TREPOXICAM-7.5 — meloxicam, histidine
Physician Therapeutics LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS
Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)]. MOBIC is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4.2) and Warnings and Precautions (5.1)]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions 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 are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)].
1.1 Osteoarthritis (OA) 1.2 Rheumatoid Arthritis (RA) 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course1 INDICATIONS AND USAGE
1.1 Osteoarthritis (OA) MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA) MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)].
1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [see Clinical Studies (14.2)].
2.1 General Instructions 2.3 Rheumatoid Arthritis
2 DOSAGE AND ADMINISTRATION
2.1 General Instructions Carefully
consider the potential benefits and risks of MOBIC and other treatment
options before deciding to use MOBIC. Use the lowest effective dose for
the shortest duration consistent with individual patient treatment
goals [see Warnings and Precautions (5.4)]. After observing the response to initial therapy with MOBIC, adjust the dose to suit an individual patient’s needs. In
adults, the maximum recommended daily oral dose of MOBIC is 15 mg
regardless of formulation. In patients with hemodialysis, a maximum
daily dosage of 7.5 mg is recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.7), and Clinical Pharmacology
( 12.3)]. MOBIC oral suspension 7.5 mg/5 mL or 15 mg/10 mL may be substituted for MOBIC tablets 7.5 mg or 15 mg, respectively. Shake the oral suspension gently before using. MOBIC may be taken without regard to timing of meals.
2.2 Osteoarthritis For
the relief of the signs and symptoms of osteoarthritis the recommended
starting and maintenance oral dose of MOBIC is 7.5 mg once daily. Some
patients may receive additional benefit by increasing the dose to 15 mg
2.3 Rheumatoid Arthritis For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of MOBIC is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.
2.4 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course To improve dosing accuracy in smaller weight children, the use of the MOBIC oral suspension is recommended. MOBIC oral suspension is available in the strength of 7.5 mg/5 mL. For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of MOBIC is 0.125 mg/kg once daily up to a maximum of 7.5 mg. There was no additional benefit demonstrated by increasing the dose above 0.125 mg/kg once daily in these clinical trials. Juvenile Rheumatoid Arthritis dosing using the oral suspension should be individualized based on the weight of the child:
|Weight||Dose (1.5 mg/mL)||Delivered dose|
|12 kg (26 lb)||1.0 mL||1.5 mg|
|24 kg (54 lb)||2.0 mL||3.0 mg|
|36 kg (80 lb)||3.0 mL||4.5 mg|
|48 kg (106 lb||4.0 mL||6.0 mg|
|≥60 kg (132 lb)||5.0 mL||7.5 mg|
3 DOSAGE FORMS AND STRENGTHS3 DOSAGE FORMS AND STRENGTHS Tablets: 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg. Impressed with the Boehringer Ingelheim logo on one side and the letter “M” on the other. 15 mg: pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. Impressed with the tablet code “15” on one side and the letter “M” on the other. Oral Suspension: yellowish green tinged viscous suspension containing 7.5 mg meloxicam in 5 mL.
4.1 Allergic Reactions 4.2 Coronary Surgery4 CONTRAINDICATIONS
4.1 Allergic Reactions MOBIC is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. MOBIC should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7, 5.13)].
4.2 Coronary Surgery MOBIC is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)].
5.1 Cardiovascular Thrombotic Events 5.2 Gastrointestinal (GI) Effects — Risk of GI Ulceration, Bleeding, and Perforation 5.3 Hepatic Effects 5.4 Hypertension 5.5 Congestive Heart Failure and Edema 5.6 Renal Effects 5.7 Anaphylactoid Reactions 5.8 Adverse Skin Reactions 5.9 Pregnancy 5.12 Hematological Effects 5.13 Use in Patients with Pre-existing Asthma
5 WARNINGS AND PRECAUTIONS
5.1 Cardiovascular Thrombotic Events Clinical
trials of several COX-2 selective and nonselective NSAIDs of up to
three years’ duration have shown an increased risk of serious
cardiovascular (CV) thrombotic events, myocardial infarction, and
stroke, which can be fatal. All NSAIDs, both COX-2 selective and
nonselective, may have a similar risk. Patients with known CV disease
or risk factors for CV disease may be at greater risk. To minimize the
potential risk for an adverse CV event in patients treated with an
NSAID, the lowest effective dose should be used for the shortest
duration possible. Physicians and patients should remain alert for the
development of such events, even in the absence of previous CV
symptoms. Patients should be informed about the signs and/or symptoms
of serious CV events and the steps to take if they occur. Two
large, controlled, clinical trials of a COX-2 selective NSAID for the
treatment of pain in the first 10 to 14 days following CABG surgery
found an increased incidence of myocardial infarction and stroke [see
Contraindications (4.2)]. There is no consistent evidence that
concurrent use of aspirin mitigates the increased risk of serious CV
thrombotic events associated with NSAID use. The concurrent use of
aspirin and an NSAID does increase the risk of serious GI events [see
Warnings and Precautions (5.2)].
