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Rx Item-Synjardy 5Mg 500Mg Tab 180 By Boehringer Ingelheim

NDC 00597-0159-18 UPC/GTIN No.3-05970-15918-6 Mfg.Part No.15918BRAND: SYNJARDY NDC: 00597-0159-18,597015918 UPC: 3-05970-15918-6,305970159186 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Synjardy 5Mg 500Mg Tab 180 By Boehringer Ingelheim

$1974.73$1794.19

Item No.: RX463378 NDC No.597015918 UPC No.:305970159186 NDC No. 00597-0159-18 UPC/GTIN No. 3-05970-15918-6 MPN 15918 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx463378 Synjardy 5mg/500mg Tab 180 by Boehringer Ingelheim Item No. 3463378 NDC No. 00597015918 UPC No. 305970159186 Other Name Sy

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SYNJARDY- empagliflozin and metformin hydrochloride tablet
Boehringer Ingelheim Pharmaceuticals, Inc.
WARNING: LACTIC ACIDOSIS

? Postmarketing cases of metformin-associated lactic acidosis haveresulted in death, hypothermia, hypotension, and resistant bradyarrhythmias.The onset of metformin-associated lactic acidosis is often subtle,accompanied only by nonspecific symptoms such as malaise, myalgias,respiratory distress, somnolence, and abdominal pain. Metformin-associatedlactic acidosis was characterized by elevated blood lactate levels(>5 mmol/Liter), anion gap acidosis (without evidence of ketonuriaor ketonemia), an increased lactate/pyruvate ratio; and metforminplasma levels generally >5 mcg/mL [see Warnings and Precautions(5.1)].



? Risk factors for metformin-associatedlactic acidosis include renal impairment, concomitant use of certaindrugs (e.g., carbonic anhydrase inhibitors such as topiramate), age65 years old or greater, having a radiological study with contrast,surgery and other procedures, hypoxic states (e.g., acute congestiveheart failure), excessive alcohol intake, and hepatic impairment.

? Steps to reducethe risk of and manage metformin-associated lactic acidosis in thesehigh risk groups are provided in the full prescribing information [see Dosage and Administration (2.2), Contraindications (4), Warningsand Precautions (5.1), Drug Interactions(7.2), and Use in Specific Populations(8.6, 8.7)].

? If metformin-associated lactic acidosis is suspected, immediatelydiscontinue SYNJARDY and institute general supportive measures ina hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1)].

1??INDICATIONS AND USAGE

SYNJARDY is a combination of empagliflozin and metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.

? Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14.2)]. However, the effectiveness of SYNJARDY on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.

Limitations of Use
SYNJARDY is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis [see Warnings and Precautions (5.3)].

2??DOSAGE AND ADMINISTRATION

2.1?Recommended Dosage
In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating SYNJARDY [see Warnings and Precautions (5.2)].
Individualize the starting dose of SYNJARDY based on the patient�s current regimen:

In patients on metformin hydrochloride, switch to SYNJARDY containing empagliflozin 5 mg with a similar total daily dose of metformin hydrochloride;

In patients on empagliflozin, switch to SYNJARDY containing metformin hydrochloride 500 mg with a similar total daily dose of empagliflozin;

In patients already treated with empagliflozin and metformin hydrochloride, switch to SYNJARDY containing the same total daily doses of each component.
Take SYNJARDY twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin [see Dosage Forms and Strengths (3)].
Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin hydrochloride 2000 mg and empagliflozin 25 mg [see Dosage and Administration (2.2)].
2.2?Recommended Dosage in Patients with Renal Impairment
Assess renal function prior to initiation of SYNJARDY and periodically, thereafter.
? SYNJARDY is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.1, 5.4)].
DOSAGE FORMS AND STRENGTHS

SYNJARDY is a combination of empagliflozin and metformin hydrochloride. SYNJARDY is available in the following dosage forms and strengths:

5 mg empagliflozin/500 mg metformin hydrochloride tablets are orange yellow, oval, biconvex, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol and �S5"; the other side is debossed with �500".
5 mg empagliflozin/1000 mg metformin hydrochloride tablets are brownish yellow, oval, biconvex, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol and �S5"; the other side is debossed with �1000".
12.5 mg empagliflozin/500 mg metformin hydrochloride tablets are pale brownish purple, oval, biconvex, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol and �S12"; the other side is debossed with �500".
12.5 mg empagliflozin/1000 mg metformin hydrochloride tablets are dark brownish purple, oval, biconvex, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol and �S12"; the other side is debossed with �1000".
4??CONTRAINDICATIONS

SYNJARDY is contraindicated in patients with:

? Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2), end stage renal disease, or dialysis [see Warnings and Precautions (5.1, 5.4) and Use in Specific Populations (8.6)].
Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin [see Warnings and Precautions (5.1)].
History of serious hypersensitivity reaction to empagliflozin or metformin.
DESCRIPTION

SYNJARDY tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: empagliflozin and metformin hydrochloride.

Empagliflozin
Empagliflozin is 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 C23 H27 ClO7 and the molecular weight is 450.91
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.

Metformin hydrochloride Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4 H11 N5 �HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
SYNJARDY
SYNJARDY tablets for oral administration are available in four dosage strengths containing 5 mg empagliflozin and 500 mg metformin hydrochloride, 5 mg empagliflozin and 1000 mg metformin hydrochloride, 12.5 mg empagliflozin and 500 mg metformin hydrochloride, or 12.5 mg empagliflozin and 1000 mg metformin hydrochloride.

Each film-coated tablet of SYNJARDY contains the following inactive ingredients: copovidone, corn starch, colloidal silicon dioxide, magnesium stearate. Film-coating: hypromellose, titanium dioxide, talc, polyethylene glycol 400, and yellow ferric oxide (5 mg/500 mg, 5 mg/1000 mg) or red ferric oxide and black ferrosoferric oxide (12.5 mg/500 mg, 12.5 mg/1000 mg).
CLINICAL PHARMACOLOGY

12.1?Mechanism of Action
SYNJARDY
SYNJARDY combines 2 antihyperglycemic agents with complementary mechanisms of action to improve glycemic control in patients with type 2 diabetes: empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a member of the biguanide class.

Empagliflozin
Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Metformin
Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose

NDC 00597-0159-18 UPC/GTIN No.3-05970-15918-6 Mfg.Part No.15918
RX ITEM-Synjardy 5Mg 500Mg Tab 180 By Bo
NDC 00597-0159-18 UPC/GTIN No.3-05970-15918-6 Mfg.Part No.15918

BRAND: SYNJARDY NDC: 00597-0159-18,597015918 UPC: 3-05970-15918-6,305970159186
Synjardy 5Mg 500Mg Tab 180 By Boehringer
BRAND: SYNJARDY NDC: 00597-0159-18,597015918 UPC: 3-05970-15918-6,305970159186

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Synjardy
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.