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Mobic
Overview
What is Mobic?
MOBIC (meloxicam) is a nonsteroidal
anti-inflammatory drug (NSAID). Each bottle of MOBIC oral suspension
contains 7.5 mg meloxicam per 5 mL. Meloxicam is chemically designated
as 4-hydroxy-2-methyl--(5‑methyl‑2‑thiazolyl)-2-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular
weight is 351.4. Its empirical formula is CHNOS and it has the following structural formula:
Meloxicam is a pastel
yellow solid, practically insoluble in water, with higher solubility
observed in strong acids and bases. It is very slightly soluble in
methanol. Meloxicam has an apparent partition coefficient (log P) = 0.1 in -octanol/buffer pH 7.4.
Meloxicam has pKa values of 1.1 and 4.2.
MOBIC is available as an oral suspension
containing 7.5 mg meloxicam per 5 mL.
The inactive ingredients in MOBIC oral suspension
include colloidal silicon dioxide, hydroxyethylcellulose, sorbitol,
glycerol, xylitol, monobasic sodium phosphate (dihydrate), saccharin
sodium, sodium benzoate, citric acid (monohydrate), raspberry flavor,
and purified water.
What does Mobic look like?
What are the available doses of Mobic?
MOBIC (meloxicam) Oral Suspension:
What should I talk to my health care provider before I take Mobic?
How should I use Mobic?
MOBIC is indicated for relief
of the signs and symptoms of osteoarthritis [].
Carefully consider the potential
benefits and risks of MOBIC and other treatment options before deciding
to use MOBIC. Use the lowest effective dosage for the shortest duration
consistent with individual patient treatment goals [].
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 [].
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.
What interacts with Mobic?
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What are the warnings of Mobic?
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What are the precautions of Mobic?
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What are the side effects of Mobic?
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What should I look out for while using Mobic?
MOBIC is contraindicated in
the following patients:
What might happen if I take too much Mobic?
Symptoms following acute NSAID overdosages have been typically limited
to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which
have been generally reversible with supportive care. Gastrointestinal
bleeding has occurred. Hypertension, acute renal failure, respiratory
depression, and coma have occurred, but were rare [].
Manage patients with symptomatic and supportive
care following an NSAID overdosage. There are no specific antidotes.
Consider emesis and/or activated charcoal (60 to 100 grams in adults,
1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic
cathartic in symptomatic patients seen within four hours of ingestion
or in patients with a large overdosage (5 to 10 times the recommended
dosage). Forced diuresis, alkalinization of urine, hemodialysis, or
hemoperfusion may not be useful due to high protein binding.
There is limited experience
with meloxicam overdosage. Cholestyramine is known to accelerate the
clearance of meloxicam. Accelerated removal of meloxicam by 4 g oral
doses of cholestyramine given three times a day was demonstrated in
a clinical trial. Administration of cholestyramine may be useful following
an overdosage.
For
additional information about overdosage treatment, call a poison control
center (1-800-222-1222).
How should I store and handle Mobic?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.MOBIC is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.MOBIC (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mLStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep oral suspension container tightly closed.Keep this and all medications out of the reach of children.MOBIC is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.MOBIC (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mLStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep oral suspension container tightly closed.Keep this and all medications out of the reach of children.MOBIC is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.MOBIC (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mLStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep oral suspension container tightly closed.Keep this and all medications out of the reach of children.MOBIC is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.MOBIC (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mLStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep oral suspension container tightly closed.Keep this and all medications out of the reach of children.MOBIC is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.MOBIC (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mLStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep oral suspension container tightly closed.Keep this and all medications out of the reach of children.MOBIC is available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.MOBIC (meloxicam) oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mLStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep oral suspension container tightly closed.Keep this and all medications out of the reach of children.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Meloxicam has analgesic, anti-inflammatory,
and antipyretic properties.
