Oriham Capsule

Oriham Capsule is used for: Attention deficit hyperactivity disorder (ADHD)

Oral Attention deficit hyperactivity disorder Adult: Initially, 40 mg/day may increase gradually after at least 7 days to 80 mg/day, up to 100 mg/day may be used after 2-4 wk.

Oral Attention deficit hyperactivity disorder Child: >6 yr <70 kg: Initially, 0.5 mg/kg/day, may increase gradually to approx 1.2 mg/kg/day. Max: 1.4 mg/kg or 100 mg, whichever is lower; >70 kg: Initially, 40 mg/day, may increase gradually after at least 7 days to 80 mg/day, up to100 mg/day may be used after 2-4 wk.

Renal impairment: Dosage adjustment not necessary

Oral Administration May be taken with or without food. Administer either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening

Hypersensitivity to atomoxetine or other constituents of the product. Atomoxetine use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. Narrow-Angle Glaucoma. Pheochromocytoma or history of pheochromocytoma.

• Atomoxetine use has been associated with increased risk of suicidal ideation in short-term studies in children or adolescents with ADHD; this risk must be balanced against clinical need in patients with ADHD. • Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. • Serious Cardiovascular Events – Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for the presence of cardiovascular disease. Atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using Atomoxetine in adults with clinically significant cardiac abnormalities. • Emergent Cardiovascular Symptoms – Patients should undergo prompt cardiac evaluation. • Effects on Blood Pressure and Heart Rate – Can increase blood pressure and heart rate; orthostasis, syncope and Raynaud’s phenomenon may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. • Emergent Psychotic or Manic Symptoms – Consider discontinuing treatment if such new symptoms occur. • Bipolar Disorder – Screen patients to avoid possible induction of a mixed/manic episode. • Aggressive behavior or hostility should be monitored. • Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash. • Effects on Urine Outflow – Urinary hesitancy and retention may occur. • Priapism – Prompt medical attention is required in the event of suspected priapism. • Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs – Dose adjustment of Atomoxetine may be necessary. Monitoring Parameters Monitor for appearance or worsening of anxiety, depression or tics. Monitor for signs of clinical worsening, suicidality or unusual behavioral changes especially during the start of treatment and during dose changes. Pulse, blood pressure, psychiatric symptoms, appetite, weight and height should be recorded at the initiation of therapy, following each dose adjustment, and at least every 6 months thereafter. Growth – Height and weight should be monitored in pediatric patients.

Pregnancy Available published studies use in pregnant females are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes Animal data Pregnant rabbits treated with up to 100 mg/kg/day during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery; observed at 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 rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m2 basis Lactation There are no data on presence of atomoxetine or its metabolite in human milk, effects on the breastfed children, or its effects on milk production Present in animal milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk

MAO-I Contraindicated With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) CYP2D6 inhibitors Reduce dose In extensive metabolizers, CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to poor metabolizers Antihypertensive drugs and pressor agents Use with caution Atomoxetine may increase in blood pressure Albuterol Use caution with patients being treated with systemically-administered (oral or IV) albuterol (or other beta2 agonists) Coadministration of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure Potentially Fatal: Increased neurotoxic effect w/ MAOIs. Contraindicated (13) cisapride dronedarone iobenguane I 123 isocarboxazid linezolid mavorixafor phenelzine procarbazine rasagiline selegiline selegiline transdermal thioridazine tranylcypromine

Side effects of Atomoxetine : >10% Xerostomia (dry mouth) (21%),Headache (2-19%),Abdominal pain (7-18%),Decreased appetite (11-16%),Insomnia (2-15%),Cough (11%),Somnolence (11%),Vomiting (3-11%) 1-10% Nausea (10%),Increases in blood pressure (BP; ≥15-20 mm Hg) and heart rate (HR; ≥20 beats/min) (5-10%),Erectile dysfunction (9%),Hot flashes (8%),Dizziness (5-8%),Urinary hesitation or retention (7%),Decreased weight (4-7%),Depression (4-7%),Irritability (<6%),Dyspepsia (4%),Ejaculation disorder (3%),Sinus headache (3%),Constipation (2%),Dermatitis (2%),Menstrual disorder (2%),Mood swings (1-2%)

Atomoxetine hydrochloride selectively inhibits noradrenaline reuptake w/ minimal affinity for other noradrenergic receptors or for other neurotransmitter receptors or transporters. It is used in the treatment of attention deficit hyperactivity disorder.

Oriham 10 mg Capsule manufactured by Incepta Pharmaceuticals Ltd.. Its generic name is Atomoxetine. Oriham is availble in Bangladesh. Farmaco BD drug index information on Oriham Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.