Apo Methazide 15: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-METHAZIDE is recommended for maintenance therapy of patients with essential hypertension.

What it does:

APO-METHAZIDE contains a combination of 2 drugs, methyldopa and hydrochlorothiazide:

• Methyldopa reduces both lying down and standing blood pressure.
• Hydrochlorothiazide is a diuretic or “water pill” that increases urination. This lowers blood pressure.

This medicine does not cure high blood pressure. It helps to control it. Therefore, it is important to continue taking APO-METHAZIDE regularly even if you feel fine.

When it should not be used:

Do not take APO-METHAZIDE if you:

• Are allergic to methyldopa and hydrochlorothiazide, or to any non-medicinal ingredient in the formulation.
• Are allergic to any sulfonamide-derived drugs (sulfa drugs); most of them have a medicinal ingredient that ends in “-MIDE”.
• Have difficulty urinating or produce no urine.

• Are breastfeeding. APO-METHAZIDE passes into breast milk.

• Have active liver disease

What the medicinal ingredients are:

methyldopa and hydrochlorothiazide.

What the non-medicinal ingredients are:

Carnauba Wax (Powder), Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Red Ferric Oxide-Red Shade, Titanium Dioxide.

What dosage forms it comes in:

Tablet; methyldopa and hydrochlorothiazide

250 mg/15mg

250 mg/25mg

WARNINGS AND PRECAUTIONS

BEFORE you use APO-METHAZIDE talk to your doctor, nurse, or

pharmacist if you:

• Are allergic to penicillin.

  • Have diabetes, liver or kidney disease.
  • Have lupus or gout.
  • Are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
  • Are less than 18 years old.
  • Had a sympathectomy (a surgery to remove part of a nerve from your spinal cord)
  • Suffer from pheochromocytoma (a tumor of the adrenal glands)
  • Are pregnant, or plan to become pregnant,
  • Are on dialysis

Hydrochlorothiazide in APO-METHAZIDE can cause sudden eye disorders:

●Myopia: sudden nearsightedness or blurred vision. ●Glaucoma: an increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss. These eye disorders are related and can develop within hours to weeks of starting APO-METHAZIDE.

You may become sensitive to the sun while taking APO-METHAZIDE. Exposure to sunlight should be minimized until you know how you respond.

Your doctor may tell you to limit how much fluid you take. The doctor may tell you to eat a high potassium diet while you are on APO-METHAZIDE. Always follow your doctor’s instructions.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to APO-METHAZIDE. Dizziness, lightheadedness, or fainting can especially occur after the first dose and when the dose is increased.

INTERACTIONS WITH THIS MEDICATION

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with APO-METHAZIDE:

• Adrenocorticotropic hormone (ACTH) used to treat West

  Syndrome.

• Alcohol, barbiturates (sleeping pills), or narcotics (strong pain medications). They may cause low blood pressure and dizziness when you go from lying or sitting to standing up.
• Amphotericin B, an antifungal drug.
• Anticancer drugs, including cyclophosphamide and methotrexate.
• Antidepressants, in particular selective serotonin reuptake inhibitors (SSRIs), including citalopram, escitalopram, and sertraline.
• Antidiabetic drugs, including insulin and oral medicines.
• Bile acid resins used to lower cholesterol.
• Calcium or vitamin D supplements.
• Corticosteroids used to treat joint pain and swelling.
• Digoxin, a heart medication.
• Drugs that slow down or speed up bowel function, including atropine, metoclopramide, and domperidone.
• Drugs used to treat epilepsy, including carbamazepine and topiramate.
• Gout medications, including allopurinol and probenecid.
• Lithium used to treat bipolar disease.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
• Other blood pressure lowering drugs. When taken in combination with APO-METHAZIDE, they may cause excessively low blood pressure.
• Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
• Anesthetics used for surgery

PROPER USE OF THIS MEDICATION

Take APO-METHAZIDE exactly as prescribed. It is recommended to take your dose at about the same time every day.

APO-METHAZIDE can be taken with or without food. If APO-METHAZIDE causes upset stomach, take it with food or milk.

Usual Adult dose:

Patients should be individually titrated for each component separately. Usual maintenance dose is: 1 to 4 tablets twice daily.

The usual maximum recommended daily dose is 3 g of methyldopa and 100 to 200 mg of hydrochlorothiazide.

Overdose:

If you think you have taken too much APO-METHAZIDE contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you have forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects may include:

• muscle cramps, spasms, and pain, weakness, muscular fatigue, joint pain
• lethargy, drowsiness, restlessness
• dizziness, pins and needles in your fingers, headache
• constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth
• reduced libido, impotence,
• bleeding under the skin, rash, red patches on the skin
• Seeing yellow
• dryness of mouth, thirst,
• breast enlargement in both men and women

If any of these affects you severely, tell your doctor, nurse or

pharmacist.

APO-METHAZIDE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

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

HOW TO STORE IT

Store at room temperature 15-30°C (59-86°F).

Keep out of reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting DISpedia, Apotex's Drug Information Service, at: 1-800-667-4708.

This leaflet can also be found at http://www.apotex.ca/products.

Last revised: January 21, 2013