Strattera (Atomoxetine)

What Is Strattera and What Is It Used for?

Strattera is a non-stimulant medicine used to treat attention-deficit and hyperactivity disorder (ADHD) in children over six years of age and in adolescents as part of a complex treatment that can include psychological, educational, and social measures.

Strattera contains atomoxetine, which increases the amount of noradrenaline in the brain. This substance in the brain is produced naturally, increasing attention and decreasing impulsiveness and hyperactivity in patients with ADHD. Therefore, this medicine has been prescribed to help control the symptoms of ADHD. Strattera is not addictive. Strattera NDC is 0002-3229.

After starting Strattera, it may take a few weeks to improve your symptoms.

When treatment has started at a younger age, it might be appropriate to continue taking Strattera when you become an adult. Your specialist will advise you about this.

Before You Take Strattera

Talk to your doctor before taking Strattera in the following cases:

• If you have or had liver problems. You may need a lower dose if you have high blood pressure. Strattera can increase blood pressure if you have problems with your heart or an increased heartbeat. Strattera can increase your heart rate (pulse). Sudden death has been reported in patients with heart defects.
• If you have low blood pressure. Strattera can cause dizziness or fainting in people with low blood pressure.
• If you have a cardiovascular disease or past medical history of stroke if you have a history of epilepsy or have had seizures for any other reason. Strattera might lead to an increase in seizure frequency.

Do not take Strattera in the following cases:

• if you are allergic (hypersensitive) to atomoxetine or any of the other ingredients of Strattera;
• if you took a medicine known as a monoamine oxidase inhibitor (MAOI), for example, phenelzine, in the last two weeks; an MAOI is sometimes used for depression and other mental-health problems; taking Strattera with an MAOI could cause serious side effects or be life-threatening (you also need to wait at least 14 days after you stop taking Strattera before you take an MAOI);
• if you have an eye disease called narrow-angle glaucoma (increased pressure in your eye).

Strattera should not be used in children under six years of age.

There is a possibility of rare, psychiatric severe adverse effects, including psychotic reactions (such as believing things that are not true or being suspicious), hallucinations (such as hearing voices or seeing things that are not there), mania (feeling elated or overexcited, which causes unusual behavior) and agitation.

Taking Other Medicines

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take, including prescription and non-prescription medicines, dietary supplements, and herbal remedies. Your doctor will decide if you can take Strattera with the other medicines.

Strattera should not be used with medicines called MAOIs (monoamine oxidase inhibitors). 

If you take Strattera at the same time as some other medicines (see examples below), the treatment with these medicines or Strattera may be affected, so caution is needed. Check the list of the following medications:

• medicines that increase blood pressure (Strattera can alter blood pressure);
• medicines that interact with noradrenaline, such as antidepressants, for example, imipramine, venlafaxine, and mirtazapine, or decongestants such as pseudoephedrine or phenylephrine (Strattera also affects noradrenaline);
• some medicines used to treat mental health conditions (such as antipsychotics, lithium for manic depression, and tricyclic antidepressants), medicines used to control the rhythm of the heart (such as quinidine and amiodarone), medicines that change the concentration of salts in the blood (water pills such as thiazide diuretics), methadone, mefloquine (for malaria prevention and treatment) and some antibiotics (such as erythromycin and moxifloxacin). These medicines may increase the risk of an abnormal heart rhythm when taken with Strattera;
• medications that are known to increase the risk of seizures. These can include antidepressants, some antipsychotic medicines, bupropion (for smoking cessation), antimalarial tablets, and some painkillers (such as tramadol). Taking Strattera might lead to an increase in seizure frequency.

How Strattera is broken down in the body can be affected by other medicines and can mean that Strattera may stay in the body longer than expected. Examples of medications that can do this include some antidepressants, e.g., fluoxetine and paroxetine, or other medications, such as quinidine and terbinafine. As a result, your doctor may need to adjust your dose or increase your dose much more slowly.

Strattera may change how your body reacts to salbutamol (a medicine for asthma) and other similar medicines. If you are taking salbutamol by a nebulizer, or by mouth (for example, syrup or tablets), or having a salbutamol injection together with Strattera, you may feel as if your heart is racing, but this will not make your asthma worse. Talk to your doctor before taking Strattera if you take salbutamol by a nebulizer, orally, or have salbutamol injections. You do not need to worry if you are using only an inhaler.

Pregnancy and Breastfeeding

If you think you might be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before you take Strattera.

