Proamatine

DRUG DESCRIPTION

Name: ProAmatine® (midodrine hydrochloride) Tablets

Dosage Form: 2.5-mg, 5-mg and 10-mg tablets for oral administration

Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg

Inactive Ingredients: Colloidal Silicone Dioxide NF, Corn Starch NF, FD&C Blue No. 2 Lake (10-mg tablets), FD&C Yellow No. 6 Lake (5-mg tablet), Magnesium Stearate NF, Microcrystalline Cellulose NF, Talc USP

Pharmacological Classification: Vasopressor/Antihypotensive

Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(?-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine

Structural formula:

ProAmatine®  (midodrine hydrochloride)   Structural Formula Illustration

Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.7

Organoleptic Properties: Odorless, white, crystalline powder

Solubility: Water:Soluble

                   Methanol: Sparingly soluble

pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution)

Melting Range: 200 to 203°C

What are the possible side effects of midodrine (ProAmatine)?

In some cases, midodrine may cause an excessive increase in blood pressure, especially when lying down. Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.

In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an...

Read All Potential Side Effects and See Pictures of Proamatine »

What are the precautions when taking midodrine hydrochloride (Proamatine)?

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...

Read All Potential Precautions of Proamatine »


Proamatine Consumer (continued)

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.


Proamatine Patient Information Including Side Effects

Brand Names: ProAmatine

Generic Name: midodrine (Pronunciation: MY doe drin)

  • What is midodrine (Proamatine)?
  • What are the possible side effects of midodrine (Proamatine)?
  • What is the most important information I should know about midodrine (Proamatine)?
  • What should I discuss with my healthcare provider before taking midodrine (Proamatine)?
  • How should I take midodrine (Proamatine)?
  • What happens if I miss a dose (Proamatine)?
  • What happens if I overdose (Proamatine)?
  • What should I avoid while taking midodrine (Proamatine)?
  • What other drugs will affect midodrine (Proamatine)?
  • Where can I get more information?

What is midodrine (Proamatine)?

Midodrine is a vasopressor. Midodrine causes constriction (tightening) of the blood vessels which leads to an increase in blood pressure.

Midodrine is used to treat low blood pressure.

Midodrine may also be used for purposes other than those listed here.

What are the possible side effects of midodrine (Proamatine)?

In some cases, midodrine may cause an excessive increase in blood pressure, especially when lying down. Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.

In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an unusual awareness of heartbeats. These may be signs of a slowed heart rate.

If you experience any of the following serious side effects, stop taking midodrine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting); or
  • irregular heartbeats, fluttering feeling in the chest, or chest pain.

Other, less serious side effects may be more likely to occur. Continue to take midodrine and talk to your doctor if you experience

  • chills or goosebumps;
  • itching or tingling of the skin;
  • increased need to urinate or difficulty with urination;
  • feeling of pressure or fullness in the head;
  • dryness of the mouth; or
  • nervousness or anxiety.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about midodrine (Proamatine)?

In some cases, midodrine may cause an excessive increase in blood pressure, especially when lying down. Contact your doctor immediately or seek emergency medical attention if you experience an unusual awareness of heartbeats, pounding in the ears, headache, or blurred vision. These may be signs of increased blood pressure.

In some cases, increased blood pressure may cause a slowed heart rate. Contact your doctor immediately or seek emergency medical attention if you experience decreased pulse rate, increased dizziness, fainting, or an unusual awareness of heartbeats. These may be signs of a slowed heart rate.

Midodrine can cause increased blood pressure when lying down. The last dose of midodrine should be taken at least 3 to 4 hours before bedtime. If you are going to be lying down for any length of time during the day, you may need to skip a dose of midodrine. Talk to your doctor about how to take midodrine if you lie down during the day.

Other prescription and over-the-counter medicines may cause an increase in blood pressure, which may be dangerous when taken with midodrine. Do not take any other prescription or over-the-counter medicines or herbal products especially cough, cold, or allergy products, weight loss products, asthma or respiratory medicines, migraine headache medicines, heart or blood pressure medicines, or antidepressants without first talking to your doctor.

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