Description
Dextromethorphan and bupropion combination is used to treat major depressive disorder (MDD).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dextromethorphan and bupropion combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dextromethorphan and bupropion combination in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Bromopride
- Clorgyline
- Furazolidone
- Iproniazid
- Isocarboxazid
- Linezolid
- Mavorixafor
- Methylene Blue
- Moclobemide
- Nialamide
- Ozanimod
- Pargyline
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Selegiline
- Toloxatone
- Tranylcypromine
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.
- Acetophenazine
- Aclidinium
- Acrivastine
- Acyclovir
- Alcaftadine
- Alfentanil
- Almotriptan
- Amantadine
- Ambenonium
- Amdinocillin
- Amiloride
- Amineptine
- Aminophylline
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amphotericin B
- Ampicillin
- Anisotropine
- Antazoline
- Aripiprazole
- Aripiprazole Lauroxil
- Astemizole
- Atomoxetine
- Atovaquone
- Atropine
- Azatadine
- Azelastine
- Azlocillin
- Aztreonam
- Bacampicillin
- Baclofen
- Balofloxacin
- Belladonna Alkaloids
- Benperidol
- Benzhydrocodone
- Benzphetamine
- Bepotastine
- Besifloxacin
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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Haloperidol
- Isavuconazonium Sulfate
- Lofexidine
- Metoprolol
- Nirmatrelvir
- Quinidine
- St John's Wort
- Terbinafine
- Tipranavir
Other Interactions
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.
- Ethanol
Using this medicine with any of the following may cause an increased risk of certain side effects 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.
- Grapefruit Juice
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
- Seizures or
- Seizure medicine use, if stopped suddenly, or
- Sleeping or anxiety medicine use, if stopped suddenly—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, severe 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 (mood disorder with mania and depression), or risk of or
- Falls, history of or
- Glaucoma, angle closure or
- Heart attack or
- Heart problems or
- High blood pressure or
- Kidney disease, moderate or
- Mania or hypomania, history of or
- Problems with movement or walking or
- Psychosis—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, severe—Use is not recommended in patients with these conditions.
Proper Use
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.
This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
You may take this medicine with or without food.
Swallow the extended-release tablet whole. Do not crush, divide, or chew it.
Do not drink alcohol while you are using this medicine. Talk with your doctor before suddenly stopping drinking alcohol.
Dosing
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 depression:
- Adults—At first, one tablet once a day in the morning for 3 days. Your doctor may increase your dose to one tablet 2 times a day at least 8 hours apart. However, the dose is usually not more than 2 tablets per day. Each tablet contains 45 milligrams (mg) dextromethorphan and 105 mg bupropion.
- Children—Use and dose must be determined by your doctor.
- For depression:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
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
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. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
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 treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause some teenagers and young adults 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. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
Check with your doctor right away if you have loss of bladder control, muscle spasm or jerking of all extremities, or sudden loss of consciousness. These may be symptoms of seizures.
Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.
This medicine may make you dizzy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
This medicine may cause a condition called serotonin syndrome when used together with certain MAO inhibitors (eg, phenelzine, rasagiline, tranylcypromine) and medicines to treat depression (eg, amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft®). Check with your doctor right away if you have anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there.
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
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:
Less common
- Fear, nervousness
Incidence not known
- Absence of or decrease in body movement
- attack, assault, force
- bigger, dilated, or enlarged pupils (black part of the eye)
- bleeding gums
- blistering, peeling, or loosening of the skin
- bloating
- bloody, black, tarry stools
- bloody or cloudy urine
- bluish color
- blurred vision
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- change in vision
- changes in patterns and rhythms of speech
- changes in skin color
- chest pain or tightness
- chills
- cold sweats
- coma
- confusion
- confusion as to time, place, or person
- cool, pale skin
- cough
- cracks in the skin
- dark urine
- deafness
- decrease in frequency of urination
- decreased urine output
- depression
- diarrhea
- difficult, burning, or painful urination
- difficulty in passing urine (dribbling)
- difficulty in swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- extra heartbeats
- eye pain
- fainting
- false or unusual sense of well-being
- feeling, seeing, or hearing things that are not there
- feeling that others can hear your thoughts
- feeling that others are watching you or controlling your behavior
- fever
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- hallucinations
- headache
- heartburn
- holding false beliefs that cannot be changed by fact
- inability to move the eyes
- increased blinking or spasms of the eyelid
- increased hunger
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity of the eyes to light
- increased thirst
- increased urination
- indigestion
- irritability
- itching
- itching of the vagina or genital area
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lip smacking or puckering
- loss of appetite
- loss of bladder control
- loss of heat from the body
- loss of vision
- muscle cramps, spasms, pain, stiffness, tightness, or weakness
- nausea
- nerve pain
- nightmares
- pain during sexual intercourse
- pain or burning in the throat
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pounding, slow heartbeat
- pounding in the ears
- problems with speech or speaking
- puffing of cheeks
- rapid or worm-like movements of tongue
- red, swollen, or scaly skin
- red irritated eyes
- red skin lesions, often with a purple center
- restlessness
- seizures
- sensation of pins and needles
- severe mood or mental changes
- shakiness
- slurred speech
- sore throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stabbing pain
- sticking out of the tongue
- stomach cramps, tenderness, pain, or burning
- sugar in the urine
- sweating
- swelling of the breasts or breast soreness in both females and males
- swelling of the face, ankles, or hands
- swelling of the foot or leg
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- swollen glands
- tenderness
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- thick, white vaginal discharge with no odor or with a mild odor
- thoughts of killing oneself changes in behavior
- trouble breathing
- trouble sleeping
- trouble speaking
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- uncontrolled chewing movements
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unexplained weight loss
- unusual behavior
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual facial expressions
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- vomiting of blood or material that looks like coffee grounds
- watery or bloody diarrhea
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- blurred vision
- coma
- confusion
- dark-colored urine
- decreased awareness or responsiveness
- diarrhea
- difficult or trouble breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fever
- hyperexcitability
- inability to move the eyes
- increased blinking or spasms of the eyelid
- irregular, fast or slow, or shallow breathing
- loss of consciousness
- mental depression or anxiety
- muscle cramps, spasms, pain, stiffness, or tightness
- nausea
- nightmares or unusually vivid dreams
- overactive reflexes
- pale or blue lips, fingernails, or skin
- poor coordination
- seeing, hearing, or feeling things that are not there
- seizures
- severe sleepiness
- shakiness and unsteady walk
- shivering
- sticking out of the tongue
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual facial expressions
- unusual tiredness or weakness
- vomiting
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
- Increased sweating
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
Incidence not known
- Feeling of discomfort
- inflammation of the joints
- loss or thinning of the hair
- muscle aches
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.
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