Strattera should not be used during pregnancy unless your doctor has advised you to do so.

It is not known if Strattera can pass into breast milk. Therefore you should either avoid taking Strattera if you are breastfeeding or discontinue breastfeeding. If you are breastfeeding or planning to breastfeed your baby, ask your doctor or pharmacist for advice before taking Strattera.

Driving and Using Machines

You may feel tired or sleepy after taking Strattera. You should be careful when driving a car or operating heavy machinery until you know how Strattera affects you. If you feel tired or sleepy, you should not drive or operate hazardous machinery.

Important Information about the Content of the Capsules

Strattera capsules are not intended to be opened. Strattera can irritate the eye. If the contents of the capsules come into contact with the eye, the affected eye should be flushed immediately with water, and medical advice should be obtained. Hands and any other part of the body that may have come into contact with the capsule contents should also be washed as soon as possible.

How to Take Strattera

Take Strattera as your doctor has instructed you. This is usually one or two times a day (morning, late afternoon, or early evening).

Strattera is for oral use, and you can take Strattera with or without food.

Taking Strattera at the same time each day may help you remember to take it.

Your doctor will tell you how much Strattera you should take and calculate this according to your weight. They will start with a lower dose; before increasing the amount of Strattera, you need to take it according to the instructions below:

Children (6 years of age and older) and adolescents:

• Body weight up to 70kg: Strattera should be started at a daily dose of approximately 0.5mg per kilogram. This dose should be continued for a minimum of 7 days. Your doctor may then increase this to a usual maintenance dose of approximately 1.2mg per kilogram of body weight daily.
• Body weight over 70kg: Strattera should be started at a total daily dose of 40 mg. This dose should be continued for a minimum of 7 days. Your doctor may then increase this to a usual maintenance dose of 80mg daily. The maximum daily dose your doctor will prescribe is 100 mg.

If you have problems with your liver, your doctor may prescribe a smaller dose.

A child taking Strattera may lose a little weight after starting treatment. Therefore, your doctor will watch your child’s height and weight. If your child is not growing or gaining weight as expected, your doctor may change your child’s dose or temporarily stop Strattera.

If you take more Strattera, you should immediately contact your doctor or the nearest hospital casualty department and tell them how many capsules you have taken. The most commonly reported symptoms accompanying overdoses were sleepiness, agitation, hyperactivity, abnormal behavior, and gastrointestinal symptoms.

If you Forget to Take Strattera

If you miss a dose, you should take it as soon as possible, but you should not take more than your total daily dose in 24 hours. Do not take a double dose to make up for forgotten doses.

If You Stop Taking Strattera

If you stop taking Strattera, there are usually no side effects, but you should talk to your doctor before you stop treatment.

Possible Side Effects

Strattera can cause side effects like all medicines, although not everybody gets them.

Strattera can cause a severe allergic reaction (affects 1 to 10 users in 1,000).

You should stop taking Strattera and call your doctor or hospital immediately if you have any of the following:

• swelling of the face and throat;
• difficulty breathing;
• hives (small, raised, itchy patches of skin).

Very rare side effects (affects less than 1 user in 10,000).

There have been reports of liver injury. You should stop taking Strattera and call your doctor immediately if you have any of the following:

• dark urine;
• yellow skin or yellow eyes;
• tummy pain which is sore when you press it (you feel pain) on the right side just below your ribs;
• a feeling of sickness (nausea) that is unexplained tiredness itching
• feeling that you got flu; these symptoms should not be ignored as they may be the start of something more serious.

Patients under 18 have an increased risk of side effects:

• suicidal thoughts;
• hostility (predominantly aggression, oppositional behavior, and anger);
• emotional lability.

You should inform your doctor if any of the above symptoms develop or worsen after treatment has begun. Also, you should know that, as with other psychotropic medications, there is a possibility of rare, severe psychiatric adverse effects. The long-term effects on this age group’s growth, maturation, and cognitive and behavioral development have not yet been demonstrated.

There have been reports in some patients of abnormal heart rhythms, which can be severe, and also seizures. You should contact your doctor if you suspect a heart problem or have a seizure.

Side effects reported in clinical trials of Strattera in teenagers and children over six years old

Very common side effects (affect more than 1 user in 10) are:

• headache;
• decreased appetite (not feeling hungry);
• being sick (vomiting);
• feeling sick (nausea);
• pain in the stomach (abdomen);
• sleepiness.

