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FORXIGA (DAPAGLIFLOZIN): PRESCRIBING INFORMATION

DESCRIPTION

Trade Name: Forxiga

Common Name: Dapagliflozin Propanediol Monohydrate

Chemical Name: D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-,compd. with (2S)-1,2-propanediol, hydrate (1:1:1)

Molecular Formula and Molecular Mass: C21H25ClO6 x C3H8O2 x H2O

Physicochemical Properties: Dapagliflozin propanediol is a white to off-white non-hygroscopic crystalline powder. It is slightly soluble in water, soluble in acetonitrile and freely soluble in acetone, ethanol, isopropanol, methanol and tetrahydrofuran.

Route of administration: oral

Dosage Form: tablet

Strength: 5 mg, 10 mg

Clinically relevant nonmedicinal ingredients: Lactose


INDICATIONS AND USAGE

Forxiga indications and usage


CONTRAINDICATIONS

Forxiga (Dapagliflozin) is contraindicated in:

  • Patients with a history of hypersensitivity reaction to the active substance or to any of the excipients.
  • Patients with moderate to severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2, end-stage renal disease [ESRD] and patients on dialysis.


    DOSAGE AND ADMINISTRATION

    Forxiga dosage and administration


    CLINICAL PHARMACOLOGY

    Forxiga clinical pharmacology


    PHARMACODYNAMICS

    Forxiga pharmacodynamics


    PHARMACOKINETICS

    Forxiga pharmacokinetics


    SPECIAL POPULATIONS AND CONDITIONS

    Forxiga special populations and conditions


    WARNINGS

    Forxiga warnings


    PRECAUTIONS

    Forxiga precautions


    USE IN SPECIAL POPULATIONS

    Forxiga use in special populations


    ADVERSE REACTIONS

    Forxiga adverse reactions


    DRUG INTERACTIONS

    Forxiga drug interactions


    OVERDOSAGE

    It is reasonable to employ supportive measures, as dictated by the patient's clinical status. The removal of dapagliflozin by hemodialysis has not been studied.

    For management of a suspected drug overdose by Dapagliflozin (Forxiga) tablets, contact your regional Poison Control Centre.


    STORAGE / HOW SUPPLIED

    Dosage Forms and Packaging

    Forxiga (Dapagliflozin) 5 mg tablets are yellow, biconvex, round, film coated tablets with "5" engraved on one side and "1427" engraved on the other side.

    Forxiga (Dapagliflozin) 10 mg tablets are yellow, biconvex, diamond, film coated tablets with "10" engraved on one side and "1428" engraved on the other side.

    The 5 mg and 10 mg tablets are provided in blisters in cartons of 30.

    Information for the patient is provided as a package insert in the Dapagliflozin (Forxiga) packages.

    Composition

    Forxiga is available as a film-coated tablet for oral administration containing the equivalent of 5 mg or 10 mg dapagliflozin as dapagliflozin propanediol monohydrate.

    Each film-coated tablet of Forxiga also contains the following inactive ingredients: crospovidone, lactose anhydrous, magnesium stearate, silicon dioxide, microcrystalline cellulose. In addition, the film coating contains the following inactive ingredients: titanium dioxide, polyvinyl alcohol, polyethylene glycol, talc and yellow iron oxide.

    Storage

    Store Forxiga (Dapagliflozin) tablets at room temperature (15-30°C).

    Store in a safe place and out of the reach of children.

    Manufactured and distributed by AstraZeneca pharmaceutical company and its divisions.

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