
Table Of Contents
- Mobic Price Comparison Table
- Mobic Information
- Mobic Ingredients and Composition
- Mobic Structural Formula and Composition
- How To Take Mobic and Mobic Dosage and Administration
- If you suspect a Mobic Overdose
- Mobic Side Effects
- Mobic Precautions and Contraindications
- Detailed Precautions
- Mobic Drug Interactions
- Taking Mobic during Pregnancy or Breast-feeding
- Storing Mobic
- Mobic Clinical Trials and Studies
- Mobic Warnings
- Mobic Pill Identification / ID and Appearance
- Articles and information related to Mobic
- Credits for Mobic Information
Brand names: Mobic
Mobic Price Comparison Table
| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
|---|---|---|---|---|---|
| Mobic 15mg | 50 | $18.00 | $5.18ea | $259.00 | Buy from Billing-md |
| Mobic 15mg | 100 | $10.95 | $0.81ea | $80.95 | Buy from PharmaWebCanada |
| Mobic 15mg | 100 | $18.00 | $4.09ea | $409.00 | Buy from Billing-md |
| Mobic 15mg | 200 | $10.95 | $0.69ea | $137.62 | Buy from PharmaWebCanada |
| Product | Qty | Medical Fees & Shipping | Price/ Qty | Price | Click to Order |
|---|---|---|---|---|---|
| Mobic 7.5mg | 50 | $18.00 | $4.54ea | $227.00 | Buy from Billing-md |
| Mobic 7.5mg | 100 | $10.95 | $0.70ea | $69.83 | Buy from PharmaWebCanada |
| Mobic 7.5mg | 100 | $18.00 | $3.69ea | $369.00 | Buy from Billing-md |
| Mobic 7.5mg | 200 | $10.95 | $0.59ea | $118.71 | Buy from PharmaWebCanada |
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Mobic Information
Brand Name: Mobic
Generic Name: Meloxicam
Other Common Names: Movicox
Mobic (meloxicam) is used to relieve the signs and symptoms of osteoarthritis in adults.
It is a nonsteroidal anti-inflammatory drug (NSAID(Nonsteroidal Anti-Inflammatory Drugs)).
Mobic (meloxicam), an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAID(Nonsteroidal Anti-Inflammatory Drugs)s). Each yellow tablet contains meloxicam 7.5 mg for oral administration.
Mobic Ingredients and Composition
The active ingredient in Mobic is meloxicam.
The inactive ingredients in Mobic include:
- colloidal silicon dioxide
- crospovidone
- lactose monohydrate
- magnesium stearate
- microcrystalline cellulose
- povidone
- sodium citrate dihydrate
Mobic Structural Formula and Composition
Each yellow tablet contains meloxicam 7.5 mg for oral administration. It is chemically designated as 4-hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide 1, 1-dioxide. The molecular weight is 351.4. Its empirical formula is C14H13N3O4S2 and it has the structural formula illustrated to the right.
Meloxicam is a 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)app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2.
Mobic is available as a tablet for oral administration containing 7.5 mg meloxicam.
The inactive ingredients in Mobic include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.
Clinical Pharmacology: Mechanism of Action
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID(Nonsteroidal Anti-Inflammatory Drugs)) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, may be related to prostaglandin synthetase (cyclooxygenase) inhibition.
Pharmacokinetics: Absorption
The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Meloxicam capsules have been shown to be bioequivalent to Mobic tablets. Following single intravenous doses, dose-proportional pharmacokinetics were shown in the range of 5 mg to 60 mg.
After multiple oral doses the pharmacokinetics of meloxicam capsules were dose-proportional over the range of 7.5 mg to 15 mg. Mean Cmax was achieved within four to five hours after a 7.5 mg meloxicam tablet was taken under fasted conditions, indicating a prolonged drug absorption. The rate or extent of absorption was not affected by multiple dose administration, suggesting linear pharmacokinetics.
With multiple dosing, steady state conditions were reached by day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting gastrointestinal recirculation.
Food and Antacid Effects
Drug intake after a high fat breakfast (75 g of fat) did not affect extent of absorption of meloxicam capsules, but led to 22% higher Cmax values. Mean Cmax values were achieved between five and six hours. No pharmacokinetic interaction was detected with concomitant administration of antacids. Mobic tablets can be administered without regard to timing of meals and antacids.