The mechanism of action of MOBIC, like that
of other NSAIDs, is not completely understood but involves inhibition
of cyclooxygenase (COX-1 and COX-2).
Meloxicam is a potent inhibitor of prostaglandin
synthesis . Meloxicam concentrations reached
during therapy have produced effects. Prostaglandins
sensitize afferent nerves and potentiate the action of bradykinin
in inducing pain in animal models. Prostaglandins are mediators of
inflammation. Because meloxicam is an inhibitor of prostaglandin synthesis,
its mode of action may be due to a decrease of prostaglandins in peripheral
tissues.
Non-Clinical Toxicology
MOBIC is contraindicated in the following patients:Potential Effects of Coadministration of Drugs Highly Bound to Plasma Proteins
In a study comparing prothrombin time AUC (0-120 hr) following dosing with warfarin (0.75 mg/kg) before and after 21 days of dosing with either sertraline hydrochloride (50-200 mg/day) or placebo, there was a mean increase in prothrombin time of 8% relative to baseline for sertraline hydrochloride compared to a 1% decrease for placebo (p<0.02). The normalization of prothrombin time for the sertraline hydrochloride group was delayed compared to the placebo group. The clinical significance of this change is unknown. Accordingly, prothrombin time should be carefully monitored when sertraline hydrochloride therapy is initiated or stopped.
Cimetidine
CNS Active Drugs
In a placebo-controlled trial in normal volunteers, the administration of two doses of Sertraline hydrochloride did not significantly alter steady-state lithium levels or the renal clearance of lithium.
Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of Sertraline hydrochloride therapy with appropriate adjustments to the lithium dose.
In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) co-administration to steady state was associated with a mean increase in pimozide AUC and C of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of Sertraline hydrochloride and pimozide should be contraindicated (see ).
Results of a placebo-controlled trail in normal volunteers suggest that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism. Nonetheless, at this time, it is recommended that plasma phenytoin concentrations be monitored following initiation of Sertraline Hydrochloride therapy with appropriate adjustments to the phenytoin dose, particularly in patients with multiple underlying medical conditions and/or those receiving multiple concomitant medications.
The effect of Sertraline hydrochloride on valproate levels has not been evaluated in clinical trials. In the absence of such data, it is recommended that plasma valproate levels be monitored following initiation of Sertraline hydrochloride therapy with appropriate adjustments to the valproate dose.
The risk of using sertraline hydrochloride in combination with other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of sertraline hydrochloride and such drugs is required.
There is limited controlled experience regarding the optimal timing of switching from other drugs effective in the treatment of major depressive disorder, premenstrual dysphoric disorder to sertraline hydrochloride. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents. The duration of an appropriate washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established.
Monoamine Oxidase Inhibitors
Drugs Metabolized by P450 2D6
Serotonergic Drugs:
Triptans:
Sumatriptan
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs)
Hypoglycemic Drugs
Atenolol
Digoxin
Microsomal Enzyme Induction
Drugs that Interfere with Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Sertraline hydrochloride is initiated or discontinued.
Electroconvulsive Therapy
Alcohol
Carcinogenesis
Impairment of Fertility
Pregnancy-Nonteratogenic Effects
Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 – 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including sertraline hydrochloride) in pregnancy and PPHN. Other studies do not show a significant statistical association.
Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission. Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy.
When treating a pregnant woman with sertraline hydrochloride, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis (see ).
Labor and Delivery
Nursing Mothers
Pediatric Use
The safety of Sertraline hydrochloride use in children and adolescents with OCD, ages 6-18, was evaluated in a 12-week, multicenter, placebo-controlled study with 187 outpatients, ages 6-17, and in a flexible dose, 52 week open extension study of 137 patients, ages 6-18, who had completed the initial 12week, double-blind, placebo-controlled study. Sertraline hydrochloride was administered at doses of either 25 mg/day (children, ages 6-12) or 50 mg/day (adolescents, ages 13-18) and then titrated in weekly 25 mg/day or 50 mg/day increments, respectively, to a maximum dose of 200 mg/day based upon clinical response. The mean dose for completers was 157 mg/day. In the acute 12 week pediatric study and in the 52 week study, Sertraline hydrochloride had an adverse event profile generally similar to that observed in adults.
