"The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical"...
Proamatine Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication can cause your blood pressure to increase, especially when you are lying down (supine hypertension). Stop taking midodrine and contact your doctor immediately if you experience the following signs of supine hypertension: pounding heartbeat, pounding in the ears, headache, blurred vision.
Tell your doctor immediately if any of these unlikely but serious side effects occur: slow heartbeat, unusual feeling in the chest, fainting, pressure/fullness in the head, confusion, anxiety, weakness, vision problems.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Proamatine (midodrine hydrochloride) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking midodrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: high blood pressure, pheochromocytoma, thyroid disease (severe hyperthyroidism), severe difficulty urinating (due to urinary retention or an enlarged prostate).
Before using this drug, tell your doctor your entire medical history, including: heart disease, liver disease, kidney disease, diabetes.
Get up slowly to reduce dizziness when rising from a sitting or lying position. Also, limit your intake of alcoholic beverages, which will worsen this effect.
This drug may rarely make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Before having surgery, tell your doctor or dentist that you are taking this medication.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Consult your doctor for more details.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Additional Proamatine Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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