AXETRA-10/25 (ATOMOXETINE TABLETS)
DESCRIPTION
Atomoxetine is a selective norepinephrine reuptake inhibitor used to treat attention-deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain which controls the behavior of the patient.
CLINICAL PHARMACOLOGY
Atomoxetine is thought to be related to its selective inhibition of presynaptic norepinephrine reuptake in the prefrontal cortex. Atomoxetine has a high affinity and selectivity for norepinephrine transporters. Atomoxetine is effective and generally well tolerated. It is significantly more effective than placebo and standard current therapy.
Atomoxetine is particularly useful for patients at risk of substance abuse, as well as those who have co-morbid anxiety or tics, or who do not wish to take a controlled substance. Thus, atomoxetine is a useful option in the treatment of ADHD in children and adolescents. Atomoxetine efficacy did not appear to differ between children and adolescents. Stimulant-naive patients also respond well to the administration of Atomoxetine.
DOSAGE
The initial starting dose of Atomoxetine is 40mg per day for the first 3 days and is then increased to 80mg per day. Atomoxetine can be administered either as a single daily dose or split into two evenly divided doses. In the case of divided doses, morning and afternoon doses are recommended. A late evening or night dose of Atomoxetine may often result in sleep disorders or insomnia. Do not crush or chew the tablet, it has to be swallowed. The dosage is based on your medical condition, response to treatment, and other drugs you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or take this drug more often than directed. It has a negligible risk of abuse or misuse, and is not a controlled substance.
INDICATIONS
Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) alone or in combination with behavioral treatment, as an adjunct to psychological, educational, social, and other remedial measures.
CONTRA INDICATIONS
Atomoxetine is contraindicated in patients known to be hypersensitive to Atomoxetine or other constituents of the product. It should not be taken with MAOI or if you have stopped taking them within the past 2 weeks. All pediatric patients being treated with STRATTERA should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
SIDE EFFECTS
It is unadvisable to take this medication at night time as it may cause trouble sleeping or insomnia. Common adverse events included headache, abdominal pain, decreased appetite, vomiting, somnolence, and nausea. The majority of adverse events were mild or moderate and there was a very low incidence of serious adverse events. Hardly any patients have discontinued Atomoxetine treatment because of adverse events. Atomoxetine discontinuation appeared to be well tolerated, with a low incidence of discontinuation-emergent adverse events.
DRUG INTERACTIONS
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use and share it with your doctor. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Taking MAO inhibitors with this medication may sometimes cause serious drug interactions.
AVAILABILITY
AXETRA is available in strips of ten uncoated tablets containing Atomoxetine 10/25mg.