Distribution
The mean volume of distribution (Vss) of meloxicam is approximately 10 L. Meloxicam is ~ 99.4% bound to human plasma proteins (primarily albumin) within the therapeutic dose range. The fraction of protein binding is independent of drug concentration, over the clinically relevant concentration range, but decreases to ~ 99% in patients with renal disease. Meloxicam penetration into human red blood cells, after oral dosing, is less than 10%. Following a radiolabeled dose, over 90% of the radioactivity detected in the plasma was present as unchanged meloxicam.
Meloxicam concentrations in synovial fluid, after a single oral dose, range from 40% to 50% of those in plasma. The free fraction in synovial fluid is 2.5 times higher than in plasma, due to the lower albumin content in synovial fluid as compared to plasma. The significance of this penetration is unknown.
Metabolism
Meloxicam is almost completely metabolized to four pharmacologically inactive metabolites. The major metabolite, 5'-carboxy meloxicam (60% of dose), from P-450 mediated metabolism was formed by oxidation of an intermediate metabolite 5'-hydroxymethyl meloxicam which is also excreted to a lesser extent (9% of dose). In vitro studies indicate that cytochrome P-450 2C9 plays an important role in this metabolic pathway with a minor contribution of the CYP 3A4 isozyme. Patients' peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively.
Excretion
Meloxicam excretion is predominantly in the form of metabolites, and occurs to equal extents in the urine and feces. Only traces of the unchanged parent compound are excreted in the urine (0.2%) and feces (1.6%). The extent of the urinary excretion was confirmed for unlabeled multiple 7.5 mg doses: 0.5%, 6% and 13% of the dose were found in urine in the form of meloxicam, and the 5'-hydroxymethyl and 5'-carboxy metabolites, respectively. There is significant biliary and/or enteral secretion of the drug. This was demonstrated when oral administration of cholestyramine following a single IV dose of meloxicam decreased the AUC of meloxicam by 50%.
The mean elimination half-life (t1/2) ranges from 15 hours to 20 hours. The elimination half-life is constant across dose levels indicating linear metabolism within the therapeutic dose range. Plasma clearance ranges from 7 to 9 mL/min.
Special Populations: Pediatric
The pharmacokinetics of Mobic in pediatric patients under 18 years of age have not been investigated.
Special Populations: Geriatric
Elderly males (≤ 65 years of age) exhibited meloxicam plasma concentrations and steady state pharmacokinetics similar to young males. Elderly females (≤ 65 years of age) had a 47% higher AUCss and 32% higher Cmax ss as compared to younger females (≤ 55 years of age) after body weight normalization. Despite the increased total concentrations in the elderly females, the adverse event profile was comparable for both elderly patient populations. A smaller free fraction was found in elderly female patients in comparison to elderly male patients.
Special Populations: Gender
Young females exhibited slightly lower plasma concentrations relative to young males. After single doses of 7.5 mg Mobic, the mean elimination half-life was 19.5 hours for the female group as compared to 23.4 hours for the male group. At steady state, the data were similar (17.9 hours vs. 21.4 hours). This pharmacokinetic difference due to gender is likely to be of little clinical importance. There was linearity of pharmacokinetics and no appreciable difference in the Cmax or Tmax across genders.
Special Populations: Hepatic Insufficiency
Following a single 15 mg dose of meloxicam there was no marked difference in plasma concentrations in subjects with mild (Child-Pugh Class I) and moderate (Child-Pugh Class II) hepatic impairment compared to healthy volunteers. Protein binding of meloxicam was not affected by hepatic insufficiency. No dose adjustment is necessary in mild to moderate hepatic insufficiency. Patients with severe hepatic impairment
(Child-Pugh Class III) have not been adequately studied.
Renal Insufficiency
Meloxicam pharmacokinetics have been investigated in subjects with different degrees of renal insufficiency. Total drug plasma concentrations decreased with the degree of renal impairment while free AUC values were similar. Total clearance of meloxicam increased in these patients probably due to the increase in free fraction leading to an increased metabolic clearance. There is no need for dose adjustment in patients with mild to moderate renal failure (CrCL >15 mL/min). Patients with severe renal insufficiency have not been adequately studied. The use of Mobic in subjects with severe renal impairment is not recommended (see Warnings, Advanced Renal Disease).
