Mar-Midodrine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MAR-MIDODRINE is used for certain patients that have low blood pressure when standing up from a sitting or lying position.

It is used in people whose living activities are severely impaired even after lifestyle changes and other treatments are used.

What it does:

Midodrine increases blood pressure by causing blood vessels to tighten.

When it should not be used:

MAR-MIDODRINE should not be taken without first consulting your doctor if you have any of the following conditions:

• High blood pressure

• Problems with your blood vessels, including

  blockage, narrowing or spasms:

• Severe heart disease
• Kidney disease
• Urinary difficulties

• Enlarged prostate with difficulties completely

  emptying your bladder:

• Pheochromocytoma (a tumour of the adrenal

  gland that causes excess release of hormones that regulate blood pressure)

• Overactive thyroid

• Sudden visual problems, such as loss of

  peripheral vision or seeing halos around lights;

• Allergy to midodrine hydrochloride or to any of

  the nonmedicinal ingredients listed under “What the important nonmedicinal ingredients are”

What the medicinal ingredient is:

Midodrine hydrochloride

What the important nonmedicinal ingredients are:

MAR-MIDODRINE 2.5 mg and 5 mg tablets contains the following nonmedicinal ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and Pregelatinized starch.

MAR-MIDODRINE 5 mg tablets also contain the colourant FD&C Yellow #6 / Sunset Yellow FCF Aluminum Lake 10%.

What dosage forms it comes in:

MAR-MIDODRINE is available as 2.5 mg and 5 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

BEFORE you use MAR-MIDODRINE talk to your doctor or pharmacist if you:

Are taking any of the medications listed in the section entitled “Interactions With This Medication”

• Have urinary difficulties
• Have fast heart beats
• Are diabetic or have a history of visual problems, such as glaucoma
• Have kidney or liver problems

• Are pregnant or planning to become pregnant

• Are breastfeeding
• Are aged under 18 years

Effects of Ability to drive and use Machinery: It is unlikely that APO-MIDODRINE will affect your ability to drive or use machines. Be careful when driving or using machines if you feel dizzy or lightheaded.

INTERACTIONS WITH THIS MEDICATION

You should always tell your physician about all drugs you are taking or planning to take, including those obtained without a prescription.

This is not a complete list of side effects. For any unexpected effects while taking MAR-MIDODRINE, contact your doctor or pharmacist.

Drugs that may interact with MAR-MIDODRINE include:

• Digitalis glycosides (e.g. digoxin, digitoxin)

• Adrenaline-like drugs (e.g., phenylephrine,

  pseudoephedrine, ephedrine, phenylpropanolamine or dihydroergotamine), Alpha blockers (e.g., phentolamine, prazosin, doxazosin and labetalol);

• Beta-blockers (e.g., atenolol, bisoprolol,

  acebutolol, propranolol);

• Drugs that may increase your blood pressure (e.g.,

  thyroid hormones and some antidepressants, such as phenelzine and selegiline);

• Steroids that cause salt-retention (e.g.,

  fludrocortisone);

• Atropine;
• Reserpine;

PROPER USE OF THIS MEDICATION

Usual dose:

Treatment with MAR-MIDODRINE should be started under close medical supervision so that your blood pressure can be monitored carefully. The starting dose of MAR-MIDODRINE is 2.5 mg 3 times daily or as directed by your doctor. The drug should be taken during daytime hours, when you are likely to be upright most often. MAR-MIDODRINE should not be taken after the evening meal or less than 4 hours before bedtime.

Overdose:

Seek emergency medical attention if an overdose of this medication is suspected.

Symptoms of a midodrine overdose may include increased blood pressure (heart pounding or slower heartbeat, pounding sensation in your ears, headache or blurred vision), goose bumps, a feeling of being cold and difficulty urinating.

If you think you have taken too much MAR-MIDODRINE, contact your healthcare professional, hospital emergency

department of regional poison control center immediately, even if there are no symptoms.

Missed Dose:

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects of MAR-MIDODRINE are: High blood pressure experienced

when sitting; Tingling, itching or burning sensation of the skin, mainly of the scalp; Goose bumps; Chills; Urinary problems; Abnormal loss of strength; Dizziness; Pain in the upper area of the stomach; Erection of body hair; Headache; Shortness of breath; Nausea; Nervousness; Irritability; Pain; Rash

HOW TO STORE IT

Store at room temperature (15°C to 30°C).

Store away from heat and direct light. Keep out of reach and sight of children.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse

  Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs- health-

  products/medeffect-canada/adverse-reaction- reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about Mar-Midodrine:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website (https://www.canada.ca/en/health- canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website www.marcanpharma.com or by calling at: 1-855-627-2261

The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.

Marcan Pharmaceuticals Inc.

2 Gurdwara Road, Suite #112,

Ottawa, ON, K2E 1A2

Last revised: June 16, 2020