Hanshinnocol
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)].
JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
History
There is currently no drug history available for this drug.
Other Information
JARDIANCE tablets contain empagliflozin, an orally-active inhibitor of the sodium-glucose co-transporter 2 (SGLT2).
The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S).
Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:
Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene.
Each film-coated tablet of JARDIANCE contains 10 mg or 25 mg of empagliflozin (free base) and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide.
Sources
Hanshinnocol Manufacturers
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Han Kook Shin Yak Pharmaceutical Co., Ltd.
![Hanshinnocol (Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide) Capsule [Han Kook Shin Yak Pharmaceutical Co., Ltd.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hanshinnocol | Boehringer Ingelheim Pharmaceuticals, Inc.
2.1 Recommended DosageThe recommended dose of JARDIANCE is 10 mg once daily in the morning, taken with or without food. In patients tolerating JARDIANCE, the dose may be increased to 25 mg [see Clinical Studies (14)].
In patients with volume depletion, correcting this condition prior to initiation of JARDIANCE is recommended [see Warnings and Precautions (5.1), Use in Specific Populations (8.5), and Patient Counseling Information (17)].
2.2 Patients with Renal ImpairmentAssessment of renal function is recommended prior to initiation of JARDIANCE and periodically thereafter.
JARDIANCE should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.
No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2.
JARDIANCE should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.1, 5.2), and Use in Specific Populations (8.6)].
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Han Kook Shin Yak Pharmaceutical Co., Ltd.
Hanshinnocol | Han Kook Shin Yak Pharmaceutical Co., Ltd.
![Hanshinnocol (Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide) Liquid [Han Kook Shin Yak Pharmaceutical Co., Ltd.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ab376567-b90b-44d6-873e-9bb5116c0e5c&name=nocolliquidrevision.jpg)
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