IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

MIDODRINE - ORAL

(MY-doh-dreen)

COMMON BRAND NAME(S): ProAmatine

WARNING: Midodrine should only be used in carefully selected patients. When you are lying on your back, this medication causes a significant increase in blood pressure. Your blood pressure will be monitored carefully during treatment.

USES: This medication is used for certain patients who have symptoms of low blood pressure when standing. This condition is also known as orthostatic hypotension. Midodrine is used in people whose daily activities are severely affected by this condition, even after other treatments are used (e.g., support stockings). It is known as a sympathomimetic (alpha receptor agonist) that acts on the blood vessels to raise blood pressure.

HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily with at least 4 hours between doses or as directed by your doctor. Follow all your doctor's instructions carefully. This drug is taken during daytime hours, when people stand most often. This medicine should not be taken after the evening meal or less than 4 hours before bedtime. Taking your dose is not recommended if you plan to lie down for a long time afterward (e.g., taking a nap).

Dosage is based on your medical condition and response to treatment. Usually, your doctor will start you at a low dose and gradually increase your dose in order to reduce side effects. Do not increase your dose or take it more frequently than prescribed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition persists or worsens. This drug should be continued only in those people whose symptoms improve during treatment.

SIDE EFFECTS: Skin tingling, chills, "goose bumps," stomach pain, or urinary problems (strong/frequent urge to urinate, frequent urination, trouble urinating) may occur. Less common side effects include dry mouth, dizziness, drowsiness, trouble sleeping, or leg cramps. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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.

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.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: adrenaline-like drugs (e.g., ephedrine, phenylephrine, pseudoephedrine), alpha blockers (e.g., doxazosin, prazosin, terazosin), beta-blockers (e.g., atenolol, metoprolol), digoxin, ergot alkaloids (e.g., dihydroergotamine, ergotamine), drugs to control high blood pressure, psychiatric medications (especially certain antidepressants and antipsychotic drugs).

If you are also taking fludrocortisone for low blood pressure when standing, be sure to regularly monitor your blood pressure, especially when you are lying down. You will be at a greater risk for developing supine hypertension while using these 2 drugs together. (See also Side Effects section.)

Check the labels on all your medicines (such as cough-and-cold products, diet aids, NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure. Ask your pharmacist for more details.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include "goose bumps," difficulty urinating, feeling cold.

NOTES: Do not share this medication with others.

Blood pressure checks (lying, sitting, and standing) should be routinely taken. Share the results with your doctor. (See also Side Effects section.)

You may lessen high blood pressure while lying down by sleeping with the head of the bed lifted up.

Laboratory and/or medical tests (e.g., kidney function, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.