Details for: AURO-LOSARTAN
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02403323 | AURO-LOSARTAN | LOSARTAN POTASSIUM | 25.0 MG | TABLET | ORAL |
| 02403331 | AURO-LOSARTAN | LOSARTAN POTASSIUM | 50.0 MG | TABLET | ORAL |
| 02403358 | AURO-LOSARTAN | LOSARTAN POTASSIUM | 100.0 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Adults
- AURO-LOSARTAN lowers high blood pressure.
- AURO-LOSARTAN provides kidney protection by delaying the worsening of kidney disease in type 2 diabetic patients with protein in the urine (proteinuria) and high blood pressure.
Children (6–16 years)
- AURO-LOSARTAN lowers high blood pressure.
What it does
AURO-LOSARTAN is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “-SARTAN”. It lowers blood pressure.
This medicine does not cure high blood pressure.
It helps to control it. Therefore, it is important to
continue taking AURO-LOSARTAN regularly
even if you feel fine.
When it should not be used
Do not take AURO-LOSARTAN if you:
- are allergic to losartan potassium or any of the non-medicinal ingredients in the formulation.
- have difficulty urinating or produce no urine.
- are already taking a blood pressurelowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
What the medicinal ingredient is
losartan potassium.
What the non-medicinal ingredients are
AURO-LOSARTAN contains the following nonmedicinal ingredients: Cellulose microcrystalline, Lactose monohydrate, Starch pregelatinised, Low Substituted Hydroxypropyl cellulose, Magnesium stearate, Opadry White 20A58900.
AURO-LOSARTAN 25 mg, 50 mg and 100 mg tablets contain the following amounts of potassium: 2.12 mg (<1 mmol), 4.24 mg (<1 mmol), and 8.48 mg (<1 mmol) respectively.
Although AURO-LOSARTAN tablets contain potassium, this amount is too small to replace potassium supplements. If your healthcare professional has prescribed potassium supplements, continue to follow their advice.
What dosage form it comes in
AURO-LOSARTAN is available in tablets containing 25mg, 50 mg and 100 mg.
Warnings and precautions
Serious Warning and Precautions
AURO-LOSARTAN should not be used during pregnancy. If you discover that you are pregnant while taking AURO-LOSARTAN stop the medication and contact your healthcare professional as soon as possible.
BEFORE you use AURO-LOSARTAN talk to your healthcare professional if you:
- are allergic to any drug.
- have experienced an allergic reaction (angioedema) with swelling of the hands, feet, or ankles, face, lips, tongue, throat, or sudden difficulty breathing or swallowing to any drug that blocks the renin-angiotensin renin system (ACEi, ARB, renin inhibitors). Be sure to tell your healthcare professional that this has happened to you.
- have narrowing of an artery or a heart valve. have had a heart attack or stroke.
- are taking a salt substitute that contains potassium, potassium supplements, or a potassium-sparing diuretic (a specific kind of “water pill” that makes your body keep potassium).
- are on a low salt diet.
- are less than 18 years old.
- are taking a medicine that contains aliskiren, such as Rasilez, used to lower high blood pressure. The combination with AURO-LOSARTAN is not recommended.
- are taking an angiotensin-convertingenzyme inhibitor (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in “-PRIL”.
- are on dialysis.
- are taking any medication including nonprescription and herbal products.
- are dehydrated or suffer from excessive vomiting, diarrhea or sweating.
- have heart failure.
- have diabetes, liver or kidney disease.
- have to undergo any kind of surgery and general anesthesia (even at the dentist’s office). Tell the healthcare professional or dentist that you are taking AURO-LOSARTAN, as there may be a sudden fall in blood pressure associated with general anesthesia.
- are allergic to this drug or to any ingredient in the formulation.
- are taking other drugs that may increase serum potassium (e.g. trimethoprimcontaining products).
You may become sensitive to the sun while taking AURO-LOSARTAN. Exposure to sunlight should be minimized until you know how you respond.
Driving and using machines: Before doing tasks which require special attention, wait until you know how you respond to AURO-LOSARTAN. Being dizzy, lightheaded, or fainting can occur. Take care especially after the first dose and when the dose is increased.