5.2 Gastrointestinal (GI) Effects — Risk of GI Ulceration, Bleeding, and Perforation NSAIDs,
including MOBIC, can cause serious gastrointestinal (GI) adverse events
including inflammation, bleeding, ulceration, and perforation of the
stomach, small intestine, or large intestine, which can be fatal. These
serious adverse events can occur at any time, with or without warning
symptoms, in patients treated with NSAIDs. Only one in five patients
who develop a serious upper GI adverse event on NSAID therapy is
symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by
NSAIDs, occur in approximately 1% of patients treated for 3 to 6
months, and in about 2% to 4% of patients treated for one year. These
trends continue with longer duration of use, increasing the likelihood
of developing a serious GI event at some time during the course of
therapy. However, even short-term therapy is not without risk. Prescribe
NSAIDs, including MOBIC, with extreme caution in those with a prior
history of ulcer disease or gastrointestinal bleeding. Patients with a
prior history of peptic ulcer disease and/or gastrointestinal bleeding
who use NSAIDs have a greater than 10-fold increased risk for
developing a GI bleed compared to patients with neither of these risk
factors. Other factors that increase the risk for GI bleeding in
patients treated with NSAIDs include concomitant use of oral
corticosteroids or anticoagulants, longer duration of NSAID therapy,
smoking, use of alcohol, older age, and poor general health status.
Most spontaneous reports of fatal GI events are in elderly or
debilitated patients and therefore, special care should be taken in
treating this population. To minimize the potential risk for an
adverse GI event in patients treated with an NSAID, use the lowest
effective dose for the shortest possible duration. Patients and
physicians should remain alert for signs and symptoms of GI ulceration
and bleeding during MOBIC therapy and promptly initiate additional
evaluation and treatment if a serious GI adverse event is suspected.
This should include discontinuation of MOBIC until a serious GI adverse
event is ruled out. For high-risk patients, consider alternate
therapies that do not involve NSAIDs.
5.3 Hepatic Effects Borderline
elevations of one or more liver tests may occur in up to 15% of
patients taking NSAIDs including MOBIC. These laboratory abnormalities
may progress, may remain unchanged, or may be transient with continuing
therapy. Notable elevations of ALT or AST (approximately three or more
times the upper limit of normal) have been reported in approximately 1%
of patients in clinical trials with NSAIDs. In addition, rare cases of
severe hepatic reactions, including jaundice and fatal fulminant
hepatitis, liver necrosis and hepatic failure, some of them with fatal
outcomes have been reported [see Adverse Reactions (6.1)]. A
patient with symptoms and/or signs suggesting liver dysfunction, or in
whom an abnormal liver test has occurred, should be evaluated for
evidence of the development of a more severe hepatic reaction while on
therapy with MOBIC. If clinical signs and symptoms consistent with
liver disease develop, or if systemic manifestations occur (e.g.,
eosinophilia, rash, etc.), discontinue MOBIC [see Use in Specific
Populations (8.6) and Clinical Pharmacology (12.3)].
5.4 Hypertension NSAIDs,
including MOBIC, can lead to onset of new hypertension or worsening of
pre-existing hypertension, either of which may contribute to the
increased incidence of CV events. NSAIDs, including MOBIC, should be
used with caution in patients with hypertension. Blood pressure (BP)
should be monitored closely during the initiation of NSAID treatment
and throughout the course of therapy. Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs.
5.5 Congestive Heart Failure and Edema Fluid
retention and edema have been observed in some patients taking NSAIDs.
Use MOBIC with caution in patients with fluid retention, hypertension,
or heart failure.
