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U.S. Brand
Names |
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Mobic® |

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Pharmacological Index |
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Nonsteroidal Anti-Inflammatory Agent (NSAID) |

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Use |
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Relief of signs and symptoms of osteoarthritis |

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Pregnancy Risk
Factor |
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C (D in third trimester) |

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Pregnancy/Breast-Feeding
Implications |
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May cause premature closure of the ductus arteriosus in the third trimester
of pregnancy. It is not known whether meloxicam is excreted in human milk. Due
to a potential for serious adverse reactions, the manufacturer recommends that a
decision be made whether to discontinue nursing or discontinue the drug, taking
into account the importance of the drug to the mother. |

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Contraindications |
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Hypersensitivity to meloxicam or any component, aspirin, or other
nonsteroidal anti-inflammatory drugs (NSAIDs). |

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Warnings/Precautions |
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Gastrointestinal irritation, ulceration, bleeding, and perforation may occur
with NSAIDs. Serious complications may occur without prior symptoms of
gastrointestinal distress. Use with caution in patients with a history of GI
disease (bleeding or ulcers), decreased renal function, hepatic disease,
congestive heart failure, dehydration, hypertension, or asthma. Use with caution
in elderly patients. Anaphylactoid reactions may occur, even with no prior
exposure to meloxicam. Use in advanced renal disease is not recommended. May
alter platelet function; use with caution in patients receiving anticoagulants
or with hemostatic disorders. Safety and efficacy in pediatric patients have not
been established. |

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Adverse
Reactions |
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1% to 10%:
Cardiovascular: Edema (2% to 5%)
Central nervous system: Headache and dizziness occurred in 2% to 8% of
patients, but occurred less frequently than placebo in controlled trials
Dermatologic: Rash (1% to 3%)
Gastrointestinal: Diarrhea (3% to 8%), dyspepsia (5%), nausea (4%),
flatulence (3%), abdominal pain (2% to 3%)
Respiratory: Upper respiratory infection (2% to 3%), pharyngitis (1% to 3%)
Miscellaneous: Flu-like symptoms (4% to 5%), falls (3%)
<2%: Allergic reaction, anaphylactic reaction, shock, fatigue, hot
flashes, malaise, syncope, weight changes, angina, cardiac failure,
hypertension, hypotension, myocardial infarction, vasculitis, seizures,
paresthesia, tremor, vertigo, colitis, xerostomia, duodenal ulcer, gastric
ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage,
hematemesis, intestinal perforation, melena, pancreatitis, duodenal perforation,
gastric perforation, ulcerative stomatitis, arrhythmia, palpitations,
tachycardia, agranulocytosis, leukopenia, purpura, thrombocytopenia, increased
ALT, increased AST, hyperbilirubinemia, increased GGT, hepatitis, jaundice,
hepatic failure, dehydration, abnormal dreams, anxiety, confusion, depression,
nervousness, somnolence, asthma, bronchospasm, dyspnea, alopecia, angioedema,
bullous eruption, erythema multiforme, photosensitivity reaction, pruritus,
Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, abnormal
vision, conjunctivitis, taste perversion, tinnitus, albuminuria, increased BUN,
increased creatinine, hematuria, interstitial nephritis, renal failure
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Overdosage/Toxicology |
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Symptoms of overdose include lethargy, drowsiness, nausea, vomiting, and
epigastric pain. Rarely, severe symptoms have been associated with NSAID
overdose including apnea, metabolic acidosis, coma, nystagmus, seizures,
leukocytosis, and renal failure. Management of nonsteroidal anti-inflammatory
(NSAID) intoxication is supportive and symptomatic. Since meloxicam undergoes
enterohepatic cycling, multiple doses of charcoal may be needed to reduce the
potential for delayed toxicities. Cholestyramine has been shown to increase
meloxicam clearance. |

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Drug
Interactions |
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Ace inhibitors: Antihypertensive effects of ACE inhibitors may be diminished
by NSAID administration.
Anticoagulants (warfarin, heparin, LHWHs) in combination with NSAIDs can
cause increased risk of bleeding.
Antiplatelet drugs (ticlopidine, clopidogrel, aspirin, abciximab,
dipyridamole, eptifibatide, tirofiban) can cause an increased risk of bleeding.
Aspirin increases serum concentrations (AUC) of meloxicam (in addition to
potential for additive adverse effects); concurrent use is not recommended.
Cholestyramine (and possibly colestipol) increases the clearance of
meloxicam.
Corticosteroids may increase the risk of GI ulceration; avoid concurrent use.
Cyclosporine: NSAIDs may increase serum creatinine, potassium, blood
pressure, and cyclosporine levels; monitor cyclosporine levels and renal
function carefully.
Hydralazine's antihypertensive effect is decreased; avoid concurrent use.
Lithium levels can be increased; avoid concurrent use if possible or monitor
lithium levels and adjust dose. When NSAID is stopped, lithium will need
adjustment again.
Loop diuretic's efficacy (diuretic and antihypertensive effect) may be
reduced by NSAIDs.
Antihypertensive effects of thiazide diuretics are decreased; avoid
concurrent use.
Warfarin INRs may be increased by meloxicam. Monitor INR closely,
particularly during initiation or change in dose. May increase risk of bleeding.
Use lowest possible dose for shortest duration possible. |

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Stability |
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Store at 25°C
(77°F) |

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Mechanism of
Action |
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Inhibits prostaglandin synthesis by decreasing the activity of the enzyme,
cyclo-oxygenase, which results in decreased formation of prostaglandin
precursors |

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Pharmacodynamics/Kinetics |
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Distribution: 10 L
Protein binding: 99.4%
Metabolism: Hepatic, including metabolism by CYP2C9 and CYP3A4 (minor)
Bioavailability: 89%
Half-life: 15-20 hours
Time to peak: 5-10 hours
Elimination: As inactive metabolites, in urine and feces (bile or enteral
secretion) |

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Usual Dosage |
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Adult: Oral: Initial: 7.5 mg once daily; some patients may receive additional
benefit from an increased dose of 15 mg once daily
Dosage adjustment in hepatic impairment: No specific adjustment is
recommended in hepatic impairment; patients with severe hepatic impairment have
not been adequately studied
Elderly: Increased concentrations may occur in elderly patients (particularly
in females); however, no specific dosage adjustment is recommended
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Dietary
Considerations |
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Should be taken with food or milk to minimize gastrointestinal
irritation |

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Monitoring
Parameters |
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CBC, periodic liver function, renal function (serum BUN, and
creatinine) |

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Patient
Information |
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If self-administered, use exactly as directed (do not increase dose or
frequency); adverse reactions can occur with overuse. Take with food or milk.
While using this medication, do not use alcohol, excessive amounts of vitamin C,
or salicylate-containing foods (curry powder, prunes, raisins, tea, or
licorice), other prescription or OTC medications containing aspirin or
salicylate, or other NSAIDs without consulting prescriber. Maintain adequate
hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You
may experience nausea, vomiting, gastric discomfort (frequent mouth care, small
frequent meals, chewing gum, sucking lozenges may help). GI bleeding,
ulceration, or perforation can occur with or without pain. Stop taking
medication and report ringing in ears; persistent cramping or pain in stomach;
unresolved nausea or vomiting; difficulty breathing or shortness of breath;
unusual bruising or bleeding (mouth, urine, stool); skin rash; unusual swelling
of extremities; chest pain; or palpitations. |

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Dosage Forms |
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Tablet: 7.5 mg |

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