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ALFUSIN-D (ALFUZOSIN/DUTASTERIDE) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Alfusin-D tablets contain alfuzosin hydrochloride and dutasteride as active pharmaceutical ingredients (APIs). Alfuzosin HCl is a selective alpha1-adrenoreceptor blocking agent and exhibits selectivity for alpha1-adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors can cause smooth muscles in the bladder neck and prostate to relax, resulting in an improvement in urine flow and a reduction in the symptoms of benign prostatic hyperplasia (BPH).

Dutasteride is a synthetic 4-azasteroid compound that is a selective inhibitor of both type I and type II isoforms of steroid 5 alpha-reductase (5AR), an intracellular enzyme that converts testosterone to 5 alpha-dihydrotestosterone (DHT). DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. The type II isoenzyme is primarily active in the reproductive tissues while the type I isoenzyme is also responsible for testosterone conversion in the skin and liver. Alfusin-D tablets act on both the dynamic and the static components of BPH.

Composition

Alfusin-D Tablets

Each film-coated tablet contains:
Alfuzosin Hydrochloride BP 10 mg (as extended-release)
Dutasterid 0.5 mg
Colour: Titanium Dioxide IP


CLINICAL PHARMACOLOGY

Pharmacodynamics

  • Alfusin-D pharmacodynamics

    Pharmacokinetics

  • Alfusin-D pharmacokinetics

  • Alfusin-D pharmacokinetics in special populations


    INDICATIONS AND USAGE

    Alfusin-D tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.
    The tablets are not intended for use as an anti-hypertensive drug.
    Dutasteride is not approved for the prevention of prostate cancer.


    DOSAGE AND ADMINISTRATION

  • Alfusin-D dosage and administration


    CONTRAINDICATIONS

  • Alfusin-D contraindications


    WARNINGS

  • Alfusin-D warnings


    PRECAUTIONS

  • Alfusin-D precautions


    DRUG INTERACTIONS

  • Alfusin-D drug interactions


    USE IN SPECIFIC POPULATIONS

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    ADVERSE REACTIONS

  • Alfusin-D adverse reactions


    ADVERSE REACTIONS

  • Alfusin-D adverse reactions: postmarketing experience


    OVERDOSAGE

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    STORAGE AND HANDLING

    Store this medication in a cool and dry place, protected from light.

    Packaging Information

    Alfusin-D

    Strip of 10 tablets

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