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VIVLODEX (meloxicam) capsules

2016-01-26 06:56:56 来源: 作者: 【大中小】浏览:339次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full prescribing information for VIVLODEX.
VIVLODEX (meloxicam) capsules, for oral use
Initial U.S. Approval: 2000
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (5.1)
VIVLODEX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. (5.2)

INDICATIONS AND USAGE

VIVLODEX is a non-steroidal anti-inflammatory drug indicated for management of osteoarthritis (OA) pain. (1)

DOSAGE AND ADMINISTRATION

Start with 5 mg orally once daily. May increase dose to 10 mg in patients who require additional analgesia (2.1)
Use the lowest effective dose for shortest duration consistent with individual patient treatment goals (2.1)
VIVLODEX capsules are not interchangeable with other formulations of oral meloxicam even if the milligram strength is the same. (2.2)

DOSAGE FORMS AND STRENGTHS

VIVLODEX (meloxicam) Capsules: 5 mg or 10 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to meloxicam or any components of the drug product (4)
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
In the setting of CABG surgery (4)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop (5.3)
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure (5.4, 7)
Heart Failure and Edema: Avoid use of VIVLODEX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure (5.5)
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of VIVLODEX in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function (5.6)
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs (5.7)
Exacerbation of Asthma Related to Aspirin Sensitivity: VIVLODEX is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity) (5.8)
Serious Skin Reactions: Discontinue VIVLODEX at first appearance of skin rash or other signs of hypersensitivity (5.9)
Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation (5.10, 8.1)
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia (5.11, 7)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥2% in controlled clinical trials of VIVLODEX 5 mg or 10 mg group) are diarrhea, nausea, abdominal discomfort. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Iroko Pharmaceuticals, LLC at 1-877-757-0676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking VIVLODEX with drugs that interfere with hemostasis. Concomitant use of VIVLODEX and analgesic doses of aspirin is not generally recommended (7)

ACE inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with VIVLODEX may diminish the antihypertensive effect of these drugs. Monitor blood pressure (7)

ACE Inhibitors and ARBs: Concomitant use with VIVLODEX in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function (7)

Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects (7)