Physicians Academy
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Editorial :
 The Real Paradigm Shift in Management of T2DM
Article 1 :
 Introduction of DMS irrigation to heal Endo–Perio lesions and Cysts
Article 2 :
 Alagille Syndrome in a Neonate
Picture of The Month :
 POTM-April 2018
Drug Update :
 SEGLUROMET (ertugliflozin+metformin)
Abstracts from Other Journals :
 Abstracts from Other Journals-April 2018

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Dec 2017 ( Volume -11 Number -12)

Drug Update
ELIQUIS (Apixaban)
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DRUG UPDATE

DECEMBER 2017

ELIQUIS (Apixaban)

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS. ELIQUIS(apixaban) tablets, for oral use Initial U.S. Approval: 2012

WARNING:

(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS

(B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy. (2.4, 5.1, 14.1)

(B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. (5.3)

INDICATIONS AND USAGE

ELIQUIS is a factor Xa inhibitor indicated:

to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1)

for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2)

for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5)

DOSAGE AND ADMINISTRATION

• Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation:

The recommended dose is 5 mg orally twice daily. (2.1)

In patients with at least 2 of the following characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL, the recommended dose is 2.5 mg orally twice daily. (2.1)

• Prophylaxis of DVT following hip or knee replacement surgery:

• The recommended dose is 2.5 mg orally twice daily. (2.1)

• Treatment of DVT and PE:

• The recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily. (2.1)

Reduction in the risk of recurrent DVT and PE following initial therapy:

• The recommended dose is 2.5 mg taken orally twice daily. (2.1)

DOSAGE FORMS AND STRENGTHS

• Tablets: 2.5 mg and 5 mg (3)

CONTRAINDICATIONS

Active pathological bleeding (4)

Severe hypersensitivity to ELIQUIS (4)

WARNINGS AND PRECAUTIONS

ELIQUIS can cause serious, potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss. (5.2)

Prosthetic heart valves: ELIQUIS use not recommended. (5.4)

ADVERSE REACTIONS

Most common adverse reactions (>1%) are related to bleeding. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Strong dual inhibitors of CYP3A4 and P-gp increase blood levels of apixaban. Reduce ELIQUIS dose or avoid coadministration. (2.5, 7.1, 12.3)

Simultaneous use of strong dual inducers of CYP3A4 and P-gp reduces blood levels of apixaban: Avoid concomitant use. (7.2, 12.3)

USE IN SPECIFIC POPULATIONS

Pregnancy: Not recommended. (8.1)

Nursing Mothers: Discontinue drug or discontinue nursing. (8.3)

Severe Hepatic Impairment: Not recommended. (8.7, 12.2)

For Detailed Product Information CLICK HERE to download in PDF (1.43 MB). Or go back to TOCs and download. 

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