You are pregnant, breast-feeding or thinking
of becoming pregnant?
Taking AURO-LOSARTAN during pregnancy
can cause injury and even death to your baby.
This medicine should not be used during
pregnancy. If you are planning to become
pregnant while taking AURO-LOSARTAN,
contact your healthcare professional
immediately.
It is possible that AURO-LOSARTAN passes into breast milk. You should discuss with your healthcare professional about taking AURO-LOSARTAN while breastfeeding.
Interactions with this medication
As with most medicines, interaction with other drugs are possible. Tell your healthcare professional about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with AURO-LOSARTAN
- Digoxin, a heart medication.
- 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, including diuretics (“water pills”), aliskirencontaining products (e.g. Rasilez), or angiotensin converting enzyme (ACE) inhibitors. When taken in combination with AURO-LOSARTAN, they may cause excessively low blood pressure.
- Warfarin used to thin the blood and prevent blood clots.
- Antibiotics used to treat bacterial infections, such as rifampin and erythromycin.
- Fluconazole, used to treat fungal infections.
- Phenobarbital, used to treat epilepsy.
- Cimetidine, used to treat heartburn and stomach ulcers.
- Agents increasing serum potassium, such as potassium supplements, salt substitutes containing potassium, a potassium-sparing diuretic (a specific kind of “water pill”) or other drugs that may increase serum potassium (e.g., trimethoprim-containing products).
Proper use of this medication
Take AURO-LOSARTAN exactly as prescribed. It is recommended to take your dose at about the same time every day.
Usual dose
- Take AURO-LOSARTAN every day exactly as your doctor has instructed. It is important to continue taking AURO-LOSARTAN for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.
- AURO-LOSARTAN may be taken with or without food, but it should be taken consistently with respect to food intake, at about the same time every day.
Hypertension:
Adults:
- For adult patients, the usual starting dose is 50 mg once daily. The usual dose range is 50 to 100 mg once daily.
- Most older patients require the same dose as younger patients, since AURO-LOSARTAN works equally well and is equally well tolerated by most older and younger adult patients.
Children (6 – 16 years):
- For pediatric patients (6-16 years of age) who can swallow tablets, the recommended dose is 25 mg once daily in patients between 20 and 49 kg. The dose can be increased to a maximum of 50 mg once daily. In patients greater or equal to 50 kg, the starting dose is 50 mg once daily. The dose can be increased to a maximum of 100 mg once daily.
Type 2 diabetes patients with protein in the uria and high blood pressure:
- For adults, the usual starting dose is 50 mg once daily. The dose may be increased to 100 mg once daily.
Overdose
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
Any medicine may have unintended or undesirable effects, so called side effects. Socalled side effects. Tell your healthcare professional promptly about these or any other unusual symptoms.
Side effects may include:
- Dizziness
- Fatigue
- Rash
- Diarrhea, vomiting
- Change in taste
- Headache
- Back or leg pain, muscle cramps
Some patients, especially those with type 2 diabetes with protein in the urine, may also develop increased levels of potassium in their blood.
If any of these affects you severely, tell your healthcare professional.
AURO-LOSARTAN can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results
| Symptom / effect | Talk with your healthcare professional Only if severe | Talk with your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness | ✔ | ||
| Increased levels of potassium in the blood: irregular heartbeats, muscle weakness and generally feeling unwell | ✔ | ||
| Uncommon | |||
| Allergic reaction: rash, hives, swelling of the face, lips, throat or tongue, difficulty breathing or swallowing | ✔ | ||
| Kidney Disorder: change in frequency of urination, nausea, vomiting, swelling of extremities, fatigue | ✔ | ||
| Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
| Rare | |||
| Rhabdomyolysis: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine | ✔ | ||
| Very rare | |||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AURO-LOSARTAN, contact your healthcare professional.
How to store
Store at room temperature between 15 and 30°C.
Keep all medicines out of the 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 (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 AURO-LOSARTAN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648-6681.
This leaflet was prepared by,
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8
Canada
Date of Revision: November 30, 2018