Mint-Furosemide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MINT-FUROSEMIDE has been prescribed to you by your health provider to treat your edema (water retention) or hypertension (high blood pressure).

What it does:

MINT-FUROSEMIDE belongs to a group of medicines known as diuretic drugs which improve the elimination of water and salts (electrolytes) in the urine.

When it should not be used:

Do not use MINT-FUROSEMIDE if you are allergic to it or to any of the components of its formulation (for list of components see the section on “What the nonmedicinal ingredients are”), or to any sulfonamide-derived drugs. Ask your physician or pharmacist if you are not sure what sulfonamide- derived drugs are.

Do not use MINT-FUROSEMIDE if:

• You are suffering kidney failure, hepatic

  (liver) coma or precoma disease

• You have electrolyte depletion (loss of blood salts e.g. dehydration, hot weather, excessive sweating…) or severe hyponatremia (low blood sodium), hypokalemia (low blood potassium), hypovolemia (low blood volume), hypotension (low blood pressure) or dehydration until your electrolytes and fluid balance are restored.
• Your newborn infant has jaundice (yellowing of the skin and/or eyes) or infants suffering from certain diseases (e.g. Rh incompatibility, familial non-hemolytic jaundice (yellowing of the skin and/or eyes without evidence of liver damage))

• Do not breastfeed if you intend to use MINT-FUROSEMIDE.

What the medicinal ingredient is:

Furosemide

What the nonmedicinal ingredients are:

20 mg tablets: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium starch glycolate.

40 mg tablets: corn starch, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium starch glycolate.

80 mg tablets: Color D&C Yellow No. 10, corn starch, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium starch glycolate.

What dosage forms it comes in:

Tablets of 20 mg, 40 mg and 80 mg.

WARNINGS AND PRECAUTIONS

MINT-FUROSEMIDE IS A VERY STRONG WATER PILL WHICH IF GIVEN IN EXCESSIVE AMOUNTS CAN LEAD TO A PROFOUND WATER AND ELECTROLYTE LOSS FROM THE BODY. THEREFORE, CAREFUL MEDICAL SUPERVISION IS REQUIRED. THE DOSE AND DOSE SCHEDULE HAVE TO BE ADJUSTED TO THE INDIVIDUAL PATIENT’S NEEDS.

BEFORE you use MINT-FUROSEMIDE talk to your health provider if:

• You have decreased blood pressure
• You have liver disease or disorder
• You have kidney disease or disorder
• It is suspected you might be diabetic (high blood sugar)
• You have decreased ability to pass urine
• You had an organ transplant
• You have gout
• You have been told by the doctor that you suffer from a narrowing of the arteries that supply your heart or brain
• You have recently suffered from excess vomiting or diarrhea
• You intend to have a surgery and general anesthesia (even at the dentist’s office), as there may be a sudden fall in blood pressure associated with general anesthesia
• You are breastfeeding. Furosemide is passed to the infant during breastfeeding. Do not breastfeed if you intend to take MINT-FUROSEMIDE
• You are pregnant, or think you might be pregnant

IMPORTANT: PLEASE READ

• You intend to change your eating habits
• You are less than 18 years old
• You are older than 61 years old

When administered to children, MINT-FUROSEMIDE therapy should be started in the hospital, in carefully selected patients, under close observation with frequent blood tests to measure electrolytes such as sodium, potassium, chloride, magnesium and calcium.

For elderly patients, (over 61 years old), the dose selection should be cautious, usually starting at the low end of dosage range, reflecting the greater frequency of decreased liver, kidney or heart function.

Studies in elderly patients with dementia have shown that taking furosemide with risperidone is associated with a higher rate of death.

The administration of MINT-FUROSEMIDE to diabetic patients may result in possible decrease of diabetic control. Dosage adjustments of the antidiabetic agent may be needed.

There have been cases of ringing in the ears, reversible and non-reversible deafness especially in children. This is most true when the patient has severe kidney disease or is taking drugs that are known to sometimes damage the ears while they are taking furosemide. Your doctor will decide if MINT-FUROSEMIDE is the right medication for you/your child based on your particular condition.

MINT-FUROSEMIDE should not be used in pregnant women or in women of childbearing potential unless in the opinion of the attending physician the benefits to the patient outweigh the possible risk to the foetus. Treatment during pregnancy requires monitoring of fetal growth by your doctor.

If you are suffering from hyperuricemia (high uric acid levels in your blood), taking MINT-FUROSEMIDE can sometimes make a gout attack more likely.

Almost all patients can drive or operate machinery while taking MINT-FUROSEMIDE, but you should not perform these tasks, which may require attention, until you know how you tolerate your medicine.

