Qmiiz-ODT

What Is QMIIZ ODT?

QMIIZ ODT (meloxicam) is a nonsteroidal anti-inflammatory drug indicated for osteoarthritis (OA) in adults, rheumatoid arthritis (RA) in adults, and juvenile rheumatoid arthritis (JRA) pauciarticular and polyarticular course, in pediatric patients who weigh greater than or equal to 60 kg.

What Are Side Effects of QMIIZ ODT?

Common side effects of QMIIZ ODT include:

• diarrhea,
• upper respiratory tract infections,
• indigestion/heartburn,
• flu-like symptoms,
• headache,
• gas,
• nausea,
• dizziness,
• abdominal pain,
• swelling,
• sore throat, and
• skin rash

Dosage for QMIIZ ODT

The starting dose of QMIIZ ODT to treat OA or RA is 7.5 mg once daily. The dose may be increased to 15 mg once daily. The starting dose of QMIIZ ODT to treat JRA is 7.5 mg once daily in children greater than or equal to 60 kg.

What Drugs, Substances, or Supplements Interact with QMIIZ ODT?

QMIIZ ODT may interact with anticoagulants, aspirin, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, diuretics, lithium, methotrexate, other NSAIDs or salicylates, pemetrexed, amiodarone, fluconazole, and sulphaphenazole. Tell your doctor all medications and supplements you use.

QMIIZ ODT During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using QMIIZ ODT; use of NSAIDs such as QMIIZ ODT during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Pregnant women should avoid use of QMIIZ ODT starting at 30 weeks gestation. It is unknown if QMIIZ ODT passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our QMIIZ ODT (meloxicam) Orally Disintegrating Tablet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Qmiiz-ODT Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using meloxicam and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed, cold hands and feet; or
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• stomach pain, nausea, vomiting, heartburn;
• diarrhea, constipation, gas;
• dizziness; or
• cold symptoms, flu symptoms.

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 entire detailed patient monograph for Qmiiz-ODT (Meloxicam Orally Disintegrating Tablets)

 

Qmiiz-ODT Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration, and Perforation [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
• Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

A total of 100 subjects entered four studies with QMIIZ ODT; 36 subjects entered two separate pilot bioavailability studies (BA); 32 subjects entered a bioequivalence (BE) study, and 32 subjects entered a food-effect study. The adverse reactions from the BA, BE, and food-effect studies are summarized in Table 1.

Ten (10) adverse reactions were reported after receiving QMIIZ ODT and ten (10) adverse reactions were reported after receiving meloxicam tablets.

Table 1 : Adverse Reactions in BA, BE, and Food-Effect Study in ≥ 2% of Subjects

Adverse Reaction	QMIIZ ODT N1(%)2	Meloxicam N1(%)2
Alanine aminotransferase increased	0 (0.0)	2 (2.0)
Blood pressure decreased	2 (2.0)	3 (3.0)
Headache	2 (2.0)	1 (1.0)
1N = number of subjects that reported adverse reactions 2N = % of subjects that reported adverse reactions

The most frequently reported adverse reactions associated with QMIIZ ODT were: blood pressure decreased (2 subjects, 2.0%) and headache (2 subjects, 2.0%). The most frequently reported adverse reactions associated with meloxicam tablets were: blood pressure decreased (3 subjects, 3.0%) and alanine aminotransferase increased (2 subjects, 2.0%).

Adults

Osteoarthritis And Rheumatoid Arthritis

The meloxicam Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with meloxicam 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with meloxicam 15 mg/day. Meloxicam 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 meloxicam 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 meloxicam 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 meloxicam with placebo.

• Table 2 depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.
• Table 3 depicts adverse events that occurred in ≥2% of the meloxicam treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

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

	Placebo	Meloxicam 7.5 mg daily	Meloxicam 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	1.6	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 3 : Adverse Events (%) Occurring in ≥ 2% of Meloxicam Patients in two 12-Week Rheumatoid Arthritis Placebo-Controlled Trials

	Placebo	Meloxicam 7.5 mg daily	Meloxicam 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
Nausea	2.6	3.3	3.8
General Disorders and Administrative 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
1 MedDRA high level term, (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogens unspecified (laryngitis NOS, sinusitis NOS) joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion joint swelling), 2 MedDRA preferred terms: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS

The adverse events that occurred with meloxicam 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 4.

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

	4 to 6 Weeks Controlled Trials		6 Month Controlled Trials
	Meloxicam 7.5 mg daily	Meloxicam 15 mg daily	Meloxicam 7.5 mg daily	Meloxicam 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 meloxicam (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of QMIIZ ODT 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 meloxicam 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 meloxicam 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 meloxicam. 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 meloxicam 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, gamma-glutamyl transferase (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, blood urea nitrogen (BUN) increased, creatinine increased, hematuria, renal failure

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of meloxicam. 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; toxic epidermal necrolysis, and infertility female.

DRUG INTERACTIONS

See Table 5 for clinically significant drug interactions with meloxicam [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Table 5 : Clinically Significant Drug Interactions with Meloxicam

Drugs that Interfere with Hemostasis
Clinical Impact:	Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention:	Monitor patients with concomitant use of QMIIZ ODT with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].
Aspirin
Clinical Impact:	Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervention:	Concomitant use of QMIIZ ODT and low dose aspirin or analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. QMIIZ ODT is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, or Beta-Blockers
Clinical Impact:	NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:	During concomitant use of QMIIZ ODT and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of QMIIZ ODT and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS]. When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact:	Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID 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.
Intervention:	During concomitant use of QMIIZ ODT with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Lithium
Clinical Impact:	NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis [see CLINICAL PHARMACOLOGY].
Intervention:	During concomitant use of QMIIZ ODT and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact:	Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:	During concomitant use of QMIIZ ODT and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact:	Concomitant use of QMIIZ ODT and cyclosporine may increase cyclosporine's nephrotoxicity.
Intervention:	During concomitant use of QMIIZ ODT and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact:	Concomitant use of meloxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].
Intervention:	The concomitant use of meloxicam with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact:	Concomitant use of QMIIZ ODT and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention:	During concomitant use of QMIIZ ODT and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. Patients taking meloxicam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. In patients with creatinine clearance below 45 mL/min, the concomitant administration of meloxicam with pemetrexed is not recommended.
CYP2C9 inhibitors
Clinical Impact:	In vitro studies indicate that CYP2C9 (cytochrome P450 metabolizing enzyme) plays an important role in the metabolic pathway for meloxicam with a minor contribution of the CYP3A4 isozyme. Thus, concomitant usage of CYP2C9 inhibitors (such as amiodarone, fluconazole, and sulphaphenazole) may lead to abnormally high plasma levels of meloxicam due to reduced metabolic clearance [see Use In Specific Populations; CLINICAL PHARMACOLOGY].
Intervention:	Consider dose reduction in patients undergoing treatment with CYP2C9 inhibitors, and monitor patients for adverse effects.

Read the entire FDA prescribing information for Qmiiz-ODT (Meloxicam Orally Disintegrating Tablets)