Country: Canada
Language: English
Source: Health Canada
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE)
ANGITA PHARMA INC.
N06BA09
ATOMOXETINE
18MG
CAPSULE
ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) 18MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0150434002; AHFS:
APPROVED
2020-11-30
AG-ATOMOXETINE Product Monograph Page 1 PRODUCT MONOGRAPH PR AG-ATOMOXETINE Atomoxetine Capsules 10, 18, 25, 40, 60, 80 and 100 mg atomoxetine (as atomoxetine hydrochloride) House standard SELECTIVE NOREPINEPHRINE REUPTAKE INHIBITOR FOR ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) Angita Pharma Inc. 1310, rue Nobel Boucherville, Québec J4B 5H3 Date of Revision: November 26, 2020 Submission Control No. 245703 AG-ATOMOXETINE Product Monograph Page 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 12 DRUG ABUSE AND DEPENDENCE ............................................................................ 22 DRUG INTERACTIONS .................................................................................................. 23 DOSAGE AND ADMINISTRATION ............................................................................. 24 OVERDOSAGE ................................................................................................................. 27 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 28 STORAGE AND STABILITY ......................................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 33 PART II: SCIENTIFIC INFORMATION ............................................................................ 34 PHARMACEUTICAL INFORMATION ........................ Read the complete document