Patients with long-term treatment of Flamaryx
Patients with long-term treatment of Flamaryx are at an increased risk. Long-term use of Flamaryx may cause severe stomach or intestinal ulcerations and
bleeding. The Flamaryx should not be used, if systemic events such as increased number of white blood cell (
eosinophilia) or rash occur if clinical symptoms of liver disease develop and if abnormal liver function tests worsen or persist.
Patients on long-term corticosteroid therapy
Discontinuation of
corticosteroids may lead to worsening of corticosteroid insufficiency. Patients should discontinue corticosteroids slowly when discontinuation of corticosteroids is necessary.
Masking of inflammation and fever
The use of Flamaryx in patients with complications of presumed painful and noninfectious conditions may reduce the utility of diagnostic sign of
fever and inflammation.
Patients with blood vessel related heart and brain disease
Patients with high blood pressure, heart failure, heart disease, narrowing of blood vessels leading to reduced blood flow to the limbs (peripheral arterial disease) and blood vessel related brain disease (cerebrovascular disease) are at an increased risk when using this medicine. Using Flamaryx in these patients may cause fluid retention and excessive fluid build up in the body. When non-steroidal anti-inflammatory drugs are used at high doses for the long term, it may increase the risk of heart attack and
stroke. Proper monitoring of blood pressure should be done while starting Flamaryx therapy in such patients. Careful consideration should also be made in patients with risk factors such as high blood pressure,
smoking, high blood sugar, or high levels of fat particles in the blood before starting long-term treatment with Flamaryx.
Serious skin reactions
Patients on Flamaryx therapy are at an increased risk. Patients using Flamaryx may experience serious skin adverse events such as life-threatening skin reaction (Stevens-Johnson
Syndrome), redness and peeling of the skin (exfoliative
dermatitis) and life-threatening drug-induced skin reaction, which can be fatal. Inform the patients about the symptoms of skin rash,
fever,
blisters, or other signs of allergic reaction such as
itching. The Flamaryx should not be used at the first occurrence of skin rash and any other sign of allergic reaction.
Kidney effects
Patients with kidney disease, using non-steroidal anti-inflammatory drugs for long-term or dehydrated patients are at increased risk. Kidney inflammation (interstitial
nephritis), swelling of the tiny filters in the kidneys (
glomerulonephritis), kidney cell damage, or excretion of too much protein in the urine (nephrotic
syndrome) may occur in patients using non-steroidal anti-inflammatory drugs. Patients with abnormal functioning of the kidney or liver, kidney failure, volume depletion, too much protein in the urine (nephrotic syndrome), inflammation of the kidney (
lupus nephropathy), heart failure, liver dysfunction, taking angiotensin-converting enzyme inhibitors,
diuretics, or angiotensin II receptor antagonists, and elderly patients are at higher risk of this reaction. Non-steroidal anti-inflammatory drug therapy should not be used in patients with kidney failure or increased levels of the kidney parameters. It is advised first to rehydrate the patients and then to initiate the therapy with # NAME#. Caution and monitoring should also be considered in patients with abnormal functioning of the kidney and kidney disease.
Pregnant women
Pregnant women are at an increased risk when using this medicine. The use of Flamaryx during early
pregnancy may increase the risk of
miscarriage, defects of the abdominal wall and heart. Using Flamaryx during the third trimester of pregnancy may increase the harmful effect of the heart (high blood pressure or premature closure of the ductus arteriosus) and kidney failure with deficiency of amniotic fluid in the fetus (
oligohydramnios). At the end of pregnancy, Flamaryx may also cause inhibition of uterine contractions in pregnant mother which can lead to delayed or prolonged labour and prolongation of
bleeding time in mother and baby. This medicine should not be used in the third trimester of pregnancy.
Life-threatening allergic reaction (anaphylactoid reactions)
Patients receiving Flamaryx therapy are at an increased risk. Patients receiving Flamaryx therapy may see an increased risk of a life-threatening allergic reaction (anaphylactoid reactions). This symptom worse typically in asthmatic patients who experience swelling of the nasal passages complicated by non-cancerous growth in the lining of the nose, fatal difficulty in breathing (bronchospasm), after taking aspirin or other
NSAIDs. Patients should take immediate medical attention if such symptoms occur. Inform the patients about the signs of a life-threatening allergic reaction such as difficulty breathing, swelling of the face or throat.
Blood-related effects
Patients receiving Flamaryx therapy are at an increased risk. Patients receiving Flamaryx therapy may experience
anemia, and this may be due to excess fluid build up in the body, stomach or intestinal blood loss, or an incomplete production of red blood cells (erythropoiesis). If signs or symptoms of anemia occur while using long-term therapy of Flamaryx, proper monitoring of blood levels (hemoglobin or hematocrit) should be done.
Patients with asthma
Patients with
asthma are at an increased risk when using this medicine. Patients with asthma may have experience aspirin-sensitive asthma. The use of aspirin and other
NSAIDs in these patients may cause a fatal difficulty in breathing (bronchospasm). Take the necessary precautions while using this medicine in asthmatic patients. The Flamaryx should not be used in patients with aspirin sensitivity.
Heart-related blood clotting problems
Patients taking Flamaryx and non-steroidal anti-inflammatory drugs therapy for more than three years are at an increased risk. These patients are at increased risk of heart and blood vessels disorders such as heart attack and
stroke, which can be possibly fatal. Patients with heart disease are at higher risk. The lowest effective dose for a short period should be used in such patients. Patients should be notified about the symptoms of heart disease events and essential measures to take if symptoms occur.
Patients with a recent history of heart bypass surgery (coronary artery bypass graft or CABG)
Patients with a recent history of heart bypass
surgery are at an increased risk when using this medicine. Such patients are at an increased risk of heart attack and
stroke when taking cyclooxygenase- 2 selective nonsteroidal anti-inflammatory drugs within the first 10 to 14 days following heart surgery. Flamaryx therapy should not be used in such patients.
Bleeding, ulcers, or rupture in the wall of the stomach and intestinal tract
Patients with a history of stomach or intestinal
bleeding,
ulcer disease, or a rupture in the wall of the digestive tract are at an increased risk. Such patients are at ten-fold greater risk for developing stomach and intestinal tract bleeding. Take necessary precautions while using Flamaryx with protective agents (proton pump inhibitors or misoprostol) in these patients. A lowest effective dose of Flamaryx for a short period should be used in such patients.
Liver effects
Patients taking Flamaryx are at increased risk. Such patients may experience
jaundice, fatal swelling of the liver, liver cell damage (liver necrosis), liver failure, and increased level of liver enzymes. Patients with abnormal liver test or with signs and symptoms of an abnormality in the functioning of the liver should be examined for more severe liver reaction while on Flamaryx therapy. Dose modification is not required in patients with an abnormality in the functioning of the liver. Take necessary precautions while using Flamaryx in such patients.
Heart failure, high blood pressure, or swelling of the skin
Patients with fluid retention, high blood pressure, cardiac failure, or swelling of the skin, taking Flamaryx, antihypertensive medicines (angiotensin-converting enzyme inhibitors, thiazides, loop
diuretics), are at increased risk. Such patients may experience an increased risk of heart disease events. Also, induction of
potassium,
sodium and water retention may occur while taking non-steroidal anti-inflammatory drugs. Precaution and monitoring should be considered in such patients. In patients with high blood pressure, close monitoring of the high blood pressure should be done while starting and during non-steroidal anti-inflammatory drugs therapy.