Strattera

Primary Use

Strattera is primarily prescribed to manage the symptoms of attention deficit hyperactivity disorder (ADHD). It is approved for use in adults and pediatric patients who are at least 6 years old. It is not intended for use in children under the age of 6.

How It Helps

This medication is used to help improve specific symptoms associated with ADHD, including:

• Increasing the ability to pay attention and stay focused.
• Reducing impulsive behavior.
• Decreasing hyperactivity or restlessness.

Comprehensive Treatment

Healthcare providers typically prescribe Strattera as part of a total treatment program. This program often includes other non-drug components such as:

• Psychological counseling.
• Educational support.
• Social therapy.

Unlike many other medications used for ADHD, Strattera is not a stimulant. It may be used in situations where stimulants are not appropriate, are not effective, or cause intolerable side effects for a patient.

Mechanism of Action

Strattera is a selective norepinephrine reuptake inhibitor (SNRI). Unlike many other medications used for attention deficit hyperactivity disorder (ADHD), Strattera is not a stimulant.

The medication works by affecting norepinephrine, a natural chemical in the brain that helps regulate attention, impulsivity, and activity levels. It specifically blocks the norepinephrine transporter, which prevents the brain's nerve cells from reabsorbing the chemical too quickly. This results in an increased amount of norepinephrine available to send messages between nerve cells.

While the precise way this improves ADHD symptoms is not fully understood, it is believed that increasing norepinephrine levels helps to:

• Improve focus and the ability to stay on task.
• Decrease restless or hyperactive behavior.
• Help control impulsive actions.

Because of its specific mechanism, the effects of Strattera typically develop gradually over several weeks of regular use, rather than providing the immediate response often seen with stimulant medications.

Common Side Effects

Many people experience mild side effects when starting Strattera. These often improve as the body adjusts to the medication. Common side effects include:

• Nausea, vomiting, or stomach pain
• Constipation
• Dry mouth
• Loss of appetite and weight loss
• Feeling tired or drowsy
• Dizziness
• Mood swings or irritability
• Trouble sleeping
• Sexual side effects, such as decreased desire or erectile dysfunction
• Menstrual cramps or irregular periods

Serious Side Effects

While less common, some side effects require immediate medical attention. Contact a healthcare provider right away if you experience:

• Signs of liver problems, such as yellowing of the skin or eyes (jaundice), dark urine, or pain in the upper right stomach area
• Heart-related issues, including chest pain, shortness of breath, or a fast or irregular heartbeat
• Mental or mood changes, such as new or worsening aggression, hallucinations, or mania
• Difficulty urinating or painful urination
• Signs of an allergic reaction, such as hives, swelling of the face or throat, or difficulty breathing
• A painful or prolonged erection lasting four hours or more

In children and teenagers, Strattera may cause a temporary slowing of growth in height and weight. Healthcare providers typically monitor growth progress during treatment.

Suicidal Ideation

Strattera has a boxed warning for an increased risk of suicidal thinking in children and adolescents. Healthcare providers monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial months of therapy or following dosage adjustments.

Cardiovascular Risks

This medication can increase blood pressure and heart rate. It is generally avoided in patients with known serious structural heart abnormalities, cardiomyopathy, or serious heart rhythm problems. Sudden death, stroke, and heart attack have been reported in patients taking medications for ADHD that have stimulant-like effects on the cardiovascular system.

Liver Injury

Severe liver injury has been reported in rare cases. Patients are advised to watch for signs such as yellowing of the skin or eyes (jaundice), dark urine, itching, or right-sided upper abdominal tenderness. Treatment is typically discontinued if laboratory evidence of liver injury is found.

Psychiatric Symptoms

Strattera may cause or worsen psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, even in patients without a prior history of these conditions. It may also increase aggressive behavior or hostility in some children and adolescents.

Contraindications

Strattera is contraindicated in individuals who:

• Have taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.
• Have narrow-angle glaucoma.
• Have a history of pheochromocytoma (a tumor of the adrenal gland).
• Have severe cardiovascular disorders that could be worsened by increases in blood pressure or heart rate.

Other Precautions

Rare cases of priapism (painful or prolonged erections) have been reported and require immediate medical attention to prevent permanent damage. Additionally, healthcare providers typically monitor the height and weight of children and adolescents during treatment, as the medication may cause a temporary slowing of growth. Allergic reactions, including angioedema and hives, have also been reported.

Pregnancy

There are no adequate and well-controlled studies of Strattera in pregnant women. Research in animals has shown some adverse effects on fetal development when the drug was administered at high doses. Because human data is limited, Strattera should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Breastfeeding

It is not known whether atomoxetine, the active ingredient in Strattera, is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Strattera is administered to a nursing woman. Healthcare providers should be consulted to weigh the benefits of breastfeeding against the potential risks of infant exposure to the medication.

Consult Your Healthcare Provider

If you are pregnant, planning to become pregnant, or are breastfeeding, discuss your treatment options with your doctor. They can help determine the safest course of action for managing ADHD symptoms during this time.

Available Dosage Forms

Strattera is supplied as a capsule for oral use. The capsules are designed to be swallowed whole and should not be opened, crushed, or chewed.

• Oral capsule

The capsules are produced in various color combinations to identify different options. If a capsule is accidentally broken or opened, the powder inside should not be touched or allowed to come into contact with the eyes, as it can cause irritation.

FDA Approval and Indications

Strattera (atomoxetine) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention-deficit hyperactivity disorder (ADHD). It is indicated for use in pediatric patients 6 years of age and older, adolescents, and adults.

Boxed Warning

The FDA requires a boxed warning for Strattera because clinical trials showed an increased risk of suicidal ideation (thoughts of suicide) in children and adolescents. Healthcare providers and caregivers should closely monitor patients for any unusual changes in behavior, clinical worsening, or suicidal tendencies, especially during the first few months of treatment or when the dose is changed.

Safety Communications and Warnings

• Liver Injury: The FDA has issued warnings regarding the potential for severe liver injury. Patients should seek medical attention if they develop signs of liver dysfunction, such as jaundice (yellowing of the skin or eyes), dark urine, or unexplained flu-like symptoms.
• Cardiovascular Risks: Strattera can increase blood pressure and heart rate. It should be used with caution in patients with known heart defects, heart disease, or high blood pressure, as serious cardiovascular events have been reported.
• Psychiatric Symptoms: The FDA warns that Strattera may cause treatment-emergent psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania, in children and adolescents without a prior history of such conditions.

Regulatory Classification

Unlike many other medications used to treat ADHD, Strattera is not classified as a controlled substance by the Drug Enforcement Administration (DEA). It is a non-stimulant medication and has not shown a potential for abuse or dependence in clinical trials.

Stopping Strattera

Unlike many other medications used to treat ADHD, Strattera is not a stimulant and is not a controlled substance. It is not known to cause physical dependence, and patients do not typically experience a withdrawal syndrome or a physical "crash" when they stop taking it.

Managing Symptoms

While there is no specific withdrawal process required for safety, you should still consult your healthcare provider before discontinuing the medication. Considerations for stopping include:

• Return of ADHD symptoms: The most common effect of stopping Strattera is the return of original ADHD symptoms, such as inattention, hyperactivity, or impulsivity.
• Medical supervision: Healthcare providers generally recommend that you continue taking the medication even if you feel well. If you decide to stop, your doctor can help monitor your symptoms and discuss alternative treatment options.
• Tapering: Although not always medically necessary to prevent physical illness, some doctors may suggest gradually reducing the dose to see how your symptoms respond as the medication levels decrease.