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FORXIGA (DAPAGLIFLOZIN): PRESCRIBING INFORMATION
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
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
Forxiga clinical pharmacology
SPECIAL POPULATIONS AND CONDITIONS
Forxiga special populations and conditions
USE IN SPECIAL POPULATIONS
Forxiga use in special populations
Forxiga adverse reactions
Forxiga drug interactions
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.
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.
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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