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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): FULL PRESCRIBING INFORMATION
Name of the medication: Duodart (Dutasteride / Tamsulosin hydrochloride) capsules
Dutasteride is a white to pale yellow powder. It is practically insoluble in water, and soluble in organic solvents, dimethyl sulfoxide, acetone, methanol, ethanol and ispropanol.
Chemical Name: 4-Azaandrost-1-ene-17-carboxamide, N-(2,5-Bis(trifluoromethyl)phenyl)-3-oxo-, (5alpha, 17beta)-
Molecular Formula: C27H30F6N2O2
Tamsulosin HCl is a white or almost white crystalline powder. It is sparingly soluble in water, and slightly soluble in the following solvents; acetone, ethanol, ethyl acetate and methanol.
The pKa values for tamsulosin are as follows: pKa1 = 8.4 (secondary amine) and pKa2 = 10.7 (sulphonamide). The partition coefficient is clogP = 2.2 (calculated using Property
Chemical Name: (-)-(R)-5-[2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride
Molecular Formula: C20H28N2O5S x HCl
PHARMACOKINETICS IN SPECIAL POPULATIONS
Duodart pharmacokinetics in special populations
Duodart clinical trials
INDICATIONS AND USAGE
Duodart (Dutasteride and Tamsulosin HCl) is indicated for the management of moderate to severe symptomatic benign prostatic hyperplasia (BPH).
Dutasteride with Tamsulosin HCl (Duodart) is contraindicated in:
women and children.
patients with known hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin hydrochloride or any component of the medication.
patients with a history of orthostatic hypotension
patients with severe renal impairment (creatinine clearance less than 10 mL/min).
patients with severe hepatic impairment (child-Pugh scores >9).
combination with another alpha-1 adrenergic blocker.
USE IN SPECIFIC POPULATIONS
Duodart use in specific populations
Duodart drug interactions
Duodart adverse reactions
DOSAGE AND ADMINISTRATION
Duodart dosage and administration
PRESENTATION AND STORAGE CONDITIONS
Store Duodart capsules below 25°C.
Duodart (Dutasteride 0.5 mg / Tamsulosin hydrochloride 0.4 mg) capsules: oblong, hardshell capsules with a brown body and an orange cap imprinted with "GS 7CZ" in black ink
[each containing one oblong, opaque, dull-yellow dutasteride soft gelatin capsule (0.5 mg dutasteride) and white to off-white tamsulosin hydrochloride pellets (0.4 mg tamsulosin
Duodart capsules are packed into the following container closure systems: opaque, white high density polyethylene (HDPE) bottles with polypropylene child-resistant closures with induction-seal liners.
Manufactured and distributed by GlaxoSmithKline pharmaceutical company and its divisions.
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