ملوکسیکام
Meloxicam (Mobic)
ملوکسیکام

نام ژنریک

Meloxicam

شکل دارویی

اشكال دارويي:


Tablet: 7.5, 15 mg

موارد مصرف

موارد و مقدار مصرف


الف) آرتريت روماتوئيد ، استئوآرتريت.


بزرگسالان: mg/day 5/7 خوراكي مصرف مي‌ شود. در صورت نياز مي‌ توان تا حداكثر دوز روزانه mg 15 افزايش داد.


ب) آرتريت روماتوئيد جوانان با درگيري يك يا چند مفصل.


كودكان 17-2 ساله: روزانه mg/kg 125/0 تا حداكثر دوز روزانه mg 5/7 مصرف مي‌ شود.


مكانيسم اثر


‌اثرات ضد درد و ضد التهاب: اثرات ملوكسيكام ممكن است مربوط به مهار آنزيم پروستاگلاندين سنتتاز (COX) باشد.

موارد منع مصرف

تداخل دارويي


ملوكسيكام ممكن است باعث كاهش اثر داروهاي ACEI در كاهش فشار خون شود .


مصرف همزمان اين دارو با آسپيرين خطر عوارض جانبي را زياد مي‌ كند.


مصرف ملوكسيكام همراه با فوروزمايد و ديورتيكهاي تيازيدي، ممكن است اثر آنها را در ترشح سديم كاهش داده و موجب احتباس آن شود.


ملوكسيكام ممكن است باعث افزايش سطح متوتركسات و ليتيم و مسموميت ناشي از آنها شود. همچنين اين دارو ممكن است باعث تشديد اثرات وارفارين و خونريزي شود. PT و INR با يد به دقت کنترل شود.


سيگار و الكل خطر تحريك و خونريزي گوارش ي را افزايش مي‌ دهند.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي


افزايش ALT، AST، بيلي روبين، BUN، Cr.


كاهش سطح Hgb و شمارش WBC و پلاكت ها .

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي


افزايش ALT، AST، بيلي روبين، BUN، Cr.


كاهش سطح Hgb و شمارش WBC و پلاكت ها .

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت به دارو، ‌بيماراني كه پس از مصرف آسپيرين يا ديگر داروهاي NSAID دچار آسم ، كهير يا واكنشهاي آلرژيك شده‌اند، كنترل درد در حين جراحي CABG، اواخر بارداري.


موارد احتياط: سابقه زخم يا خونريزي گوارشي؛ ‌بيماران مبتلا به دهيدراسيون، آنمي، بيماري كبدي يا كليوي، پر فشار خوني، ‌احتباس مايعات، ‌نارسايي قلبي و آسم؛ افراد سالمند يا ناتوان به دليل خطر خونريزي گوارشي كشنده.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: ضد التهاب غير استروئيدي.


طبقه‌بندي درماني: ضد درد، ضد التهاب.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


بيماران داراي سابقه زخم يا خونريزي گوارشي خطر بيشتري براي خونريزي در اثر مصرف داروهاي NSAID مثل ملوكسيكام دارند . فاكتورهاي خطر ديگر عبارتند از درمان با كورتيكواستروئيدها يا داروهاي ضد انعقاد، ‌درمان طولاني مدت، كشيدن سيگار، مصرف الكل، سن بالا، سطح سلامتي ضعيف.


هشدار: داروهاي NSAID ممكن است خطر وقايع ترومبوتيك ، MI يا سكته مغزي را افزايش دهند. اين خطر در مصرف طولاني تر و نيز در بيماران قلبي يا داراي فاكتورهاي خطر براي مشكلات قلبي عروقي بيشتر است .


در بيماران دهيدره، پيش از شروع درمان، آب و الكتروليت‌ها بايد جايگزين شود.


در بيماراني كه اين دارو را براي مدت‌هاي طولاني مي‌ گيرند، به‌صورت دور ه‌اي CBC و آزمايشات روتين بايد پايش شود .


بيمار بايد از نظر خونريزي آشكار و مخفي كنترل شود.


