To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals at 1-85, or FDA at 1-80 or if I find a lower price with another pharmacy?
This Important Safety Information does not include all the information needed to use KATERZIA safely and effectively. In general, dose selection for elderly patients should be cautious, usually starting with a lower initial dose.Ī lower initial dose may be required for patients with hepatic insufficiency. The effect of amlodipine on blood pressure in patients less than 6 years of age is not known. No adverse effects of amlodipine on the breastfed infant have been observed.Īmlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years. Limited available data from a published clinical lactation study reports that amlodipine is present in human milk. There are risks to the mother and fetus associated with poorly controlled hypertension during pregnancy. Limited data on post-marketing use of amlodipine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriages.
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See Full Prescribing Information for Additional Information (8). Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.Īmlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.īlood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.Ĭo-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Drug Interactions:Ĭo-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Other adverse experiences not dose-related but reported are fatigue, nausea, abdominal pain, and somnolence. Incidents of dose-related dizziness, flushing, and palpitation also have been observed.įor several reported adverse experiences that appear to be drug and dose related (edema, flushing, palpitations), there was a greater incidence in women than in men associated with amlodipine treatment. The most common dose-related adverse reaction to amlodipine is edema. See Full Prescribing Information for additional Adverse Reactions (6). Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of KATERZIA, particularly in patients with severe obstructive coronary artery disease.īecause KATERZIA is extensively metabolized by the liver, and the plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering KATERZIA to patients with severe hepatic impairment. Because of the gradual onset of action, acute hypotension is unlikely. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. KATERZIA is contraindicated in patients with known sensitivity to amlodipine. ADDITIONAL IMPORTANT SAFETY INFORMATION: Contraindications:
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