fat meals. This may increase your risk of seizures.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (extended-release tablets):
- For weight loss:
- Adults—At first, one tablet in the morning taken on week 1. Your doctor will increase your dose to one tablet in the morning and one tablet in the evening on week 2. Then, two tablets in the morning and one tablet in the evening on week 3. On week 4, two tablets in the morning and two tablets in the evening.
- Children—Use is not recommended.
- For weight loss:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy. If you think you have become pregnant while using this medicine, tell your doctor right away.
Do not take naltrexone and bupropion combination with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking naltrexone and bupropion combination during the 2 weeks after you stop a MAO inhibitor. Wait 2 weeks after stopping naltrexone and bupropion combination before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may have confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.
Do not use naltrexone and bupropion combination if you are also using Zyban® to quit smoking or Aplenzin® or Wellbutrin® for depression, because they also contain bupropion. Also, do not take this medicine if you are using or have used narcotic drugs (such as buprenorphine, methadone, or other habit-forming painkillers) within the past 7 to 10 days.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
You have a higher risk of accidental overdose, serious injury, or death if you use heroin or any other narcotic medicine while you are being treated with naltrexone and bupropion combination. Also, naltrexone prevents you from feeling the effects of heroin if you use it.
Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having certain side effects when you stop the medicine, such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headaches, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness.
Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, swelling of the face, tongue, or throat, trouble breathing, or chest pain.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor right away if blurred vision, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).
This medicine may increase the risk of hypoglycemia (low blood sugar) in patients with diabetes. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. You should check your blood sugar before you start treatment and while you are taking this medicine.
Drinking alcoholic beverages should be limited or avoided, if possible, with this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Blurred vision
- fear or nervousness
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- pounding in the ears
- slow or fast heartbeat
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
- Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- fast, irregular, pounding, or racing heartbeat or pulse
- frequent urge to urinate
- lower back or side pain
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
- Less common or rare
- Chest pain or discomfort
- pain or discomfort in the arms, jaw, back, or neck
- Changes in behavior
- thoughts of killing oneself
- Incidence not known
- Aggressive or angry
- blistering, peeling, or loosening of the skin
- clay colored stools
- dark urine
- delusions of persecution, mistrust, suspiciousness, or combativeness
- difficulty with moving
- difficulty with swallowing
- dry mouth
- false beliefs that cannot be changed by facts
- feeling that others are watching you or controlling your behavior
- feeling, seeing, or hearing things that are not there
- hives, itching, or rash
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle stiffness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- severe mood or mental changes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain or tenderness
- swelling of the feet or lower legs
- tightness in the chest
- unusual behavior
- yellow eyes or skin
- Symptoms of overdose
- Blue lips, fingernails, or skin
- change in or loss of consciousness
- decreased awareness or responsiveness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- muscle cramps or spasms
- severe sleepiness
- More common
- Difficulty having a bowel movement
- Less common
- Change or loss of taste
- continuing ringing or buzzing or other unexplained noise in the ears
- feeling of warmth
- hearing loss
- increased sweating
- redness of the face, neck, arms, and occasionally, upper chest
- stomach pain
- Less common or rare
- Feeling of constant movement of self or surroundings
- sensation of spinning
- severe nausea or vomiting
- thinning of the hair or hair loss
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 6/18/2019