Sertraline pharmacokinetics were evaluated in 61 pediatric patients between 6 and 17 years of age with major depressive disorder or OCD and revealed similar drug exposures to those of adults when plasma concentration was adjusted for weight (see under ).
Approximately 600 patients with major depressive disorder or OCD between 6 and 17 years of age have received Sertraline hydrochloride in clinical trials, both controlled and uncontrolled. The adverse event profile observed in these patients was generally similar to that observed in adult studies with sertraline hydrochloride (see ). As with other SSRIs, decreased appetite and weight loss have been observed in association with the use of Sertraline hydrochloride. In a pooled analysis of two 10-week, double-blind, placebo-controlled, flexible dose (50-200 mg) outpatient trials for major depressive disorder (n=373), there was a difference in weight change between sertraline and placebo of roughly 1 kilogram, for both children (ages 6-11) and adolescents (ages 12-17), in both cases representing a slight weight loss for sertraline compared to a slight gain for placebo. At baseline the mean weight for children was 39.0 kg for sertraline and 38.5 kg for placebo. At baseline the mean weight for adolescents was 61.4 kg for sertraline and 62.5 kg for placebo. There was a bigger difference between sertraline and placebo in the proportion of outliers for clinically important weight loss in children than in adolescents. For children, about 7% had a weight loss > 7% of body weight compared to none of the placebo patients; for adolescents, about 2% had a weight loss > 7% of body weight compared to about 1% of the placebo patients. A subset of these patients who completed the randomized controlled trials (sertraline n=99, placebo n=122) were continued into a 24-week, flexible-dose, open-label, extension study. A mean weight loss of approximately 0.5 kg was seen during the first eight weeks of treatment for subjects with first exposure to sertraline during the open-label extension study, similar to mean weight loss observed among sertraline treated subjects during the first eight weeks of the randomized controlled trials. The subjects continuing in the open label study began gaining weight compared to baseline by week 12 of sertraline treatment. Those subjects who completed 34 weeks of sertraline treatment (10 weeks in a placebo controlled trial + 24 weeks open label, n=68) had weight gain that was similar to that expected using data from age-adjusted peers. Regular monitoring of weight and growth is recommended if treatment of a pediatric patient with an SSRI is to be continued long term. Safety and effectiveness in pediatric patients below the age of 6 have not been established.
The risks, if any, that may be associated with Sertraline hydrochloride’s use beyond 1 year in children and adolescents with OCD or major depressive disorder have not been systematically assessed. The prescriber should be mindful that the evidence relied upon to conclude that sertraline is safe for use in children and adolescents derives from clinical studies that were 10 to 52 weeks in duration and from the extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long-term sertraline use on the growth, development, and maturation of children and adolescents. Although there is no affirmative finding to suggest that sertraline possesses a capacity to adversely affect growth, development or maturation, the absence of such findings is not compelling evidence of the absence of the potential of sertraline to have adverse effects in chronic use (see – ).
Geriatric Use
Other Adverse Events in Geriatric Patients. In 354 geriatric subjects treated with Sertraline hydrochloride in placebo-controlled trials, the overall profile of adverse events was generally similar to that shown in Tables 2 and 3. Urinary tract infection was the only adverse event not appearing in Tables 2 and 3 and reported at an incidence of at least 2% and at a rate greater than placebo in placebo-controlled trials.
SSRIS and SNRIs, including Sertraline hydrochloride, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see , ).
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, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
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, such as meloxicam, increases the risk of serious gastrointestinal (GI) events [].
Post-MI Patients
Avoid the use of MOBIC in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If MOBIC is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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