Apo-Atomoxetine

Atomoxetine hydrochloride.

Each APO-ATOMOXETINE capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine.
Excipients/Inactive Ingredients: The capsules also contain pregelatinized starch. The capsule shells are imprinted with black edible ink and contain the non-medicinal ingredient gelatin, and also contain one or more of the following: FD&C Blue No. 2, yellow iron oxide, red iron oxide, titanium dioxide.

APO-ATOMOXETINE is a medicine that is taken either once or twice a day for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, and adults. APO-ATOMOXETINE should not be used in children under 6 years of age.
APO-ATOMOXETINE is a part of the overall treatment program for ADHD that may include other measures (psychological, educational, and social). The doctor may also recommend other therapy.
APO-ATOMOXETINE works differently from other medicines used for the treatment of ADHD. Atomoxetine is not a stimulant and studies have shown that it has no potential for drug abuse or dependence.

Usual dose: Take the capsules as a whole. Do not open, do not chew, do not crush them.
Take APO-ATOMOXETINE exactly as directed by the doctor. It is very important to not take a larger dose of atomoxetine than prescribed by the doctor.
The doctor may tell the patient to take APO-ATOMOXETINE once a day or twice a day (morning and late afternoon/early evening). To help in remembering to take APO-ATOMOXETINE, the patient may want to take it at the same time every day.
Improvement of ADHD symptoms is generally observed within 1 to 4 weeks of starting APO-ATOMOXETINE.
APO-ATOMOXETINE may be taken with or without food.
Do not open APO-ATOMOXETINE capsules, but if they are accidentally opened or broken, avoid contact with the powder and wash away any loose powder as soon as possible with water. If any of the powder gets in the eyes, rinse them with water immediately and contact the doctor.
Missed Dose: If a dose is missed, take it as soon as possible, but do not take more than the total daily dose in any 24-hour period.

Call the doctor immediately if more than the prescribed amount of APO-ATOMOXETINE is taken.
In case of drug overdose, contact a health care practitioner, or go to the Accident and Emergency Department in the nearest hospital, even if there are no symptoms.

The patient should not take APO-ATOMOXETINE if he/she: is taking or has recently taken an antidepressant medicine known as a monoamine oxidase inhibitor (MAOI), including phenelzine sulfate and tranylcypromine sulfate; has narrow angle glaucoma, an eye disease; is allergic to atomoxetine or any other ingredient of APO-ATOMOXETINE; has symptomatic cardiovascular disease; has moderate to severe high blood pressure; has advanced arteriosclerosis (hardened arteries); has uncontrolled hyperthyroidism (an overactive thyroid gland).

The following have been reported with use of atomoxetine and also with stimulant medications: Suicidal thoughts and actions in children and teenagers: Some children and teenagers may have a higher chance of having suicidal thoughts or actions. Tell the child or teenager's doctor if the child or teenager (or there is a family history of): has bipolar illness (manic-depressive illness); had suicide thoughts or actions before starting atomoxetine.
The chance for suicidal thoughts and actions are higher: early during atomoxetine treatment; during dose adjustments.
Prevent suicidal thoughts and action in the child or teenager by: paying close attention to the child or teenager's moods, behaviours, thoughts, and feelings during atomoxetine treatment; keeping all follow-up visits with the child or teenager's doctor as scheduled.
Watch for the following signs in the child or teenager during atomoxetine treatment: anxiety, agitation, panic attacks, trouble sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, mania, depression, suicide thoughts.
Call the child or teenager's doctor right away if they have any of the previously mentioned signs, especially if they are new, sudden, or severe. The child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.
Severe liver damage: Call the doctor right away if the following signs of liver problems are present: itching, right upper belly pain, dark urine, yellow skin or eyes, unexplained flu-like symptoms.
Heart-related problems: sudden death in patients who have heart problems or heart defects as well as in patients without pre-existing cardiac disease; stroke and heart attack in adults; increased blood pressure and heart rate.
Tell the doctor if any heart problems, heart defects, high blood pressure, or a family history of these problems are present. The doctor may wish to carefully check for heart problems before starting APO-ATOMOXETINE.
The doctor may wish to check the blood pressure and heart rate regularly during treatment with atomoxetine.
Call the doctor right away if there are any signs of heart problems such as chest pain, irregular heart rate, palpitations, shortness of breath, dizziness or fainting while taking APO-ATOMOXETINE.
New mental (psychiatric) problems in children and teenagers: new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.
Call the child or teenager's doctor right away about any new mental symptoms. APO-ATOMOXETINE treatment may be stopped.

