naltrexone and bupropion (Oral route)
nal-TREX-one hye-droe-KLOR-ide, bue-PROE-pee-on hye-droe-KLOR-ide
Naltrexone hydrochloride/buPROPion hydrochloride is not approved for use in children or for the treatment of major depression or other psychiatric disorders. However, antidepressants, including bupropion, increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders; in these patients, the suicidal risk must be balanced with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Monitor patients closely for clinical worsening, suicidality, unusual changes in behavior; families and caregivers should be advised of the need for close observation and communication with the prescriber. Naltrexone hydrochloride/buPROPion hydrochloride is not approved for smoking cessation, but serious neuropsychiatric reactions have occurred in patients taking buPROPion for smoking cessation. Most reactions occurred during buPROPion treatment, but some occurred during treatment discontinuation. Patients should be observed for neuropsychiatric reactions, and patients should contact a healthcare provider if such reactions occur .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
- Tablet, Extended Release
Therapeutic Class: Antiobesity Agent
Pharmacologic Class: Naltrexone
Chemical Class: Bupropion
Uses For naltrexone and bupropion
Naltrexone and bupropion combination is used together with a reduced-calorie diet and proper exercise to help loose weight and keep it off. naltrexone and bupropion is used in people who are overweight or very overweight and who also have weight-related medical problems.
naltrexone and bupropion is available only with your doctor's prescription.
Before Using naltrexone and bupropion
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 naltrexone and bupropion, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to naltrexone and bupropion 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.
Although appropriate studies on the relationship of age to the effects of naltrexone and bupropion combination have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving naltrexone and bupropion combination.
|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.
Interactions with Medicines
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 naltrexone and bupropion, 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 naltrexone and bupropion 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 naltrexone and bupropion 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
- Nalidixic Acid
- Penicillin G
- Penicillin V
- Polyestradiol Phosphate
Using naltrexone and bupropion 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.
- Isavuconazonium Sulfate
- St John's Wort
Interactions with Food/Tobacco/Alcohol
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 naltrexone and bupropion 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 naltrexone and bupropion, 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 naltrexone and bupropion. 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
- 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—May increase risk for seizures.
- Bipolar disorder (type of depression), or risk of or
- Glaucoma, angle closure or
- Hypertension or
- Mania (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 naltrexone and bupropion
Take naltrexone and bupropion 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 directed by your doctor. To do so may increase the chance of developing unwanted side effects such as high blood pressure.
naltrexone and bupropion comes with a Medication Guide. Read and follow the instructions carefully. Talk to 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 extended-release tablet whole. Do not crush, break, or chew it.
Take naltrexone and bupropion with food. However, do not take naltrexone and bupropion with high-fat meals. This may increase your risk of seizures.
The dose of naltrexone and bupropion 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 naltrexone and bupropion. 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—One tablet in the morning taken for 1 week. Your doctor will increase your dose to one tablet in the morning and one tablet in the evening for 1 week. Then, two tablets in the morning and one tablet in the evening for 1 week. 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 naltrexone and bupropion, 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 naltrexone and bupropion
Your doctor will check your progress at regular visits, especially during the first few months that you take naltrexone and bupropion.
Using naltrexone and bupropion while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using naltrexone and bupropion, 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, and 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 intestinal 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 naltrexone and bupropion 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.
naltrexone and bupropion 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 naltrexone and bupropion 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 naltrexone and bupropion. 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.
naltrexone and bupropion may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis 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 naltrexone and bupropion. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with naltrexone and bupropion.
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.
naltrexone and bupropion may increase risk of hypoglycemia (low blood sugar) in patients with diabetes. You should check your blood sugar before you start treatment and while you are taking naltrexone and bupropion.
Drinking alcoholic beverages should be limited or avoided, if possible, with naltrexone and bupropion.
Before you have any medical tests, tell the medical doctor in charge that you are taking naltrexone and bupropion. The results of some tests may be affected by naltrexone and bupropion.
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.
naltrexone and bupropion Side Effects
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: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
- 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
- Chest pain or discomfort
- pain or discomfort in the arms, jaw, back, or neck
- Changes in behavior
- thoughts of killing oneself
- Abdominal or stomach pain or tenderness
- aggressive or angry
- blistering, peeling, or loosening of the skin
- clay colored stools
- dark urine
- decreased appetite
- 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
- loss of appetite
- 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
- swelling of the feet or lower legs
- tightness in the chest
- unusual behavior unusual tiredness or weakness yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:Symptoms of overdose
- Blue lips, fingernails, or skin
- change in consciousness
- decreased awareness or responsiveness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- loss of consciousness
- muscle cramps or spasms
- severe sleepiness
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:More common
- difficulty having a bowel movement (stool)
- Abdominal or stomach pain
- 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
- sudden sweating
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- hair loss
- sensation of spinning
- severe nausea or vomiting
- thinning of the hair
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.
See also: Side effects (in more detail)
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