Amlodipine
Generic Name: amlodipine (am LOE di peen)
Brand Names: Norvasc
What is amlodipine?
Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.
Amlodipine is used to treat high blood pressure (hypertension) or chest pain (angina) and other conditions caused by coronary artery disease. This medication is for use in adults and children who are at least 6 years old.
Amlodipine may also be used for other purposes not listed in this medication guide.
Important information about amlodipine
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Amlodipine side effects
Get emergency medical help if you have any of these signs of an allergic reaction to amlodipine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
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feeling like you might pass out;
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swelling in your hands, ankles, or feet;
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pounding heartbeats or fluttering in your chest; or
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chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
Less serious amlodipine side effects may include:
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headache;
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dizziness, drowsiness;
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tired feeling;
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stomach pain; or
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flushing (warmth, redness, or tingly feeling).
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.
See also: Amlodipine side effects (in more detail)
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http://www.drugs.com/amlodipine.html
What side effects can this medication cause?
Amlodipine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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swelling of the hands, feet, ankles, or lower legs
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headache
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upset stomach
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stomach pain
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dizziness or lightheadedness
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drowsiness
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excessive tiredness
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flushing (feeling of warmth)
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
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more frequent or more severe chest pain
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rapid, pounding, or irregular heartbeat
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fainting
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Read More...
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000914/
Norvasc (amlodipine besylate) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010 and October 2011
October 2011
DRUG INTERACTIONS
Simvastatin
- added...... Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
February 2010
WARNINGS AND PRECAUTIONS
Hypotension
- Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension in unlikely.
Increased Angina or Myocardial Infarction
- Worsening of angina and acute myocardial infarction can develop after starting or increasing the dose of Norvasc, particularly in patients with severe obstructive coronary artery disease.
Patients With Hepatic Failure
- Because Norvasc is extensively metabolized by the liver and the plasma elimination half-life (t 1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering NORVASC to patients with severe hepatic impairment.
ADVERSE REACTIONS
Clinical Trial 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.
Postmarketing Experience
- 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.
Page Last Updated: 11/29/2011
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http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm204020.htm
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