داروهاي NSAID از جمله ملوكسيكام ممكن است منجر به احتباس مايع شوند . بيماراني كه مبتلا به پر فشاري خون، ادم يا نارسايي قلبي هستند بايد به دقت پايش شوند.


اين دارو ممكن است هپاتوتوكسيك باشد. در صورت بروز شواهد سميت كبدي يا ائوزينوفيلي يا بثورات پوستي، دارو بايد قطع شود.


نكات قابل توصيه به بيمار


پيش از شروع درمان با اين دارو، بيمار بايد سابقه آلرژي به آسپيرين يا ديگر داروهاي NSAID را گزارش دهد .


در صورت بروز علائم زخم يا خونريزي گوارشي ( استفراغ خوني، وجود خون در مدفوع يا مدفوع سياه) سريعاً به پزشك اطلاع دهيد.


در صورت بروز بثورات پوستي، ‌افزايش وزن يا ادم، به پزشك اطلاع دهيد.


در صورت بروز علائم سميت كبدي (تهوع، خستگي، لتارژي، خارش، يرقان، حساسيت قسمت فوقاني و راست شكم به لمس و علائم شبه آنفلوانزا) به پزشك اطلاع دهيد.


اين دارو ممكن است باعث عود علائم آسم در افراد داراي سابقه اين بيماري شود. در اين صورت دارو بايد قطع شود.


زنان مصرف كننده اين دارو، در صورت باردار شدن يا قصد بارداري بايد پزشك خود را مطلع نمايند.


بروز اثر كامل ضد دردي اين دارو ممكن است چند روز طول بكشد.


مصرف در سالمندان: مثل همه داروهاي NSAID، بايد با احتياط مصرف شود.


مصرف در كودكان: تأثير درماني و ايمني اين دارو در كودكان زير 2 سال تأييد نشده است.


مصرف در شيردهي: ترشح دارو در شير مادر مشخص نيست و در صورت شيردهي نبايد مصرف شود.


عوارض جانبي


اعصاب مركزي: اضطراب، گيجي، افسردگي، گيجي، خستگي، تب، سردرد، ‌بي خوابي، ناخوشي، عصبانيت، ‌پارستزي، تشنج، خواب آلودگي، سنكوپ، لرزش، سرگيجه حقيقي (ورتيگو).


قلبي ـ ‌عروقي: آنژين، آريتمي، ‌نارسايي قلبي، هايپرتانسيون، هايپوتانسيون، انفاركتوس ميوكارد، طپش قلبي، تاكيكاردي.


چشم، حلق ، گوش :‌ اختلال بينايي ، ‌كونژنكتيويت، فارنژيت، وزوز گوش.


دستگاه گوارش : درد شكمي، كوليت، ‌يبوست، ‌اسهال، خشكي دهان، زخم دوازدهه، سوءهاضمه، ازوفاژيت، نفخ، زخم معده، ‌گاستريت، رفلاكس معده به مري، خونريزي، افزايش اشتها، تهوع، پانكرآتيت، ‌اختلال حس چشايي، استفراغ.


ادراري ـ تناسلي: آلبومينوري، ‌هماچوري، نارسايي كليوي، تكرر ادرار، عفونت ادراري.


خوني: آنمي، لكوپني، پورپورا، ترومبوسيتوپني، آگرانولوسيتوز.


كبدي: هايپر بيلي روبينمي، ‌هپاتيت، يرقان، نارسايي كبدي.


متابوليك:‌ دهيدراسيون، ‌افزايش يا كاهش وزن.


عضلاني ـ اسكلتي: درد مفاصل، درد پشت.


تنفسي: آسم، اسپاسم نايژه‌اي، ‌تنگي نفس، ‌سرفه، عفونت تنفسي فوقاني.


پوست: طاسي، حساسيت به نور، خارش، بثورات، تعريق، كهير، اريتم مولتي فرم، درماتيت اكسفولياتيو، سندرم استيونس ـ جانسون، نكروليز سمي اپيدرم (TEN).


ساير عوارض: واكنشهاي آلرژيك، آنژيوادم، علائم شبه آنفلوانزا، واكنشهاي آنافيلاكتوئيد شامل شوك.


