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Glyxambi 25-5 Mg 30 Tabs By Boehringer Ingelheim.

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Glyxambi 25-5 Mg 30 Tabs By Boehringer Ingelheim.

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Glyxambi 25-5 Mg 30 Tabs By Boehringer Ingelheim. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10148173/RXA323599/RXD5058573
Size : 30
Selling UoM : EA
NDC: 00597-0164-30
UPC Barcode : 305970164302
Supplier: 0050001189 BOEHRINGER INGELHEIM
Supplier Material : 016430
Generic Code : 073433 EMPAGLIFLOZIN/LINAGLIPTIN ORAL TABLET 25
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Br

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Product Description.:

logo, 25/5
Tablet , film-coated , pink , triangular 3 sided
Flat-faced beveled-edgeDebossed

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

GLYXAMBI is contraindicated in patients with severe renal impairment, end-stage renal disease, or dialysis, a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity, or a history of serious hypersensitivity reaction to empagliflozin.

WARNINGS AND PRECAUTIONS

Pancreatitis

There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin, a component of GLYXAMBI. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue GLYXAMBI and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using GLYXAMBI.

Hypotension

Empagliflozin, a component of GLYXAMBI, causes intravascular volume contraction. Symptomatic hypotension may occur after initiating empagliflozin particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Before initiating GLYXAMBI, assess for volume contraction and correct volume status if indicated. Monitor for signs and symptoms of hypotension after initiating therapy.

Impairment in Renal Function

Empagliflozin, a component of GLYXAMBI, increases serum creatinine and decreases eGFR. Renal function should be evaluated prior to initiating GLYXAMBI and periodically thereafter. More frequent monitoring is recommended with eGFR <60 mL/min/1.73 m2.

The risk of impaired renal function with empagliflozin is increased in elderly patients and patients with moderate renal impairment. GLYXAMBI should be discontinued in patients with a persistent eGFR <45 mL/min/1.73 m2.

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues

Insulin and insulin secretagogues are known to cause hypoglycemia. The use of empagliflozin or linagliptin in combination with these agents was associated with a higher rate of hypoglycemia compared with placebo. A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with GLYXAMBI.

Genital Mycotic Infections

Empagliflozin, a component of GLYXAMBI, increases the risk for genital mycotic infections. Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop these infections. Monitor and treat as appropriate.

Urinary Tract Infections

Empagliflozin, a component of GLYXAMBI, increases the risk for urinary tract infections. Monitor and treat as appropriate.

Hypersensitivity Reactions

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with linagliptin, a component of GLYXAMBI. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with linagliptin, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue GLYXAMBI, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Increased Low-Density Lipoprotein Cholesterol (LDL-C)

Increases in LDL-C can occur with empagliflozin, a component of GLYXAMBI. Monitor and treat as appropriate.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLYXAMBI or any other antidiabetic drug.

ADVERSE REACTIONS

The most common adverse reactions (𕟷%) associated with GLYXAMBI (10/5 mg, 25/5 mg) were urinary tract infections (12.5% and 11.4%, respectively), nasopharyngitis (5.9%, 6.6% respectively), and upper respiratory tract infection (7.0% in both doses).

DRUG INTERACTIONS

Coadministration of empagliflozin, a component of GLYXAMBI, with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.

The efficacy of linagliptin, a component of GLYXAMBI, may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments to GLYXAMBI is strongly recommended.

USE IN SPECIAL POPULATIONS

Pregnancy

There are no adequate and well-controlled studies of GLYXAMBI or its individual components in pregnant women. GLYXAMBI should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known if GLYXAMBI or its individual components is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, discontinue nursing or d