MELOXICAM (meloxicam)

There are 6 contraindications. Absolute contraindication.

Contraindication List
Aspirin exacerbated respiratory disease
Cerebrovascular accident
History of roux-en-Y gastric bypass
Post-operative from CABG surgery
Pregnancy
Renal transplant

There are 16 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute myocardial infarction
Alcohol use disorder
Chronic heart failure
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Gastrointestinal hemorrhage
Gastrointestinal perforation
Gastrointestinal ulcer
History of kidney donation
Increased risk of bleeding
Increased risk of bleeding due to coagulation disorder
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Nephrectomy
Systemic mastocytosis
Thrombotic disorder
Tobacco smoker

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Disease of liver
Edema
Hypertension

There are 52 severe adverse reactions.

More Frequent	Less Frequent
None.	Edema Skin rash

Rare/Very Rare

Abnormal hepatic function tests Acute eruptions of skin Acute myocardial infarction Agranulocytosis Allergic dermatitis Anaphylaxis Anemia Angina Angioedema Aphthous stomatitis Asthma Body fluid retention Bronchospastic pulmonary disease Bullous dermatitis Cerebrovascular accident Chest tightness Colitis DRESS syndrome Drug-induced hepatitis Dyspnea Erythema multiforme Exfoliative dermatitis Facial edema Gastric ulcer Gastrointestinal hemorrhage Gastrointestinal perforation Gastrointestinal ulcer Hepatic failure Hyperkalemia Hypertension Hypotension Interstitial nephritis Jaundice Leukopenia Nephrotoxicity Pancreatitis Pharyngitis Purpura Renal failure Renal papillary necrosis Stevens-johnson syndrome Tachyarrhythmia Tachycardia Thrombocytopenic disorder Toxic epidermal necrolysis Urinary retention Urticaria Vasculitis Wheezing Worsening of chronic heart failure

There are 44 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Diarrhea	Constipation Dizziness Dyspepsia Flatulence Flu-like symptoms Headache disorder Nausea Pain Upper respiratory infection Urinary tract infection

Rare/Very Rare

Acute cognitive impairment Alopecia Black tarry stools Cough Drowsy Dysgeusia Eructation Esophagitis Fatigue Fever Flushing Gastroesophageal reflux disease Hematuria Hyperhidrosis Increased urinary frequency Malaise Mood changes Nervousness Paresthesia Proteinuria Pruritus of skin Skin photosensitivity Symptoms of anxiety Syncope Tinnitus Tremor Vertigo Visual changes Vomiting Weight gain Weight loss Xerostomia

Use of NSAIAs during pregnancy at about 30 weeks of gestation or later can cause premature closure of the fetal ductus arteriosus, and use at about 20 weeks of gestation or later has been associated with fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, use of NSAIAs should be avoided in pregnant women at about 30 weeks of gestation or later; if NSAIA therapy is necessary between about 20 and 30 weeks of gestation, the lowest effective dosage and shortest possible duration of treatment should be used. Monitoring of amniotic fluid volume via ultrasound examination should be considered if the duration of NSAIA treatment exceeds 48 hours; if oligohydramnios occurs, the drug should be discontinued and follow-up instituted according to clinical practice.

Pregnant women should be advised to avoid use of NSAIAs beginning at 20 weeks' gestation unless otherwise advised by a clinician; they should be informed that NSAIAs should be avoided beginning at 30 weeks' gestation because of the risk of premature closure of the fetal ductus arteriosus and that monitoring for oligohydramnios may be necessary if NSAIA therapy is required for longer than 48 hours' duration between about 20 and 30 weeks of gestation. Known effects of NSAIAs on the human fetus during the third trimester of pregnancy include prenatal constriction of the ductus arteriosus, tricuspid incompetence, and pulmonary hypertension; nonclosure of the ductus arteriosus during the postnatal period (which may be resistant to medical management); and myocardial degenerative changes, platelet dysfunction with resultant bleeding, intracranial bleeding, renal dysfunction or renal failure, renal injury or dysgenesis potentially resulting in prolonged or permanent renal failure, oligohydramnios, GI bleeding or perforation, and increased risk of necrotizing enterocolitis. Fetal renal dysfunction resulting in oligohydramnios and, in some cases, neonatal renal impairment has been observed, on average, following days to weeks of maternal NSAIA use, although oligohydramnios has been observed infrequently as early as 48 hours after initiation of NSAIA therapy.

Oligohydramnios is often, but not always, reversible (generally within 3-6 days) following discontinuance of NSAIA therapy. Complications of prolonged oligohydramnios may include limb contracture and delayed lung maturation. A limited number of case reports have described maternal NSAIA use and neonatal renal dysfunction, in some cases irreversible, without oligohydramnios.

Some cases of neonatal renal dysfunction have required treatment with invasive procedures such as exchange transfusion or dialysis. Deaths associated with neonatal renal failure have been reported. Methodologic limitations of these postmarketing studies and case reports include lack of a control group; limited information regarding dosage, duration, and timing of drug exposure; and concomitant use of other drugs.

These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAIA use. Available data on neonatal outcomes generally involved preterm infants, and the extent to which certain reported risks can be generalized to full-term infants is uncertain. Animal data indicate that prostaglandins have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization.

In animal studies, inhibitors of prostaglandin synthesis, such as meloxicam, were associated with increased pre- and post-implantation losses. Prostaglandins also have an important role in fetal kidney development. In animal studies, inhibitors of prostaglandin synthesis impaired kidney development at clinically relevant doses.

Embryofetal deaths and an increased incidence of septal heart defects have been observed with meloxicam in animal reproduction studies. The effects of meloxicam on labor and delivery are unknown. In studies in rats, drugs that inhibit prostaglandin synthesis, including NSAIAs, increased the incidence of dystocia, delayed parturition, and decreased pup survival.

Meloxicam is distributed into milk in rats. It is not known whether meloxicam distributes into human milk, affects milk production, or affects nursing infants. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for meloxicam and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Geriatric patients receiving NSAIAs are at increased risk for serious adverse cardiovascular, GI, and renal effects. Although results from clinical studies of meloxicam revealed no overall differences in efficacy or safety of the drug between geriatric patients and younger individuals, most of the spontaneous reports of fatal adverse GI effects with NSAIAs have been in geriatric or debilitated individuals. If anticipated benefits of meloxicam outweigh the potential risks, the drug should be initiated at the low end of the dosing range and the patient should be monitored for adverse effects.