NTERACTION

INTERACTIONS WITH THIS MEDICATION

S WITH THIS MEDICATION

Before using MINT-FUROSEMIDE, tell your health provider about medication you are currently taking. This way appropriate adjustment and decision can be taken for your treatment with MINT-FUROSEMIDE.

Below are drugs or drug classes that may interact with MINT-FUROSEMIDE These include:

• Drugs to reduce blood pressure (eg. ACE inhibitors, angiotensin II receptor antagonist)
• Diuretics (waterpills), including ethacrynic acid
• Pressor amines such as epinephrine (a medication used to treat life-threatening allergic reactions)

• Medication to treat diabetes, including insulin.

  The administration of MINT-FUROSEMIDE to diabetic patients may result in possible decrease of diabetic control. Dosage adjustments of the antidiabetic agent may

  be needed.

• Theophylline, a medication used to treat asthma, chronic bronchitis, and other lung diseases
• Cisplatin (anti-cancer drug)
• Probenecid (medicine used to treat gout)
• Antibiotics (e.g cephalosporins, aminoglycosides)
• Certain pain and anti-inflammatory drugs (e.g non-steroidal anti-inflammatory drugs [NSAIDs], acetyl-salicylic acid, indomethacin)

• Drugs used in the treatment of rheumatoid arthritis

  (methotrexate, cyclosporin)

• Drugs used to treat epilepsy (e.g. phenytoin, carbamazepine, phenobarbital)
• Risperdal, a drug used to treat dementia
• Lithium (medicine used to treat bipolar depression)
• Sucralfate (antacid drug)
• Sedatives such as phenobarbital or chloral hydrate
• Stimulant laxatives and drugs which may induce low potassium levels (hypokalemia) such as glucocorticoids, and medicine derived from licorice (eg. carbenoxolone)
• Drugs known to be harmful to the ear (ototoxic) as for instance aminoglycosides antibiotics, ethacrynic acid (a “water pill”) and cisplatin (a drug used to treat some types of cancer)
• Drugs known to be harmful to the kidney
• Substances used during certain radiological investigations (radiocontrast agents).
• Digitalis (digoxin)
• Certain steroids.

PROPER USE OF THIS MEDICATION

PROPER USE OF THIS MEDICATION

During long-term therapy a high-potassium diet may be recommended. You should not be on a strict salt restricted diet. Potassium supplements may be required. Your doctor will monitor your blood tests for blood sugar, potassium and other electrolytes and to monitor liver and kidney function. This is especially important if you have other medical conditions such as diabetes, take other medications or the patient is an infant or child.

IMPORTANT: PLEASE READ

Usual dose:

Adults (oral) for edema and high blood pressure:

It is important that you take MINT-FUROSEMIDE as prescribed by your doctor.

Usually your doctor will prescribe MINT-FUROSEMIDE tablets at a dose of 20 to 80 mg per day, which you could take as single or 2-3 divided doses, based on the type of administration your physician considers to be the most appropriate for your condition.

Maximum daily dose: 200 mg.

Swallow the tablets whole with a glass of water.

You should always respect the prescribed interval between the doses. Never change the dose of MINT-FUROSEMIDE you are taking unless your doctor tells you to.

This drug is specifically prescribed for you or a child in your care. Do not give it to others, even if they have the same symptoms, and you yourself must not use it for any condition than the one for which it was prescribed.

Overdose:

IDE EFFECTS AND WHAT TO DO ABOUT

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

THEM

Along with its beneficial effects, MINT-FUROSEMIDE like all other drugs may sometimes cause undesirable effects. These may include: blurring of vision, constipation, diarrhea, dizziness, dry mouth, fatigue, tachycardia, arrhythmia (heart rhythm disturbance), feeling of pressure in the head, increase in the amount and frequency of your urine, leg cramps, mental confusion, nausea, sweating, thirst, vomiting, hepatic encephalopathy (altered mental state due to liver disease). Talk to your doctor or pharmacist if you experience any of the above.

Stop taking MINT-FUROSEMIDE and contact your doctor immediately if you experience an allergic reaction or any severe side effect.

IMPORTANT: PLEASE READ

Although not all of the above side effects are common, if you experience one of these while you are in the hospital or at home, talk to your doctor or pharmacist immediately.

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

HOW TO STORE IT

Store your tablets and solution at room temperature

(15°C– 30°C). Protect from light.

There is an expiration date on the label. Do not use the medicine after this date.

Return any leftover tablets/solution to the pharmacist, unless the doctor tells you to keep them at home.

As with all medicines, keep MINT-FUROSEMIDE out of reach and sight of children.

IMPORTANT: PLEASE READ

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Mint Pharmaceuticals Inc. at: 1-877-398-9696.

Prepared on: July 21, 2017