These effects may disappear after a while.

Other common side effects (affect 1 to 10 users in 100) may be:

• loss of appetite;
• being irritable, having mood swings;
• problems with sleeping;
• dizziness, lethargy;
• constipation, upset stomach;
• swollen, reddened, and itchy skin rash;
• tiredness;
• weight loss on Strattera;
• increased blood pressure.

Side effects that have been noticed but are uncommon (affect 1 to 10 users in 1,000) are:

• feeling or having a fast heartbeat;
• suicidal thoughts or suicidal attempts;
• aggression;
• hostility;
• emotional lability;

Please get in touch with your doctor if these side effects occur.

Other uncommon side effects may be:

• waking early, fainting, tremor, migraine;
• large pupils (the dark center of the eye), itchy skin, increased sweating, and feeling of weakness;
• allergic reactions.

Side effects reported in clinical trials of Strattera in adults

Very common side effects (affects more than 1 user in 10) are:

• decreased appetite (not feeling hungry);
• problems with sleeping;
• dry mouth;
• feeling sick (nausea).

Other common side effects (affect 1 to 10 users in 100) may be:

• decreased interest in sex;
• sleep disturbance, dizziness, headaches;
• tingling or numbness in the hands or feet, tremor;
• constipation, stomach ache, indigestion, flatulence, hot flushes;
• feeling or having a very fast heartbeat; 
• swollen, reddened, and itchy skin, increased sweating, rash;
• frequent urinating, inflammation of the prostate gland (prostatitis), groin pain in men, failure to obtain an erection, abnormal orgasm;
• menstrual cramps and irregular menstruation;
• tiredness, lethargy, chills, and weight loss.

Side effects that have been seen but are uncommon (affect 1 to 10 users in 1,000) are:

• waking up early;
• fainting;
• migraine;
• cold fingers and toes;
• absence of orgasm;
• increased blood pressure;
• allergic reactions.

Other possible side effects:

• psychotic symptoms, including hallucinations (such as hearing voices or seeing things that are not there), believing things that are not true, or being suspicious, agitation;
• problems going to the toilet (urinating) in teenagers and children, groin pain in male teenagers and children, prolonged and painful erections, and poor blood circulation, which makes toes and fingers numb and pale (Raynaud’s).

If you experience any of these side effects and they become troublesome or worsen, or if you notice any side effects not mentioned in this post, please tell your doctor or pharmacist.

How to Store Strattera

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the pack and blister after ‘Exp.’ The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Instead, ask your pharmacist how to dispose of medicines. These measures will help to protect the environment.

Additional Information

What do Strattera 10, 18, 25, 40, 60, and 80 mg hard capsules contain?

The active substance in Strattera capsules is atomoxetine hydrochloride. Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, and 80 mg of atomoxetine.

The other ingredients are pregelatinized starch and dimethicone.

The capsule shells contain sodium lauryl sulfate, gelatin, and edible black ink (containing shellac and black iron oxide El72). The capsule shell colorants are:

• yellow iron oxide El72 (18 mg, 60 mg, and 80 mg);
• titanium dioxide E171 (10 mg, 18 mg, 25 mg, 40 mg, 60 mg and 80 mg);
• FD&C blue 2 (indigo carmine) El32 (25 mg, 40 mg, and 60 mg);
• Red iron oxide El72 (80 mg).

What Strattera looks like and the contents of the pack

Capsule, hard, 10 mg (white, imprinted Lilly 3227/10 mg);

Capsule, hard, 18 mg (gold/white, imprinted Lilly 3238/18 mg);

Capsule, hard, 25 mg (blue/white, imprinted Lilly 3228/25 mg);

Capsule, hard, 40 mg (blue, imprinted Lilly 3229/40 mg);

Capsule, hard, 60 mg (blue/gold, imprinted Lilly 3239/60 mg);

Capsule, hard, 80 mg (brown/white, imprinted Lilly 3250/80 mg).

Strattera capsules are available in packs of 7, 14, 28, or 56, but not all pack sizes may be marketed.

Strattera Brand Names in Different Countries

Argentina: Recit, Strattera

Austria, Australia, Belgium, Canada, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Italy, Mexico, Malaysia, Netherlands, Norway, New Zealand, Philippines, Poland, Portugal, Russia, Sweden, Singapore, Thailand, United States, South Africa: Strattera

Chile: Abretia, Deaten, Strattera

Japan: ストラテラ