مسموميت و درمان


تظاهرات باليني: لتارژي، تهوع، ‌استفراغ، درد اپيگاستر، خونريزي گوارشي.


مسموميت شديد ممكن است باعث نارسايي حاد كليوي، اختلال كبدي، تضعيف تنفسي، اغما، تشنج، كلاپس قلبي عروقي و ايست قلبي شود. واكنشهاي آنافيلاكتوئيد نيز محتمل است.


درمان: درمان علامتي و حمايتي است. طي ساعت اول مصرف دارو، ايجاد استفراغ يا شستشوي معده كمك كننده است. طي 1 تا 2 ساعت اول مصرف مي‌ توان ذغال فعال نيز تجوير نمود .


براي بيماران شديداً مسموم و داراي علائم شديد، ‌ذغال فعال را مي‌ توان مكرراً تجويز نمود. كلستيرامين نيز ممكن است مفيد باشد.


به دليل اتصال پروتئيني بالاي دارو، ‌ديورز شديد، قليايي كردن ادرار، ‌همودياليز يا هموپرفيوژن كمك كننده نيست.

Meloxicam (Mobic)

Mobic®
(meloxicam)

WARNING

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].
  • MOBIC is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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].

DRUG DESCRIPTION

Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow MOBIC tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Each bottle of MOBIC oral suspension contains 7.5 mg meloxicam per 5 mL. Meloxicam 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 following structural formula:

Mobic®(meloxicam) Structural Formula Illustration

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)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 or 15 mg meloxicam, and as an oral suspension containing 7.5 mg meloxicam per 5 mL.

The inactive ingredients in MOBIC tablets include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium citrate dihydrate.

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 are the possible side effects of meloxicam (Mobic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using meloxicam and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain,...

Read All Potential Side Effects and See Pictures of Mobic »

What are the precautions when taking meloxicam (Mobic)?

Before taking meloxicam, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly...

Read All Potential Precautions of Mobic »

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Osteoarthritis (OA)

MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies].

Rheumatoid Arthritis (RA)

MOBIC is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies].

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].

DOSAGE AND ADMINISTRATION

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].

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, Use In Specific Populations and CLINICAL PHARMACOLOGY].

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.

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 once daily.

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.

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 0.125 mg/kg
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

HOW SUPPLIED

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.

Storage And Handling

MOBIC is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M” on the other. MOBIC is also available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL.

MOBIC tablets 7.5 mg: NDC 0597-0029-01; Bottles of 100
MOBIC tablets 15 mg: NDC 0597-0030-01; Bottles of 100
MOBIC oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mL

Storage

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Keep MOBIC tablets in a dry place.

Dispense tablets in a tight container. Keep oral suspension container tightly closed.

Keep this and all medications out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Licensed from: Boehringer Ingelheim International GmbH. Revised: 3/2012

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

Adults

Osteoarthritis and Rheumatoid Arthritis

The MOBIC Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with MOBIC 7.5 mg/day, 3505 OA patients and 1351 RA 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 and 2363 of these patients were treated in ten placebo- and/or active-controlled rheumatoid arthritis trials. Gastrointestinal (GI) 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. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of MOBIC with placebo.

Table 1a depicts adverse events that occurred in ≥ 2% of the MOBIC treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥ 2% of the MOBIC treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Table 1a : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial

  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
1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

Table 1b : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials

  Placebo MOBIC 7.5 mg daily MOBIC 15 mg daily
No. of Patients 469 481 477
Gastrointestinal Disorders 14.1 18.9 16.8
  Abdominal pain NOS2 0.6 2.9 2.3
  Dyspeptic signs and symptoms1 3.8 5.8 4.0
  Nausea2 2.6 3.3 3.8
General Disorders and Administration Site Conditions
  Influenza-like illness2 2.1 2.9 2.3
  Infection and Infestations
  Upper respiratory tract infections-pathogen class unspecified1 4.1 7.0 6.5
Musculoskeletal and Connective Tissue Disorders
  Joint related signs and symptoms1 1.9 1.5 2.3
Nervous System Disorders
  Headaches NOS2 6.4 6.4 5.5
Skin and Subcutaneous Tissue Disorders
  Rash NOS2 1.7 1.0 2.1
1MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)
2MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS

The adverse events that occurred with MOBIC in ≥ 2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2.

