The postmarketing seizure cases include patients with pre-existing seizure disorders and those with identified risk factors for seizures, as well as patients with neither a history of nor identified risk factors for seizures. The exact relationship between STRATTERA and seizures is difficult to evaluate due to uncertainty about the background risk of seizures in ADHD patients. A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must not be better accounted for by another mental disorder. It’s important to note that some individuals may confuse Strattera with similarly named medications.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant before taking Strattera. This medicine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder. By Vincent Iannelli, MD Vincent Iannelli, MD, is a board-certified pediatrician and fellow of the American Academy of Pediatrics.
Monoamine Oxidase Inhibitors (MAOI)
- SNRIs treat ADHD and other mental health conditions by increasing norepinephrine in the brain.
- However, it might take several weeks for people taking Strattera to notice its effects.
- A possible side effect of Strattera is urinary retention, which can actually be an advantage for children who have enuresis (problems with bedwetting).
- STRATTERA can therefore be administered to ADHD patients with end stage renal disease or lesser degrees of renal insufficiency using the normal dosing regimen.
An example of a liver problem is alcohol-related liver disease. Strattera can cause changes in blood pressure and heart rate. A tumor in the adrenal glands called pheochromocytoma can also cause these symptoms. If you take Strattera and have a tumor, the symptoms could become severe. Strattera belongs to a class of drugs called selective norepinephrine reuptake inhibitors.
The Vyvanse Shortage Crisis: Understanding the ADHD Medication Supply Chain…
Atomoxetine is metabolized primarily through the CYP2D6 enzymatic pathway. People with reduced activity in this pathway (PMs) have higher plasma concentrations of atomoxetine compared with people with normal activity (Ems). For PMs, AUC of atomoxetine is approximately 10-fold and Css, max is about 5-fold greater than Ems. No adverse fetal effects were seen when pregnant rats were treated with up to 150 mg/kg/day (approximately 17 times the MRHD on a mg/m2 basis) by gavage throughout the period of organogenesis. If patients miss a dose, they should be instructed to take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.
Family Issues and the ADHD Child
If you’re thinking of becoming pregnant, discuss the use of Strattera with your doctor. Animal studies indicate a potential risk of fetal harm; infants may be born prematurely, with low birth weight, with spinal abnormalities, or experience withdrawal. Strattera is passed through breastmilk, so it is recommended that mothers do not nurse while taking it. According to information provided by the drug’s manufacturers, it can take four to eight weeks for Strattera to reach the maximum therapeutic effect.
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy see Use In Specific Populations. Atomoxetine is primarily metabolized by the CYP2D6 pathway to 4-hydroxyatomoxetine. Dosage adjustment of STRATTERA may be necessary when coadministered with potent CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine) or when administered to CYP2D6 PMs see DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for STRATTERA and any potential adverse effects on the breastfed child from STRATTERA or from the underlying maternal condition. Patients should be instructed to consult a healthcare provider if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies. Instruct patients and their caregivers to contact their healthcare provider as soon as possible should they notice an increase in aggression or hostility see WARNINGS AND PRECAUTIONS. Although uncommon, allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash, have been reported in patients taking STRATTERA. Coadministration of STRATTERA (60 mg BID for 12 days) with midazolam, a model compound for CYP3A4 metabolized drugs (single dose of 5 mg), resulted in 15% increase in AUC of midazolam. No dose adjustment is recommended for drugs metabolized by CYP3A.
Children’s dosage
This mental health condition impacts attention, self-control, and the ability to sit still. Jennifer was able to tolerate and benefit from the Adderall-XR given in the morning, but she did not respond well when a second dose of Adderall was given in the afternoon. On this regimen, Jennifer did not feel anxious or restless and was able to do well during school, complete her homework in the evening, and resume her after school job. She also reported that she felt more focused when driving in the evening, at times when the stimulant would be expected to have lost effectiveness.
What if I miss a dose?
The above is not a complete list of all possible drug interactions. Since it is not a controlled substance, Strattera is available with a regular prescription. This means that doctors can call it into a pharmacy and order refills, unlike stimulants, which require a new prescription each month. Strattera is generally well-tolerated and useful for people with ADHD who want to avoid stimulants, such as people concerned about substance misuse, people with a history of seizures or improperly managed glaucoma, says Dr. Khan. Like most psychotropic medications, Strattera won’t work for everyone, says Dr. Zand.
Strattera may cause weight loss or slowed growth in some children and adolescents. These side effects are more likely to occur in the first year of treatment. To watch for these side effects, your child’s doctor will monitor their height and weight regularly while they’re taking Strattera. This is different than some other medications used to treat ADHD, including stimulants like Adderall. Strattera must be administered daily, preferably around the same time, to reach appropriate levels in the bloodstream.
ATX ADDED TO STIMULANTS
Patients initiating STRATTERA should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, is strattera a stimulant or unexplained “flu-like” symptoms see WARNINGS AND PRECAUTIONS. Poor metabolizers (PMs) of CYP2D6 have a 10-fold higher AUC and a 5-fold higher peak concentration to a given dose of STRATTERA compared with extensive metabolizers (EMs).
Strattera is now available as a generic under the active ingredient name atomoxetine. Strattera contains the active ingredient atomoxetine, which is from a group of medicines called selective norepinephrine reuptake inhibitor (SNRI). Strattera received FDA approval on November 26, 2002, for the treatment of Attention-Deficit/Hyperactivity Disorder. Strattera has not been studied in children less than 6 years old. Strattera generic is now available under the active ingredient name atomoxetine.
Not all possible interactions are listed in this medication guide. Doctors can choose from a range of drugs, including stimulant and non-stimulant ADHD medicines. However, these medications do not affect everyone in the same way. One medication might work better for one person than another. As the name suggests, it works on the reuptake of norepinephrine. Non-stimulant medications like Strattera are approved by the FDA to treat ADHD symptoms.
Some animal reproduction studies of atomoxetine had adverse developmental outcomes. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in extensive and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data).
There are no data on the presence of atomoxetine or its metabolite in human milk, the effects on the breastfed child, or the effects on milk production. When a drug is present in animal milk, it is likely that the drug will be present in human milk. STRATTERA should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. Coadministration of STRATTERA (40 or 60 mg BID for 13 days) with desipramine, a model compound for CYP2D6 metabolized drugs (single dose of 50 mg), did not alter the pharmacokinetics of desipramine. No dose adjustment is recommended for drugs metabolized by CYP2D6. Seizures – Seizures have been reported in the postmarketing period.
However, they are generally considered less effective than the stimulant medications used to treat symptoms of ADHD. Strattera is classified as a norepinephrine reuptake inhibitor. It works by increasing the amount of norepinephrine in the central nervous system, a brain chemical that helps to increase attention span and focus while reducing hyperactivity and impulsive behaviors.
Strattera is a non-stimulant; it is not considered a controlled substance by the Drug Enforcement Agency (DEA). Watch your child especially closely during the first few months of treatment and during any dose changes. Reach out to their healthcare provider right away if you notice anything concerning. At the outset of her junior year, Jennifer and her parents requested medication adjustments that would extend coverage into the evening. Because of part-time employment after school, Jennifer now had to do her homework in the evening. Also she was now driving herself to and from school, to and from her job, and to other activities.