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FARXIGA (DAPAGLIFLOZIN): PRESCRIBING INFORMATION

DESCRIPTION

Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1).

The empirical formula is C21H25ClO6 x C3H8O2 x H2O

The molecular weight is 502.98.

Farxiga is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol or the equivalent of 10 mg dapagliflozin as dapagliflozin propanediol, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, silicon dioxide, crospovidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, and yellow iron oxide.


INDICATIONS AND USAGE

Farxiga (Dapagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitation of Use

Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.


DOSAGE AND ADMINISTRATION

Farxiga dosage and administration


DOSAGE FORMS AND STRENGTHS

  • Farxiga (Dapagliflozin Propanediol Monohydrate) 5 mg tablets are yellow, biconvex, round, film-coated tablets with "5" engraved on one side and "1427" engraved on the other side.
  • Farxiga 10 mg tablets are yellow, biconvex, diamond-shaped, film-coated tablets with "10" engraved on one side and "1428" engraved on the other side.


    CONTRAINDICATIONS

  • History of a serious hypersensitivity reaction to Farxiga (Dapagliflozin).
  • Severe renal impairment, end-stage renal disease (ESRD), or patients on dialysis.


    CLINICAL PHARMACOLOGY

    Farxiga clinical pharmacology


    NONCLINICAL TOXICOLOGY

    Farxiga nonclinical toxicology


    CLINICAL STUDIES

    Overview of Clinical Studies of Farxiga (Dapagliflozin) for Type 2 Diabetes

    Farxiga has been studied as monotherapy and in combination with metformin, glimepiride, pioglitazone, sitagliptin (with or without metformin), or insulin (with or without other oral antidiabetic therapy). The efficacy of Farxiga (Dapagliflozin) tablets was compared to a sulfonylurea (glipizide) added on to metformin. This medication has also been studied in patients with type 2 diabetes and moderate renal impairment.

    Treatment with Dapagliflozin (Farxiga) as monotherapy and in combination with glimepiride, metformin, pioglitazone, sitagliptin, or insulin produced statistically significant improvements in mean change from baseline at Week 24 in HbA1c compared to control. Reductions in HbA1c were seen across subgroups including gender, age, race, duration of disease, and baseline BMI.


    WARNINGS AND PRECAUTIONS

    Farxiga warnings and precautions


    ADVERSE REACTIONS

    Farxiga adverse reactions


    DRUG INTERACTIONS

    Positive Urine Glucose Test

    Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors such as Farxiga (Dapagliflozin) as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

    Interference with 1,5-anhydroglucitol (1,5-AG) Assay

    Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.


    USE IN SPECIFIC POPULATIONS

    Farxiga use in specific populations


    OVERDOSAGE

    There were no reports of overdose during the clinical development program for Dapagliflozin (Farxiga) tablets.

    In the event of an overdose, contact the Poison Control Center. It is also reasonable to employ supportive measures, as dictated by the patient's clinical status. The removal of dapagliflozin by hemodialysis has not been studied.


    HOW SUPPLIED / STORAGE AND HANDLING

    How Supplied

    Farxiga (Dapagliflozin) tablets have markings on both sides and are available in the strengths and packages:

    Farxiga 5 mg: yellow, biconvex, round, "5" engraved on one side and "1427" engraved on the other side

    Farxiga 10 mg: yellow, biconvex, diamond-shaped, "10" engraved on one side and "1428" engraved on the other side

    Storage and Handling

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

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