Apo-Midodrine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-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:

APO-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:

APO-MIDODRINE 2.5 mg and 5 mg tablets contains the following nonmedicinal ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and starch. APO-MIDODRINE 5 mg tablets also contain the colourant FD&C Yellow #6 Aluminum Lake 40%.

What dosage forms it comes in:

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

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Use of APO-MIDODRINE can cause a marked increase in blood pressure experienced when lying down. If you experience symptoms such as, cardiac awareness, pounding in the ears, headache, blurred vision, etc., stop taking the drug and call your doctor or pharmacist immediately.

BEFORE you use APO-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.

Drugs that may interact with APO-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 APO-MIDODRINE should be started under close medical supervision so that your blood pressure can be monitored carefully. The starting dose of APO-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. APO-MIDODRINE should not be taken after the evening meal or less than 4 hours before bedtime.

Overdose:

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.

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 APO-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

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

HOW TO STORE IT

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

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

If you think you have taken too much APO-MIDODRINE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Reporting Side Effects

MORE INFORMATION

If you want more information about APO-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 (http://www.apotex.ca/products); or by calling

  1-800-667-4708.

  Date Prepared: October 16, 2018