Description
Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called selective norepinephrine reuptake inhibitors (SNRIs).
Atomoxetine works in the brain to increase attention and decrease restlessness in people who are hyperactive, have problems with concentration, or are easily distracted. This medicine may be used as part of a treatment program that includes social, educational, and psychologic treatment.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Capsule
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 atomoxetine in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of atomoxetine have not been performed in the geriatric population. Safety and efficacy have not been established.
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.
- Isocarboxazid
- Linezolid
- Mavorixafor
- Methylene Blue
- Ozanimod
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Selegiline
- 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.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Albuterol
- Amphetamine
- Azathioprine
- Bupropion
- Celecoxib
- Dacomitinib
- Desvenlafaxine
- Dextroamphetamine
- Donepezil
- Duloxetine
- Escitalopram
- Fedratinib
- Fluoxetine
- Givosiran
- Insulin Aspart, Recombinant
- Landiolol
- Levoketoconazole
- Lisdexamfetamine
- Lumefantrine
- Mercaptopurine
- Methotrexate
- Olodaterol
- Panobinostat
- Paroxetine
- Quinidine
- Ranolazine
- Sertraline
- Terbinafine
- Venlafaxine
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.
- Amitriptyline
- Amoxapine
- Clomipramine
- Desipramine
- Dibenzepin
- Dothiepin
- Imipramine
- Lofepramine
- Nortriptyline
- Opipramol
- Protriptyline
- Trimipramine
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. Discuss with your healthcare professional the use of your medicine with 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:
- Bipolar disorder (mood disorder), or family history of or
- Blood vessel problems or
- Depression, or family history of or
- Heart disease (eg, cardiomyopathy) or
- Heart rhythm problems (eg, tachycardia) or
- Hypertension (high blood pressure) or
- Hypotension (low blood pressure) or
- Mental illness (eg, hypomania, mania), or family history of or
- Problems with urination or
- Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Glaucoma, narrow angle or
- Heart disease, severe or
- Pheochromocytoma (an adrenal problem), or history of—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
If you or your child think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Check with your doctor.
This medicine should come with a Medication Guide and patient instructions. 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 capsule whole with water or other liquids. Do not crush, break, chew, or open it.
Avoid touching a broken or opened capsule or oral liquid. Wash your hands with water right away if you do touch an opened capsule or oral liquid. If this medicine comes in contact with your eyes, rinse them with water and call your doctor right away.
To use the oral liquid:
- Wash your hands before and after using this medicine.
- Use only the oral dosing syringe and bottle adapter to measure and take this medicine.
- Remove the child-resistant cap by pushing it firmly down and turning it to the left. Hold the bottle upright on a table and push the bottle adapter firmly into the neck of the bottle as far as you can.
- Put the child-resistant cap back on the bottle by turning it to the right to make sure the bottle adapter has been fully forced into the neck of the bottle. Do not remove the bottle adapter.
- Check that the plunger is pushed all the way down inside the barrel of the syringe.
- Keep the bottle upright and push the tip of the syringe firmly into the hole in the bottle adapter.
- Hold the syringe in place and carefully turn the bottle upside down. Slowly pull the plunger out to fill the syringe so that the top edge of the plunger is slightly past the prescribed dose to help remove any air bubbles. Tap the syringe barrel to move air bubbles to the top.
- Slowly push the plunger down to push out any small or large air bubbles.
- Slowly pull the plunger out until the top edge of the plunger is level with the prescribed dose. Carefully turn the bottle upright. Take the syringe out by twisting it out of the bottle adapter. The bottle adapter should stay in the bottle.
- Place the oral syringe gently into the mouth and close the mouth tightly around the barrel of the syringe. Push the plunger down slowly to make sure all the medicine is swallowed. Check to make sure that there is no medicine left in the syringe.
- Put the child-resistant cap tightly back on the bottle.
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 (capsules or solution):
- For attention-deficit hyperactivity disorder (ADHD):
- Adults and children 6 years of age and older weighing over 70 kilograms (kg)—At first, 40 milligrams (mg) once a day. The dose is increased after a minimum of 3 days to a total daily dose of 80 mg as a single dose in the morning or divided in 2 doses (morning and late afternoon). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
- Children 6 years of age and older weighing less than 70 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, 0.5 milligram (mg) per kilogram (kg) of body weight once a day. The dose is increased after a minimum of 3 days to a total daily dose of 1.2 mg/kg as a single dose in the morning or divided in 2 doses (morning and late afternoon). Your doctor may adjust your dose as needed. However, the dose is usually not more than 1.4 mg/kg per day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For attention-deficit hyperactivity disorder (ADHD):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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.