BEFORE using APO-ATOMOXETINE, the patient should talk to the doctor or pharmacist if he/she: has structural heart abnormalities; has inborn, acquired or family history of long QT interval; has mental problems, including psychosis, mania, bipolar illness, or depression; has had seizures (convulsions, epilepsy) or abnormal EEGs (electroencephalograms); has or had any disorder of the blood vessels in the brain (e.g. aneurysm, stroke, vasculitis); has a family history of sudden death or death related to heart problems; does strenuous exercise; takes other drugs for ADHD; has or had liver problems [lower dose may be needed]; has mild high blood pressure [atomoxetine can increase blood pressure]; has problems with the heart or an irregular heartbeat [atomoxetine can increase heart rate (pulse)]; has low blood pressure [atomoxetine can cause dizziness or fainting in people with low blood pressure]; is nursing, pregnant, or thinking of becoming pregnant.
Other Important Safety Information: Severe liver damage: Call the doctor right away if the following signs of liver problems are present: dark urine, yellow skin or eyes, right upper belly pain, itching, unexplained flu-like symptoms.
Sudden death has been reported in association with stimulant drugs for ADHD treatment in children with structural heart abnormalities. Although atomoxetine is not a stimulant drug, it generally should not be used in children, adolescents or adults with known structural heart abnormalities.
New or Worsened Emotional or Behavioural Problems: Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen, consult the doctor immediately. Close observation by a doctor is necessary in this situation.
During treatment with these types of medication, it is important that the patient and the doctor have good ongoing communication about how the patient is feeling.
The patient should not drive a car or operate hazardous machinery until he/she knows how APO-ATOMOXETINE affects him/her.
This medicine was prescribed for the patient's use only. The patient should not let anyone else take his/her APO-ATOMOXETINE capsules.
More Information: Atomoxetine is contraindicated in patients with symptomatic cardiovascular disease, moderate to severe hypertension or severe cardiovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important.
Atomoxetine should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate.
Atomoxetine should be used with caution in patients with congenital or acquired long QT or a family history of QT prolongation.
Patients should be screened for pre-existing or underlying cardiovascular or cerebrovascular conditions before initiation of treatment with atomoxetine and monitored during the course of treatment.
Heart rate and blood pressure should be measured at baseline, following atomoxetine dose increases, and periodically while on therapy.
Priapism: Rare post-marketing cases of priapism, defined as painful and non-painful penile erection lasting more than 4 hours, have been reported for paediatric and adult patients treated with atomoxetine.
The erections resolved in cases in which follow-up information was available, some following discontinuation of atomoxetine. Prompt medical attention is required in the event of suspected priapism.
Potential association with the occurrence of behavioural and emotional changes, including self-harm: There have been very rare reports of suicidal ideation, suicidal attempts, suicidal depression and completed suicides in children, adolescents and adults.
ADHD and its related co-morbidities may be associated with increased risk of suicidal ideation and/or behaviour. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type of emotional and behavioural changes, and clinical worsening.

All prescription medicines may cause side effects in some patients. If the patient has some side-effects such as upset stomach, nausea, sleepiness or tiredness, the doctor may ask him/her to take APO-ATOMOXETINE twice a day with meals, or in the evening. Most side effects will disappear after the first few weeks.
Weight loss may occur after starting APO-ATOMOXETINE, especially in the first few weeks. Growth rates (weight and height) after 3 years of treatment are near normal. It is not known if growth will be slowed in children who use atomoxetine for a longer period of time. The doctor will watch the weight and height. If the patient is not growing or gaining weight as expected, the doctor may change the treatment of atomoxetine.
APO-ATOMOXETINE can cause liver damage in rare cases. Call the doctor right away if presenting with dark urine, yellow skin/eyes, upper right-sided abdominal tenderness, or unexplained nausea, tiredness, itching or flu-like symptoms.
Stop taking APO-ATOMOXETINE and call the doctor right away if swelling or hives appear. Atomoxetine can cause a serious allergic reaction in rare cases.
New or Worsened Emotional or Behavioural Problems: A small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide. The doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. See also Precautions.
The following common side effects were reported in clinical trials with Atomoxetine: In teenagers and children over 6: upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, constipation, low blood pressure.
In adults: constipation, dry mouth, nausea, decreased appetite, dizziness, problems sleeping, sexual side effects, problems urinating, menstrual cramps, rapid or irregular heartbeat, tiredness.

Tell the doctor about all the medicines being taken or planned to be taken, including prescription and nonprescription medicines, dietary supplements, and herbal remedies. The doctor will decide if atomoxetine can be taken with other medicines. Also tell the doctor if there have been any changes in dosing with other medicines.
Certain medicines may change the way the body reacts to APO-ATOMOXETINE. These include medicines used to treat depression, like paroxetine hydrochloride and fluoxetine hydrochloride, and certain other medicines (like quinidine).
The doctor may need to change the dose of APO-ATOMOXETINE if it is being taken with these medicines.
Do not take APO-ATOMOXETINE if taking desipramine.
Atomoxetine may change the way the body reacts to oral, intravenous, or nebulized salbutamol (or drugs with similar actions), but the effectiveness of these drugs will not be changed. Talk with the doctor before taking APO-ATOMOXETINE if taking salbutamol.
APO-ATOMOXETINE should be used with caution if being treated with drugs for high blood pressure. Talk with the doctor before taking APO-ATOMOXETINE if taking any drug for high blood pressure.

Store below 25°C.

Other CNS Drugs & Agents for ADHD

N06BA09 - atomoxetine ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.

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