Tamsulosin + Dutasteride


Concise Prescribing Info
Indications/Uses
Benign prostatic hyperplasia.
Dosage/Direction for Use
Adult : PO Per tab contains tamsulosin 0.4 mg and dutasteride 0.5 mg: 1 tab once daily.
Dosage Details
Oral
Benign prostatic hyperplasia
Adult: Per tab contains tamsulosin 0.4 mg and dutasteride 0.5 mg: 1 tab once daily.
Administration
Should be taken with food. Take approx 30 min after meals. Swallow whole, do not crush/chew/open.
Contraindications
Hypersensitivity, severe liver impairment. Pregnancy, lactation, child, adolescent.
Special Precautions
Excreted in semen therefore use of condom is recommended. Women of childbearing potential should avoid handling leaking capsules of dutasteride. Prostate carcinoma should be ruled out before starting the therapy. Blood donation to be avoided during and at least 6 mths after discontinuance of drug.
Adverse Reactions
Impotence, decreased libido, ejaculation disorders, breast tenderness and enlargement, postural hypotension, dizziness and vertigo, headache, infection, asthenia, back pain, chest pain, somnolence, insomnia, rhinitis, pharyngitis, cough, sinusitis, diarrhoea, nausea, tooth disorder, blurred vision.
Drug Interactions
Concomitant admin with moderate or strong inhibitors of CYP2D6 (eg. fluoxetine) or CYP34A (eg. ketoconazole, cimetidine) increases tamsulosin serum concentration; increase in blood concentrations of dutasteride in the presence of inhibitors of CYP3A4/5 such as ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, and ciprofloxacin.
Food Interaction
Food prolongs time to reach max concentration.
Lab Interference
Dutaseride decreased serum prostate-specific antigen (PSA) but does not alter ratio of free to total PSA.
Action
Description: Tamsulosin is a selective α-1 adrenoceptor blocker. It blocks α-1 adrenoceptors, which are abundant in the prostate, prostatic capsule, prostatic urethra, and bladder neck, resulting relaxation of these adrenoceptors in the bladder neck and prostate. Thus, there is an improvement in urine flow rate and reduction in symptoms of benign prostatic hypertrophy (BPH). Dutasteride inhibits 5 α-reductase, the enzyme responsible for conversion of testosterone to 5α-dihydrotestosterone (DHT). DHT appears to be the principal androgen responsible for stimulation of prostatic growth.
Disclaimer: This information is independently developed by MIMS based on Tamsulosin + Dutasteride from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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