Hemodialysis
Following a single dose of meloxicam, the free Cmax plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Meloxicam is not dialyzable.
How To Take Mobic and Mobic Dosage and Administration
The lowest dose of Mobic should be sought for each patient. For the treatment of osteoarthritis the recommended starting and maintenance dose of Mobic is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily. The maximum recommended daily dose of Mobic is 15 mg.
Mobic may be taken without regard to timing of meals.
If you suspect a Mobic Overdose
Symptoms of overdose may include:
- nausea
- sluggishness
- severe stomach pain
- coffee ground-like vomit
- dark stool
Mobic Side Effects
Mobic side effects that may go away during treatment, include:
- nausea
- vomiting
- diarrhea
- gas
- constipation
- indigestion.
If they continue or are bothersome, check with your doctor.
Check with your doctor as soon as possible if you experience the following:
- swelling of hands or ankles
- ringing in ears
- fatigue
- itching
- yellow eyes or skin
- flu-like symptoms
Contact your doctor immediately if you experience:
- swelling of: face, lips, eyes, throat, tongue
- difficulty swallowing or breathing
- hoarseness
Contact your doctor immediately and stop taking Mobic if you notice any of these serious side effects:
- black stools
- persistent stomach/abdominal pain
- vomit that looks like coffee grounds
Rarely, serious ulcers have occurred in patients taking Mobic.
Mobic Precautions and Contraindications
Inform your doctor of any other medical conditions including asthma, nasal polyps, any allergies - especially aspirin/NSAID(Nonsteroidal Anti-Inflammatory Drugs) allergy (e.g., ibuprofen, celecoxib), pregnancy, or breast-feeding.
Do not take this drug if you ever had any unusual or allergic reaction to aspirin, ibuprofen, naproxen, or any other medicine used to treat pain, fever, swelling, or arthritis.
This drug may cause dizziness, thus you should not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.
This drug may cause increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
$2 mix alcohol with Mobic, unless you first discuss it with your doctor.Detailed Precautions
General
Mobic cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Mobic in reducing inflammation and possibly fever may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, 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 NSAID(Nonsteroidal Anti-Inflammatory Drugs)s. 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 with NSAID(Nonsteroidal Anti-Inflammatory Drugs)s. Patients with signs and/or symptoms 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.), Mobic should be discontinued.
Renal Effects
Caution should be used 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 (see WARNINGS, Advanced Renal Disease).
Long-term administration of NSAID(Nonsteroidal Anti-Inflammatory Drugs)s has resulted in renal papillary necrosis and other renal medullary changes. 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 NSAID(Nonsteroidal Anti-Inflammatory Drugs)s may cause dosedependent 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 and ACE inhibitors, and the elderly. Discontinuation of NSAID(Nonsteroidal Anti-Inflammatory Drugs) therapy is usually followed by recovery to the pretreatment state.
The extent to which metabolites may accumulate in patients with renal failure has not been studied with Mobic. Because some Mobic metabolites are excreted by the kidney, patients with significantly impaired renal function should be more closely monitored.
Hematological Effects
Anemia is sometimes seen in patients receiving NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, including Mobic. This may be due to fluid retention, GI(Gastrointestinal) blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, including Mobic, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
Drugs which inhibit the biosynthesis of prostaglandins may interfere to some extent with platelet function and vascular responses to bleeding.
NSAID(Nonsteroidal Anti-Inflammatory Drugs)s inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.
Unlike aspirin their effect on platelet function is quantitatively less, or of shorter duration, and reversible. Mobic does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT). Patients receiving Mobic who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Fluid Retention and Edema
Fluid retention and edema have been observed in some patients taking NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, including Mobic.
Therefore, as with other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, Mobic should be used with caution in patients with fluid retention, hypertension, or heart failure.
Pre-existing Asthma
Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirinsensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs 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.
Mobic Drug Interactions
Some drugs that may interact with Mobic include other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s aspirin, naproxen (brand names Aleve, Naprosyn) and ibuprofen (Advil, Motrin).
Other drugs that may interact include:
- warfarin (Coumadin)
- lithium (Lithobid)
- fluconazole (Diflucan)
- furosemide (Lasix)
- enalapril (Vasotec)
- lisinopril (Zestril)
ACE inhibitors
Reports suggest that NSAID(Nonsteroidal Anti-Inflammatory Drugs)s may diminish the antihypertensive effect of angiotensin-converting enzyme (ACE) inhibitors. This interaction should be given consideration in patients taking NSAID(Nonsteroidal Anti-Inflammatory Drugs)s concomitantly with ACE inhibitors.
