Consumer Information for: APO-MIDODRINE
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
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 non-medicinal 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 form 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
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| High blood pressure in lying position (cardiac awareness, pounding in the ears, headache, blurred vision | ✔ | ||
| Urinary problems (painful, urgent need to urinate; difficulty starting the flow of urine; urinary stream that is very weak and intermittent; difficulty to fully emptying your bladder; frequent need to urinate) | ✔ | ||
| Uncommon | |||
| Central retinal vein occlusion (blurred vision; wavy vision; tiny dark spots; sudden and complete loss of vision) | |||
| Slowing heart beat (increased dizziness/faintness, loss of consciousness) | |||
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
Store at room temperature (15°C to 30°C).
Store away from heat and direct light. Keep out of reach 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/drugshealth-products/medeffect-canada/adverse-reactionreporting.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 APOMIDODRINE:
- 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/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products); or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Date Prepared: October 16, 2018
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