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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): FULL PRESCRIBING INFORMATION

DESCRIPTION

Name of the medication: Duodart (Dutasteride / Tamsulosin hydrochloride) capsules

Dutasteride

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 Hydrochloride

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 Calculator 4.7)

Chemical Name: (-)-(R)-5-[2-[[2-(2-Ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide, monohydrochloride

Molecular Formula: C20H28N2O5S x HCl


CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Duodart pharmacodynamics


PHARMACOKINETICS

Duodart pharmacokinetics


PHARMACOKINETICS IN SPECIAL POPULATIONS

Duodart pharmacokinetics in special populations


CLINICAL TRIALS

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).


CONTRAINDICATIONS

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.


    WARNINGS

    Duodart warnings


    PRECAUTIONS

    Duodart precautions


    USE IN SPECIFIC POPULATIONS

    Duodart use in specific populations


    DRUG INTERACTIONS

    Duodart drug interactions


    ADVERSE REACTIONS

    Duodart adverse reactions


    DOSAGE AND ADMINISTRATION

    Duodart dosage and administration


    OVERDOSAGE

    Duodart overdosage


    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 hydrochloride)].

    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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