Dutasteride + tamsulosin


Generic Medicine Info
Administration
Should be taken with food. Take approx 30 min after meals. Swallow whole, do not crush/chew/open.
Contraindications
Hypersensitivity. History of orthostatic hypotension. Women, children and adolescents. Pregnancy and lactation. Severe hepatic impairment. Concomitant use with strong CYP3A4 inhibitors in CYP2D6 poor metabolisers.
Special Precautions
Patient with large residual urinary volume and/or severely impaired urine flow. Cataract surgery patients. Severe renal impairment (CrCl <10 mL/min) and mild to moderate hepatic impairment. Patient Counselling Women of child-bearing potential, pregnant or children should avoid handling the cap. Excreted in semen therefore use of condom is recommended. Avoid donating blood during and for at least 6 months after discontinuation of therapy. This drug may cause dizziness and vertigo, if affected, do not drive or operate machinery. Monitoring Parameters Rule out prostate cancer before initiation of therapy. Perform digital rectal examination, other assessment for prostate cancer or other conditions causing the same symptoms as BPH before and during therapy. Obtain new baseline prostate-specific antigen level after 3 months of treatment then monitor periodically thereafter. Assess for objective and subjective signs of relief of BPH (e.g. improvement in urinary flow, reduction in symptoms of urgency, relief of difficulty in micturition).
Adverse Reactions
Significant: Intraoperative floppy iris syndrome, orthostatic hypotension and syncope; rarely, priapism. Nervous system disorders: Dizziness, vertigo. Reproductive system and breast disorders: Impotence, decreased libido, ejaculation disorder, breast disorder, gynaecomastia, breast tenderness.
Drug Interactions
Dutasteride: Increased serum concentration with potent CYP3A4 inhibitors (e.g. ritonavir, indinavir, nefazodone, itraconazole, oral ketoconazole). Tamsulosin: Enhanced hypotensive effect with anaesthetic agents, PDE5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) and other α1-adrenoreceptor antagonists. Increased plasma concentration with strong CYP3A4 inhibitors (e.g. ketoconazole) or to a lesser extent, with strong CYP2D6 inhibitors (e.g. paroxetine) or a combination of both CYP3A4 and CYP2D6 inhibitors (e.g. amiodarone, cimetidine, imatinib). Decreased plasma concentration with furosemide. Increased elimination rate with diclofenac and warfarin.
ATC Classification
G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
Disclaimer: This information is independently developed by CIMS based on dutasteride + tamsulosin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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