Aspirin
Concomitant administration of aspirin (1000 mg TID) to healthy volunteers tended to increase the AUC (10%) and Cmax (24%) of meloxicam. The clinical significance of this interaction is not known; however, as with other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, concomitant administration of meloxicam and aspirin is not generally recommended because of the potential for increased adverse effects. Concomitant administration of low-dose aspirin with Mobic may result in an increased rate of GI(Gastrointestinal) ulceration or other complications, compared to use of Mobic alone. Mobic is not a substitute for aspirin for cardiovascular prophylaxis.
Cholestyramine
Pretreatment for four days with cholestyramine significantly increased the clearance of meloxicam by 50%. This resulted in a decrease in t1/2, from 19.2 hours to 12.5 hours, and a 35% reduction in AUC. This suggests the existence of a recirculation pathway for meloxicam in the gastrointestinal tract. The clinical relevance of this interaction has not been established.
Cimetidine
Concomitant administration of 200 mg cimetidine QID did not alter the single-dose pharmacokinetics of 30 mg meloxicam.
Digoxin
Meloxicam 15 mg once daily for 7 days did not alter the plasma concentration profile of digoxin after b-acetyldigoxin administration for 7 days at clinical doses. In vitro testing found no protein binding drug interaction between digoxin and meloxicam.
Furosemide
Clinical studies, as well as post-marketing observations, have shown that NSAID(Nonsteroidal Anti-Inflammatory Drugs)s can reduce the natriuretic effect of furosemide and thiazide diuretics in some patients. This effect has been attributed to inhibition of renal prostaglandin synthesis. Studies with furosemide agents and meloxicam have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of meloxicam. Nevertheless, during concomitant therapy with furosemide and Mobic, patients should be observed closely for signs of declining renal function (see PRECAUTIONS, Renal Effects), as well as to assure diuretic efficacy.
Lithium
In clinical trials, NSAID(Nonsteroidal Anti-Inflammatory Drugs)s have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. In a study conducted in healthy subjects, mean pre-dose lithium concentration and AUC were increased by 21% in subjects receiving lithium doses ranging from 804 to 1072 mg BID with meloxicam 15 mg QD as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by Mobic. Patients on lithium treatment should be closely monitored when Mobic is introduced or withdrawn.
Methotrexate
A study in 13 rheumatoid arthritis (RA) patients evaluated the effects of multiple doses of meloxicam on the pharmacokinetics of methotrexate taken once weekly. Meloxicam did not have a significant effect on the pharmacokinetics of single doses of methotrexate. In vitro, methotrexate did not displace meloxicam from its human serum binding sites.
Warfarin
Anticoagulant activity should be monitored, particularly in the first few days after initiating or changing Mobic therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding. The effect of meloxicam on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily doses of warfarin that produced an INR (International Normalized Ratio) between 1.2 and 1.8. In these subjects, meloxicam did not alter warfarin pharmacokinetics and the average anticoagulant effect of warfarin as determined by prothrombin time. However, one subject showed an increase in INR from 1.5 to 2.1. Caution should be used when administering Mobic with warfarin since patients on warfarin may experience changes in INR and an increased risk of bleeding complications when a new medication is introduced.
Taking Mobic during Pregnancy or Breast-feeding
Mobic has been shown to cause harm to the human fetus. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. It is unknown if this medicine is excreted in breast milk. If you are or will be breast feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
Storing Mobic
Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). Keep in a dry place.
Mobic Clinical Trials and Studies
The Mobic phase 2/3 clinical trial database includes 10,122 patients treated with Mobic 7.5 mg/day and 3,505 patients treated with Mobic 15 mg/day. Mobic at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo and/or active-controlled osteoarthritis trials. Gastrointestinal (GI(Gastrointestinal)) adverse events were the most frequently reported adverse events in all treatment groups across Mobic trials.
A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Mobic with placebo and with an active control. Table B depicts adverse events that occurred in 2% of the Mobic treatment groups.
