strattera

Prior to initiating treatment with STRATTERA, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 ) See table below for the recommended STRATTERA dosage. ( 2.3 ) 1 Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening. Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and adults 40 mg/day 80 mg/day 100 mg/day For the recommended dosage in patients with hepatic impairment, see Full Prescribing Information. ( 2.4 ) For the recommended dosage with concomitant use of a strong CYP2D6 inhibitor or in CYP2D6 poor metabolizers, see Full Prescribing Information. ( 2.5 ) 2.1 Recommendations Prior to Initiating STRATTERA Treatment Prior to initiating treatment with STRATTERA, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.6 )]. 2.2 Administration Instructions STRATTERA may be taken with or without food. Take STRATTERA capsules whole; do not open the capsules. 2.3 Recommended Dosage Table 1 includes the recommended STRATTERA dosage in adult patients and pediatric patients 6 years of age and older for…

Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by STRATTERA. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. STRATTERA was administered to 5,382 pediatric patients 6 years of age and older in clinical ADHD studies (Studies 1, 2, 3, 4, and 5) [see Clinical Studies ( 14.1 )] and 1,007 adults in clinical ADHD studies (Studies 6 and 7) [see Clinical Studies ( 14.2 )] . In the ADHD clinical trials, 2,529 pediatric patients were treated for over 6 months which included 1,625 pediatric patients who…

STRATTERA is contraindicated in patients: With known hypersensitivity reaction to atomoxetine or other constituents of STRATTERA. Hypersensitivity reactions included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions ( 5.8 )] . Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions ( 7 )] . With narrow angle glaucoma. In clinical trials, STRATTERA use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received STRATTERA. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had a clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions ( 5.4 )] . Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine or other constituents of STRATTERA Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow angle glaucoma With pheochromocytoma or history of pheochromocytoma With severe cardiac or vascular disorders whose condition would be expected to deteriorate with clinically important increases in blood pressure or heart rate

During postmarketing use, there have been fatalities reported involving a mixed ingestion overdose of STRATTERA and at least one other drug. There have been no reports of death involving overdose of STRATTERA alone, including intentional overdoses at amounts up to 1,400 mg (14 times the maximum recommended dosage). The most commonly reported symptoms with acute and chronic overdoses of STRATTERA were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. In some cases of overdose involving STRATTERA, seizures have been reported. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology ( 12.2 )] . If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of STRATTERA overdose.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

See Table 8 for clinically significant drug interactions with STRATTERA and other drugs. Table 8: Clinically Significant Drug Interactions with STRATTERA and Other Drugs Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management STRATTERA is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days. Mechanism and Clinical Effect(s) As with other drugs affecting brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability with fluctuations of vital signs, extreme agitation progressing to delirium/coma) with concomitant use of STRATTERA and an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of STRATTERA and a strong CYP2D6 inhibitor, increase the titration interval [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. Mechanism and Clinical Effect(s) Atomoxetine is a CYP2D6 substrate. The concomitant use of STRATTERA and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Clinical Pharmacology ( 12.3 )] . Antihypertensive Drugs Prevention or Management Increase the frequency of monitoring blood pressure and adjust STRATTERA dosage as clinically appropriate. Mechanism and Clinical Effect(s) Because of increased risk of increased blood pressure, STRATTERA should be used cautiously with antihypertensive drugs, other drugs that increase blood pressure or pressor drugs (e.g., dopamine, dobutamine). Albuterol or Other Beta2 Agonists Prevention or Management Increase the frequency of monitoring blood pressure and heart rate and adjust STRATTERA dosage as clinically appropriate. Mechanism and Clinical Effect(s) Systemically administered albuterol (e.g., oral) can be potentiated by atomoxetine, resulting in increases in heart rate and blood pressure. [see Clinical Pharmacology ( 12.3 )]. Monoamine Oxidase Inhibitors: Concomitant use contraindicated. ( 4 , 7 ) Strong CYP2D6 Inhibitors: With concomitant use of STRATTERA and strong CYP2D6 inhibitors, increase the titration intervals. ( 7 ) Antihypertensives: Increase the frequency of monitoring blood pressure and adjust STRATTERA dosage as clinically appropriate. ( 7 ) Albuterol (or other beta2 agonists): Increase the frequency of monitoring blood pressure and heart rate. ( 7 )