Table 2 : Adverse Events (%) Occurring in ≥ 2% of MOBIC Patients in 4 to 6 Weeks and 6 Month Active-Controlled Osteoarthritis Trials

  4 to 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
  Accident household 0.0 0.0 0.6 2.9
  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
  Musculoskeletal
  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
1WHO preferred terms edema, edema dependent, edema peripheral, and edema legs combined
2WHO preferred terms rash, rash erythematous, and rash maculo-papular combined

Higher doses of MOBIC (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of MOBIC should not exceed 15 mg.

Pediatrics

Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to MOBIC with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with MOBIC were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven ( < 2%) patients receiving MOBIC. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving MOBIC in clinical trials involving approximately 16,200 patients.

Body as a Whole allergic reaction, 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 leukopenia, purpura, thrombocytopenia
Liver and Biliary System ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis
Metabolic and Nutritional dehydration
Psychiatric abnormal dreaming, anxiety, appetite increased, confusion, depression, nervousness, somnolence
Respiratory asthma, bronchospasm, dyspnea
Skin and Appendages alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria
Special Senses abnormal vision, conjunctivitis, taste perversion, tinnitus
Urinary System albuminuria, BUN increased, creatinine increased, hematuria, renal failure

Post Marketing Experience

The following adverse reactions have been identified during post approval use of MOBIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Read the Mobic (meloxicam) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

See also CLINICAL PHARMACOLOGY.

ACE-inhibitors

NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking MOBIC concomitantly with ACE-inhibitors.

Aspirin

When MOBIC is administered with aspirin (1000 mg three times daily) to healthy volunteers, an increase in the AUC (10%) and Cmax (24%) of meloxicam was noted. The clinical significance of this interaction is not known; however, as with other NSAIDs 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 ulceration or other complications, compared to use of MOBIC alone. MOBIC is not a substitute for aspirin for cardiovascular prophylaxis.

Diuretics

Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. However, 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 MOBIC, patients should be observed closely for signs of renal failure [see WARNINGS AND PRECAUTIONS], as well as to ensure diuretic efficacy.

Lithium

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 twice daily with meloxicam 15 mg every day as compared to subjects receiving lithium alone. These effects have been attributed to inhibition of renal prostaglandin synthesis by MOBIC. Closely monitor patients on lithium treatment for signs of lithium toxicity when MOBIC is introduced, adjusted, or withdrawn.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Therefore, NSAIDs may reduce the elimination of methotrexate, thereby enhancing the toxicity of methotrexate. Use caution when MOBIC is administered concomitantly with methotrexate [see CLINICAL PHARMACOLOGY].

Cyclosporine

MOBIC, like other NSAIDs, may affect renal prostaglandins, thereby altering the renal toxicity of certain drugs. Therefore, concomitant therapy with MOBIC may increase cyclosporine's nephrotoxicity. Use caution when MOBIC is administered concomitantly with cyclosporine.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Monitor anticoagulant activity, 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 than with the use of either drug alone. Use caution 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 [see CLINICAL PHARMACOLOGY].

Kayexalate® (sodium polystyrene sulfonate)

Cases of intestinal necrosis (possibly fatal) have been described in patients who received concomitant sorbitol and Kayexalate® (sodium polystyrene sulfonate). Due to the presence of sorbitol in MOBIC Oral Suspension, use with Kayexalate® is not recommended.

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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].

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.

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.

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].

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 and CLINICAL PHARMACOLOGY].

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.

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.

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, Use in Specific Populations, and CLINICAL PHARMACOLOGY].

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.

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]. Seek emergency help in cases where an anaphylactoid reaction occurs.

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.

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 and Patient Counseling Information].

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 corticosteroids.

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.

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 anticoagulants.

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.

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.

Patient Counseling Information

See FDA-approved Medication Guide

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

Medication Guide

Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using MOBIC.

Cardiovascular Effects

NSAIDs including MOBIC may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Effects

NSAIDs including MOBIC, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [see WARNINGS AND PRECAUTIONS].

