Strattera Drug Description

STRATTERA® (atomoxetine HCl) is a selective norepinephrine reuptakeinhibitor. Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The Tadagra molecular formula is C₁₇H₂₁NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is:

Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.

STRATTERA (atomoxetine hcl) capsules are intended for oral administration only.

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:

FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.

SIDE EFFECTS:See also Warning section.

Stomach upset, nausea, vomiting, constipation, fatigue, loss of appetite, dry mouth, dizziness, trouble sleeping, menstrual cycle changes, or mood changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: weight loss, decrease in sexual ability/desire (e.g., impotence, ejaculation problems), difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling.

This medication may rarely cause serious problems such as heart attacks or stroke. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision).

Atomoxetine has very rarely caused very serious liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing of skin or eyes, dark urine, severe stomach pain, "flu-like" symptoms (e.g., fever, chills, unexplained fatigue). If you experience any of these symptoms ask your doctor about whether or not you should ever take atomoxetine again.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before taking atomoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart disease (e.g., high blood pressure, fast/irregular heartbeat, coronary artery disease, cardiomyopathy, structural heart abnormalities, past heart attacks), family history of irregular heartbeat (cardiac sudden death), low blood pressure, strokes, bladder or prostate problems, certain adrenal problem (pheochromocytoma), mental/mood disorders (such as bipolar disorder, depression, suicide attempts, family history of suicide).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness or fainting, get up slowly from a lying or seated position (especially when you first start using this drug or if your doctor changes your dose).

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially dizziness.

Caution is advised when using this drug in children because it may have a minor effect on weight, growth rate, and final height. Monitor your child's weight and height and consult your doctor or pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Strattera: Is it for You?

Strattera

Strattera is a recent medication, with a lot of publicity, and a lot of marketing money, which makes it seem like the best medication since antibiotics were developed. But its short history is filled with controversy.

There are a lot of serious questions to be answered about Strattera:

• Just how effective is Strattera?
• What are the short-term side effects of Strattera?
• What are the long-term side effects of Strattera?
• How does it compare to Stimulants in terms of effectiveness, or safety?
• How does Strattera compare to alternatives natural medicines like ATTEND in terms of effectiveness, or safety?

Strattera Information

Strattera is a norepinephrine reuptake inhibitor, a class of ADHD treatment that works differently from the other ADHD medications available.

Strattera works by selectively blocking the reuptake of norepinephrine, a chemical messenger, or neurotransmitter, by certain nerve cells in the brain.

This action increases the availability of norepinephrine, which is thought to be essential in regulating impulse control, organization and attention.

Taking Strattera Carefully

Take Strattera exactly as directed by your doctor.

Strattera offers flexible dosing, once or twice daily. Discuss a convenient schedule for taking Strattera with your doctor.

Do not take Strattera with any other medications, even over-the-counter medications! You must talk with your doctor first! Talk to the Pharmacist too!

Our reports indicate that there can be serious problems taking anti-depressants with Strattera.

Our reports indicate that there can be serious problems taking even Benedryl with Strattera.

Our reports indicate that small doses of stimulants may be OK with Strattera, and may enhance treatment.

Lilly to Put Suicide Warning on Strattera Label

CHICAGO — Eli Lilly and Co. (LLY) Thursday said it will add strong warnings to its label for Strattera used to treat attention-deficit/hyperactivity disorder, including the risk of suicidal thoughts among children and adolescents.

Strattera will now carry a "black box" warning the strongest required by U.S. regulators.

Such warnings typically hurt sales of products by raising concern among doctors and patients about the safety of a drug.

The Indianapolis drug maker said a Sanafi review of clinical trials data identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents.

About Strattera (atomoxetine)

Our reports indicate that it takes 4 to 6 weeks for Strattera to work well (to reach therapeutic levels).

We believe that Lilly will experience the same problems that VAXA has in getting people to stick withAttend, which also takes 4 to 6 weeks to work well. The problem is that parents usually only give an intervention 2 weeks to work, and then they move on to something else.

Stimulants, when prescribed with the correct dose, work in about 20 minutes, so parents tend to go back to using them, even with the harsher side-effects. After all, the parents don't experience the unpleasant side-effects - the kids do. But the parents do enjoy the benefits of the medication around the home.

Our reports also indicate that Strattera, like Attend, has fewer "ups and downs" than stimulants.

There can be some stomach problems, but there is less of a "rebound" effect. By the way, for reducing the "rebound" effect of stimulants, try drinking a Mountain Dew at the 3 hour mark (for Ritalin). This seems to help a great deal to eliminate the "crashing" off a dose of Ritalin, and make a smooth landing.

In one of the Strattera studies the researchers reported the following adverse events occurring in some patients:

• Rhinitis (33.3%),
• Headache (20%),
• Anorexia (16.7%),
• Dizziness (16.7%).

No serious side effects were observed and no patients stopped medication or discontinued the study due to adverse events.

There have been reports of prostate problems in men with ADHD from Strattera.

In each of six clinical trials, Strattera was statistically superior to placebo in reducing the symptoms of ADHD in children, adolescents and adults. The positive effects of Strattera were seen for overall ADHD symptoms including hyperactive /impulsive symptoms and inattentive symptoms.

Ummm. Coffee is better than placebo.

Would you take a medication that was not better than a placebo?

Remember, Attend makes statistically significant improvements on the computerized TOVA CPT test in 70% of subjects, and 80% improvement on Parent Rating Scales; Ritalin makes statistically significant improvements on the computerized TOVA CPT test in 85% of subjects.

Is Strattera better than either of these?

One of the studies [Heiligenstein J, Kaplan S, Harder D, et al.: Atomoxetine: Clinical outcomes in pediatric ADHD with comorbid ODD.] reported the following:

"The results showed that ADHD RS, CGI and CPRS ADHD Index scores from baseline to endpoint were markedly improved in patients taking atomoxetine compared to the placebo group, with no significant difference attributable to the presence or absence of comorbid ODD.

"In the atomoxetine group, clinical response was 65.4 percent for those with ODD and 58.9 percent for those without the comorbid disorder versus 36.4 percent and 29.3 percent in the placebo group (all p values less than or equal to 0.007).

ATTEND had a statistically significant response from 70 percent of those without the comorbid disorder.

"The most commonly reported treatment-emergent adverse events were headache, rhinitis and abdominal pain. Diarrhea was the only statistically significant side effect that occurred more often in children with comorbid ODD when compared with those without ODD."

It looks on the surface like Strattera may be very helpful in treating children and teens with Oppositional Defiant Disorder and ADHD. However, the results may not be as good as either Attend combined with Extress, or stimulants.

In six placebo-controlled studies, two in children, two in children and adolescents, and two in adults, Strattera significantly reduced core symptoms of ADHD, and was well tolerated. In all studies, participants met Diagnostic and Statistical Manual, 4th Edition (DSM-IV-TR), criteria for ADHD.

Both Strattera and older treatments, like methylphenidate (the active ingredient in Ritalin and Concerta), are effective in treating ADHD.

However, Strattera is the first FDA-approved treatment for ADHD that is not a stimulant and is not a controlled substance under the Controlled Substance Act. As a non-controlled substance, Strattera provides the convenience of physician samples and phone-in refills.