Table B Adverse Events (%) Occurring in 2% of Mobic Patients in a 12-Week Osteoarthritis Placebo and Active-Controlled Trial
| Body System / Adverse Event | Placebo | Mobic 7.5 mg daily | Mobic 15 mg daily | Diclofenac 100 mg daily |
| No. of Patients | 157 | 154 | 156 | 153 |
| Gastrointestinal | 17.2 | 20.1 | 17.3 | 28.1 |
| Abdominal Pain | 2.5 | 1.9 | 2.6 | 1.3 |
| Diarrhea | 3.8 | 7.8 | 3.2 | 9.2 |
| Dyspepsia | 4.5 | 4.5 | 4.5 | 6.5 |
| Flatulence | 4.5 | 3.2 | 3.2 | 3.9 |
| Nausea | 3.2 | 3.9 | 3.8 | 7.2 |
| Body as a Whole | ||||
| Accident Household | 1.9 | 4.5 | 3.2 | 2.6 |
| Edema1 | 2.5 | 1.9 | 4.5 | 3.3 |
| Fall | 0.6 | 2.6 | 0.0 | 1.3 |
| Influenza-Like Symptoms | 5.1 | 4.5 | 5.8 | 2.6 |
| Central and Peripheral Nervous System | ||||
| Dizziness | 3.2 | 2.6 | 3.8 | 2.0 |
| Headache | 10.2 | 7.8 | 8.3 | 5.9 |
| Respiratory | ||||
| Pharyngitis | 1.3 | 0.6 | 3.2 | 1.3 |
| Upper Respiratory Tract Infection | 1.9 | 3.2 | 1.9 | 3.3 |
| Skin | ||||
| Rash2 | 2.5 | 2.6 | 0.6 | 2.0 |
The adverse events that occurred with Mobic in 2% of patients treated short-term (4-6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table C.
Table C Adverse Events (%) Occurring in 2% of Mobic Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials
| Body System / Adverse Event | 4-6 Weeks Controlled Trials | - | 6 Month Controlled Trials | - |
| Mobic 7.5 mg daily | Mobic 15 mg daily | Mobic 7.5 mg daily | Mobic 15 mg daily | |
| No. of Patients | 8955 | 256 | 169 | 306 |
| Gastrointestinal | 11.8 | 18.0 | 26.6 | 24.2 |
| Abdominal Pain | 2.7 | 2.3 | 4.7 | 2.9 |
| Constipation | 0.8 | 1.2 | 1.8 | 2.6 |
| Diarrhea | 1.9 | 2.7 | 5.9 | 2.6 |
| Dyspepsia | 3.8 | 7.4 | 8.9 | 9.5 |
| Flatulence | 0.5 | 0.4 | 3.0 | 2.6 |
| Nausea | 2.4 | 4.7 | 4.7 | 7.2 |
| Vomiting | 0.6 | 0.8 | 1.8 | 2.6 |
| Body as a Whole | ||||
| Edema1 | 0.6 | 2.0 | 2.4 | 1.6 |
| Pain | 0.9 | 2.0 | 3.6 | 5.2 |
| Central and Peripheral Nervous System | ||||
| Dizziness | 1.1 | 1.6 | 2.4 | 2.6 |
| Headache | 2.4 | 2.7 | 3.6 | 2.6 |
| Hematologic | ||||
| Anemia | 0.1 | 0.0 | 4.1 | 2.9 |
| Musculo-Skeletal | ||||
| Arthralgia | 0.5 | 0.0 | 5.3 | 1.3 |
| Back Pain | 0.5 | 0.4 | 3.0 | 0.7 |
| Psychiatric | ||||
| Insomnia | 0.4 | 0.0 | 3.6 | 1.6 |
| Respiratory | ||||
| Coughing | 0.2 | 0.8 | 2.4 | 1.0 |
| Upper Respiratory Tract Infection | 0.2 | 0.0 | 8.3 | 7.5 |
| Skin | ||||
| Pruritus | 0.4 | 1.2 | 2.4 | 0.0 |
| Rash2 | 0.3 | 1.2 | 3.0 | 1.3 |
| Urinary | ||||
| Micturition Frequency | 0.1 | 0.4 | 2.4 | 1.3 |
| Urinary Tract Infection | 0.3 | 0.4 | 4.7 | 6.9 |
As with other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, higher doses of Mobic (e.g., chronic daily 30 mg dose) were associated with an increased risk of serious GI(Gastrointestinal) events, therefore the daily dose of Mobic should not exceed 15 mg. The following is a list of adverse drug reactions occurring in < 2% of patients receiving Mobic in clinical trials involving approximately 15,400 patients. Adverse reactions reported only in worldwide post-marketing experience or the literature are shown in italics and are considered rare (< 0.1%).