Throw away unused oral liquid 45 days after first opening the bottle.
Precautions
It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Do not take atomoxetine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan��], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop serious side effects.
For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, 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 pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may make you more drowsy, dizzy, less alert, sleepy, or lightheaded than normal. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Dizziness, lightheadedness, or fainting may also occur when you get up suddenly from a lying or sitting position. Getting up slowly or lying down for awhile may help.
This medicine may cause serious allergic reactions, including anaphylaxis, angioneurotic edema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, trouble breathing, or unusual tiredness or weakness after you take this medicine.
Atomoxetine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, trouble breathing, or fainting while taking this medicine.
You will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or when the dose is increased. Getting up slowly or lying down for awhile may help.
This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
This medicine may cause sexual problems. Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm, inability to have or keep an erection, or loss in sexual ability, desire, drive, or performance.
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:
More common
- Decreased interest in sexual intercourse
- discouragement
- dizziness
- feeling sad or empty
- inability to have or keep an erection
- irritability
- lack of appetite
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- sleepiness or unusual drowsiness
- trouble concentrating
- trouble sleeping
- unusual tiredness
Less common
- Back pain
- chills
- fast or irregular heartbeat
- feeling of warmth
- fever
- frequent urination
- groin pain
- hives, itching, skin rash
- increased blood pressure
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- longer than usual time to ejaculation of semen
- mood swings
- muscle aches
- pain or burning with urination
- redness of the face, neck, arms and occasionally, upper chest
- redness of the skin
- relaxed and calm
- shakiness in the legs, arms, hands, or feet
- swollen, tender prostate
- trembling or shaking of the hands or feet
Rare
- Painful, prolonged erection of your penis
Incidence not known
- Changes in behavior
- chest pain, discomfort, or tightness
- confusion
- dark colored urine
- decrease in urine volume
- difficulty in passing urine (dribbling)
- difficulty in speaking
- difficulty swallowing
- double vision
- fainting
- fear, nervousness
- flu-like symptoms
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular heartbeat recurrent
- loss of bladder control
- muscle cramps, pain, or stiffness
- muscle spasm or jerking of all extremities
- nausea or vomiting
- pain or discomfort in the arms, jaw, back, or neck
- paleness or cold feeling in the fingertips and toes
- pelvic pain in male
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- right upper stomach pain or tenderness
- seizures
- slow speech
- sudden loss of consciousness
- sweating
- thoughts of killing oneself
- tingling or pain in the fingers or toes when exposed to cold
- trouble breathing
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- vomiting
- yellow eyes or skin
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
- Acid or sour stomach
- belching
- bleeding between periods
- change in amount of bleeding during periods
- change in pattern of monthly periods
- chest tightness
- cough
- decrease in the frequency of urination
- decrease in urine amount
- decreased appetite
- difficulty having a bowel movement (stool)
- difficulty in passing urine (dribbling)
- dry mouth
- heartburn
- heavy bleeding
- indigestion
- irritability
- pain or tenderness around the eyes and cheekbones
- stomach discomfort, upset, cramps, or pain
- stuffy or runny nose
- trouble sleeping
- unusual stopping of menstrual bleeding
Less common
- Abnormal dreams
- abnormal orgasm
- bigger, dilated, or enlarged pupils (black part of eye)
- blistering, crusting, irritation, itching, or reddening of the skin
- bloated or full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- burning, dry, or itching eyes
- change in hearing
- change or problem with discharge of semen
- cold sweats
- confusion
- cracked, dry, or scaly skin
- crying
- decreased weight
- diarrhea
- discharge, excessive tearing
- difficulty with moving
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear drainage
- earache or pain in the ear
- excess air or gas in the stomach or intestines
- feeling unusually cold
- frequent urination
- general feeling of discomfort or illness
- groin pain
- increased or sudden sweating
- increased sensitivity of the eyes to light
- joint pain
- lack or loss of strength
- mood swings
- passing gas
- redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
- shivering
- sinus headache
- sleep disorder
- swelling of the skin
- swollen joints
- swollen, tender prostate
Incidence not known
- Loss or 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.
DRG-20066904