Adverse Skin Reactions

NSAIDs including MOBIC, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible [see WARNINGS AND PRECAUTIONS].

Weight Gain and Edema

Advise patients to promptly report signs or symptoms of unexplained weight gain or edema to their physicians [see WARNINGS AND PRECAUTIONS].

Anaphylactoid Reactions

Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients seek immediate emergency help [see WARNINGS AND PRECAUTIONS].

Effects During Pregnancy

Starting at 30 weeks gestation, MOBIC should be avoided as premature closure of the ductus arteriosus in the fetus may occur [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Effects On Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including

MOBIC, may be associated with a reversible delay in ovulation For women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended [see Use in Specific Populations].

Please address medical inquiries to (800) 542-6257 or (800) 459-9906 TTY.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and up to 8.0 mg/kg/day in mice (up to 0.5- and 2.6-fold, respectively, the maximum recommended human daily dose based on body surface area comparison).

Mutagenesis

Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Impairment of Fertility

Meloxicam did not impair male and female fertility in rats at oral doses up to 9 mg/kg/day in males and 5 mg/kg/day in females (up to 5.8- and 3.2-fold greater, respectively, than the maximum recommended human daily dose based on body surface area comparison).

Use In Specific Populations

Pregnancy

Pregnancy Category C; Category D starting 30 weeks gestation

There are no adequate and well-controlled studies in pregnant women. Meloxicam crosses the placental barrier. Prior to 30 weeks gestation, use MOBIC during pregnancy only if the potential benefit justifies the potential risk to the fetus. Starting at 30 weeks gestation, avoid MOBIC and other NSAIDs, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].

Teratogenic Effects

Meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [MRHD] based on body surface area [BSA] comparison). Administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. The no effect level was 20 mg/kg/day (26-fold greater than the MRHD based on BSA conversion).

Nonteratogenic Effects

In rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the MRHD based on BSA comparison) when administered throughout organogenesis.

Labor and Delivery

The effects of MOBIC on labor and delivery of pregnant women are unknown. Oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (at least 12.5 times lower than the maximum recommended human daily dose based on body surface area comparison).

Nursing Mothers

It is not known whether this drug is excreted in human milk; however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from MOBIC, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of meloxicam in pediatric JRA patients from 2 to 17 years of age has been evaluated in three clinical trials [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, and Clinical Studies].

Geriatric Use

As with any NSAID, caution should be exercised in treating the elderly (65 years and older).

Of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in OA studies and 1113 in RA studies). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment have not been adequately studied. Since meloxicam is significantly metabolized in the liver; the use of meloxicam in these patients should be done with caution [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Renal Impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been studied. The use of MOBIC in subjects with severe renal impairment is not recommended. 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). Therefore, it is recommended that meloxicam dosage in this population not exceed 7.5 mg per day. Hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. Meloxicam is not dialyzable [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].

Females of Reproductive Potential

Data from several small studies in humans and from studies in animals indicate that NSAIDs, including MOBIC, may be associated with a reversible delay in ovulation. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended.

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered. Cholestyramine is known to accelerate the clearance of meloxicam.

Symptoms following acute NSAID overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed with symptomatic and supportive care following an NSAID overdose. Administration of activated charcoal is recommended for patients who present 1 to 2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. 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 overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

CONTRAINDICATIONS

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].

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].

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of meloxicam, like that of other NSAIDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition which is involved in the initial steps of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy.

Pharmacodynamics

Meloxicam exhibits anti-inflammatory, analgesic, and antipyretic activities.

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. 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. With multiple dosing, steady-state concentrations were reached by Day 5. A second meloxicam concentration peak occurs around 12 to 14 hours post-dose suggesting biliary recycling.

Meloxicam oral suspension doses of 7.5 mg/5 mL and 15 mg/10 mL have been found to be bioequivalent to meloxicam 7.5 mg and 15 mg capsules, respectively. Meloxicam capsules have been shown to be bioequivalent to MOBIC tablets.