| Body as a Whole: | allergic reaction, anaphylactoid reactions including shock, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase |
| Cardiovascular: | angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis |
| Central and Peripheral Nervous System: | convulsions, paresthesia, tremor, vertigo |
| Gastrointestinal: | colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative |
| Heart Rate and Rhythm: | arrhythmia, palpitation, tachycardia |
| Hematologic: | agranulocytosis, leukopenia, purpura, thrombocytopenia |
| Liver and Biliary System: | ALT increased, AST increased, bilirubinema, GGT increased, hepatitis, jaundice, liver failure |
| Metabolic and Nutritional: | dehydration |
| Psychiatric Disorders: | abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence |
| Respiratory: | asthma, bronchospasm, dyspnea |
| Skin and Appendages: | alopecia, angioedema, bullous eruption, erythema multiforme, photosensitivity reaction, pruritus, Stevens-Johnson syndrome, sweating increased, toxic epidermal necrolysis, urticaria |
| Special Senses: | abnormal vision, conjunctivitis, taste perversion, tinnitus |
| Urinary System: | albuminuria, BUN increased, creatinine increased, hematuria, interstitial nephritis, renal failure |
Mobic Warnings
Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation:
Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAID(Nonsteroidal Anti-Inflammatory Drugs)s). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID(Nonsteroidal Anti-Inflammatory Drugs) therapy. Therefore, physicians and patients should remain alert for ulceration and bleeding, even in the absence of previous GI(Gastrointestinal) symptoms.
Patients should be informed about the signs and/or symptoms of serious GI(Gastrointestinal) toxicity and the steps to take if they occur. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Only one in five patients who develop a serious upper GI(Gastrointestinal) adverse event on NSAID(Nonsteroidal Anti-Inflammatory Drugs) therapy is symptomatic. It has been demonstrated that upper GI(Gastrointestinal) ulcers, gross bleeding or perforation, caused by NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, appear to occur in approximately 1% of the patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue thus, increasing the likelihood of developing a serious GI(Gastrointestinal) event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAID(Nonsteroidal Anti-Inflammatory Drugs)s should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI(Gastrointestinal) 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(Gastrointestinal) event, the lowest effective dose should be used for the shortest possible duration. For high-risk patients, alternate therapies that do not involve NSAID(Nonsteroidal Anti-Inflammatory Drugs)s should be considered.
Studies have shown that patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, have a greater than 10-fold risk for developing a GI(Gastrointestinal) bleed than patients with neither of these risk factors. In addition to a past history of ulcer disease, pharmacoepidemiological studies have identified several other co-therapies or co-morbid conditions that may increase the risk for GI(Gastrointestinal) bleeding such as: treatment with oral corticosteroids, treatment with anticoagulants, longer duration of NSAID(Nonsteroidal Anti-Inflammatory Drugs) therapy, smoking, alcoholism, older age, and poor general health status.
Anaphylactoid Reactions
As with other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s, anaphylactoid reactions have occurred in patients without known prior exposure toMobic. Mobic should not be given to patients with the aspirin triad. This symptom complex typicallyoccurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe,potentially fatal bronchospasm after taking aspirin or other NSAID(Nonsteroidal Anti-Inflammatory Drugs)s (see PRECAUTIONS, Pre-existing Asthma). Emergency help should be sought in cases where an anaphylactoidreaction occurs.
Advanced Renal Disease
In cases with advanced kidney disease, treatment with Mobic is not recommended. If NSAID(Nonsteroidal Anti-Inflammatory Drugs) therapy must be initiated, close monitoring of the patient's kidney function is advisable (see Precautions, Renal Effects).
Mobic Pill Identification / ID and Appearance
Mobic is the brand name of your medicine. The tablets are pale-yellow, round uncoated tablets, marked 59D on one side with break bar, and company logo on the other.
Mobic come in packets of blisters containing 10 and 30 tablets.
Mobic is available only with a doctor's prescription.
Articles and information related to Mobic
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Credits for Mobic Information
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Mobic 15mg