5.6 Renal Effects Long-term
administration of NSAIDs, including MOBIC, can result in renal
papillary necrosis, renal insufficiency, acute renal failure, and other
renal injury. Renal toxicity has also been seen in patients in whom
renal prostaglandins have a compensatory role in the maintenance of
renal perfusion. In these patients, administration of a nonsteroidal
anti-inflammatory drug may cause a dose-dependent reduction in
prostaglandin formation and, secondarily, in renal blood flow, which
may precipitate overt renal decompensation. Patients at greatest risk
of this reaction are those with impaired renal function, heart failure,
liver dysfunction, those taking diuretics, ACE-inhibitors, and
angiotensin II receptor antagonists, and the elderly. Discontinuation
of NSAID therapy is usually followed by recovery to the pretreatment
state. A pharmacokinetic study in patients with mild and
moderate renal impairment revealed that no dosage adjustments in these
patient populations are required. Patients with severe renal impairment
have not been studied. The use of MOBIC in patients with severe renal
impairment with CrCl less than 20 mL/min is not recommended. A study
performed in patients on hemodialysis revealed that although overall
Cmax was diminished in this population, the proportion of free drug not
bound to plasma was increased. Therefore it is recommended that
meloxicam dosage in this population not exceed 7.5 mg per day. Closely
monitor the renal function of patients with impaired renal function who
are taking MOBIC [see Dosage and Administration (2.1), Use in Specific
Populations (8.7), and Clinical Pharmacology (12.3)]. Use
caution when initiating treatment with MOBIC in patients with
considerable dehydration. It is advisable to rehydrate patients first
and then start therapy with MOBIC. Caution is also recommended in
patients with pre-existing kidney disease. The extent to which
metabolites may accumulate in patients with renal impairment has not
been studied with MOBIC. Because some MOBIC metabolites are excreted by
the kidney, monitor patients with significant renal impairment closely.
5.7 Anaphylactoid Reactions As
with other NSAIDs, anaphylactoid reactions have occurred in patients
without known prior exposure to MOBIC. MOBIC should not be given to
patients with the aspirin triad. This symptom complex typically occurs
in asthmatic patients who experience rhinitis with or without nasal
polyps, or who exhibit severe, potentially fatal bronchospasm after
taking aspirin or other NSAIDs [see Contraindications (4.1) and
Warnings and Precautions (5.12)]. Seek emergency help in cases where an
anaphylactoid reaction occurs.
5.8 Adverse Skin Reactions NSAIDs,
including MOBIC, can cause serious skin adverse events such as
exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic
epidermal necrolysis (TEN), which can be fatal. These serious events
may occur without warning. Inform patients about the signs and symptoms
of serious skin manifestations and discontinue use of the drug at the
first appearance of skin rash or any other sign of hypersensitivity.
5.9 Pregnancy Starting
at 30 weeks gestation, avoid the use of MOBIC because it may cause
premature closure of the ductus arteriosus [see Use in Specific
Populations (8.1) and Patient Counseling Information (17.8)].
5.10 Corticosteroid Treatment MOBIC
cannot be expected to substitute for corticosteroids or to treat
corticosteroid insufficiency. Abrupt discontinuation of corticosteroids
may lead to disease exacerbation. Slowly taper patients on prolonged
corticosteroid therapy if a decision is made to discontinue
5.11 Masking of Inflammation and Fever The
pharmacological activity of MOBIC in reducing fever and inflammation
may diminish the utility of these diagnostic signs in detecting
complications of presumed noninfectious, painful conditions.
5.12 Hematological Effects Anemia
may occur in patients receiving NSAIDs, including MOBIC. This may be
due to fluid retention, occult or gross GI blood loss, or an
incompletely described effect upon erythropoiesis. Patients on
long-term treatment with NSAIDs, including MOBIC, should have their
hemoglobin or hematocrit checked if they exhibit any signs or symptoms
of anemia. NSAIDs inhibit platelet aggregation and have been
shown to prolong bleeding time in some patients. Unlike aspirin, their
effect on platelet function is quantitatively less, of shorter
duration, and reversible. Carefully monitor patients treated with MOBIC
who may be adversely affected by alterations in platelet function, such
as those with coagulation disorders or patients receiving
5.13 Use in Patients with Pre-existing Asthma Patients
with asthma may have aspirin-sensitive asthma. The use of aspirin in
patients with aspirin-sensitive asthma has been associated with severe
bronchospasm, which can be fatal. Since cross reactivity, including
bronchospasm, between aspirin and other NSAIDs has been reported in
such aspirin-sensitive patients, MOBIC should not be administered to
patients with this form of aspirin sensitivity and should be used with
caution in patients with pre-existing asthma.
5.14 Monitoring Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, MOBIC should be discontinued.
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