Table 3 : Single Dose and Steady-State Pharmacokinetic Parameters for Oral 7.5 mg and 15 mg Meloxicam (Mean and % CV)1

Pharmacokinetic Parameters (% CV) Steady State Single Dose
Healthy male adults (Fed)2 Elderly males (Fed)2 Elderly females (Fed)2 Renal failure (Fasted) Hepatic insufficiency (Fasted)
7.5 mg3 tablets 15 mg capsules 15 mg capsules 15 mg capsules 15 mg capsules
N 18 5 8 12 12
C[μg/mL] 1.05 (20) 2.3 (59) 3.2 (24) 0.59 (36) 0.84 (29)
tmax[h] 4.9 (8) 5 (12) 6 (27) 4 (65) 10 (87)
t½[h] 20.1 (29) 21 (34) 24 (34) 18(46) 16 (29)
CL/f [mL/min] 8.8 (29) 9.9 (76) 5.1 (22) 19 (43) 11(44)
Vz/f4 [L] 14.7 (32) 15 (42) 10 (30) 26 (44) 14 (29)
1The parameter values in the table are from various studies
2not under high fat conditions
3MOBIC tablets
4VZ/f =Dose/(AUC•Kel)

Food and Antacid Effects

Administration of meloxicam capsules following a high fat breakfast (75 g of fat) resulted in mean peak drug levels (i.e., Cmax) being increased by approximately 22% while the extent of absorption (AUC) was unchanged. The time to maximum concentration (Tmax) was achieved between 5 and 6 hours. In comparison, neither the AUC nor the Cmax values for meloxicam suspension were affected following a similar high fat meal, while mean Tmax values were increased to approximately 7 hours. No pharmacokinetic interaction was detected with concomitant administration of antacids. Based on these results, MOBIC can be administered without regard to timing of meals or concomitant administration of 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 extensively metabolized in the liver. Meloxicam metabolites include 5'-carboxy meloxicam (60% of dose), from P-450 mediated metabolism 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 CYP2C9 (cytochrome P450 metabolizing enzyme) plays an important role in this metabolic pathway with a minor contribution of the CYP3A4 isozyme. Patients' peroxidase activity is probably responsible for the other two metabolites which account for 16% and 4% of the administered dose, respectively. All the four metabolites are not known to have any in vivo pharmacological activity.

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 (t½) 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

After single (0.25 mg/kg) dose administration and after achieving steady state (0.375 mg/kg/day), there was a general trend of approximately 30% lower exposure in younger patients (2 to 6 years old) as compared to the older patients (7 to 16 years old). The older patients had meloxicam exposures similar (single dose) or slightly reduced (steady state) to those in the adult patients, when using AUC values normalized to a dose of 0.25 mg/kg [see DOSAGE AND ADMINISTRATION]. The meloxicam mean (SD) elimination half-life was 15.2 (10.1) and 13.0 hours (3.0) for the 2 to 6 year old patients, and 7 to 16 year old patients, respectively.

In a covariate analysis, utilizing population pharmacokinetics body-weight, but not age, was the single predictive covariate for differences in the meloxicam apparent oral plasma clearance. The body-weight normalized apparent oral clearance values were adequate predictors of meloxicam exposure in pediatric patients.

The pharmacokinetics of MOBIC in pediatric patients under 2 years of age have not been investigated.

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.

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.

Hepatic Impairment

Following a single 15 mg dose of meloxicam there was no marked difference in plasma concentrations in patients with mild (Child-Pugh Class I) or moderate (Child-Pugh Class II) hepatic impairment compared to healthy volunteers. Protein binding of meloxicam was not affected by hepatic impairment. No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment (Child-Pugh Class III) have not been adequately studied [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Renal Impairment

Meloxicam pharmacokinetics have been investigated in subjects with mild and moderate renal impairment. Total drug plasma concentrations of meloxicam decreased and total clearance of meloxicam increased with the degree of renal impairment while free AUC values were similar in all groups. The higher meloxicam clearance in subjects with renal impairment may be due to increased fraction of unbound meloxicam which is available for hepatic metabolism and subsequent excretion. No dosage adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been adequately studied. The use of MOBIC in subjects with severe renal impairment is not recommended [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

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 [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, and Use In Specific Populations].

