PRODUCT MONOGRAPH

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Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY <strong>PRODUCT</strong> INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................7 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ..............................................................................10 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................13 SPECIAL HANDLING INSTRUCTIONS .......................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................13 PART II: SCIENTIFIC INFORMATION ...............................................................................14 PHARMACEUTICAL INFORMATION ..........................................................................14 CLINICAL TRIALS ..........................................................................................................14 TOXICOLOGY .................................................................................................................20 REFERENCES ..................................................................................................................22 PART III: CONSUMER INFORMATION ..............................................................................24 ANDRIOL ® (testosterone undecanoate capsules) Page 2 of 26
ANDRIOL ® testosterone undecanoate capsules PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY <strong>PRODUCT</strong> INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients oral capsule 40 mg Castor oil, gelatin, Sunset Yellow. For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE Andriol ® (testosterone undecanoate capsules) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Andriol ® should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate validated biochemical assays (morning testosterone) before initiating therapy with any testosterone replacement, including Andriol ® treatment. Geriatrics (>65 years of age): There is limited Andriol ® use in the geriatric population (see CLINICAL TRIALS). Pediatrics (
Page 1: Merck Canada Inc. 16750 route Trans
Page 5 and 6: Geriatrics (>65 years of age): Ther
Page 7 and 8: ADVERSE REACTIONS Adverse Drug Reac
Page 9 and 10: Table 2 - Adverse Drug Reactions fr
Page 11 and 12: ACTION AND CLINICAL PHARMACOLOGY Me
Page 13 and 14: Special Populations and Conditions
Page 15 and 16: In an independent study reported in
Page 17 and 18: Table 4 - LH and FSH cumulative res
Page 19 and 20: Taking Andriol ® (testosterone und
Page 21 and 22: first generation (F0) males were su
Page 23 and 24: 13. Shenfield Gillian M, Griffin Ju
Page 25 and 26: To ensure adequate absorption, Andr

PRODUCT MONOGRAPH

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