Regulatory Information
APOTHECA MARKETING PTE LTD
APOTHECA MARKETING PTE LTD
Therapeutic
Prescription Only
Formulation Information
CAPSULE
**Dosage and Administration** Where appropriate, Dutasteride/Tamsulosin Hydrochloride may be used to substitute concomitant dutasteride and Tamsulosin hydrochloride in existing dual therapy to simplify treatment. Where clinically appropriate, direct change from dutasteride or tamsulosin hydrochloride monotherapy to Dutasteride/Tamsulosin Hydrochloride may be considered. **Adult males (including elderly)** The recommended dose of Dutasteride/Tamsulosin Hydrochloride is one capsule (0.5 mg/0.4 mg) taken orally approximately 30 minutes after the same meal each day. Capsules should be swallowed whole and not chewed or opened. Contact with the contents of the dutasteride capsule contained within the hard-shell capsule may result in irritation of the oropharyngeal mucosa. Patients should be advised that Dutasteride/Tamsulosin Hydrochloride should not be taken on an empty stomach as this may increase the potential for cardiovascular related adverse events such as orthostatic hypotension (see Pharmacodynamics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment_ The effect of renal impairment on dutasteride-tamsulosin pharmacokinetics has not been studied. However, no adjustment in dosage is anticipated for patients with renal impairment (see Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ The effect of hepatic impairment on dutasteride-tamsulosin pharmacokinetics has not been studied (see Warnings and Precautions and Pharmacokinetics – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Dutasteride/Tamsulosin Hydrochloride is contraindicated in patients with severe hepatic impairment.
ORAL
Medical Information
**Indications** DUTABIT PLUS treats and prevents progression of benign prostatic hyperplasia (BPH) through alleviating symptoms, reducing prostate size (volume), improving urinary flow rate and reducing the risk of acute urinary retention (AUR) and the need for BPH-related surgery.
**Contraindications** DUTABIT PLUS is contraindicated in: - patients with known hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin hydrochloride or any component of the preparation (see List of Excipients – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - patients with a history of orthostatic hypotension - patients with severe hepatic impairment (Child-Pugh scores >9) - patients with severe renal impairment (creatinine clearance less than 10mL/min) - combination with another α-1 adrenergic blocker Dutasteride/Tamsulosin Hydrochloride is contraindicated for use in women and children (see Pregnancy and Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
G04CA52
tamsulosin and dutasteride
Manufacturer Information
APOTHECA MARKETING PTE LTD
AUROBINDO PHARMA LIMITED - UNIT VII
Active Ingredients
Documents
Package Inserts
Dutabit Plus Capsule PI.pdf
Approved: November 1, 2022