Drug Interactions

Aspirin: When MOBIC is administered with aspirin (1000 mg three times daily) to healthy volunteers, it tended to increase the AUC (10%) and Cmax (24%) of meloxicam. The clinical significance of this interaction is not known [see DRUG INTERACTIONS].

Cholestyramine: Pretreatment for four days with cholestyramine significantly increased the clearance of meloxicam by 50%. This resulted in a decrease in t½, 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 four times daily 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 β-acetyldigoxin administration for 7 days at clinical doses. In vitro testing found no protein binding drug interaction between digoxin and meloxicam.

Lithium: 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 twice daily with meloxicam 15 mg QD every day as compared to subjects receiving lithium alone [see DRUG INTERACTIONS].

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 [see DRUG INTERACTIONS].

Warfarin: 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 [see DRUG INTERACTIONS].

Clinical Studies

Osteoarthritis and Rheumatoid Arthritis

The use of MOBIC for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. MOBIC (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. The four primary endpoints were investigator's global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function, and stiffness). Patients on MOBIC 7.5 mg daily and MOBIC 15 mg daily showed significant improvement in each of these endpoints compared with placebo.

The use of MOBIC for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks' to 6 months' duration. In these trials, the efficacy of MOBIC, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial.

The use of MOBIC for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. MOBIC (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response. Patients receiving MOBIC 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

The use of MOBIC for the treatment of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials.

Both studies included three arms: naproxen and two doses of meloxicam. In both studies, meloxicam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day. One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/kg/day (22.5 mg maximum) of meloxicam and 15 mg/kg/day of naproxen.

The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the meloxicam dose groups.

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.

Last reviewed on RxList: 3/13/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Mobic Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

MELOXICAM - ORAL

(mel-OX-i-kam)

COMMON BRAND NAME(S): Mobic

WARNING: Nonsteroidal anti-inflammatory drugs (including meloxicam) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).

Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.)

Stop taking meloxicam and get medical help right away if you notice any of the following rare but serious side effects: bloody or black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, sudden vision changes, slurred speech.

Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

USES: Meloxicam is used to treat arthritis. It reduces pain, swelling, and stiffness of the joints. Meloxicam is known as a nonsteroidal anti-inflammatory drug (NSAID).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using meloxicam and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication by mouth, usually once daily or as directed by your doctor. If you are taking the liquid form, shake the bottle gently before each dose. Drink a full glass of water (8 ounces or 240 milliliters) with it unless your doctor tells you otherwise. Do not lie down for at least 10 minutes after you have taken this drug.

If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. The dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used, and only for the prescribed length of time. Do not take more than 15 milligrams per day because higher doses increase the chance of stomach ulcers/bleeding.

It may take up to two weeks before the full benefits of this drug take effect. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

Inform your doctor if your condition worsens.

Disclaimer

Mobic Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, dizziness, or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, fainting, fast/pounding heartbeat, persistent/severe headache, mental/mood changes, sudden/unexplained weight gain, swelling of the hands/feet, vision changes, unusual tiredness.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, seizures, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck.

This drug may rarely cause serious liver disease. If you notice any of the following rare but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Mobic (meloxicam) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking meloxicam, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), heart disease (e.g., congestive heart failure, history of heart attack), high blood pressure, stroke, swelling (fluid retention), a severe loss of body water (dehydration), blood disorders (e.g., anemia), bleeding/clotting problems, asthma, growths in the nose (nasal polyps).

This medication may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medication, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are using this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and kidney effects.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and are unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Mobic Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: cidofovir, ketorolac.

If you are currently using either of these medications listed above, tell your doctor or pharmacist before starting meloxicam.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), anti-platelet drugs (e.g., cilostazol, clopidogrel), oral bisphosphonates (e.g., alendronate), "blood thinners" (e.g., enoxaparin, heparin, warfarin), cholestyramine, corticosteroids (e.g., prednisone), desmopressin, certain drugs which decrease immune system function (e.g., cyclosporine, tacrolimus), lithium, methotrexate, pemetrexed, SSRI antidepressants (e.g., fluoxetine, sertraline, paroxetine).

If you are using the liquid form of meloxicam, tell your doctor if you are also using sodium polystyrene sulfonate.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib or ibuprofen). These drugs are similar to meloxicam and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slow/shallow breathing, extreme drowsiness, severe stomach pain, vomit that looks like coffee grounds.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood counts, kidney/liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for more information.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Mobic Patient Information Including Side Effects

Brand Names: Mobic

Generic Name: meloxicam (Pronunciation: mel OKS i kam)

What is meloxicam (Mobic)?

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Meloxicam works by reducing hormones that cause inflammation and pain in the body.

Meloxicam is used to treat pain or inflammation caused by arthritis.

Meloxicam may also be used for purposes not listed in this medication guide.

Meloxicam 15 mg-APO

round, yellow, imprinted with APO, MEL 15

Meloxicam 15 mg-MYL

round, yellow, imprinted with M 89

Meloxicam 15 mg-TEV

square, yellow, imprinted with 93, 7299

Meloxicam 7.5 mg-APO

round, yellow, imprinted with APO, MEL 7.5

Meloxicam 7.5 mg-MYL

round, yellow, imprinted with M 66

Meloxican 7.5 mg-TEV

oblong, yellow, imprinted with 93, 7234

Mobic 15 mg

oval, yellow, imprinted with M, 15

Mobic 7.5 mg

round, yellow, imprinted with M, LOGO

What are the possible side effects of meloxicam (Mobic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using meloxicam and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • upset stomach, diarrhea, bloating, gas;
  • dizziness, nervousness, headache;
  • runny or stuffy nose, sore throat; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Mobic (meloxicam) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about meloxicam (Mobic)?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use meloxicam just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking meloxicam, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Medicines similar to meloxicam are contained in many combination medicines. Check the label to see if a medicine contains an NSAID (non-steroidal anti-inflammatory drug) such as aspirin, ibuprofen, ketoprofen, or naproxen.

Side Effects Centers

Mobic Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking meloxicam (Mobic)?

Do not use meloxicam just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking meloxicam, especially in older adults.

You should not use this medication if you are allergic to meloxicam, or if you have a history of allergic reaction to aspirin or other NSAIDs.

To make sure you can safely take meloxicam, tell your doctor if you have any of these other conditions:

  • a history of heart attack, stroke, or blood clot;
  • heart disease, congestive heart failure, high blood pressure;
  • a history of stomach ulcers or bleeding;
  • liver or kidney disease,
  • a seizure disorder such as epilepsy;
  • asthma;
  • polyps in your nose; or
  • if you smoke.

FDA pregnancy category D. Taking meloxicam during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using meloxicam.

Meloxicam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

How should I take meloxicam (Mobic)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

The maximum amount of meloxicam for adults is 15 milligrams (mg) per day. Know the amount of meloxicam in the specific product you are taking.

If you use meloxicam long-term, your blood will need to be tested often. Visit your doctor regularly.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using meloxicam.

Store at room temperature, away from moisture, heat, and light.

Side Effects Centers

Mobic Patient Information including If I Miss a Dose

What happens if I miss a dose (Mobic)?

Since meloxicam is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Mobic)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, drowsiness, black or bloody stools, coughing up blood, fever, urinating less than usual or not at all, shallow breathing, fainting, seizure (convulsions), or coma.

What should I avoid while taking meloxicam (Mobic)?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking meloxicam together with other NSAIDs such as aspirin, ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), nabumetone (Relafen), or piroxicam (Feldene).

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Medicines similar to meloxicam are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain type of drug Check the label to see if a medicine contains an NSAID such as aspirin, ibuprofen, ketoprofen, or naproxen.

What other drugs will affect meloxicam (Mobic)?

Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all other medicines you use, especially:

  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • lithium (Eskalith, Lithobid);
  • a diuretic (water pill) such as furosemide (Lasix);
  • glyburide (DiaBeta, Micronase);
  • methotrexate (Rheumatrex, Trexall);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • sodium polystyrene sulfonate (Kayexalate, Kionex);
  • steroids (prednisone and others); or
  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen (Orudis), naproxen (Aleve, Naprosyn), and others.

This list is not complete and other drugs may interact with meloxicam. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about meloxicam.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.02. Revision date: 11/2/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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