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Teva-Irbesartan/HCTZ: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Current status: Cancelled Post Market
Strength:
300 mg / 12.5 mg, 150 mg / 12.5 mg, 300 mg / 25 mg
Active ingredients:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Teva-Irbesartan/HCTZ

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-IRBESARTAN/HCTZ lowers high blood pressure.

What it does:

TEVA-IRBESARTAN/HCTZ is a combination of 2 drugs, irbesartan and hydrochlorothiazide.

  • Irbesartan is an angiotensin receptor blocker (ARB). You can recognize an ARB because its medicinal ingredient ends in “SARTAN”. It lowers 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 TEVA-IRBESARTAN/HCTZ regularly even if you feel fine.

When it should not be used:

Do not take TEVA-IRBESARTAN/HCTZ:

  • Are allergic to irbesartan or 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 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 ARB (any drug in the same class as irbesartan). Be sure to tell your doctor, nurse, or pharmacist that this has happened to you.
  • Have difficulty urinating or produce no urine.

  • Have diabetes or kidney disease and are already taking:

    • a blood pressure-lowering medicine that contains aliskiren (such as RASILEZ®)
    • an angiotensin converting enzyme (ACE) inhibitor. You can recognize ACE inhibitors because their medicinal ingredient ends in ‘-PRIL’
  • Are pregnant or intend to become pregnant. Taking TEVA-IRBESARTAN/HCTZ during pregnancy can cause injury and even death to your baby.

  • Are breast feeding. TEVA-IRBESARTAN/HCTZ passes into breast milk.

    TEVA-IRBESARTAN/HCTZ is not recommended for use in children and adolescents (under the age of 18 years).

What the medicinal ingredients are:

Irbesartan and hydrochlorothiazide.

What the nonmedicinal ingredients are:

colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, pregelatinized starch.

150/12.5 mg and 300/12.5 mg tablets also contain as film coating: hypromellose, iron oxide black, iron oxide red, iron oxide yellow, macrogol and titanium dioxide.

300/25 mg tablets also contain as film coating: FD&C Blue # 2, hypromellose, iron oxide black, iron oxide red, macrogol and titanium dioxide.

What dosage forms it comes in:

TEVA-IRBESARTAN/HCTZ tablets are available in three different strengths.

Tablets which contain 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide come in the form of light pink to pink, film coated, capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7238".

The next strength contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. These come in a similar form and colour, light pink to pink, film coated, capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7239".

The highest strength tablets contain 300 mg of irbesartan and 25 mg of hydrochlorothiazide. These tablets come in the form of pink to dark pink, film coated, capsule shaped tablet. One side of the tablet debossed with the number "93". The other side of the tablet debossed with the number "7469".

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions-Pregnancy

TEVA-IRBESARTAN/HCTZ should not to be used during pregnancy. If you discover that you are pregnant while taking TEVA-IRBESARTAN/HCTZ stop the medication and contact your doctor, nurse or pharmacist as soon as possible.

BEFORE you use TEVA-IRBESARTAN/HCTZ tell your doctor or pharmacist if you:

  • Are allergic to any drug used to lower blood pressure, including angiotensin converting enzyme (ACE) inhibitors, or penicillin.
  • Have narrowing of an artery or a heart valve.
  • Have had a heart attack or stroke.
  • Have heart failure.
  • Have diabetes, liver or kidney disease.
  • Have gout, or lupus erythematosus
  • Are on dialysis
  • Are dehydrated or suffer from excessive vomiting, diarrhea or sweating.
  • 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 taking a medicine that contains aliskiren, such as RASILEZ ®, used to lower high blood pressure. The combination with TEVA-IRBESARTAN/HCTZ is not recommended.
  • Are taking an angiotensin converting enzyme (ACE) inhibitor. The combination with TEVA-IRBESARTAN/HCTZ is not recommended.
  • Are less than 18 years old.

Hydrochlorothiazide in TEVA-IRBESARTAN/HCTZ 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 TEVA-IRBESARTAN/HCTZ.

You may become sensitive to the sun while taking TEVA IRBESARTAN/HCTZ. Exposure to sunlight should be minimized until you know how you respond.

Before surgery and general anesthesia (even at the dentist’s office), tell the doctor or dentist that you are taking TEVA IRBESARTAN/HCTZ, as there may be a sudden fall in blood pressure associated with general anesthesia.

Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to TEVA-IRBESARTAN/HCTZ. 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 TEVA-IRBESARTAN/HCTZ:

  • 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.
  • Blood pressure-lowering drugs, including diuretics (“water pills”), aliskiren-containing products (e.g. RASILEZ ®), or angiotensin converting enzyme (ACE) inhibitors.
  • Calcium or vitamin D supplements.
  • Corticosteroids used to treat joint pain and swelling and other conditions.
  • 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.
  • Hyperglycemic agent, such as diazoxide.
  • Lithium used to treat bipolar disease.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling. Examples include ibuprofen, naproxen, and celecoxib.
  • Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes.
  • Pressor amines such as norepinephrine.
  • Skeletal muscle relaxants used to relieve muscle spasms, including tubocurare.
  • Warfarin

PROPER USE OF THIS MEDICATION

Take TEVA-IRBESARTAN/HCTZ every day exactly as prescribed. It is recommended to take your dose at about the same time every day.

TEVA-IRBESARTAN/HCTZ can be taken with or without food but it should be taken the same way each day. If TEVA-IRBESARTAN/HCTZ 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 tablet daily.

Overdose:

If you think you have taken too much TEVA-IRBESARTAN/HCTZ , contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison 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:

  • back or leg pain, muscle cramps, spasms and pain, weakness, restlessness
  • dizziness, pins and needles in your fingers, headache and fatigue
  • constipation, diarrhea, nausea, vomiting, decreased appetite, upset stomach, enlargement of the glands in your mouth, bleeding under the skin, rash, red patches on the skin
  • drowsiness, insomnia
  • reduced libido

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

TEVA-IRBESARTAN/HCTZ Can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptoms / effectTalk with your doctor or pharmacistStop taking drug and call your doctor or pharmacist
Only if severeIn all cases
Common

Low Blood

Pressure:

dizziness,

fainting,

lightheadedness

May occur when

you go from lying

or sitting to

standing up.

✓

Edema: swelling

of hands, ankles

or feet

✓

Tachycardia:

increased heart

beats

✓

Decreased or

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,

tongue or throat,

difficulty

swallowing or

breathing

✓
Uncommon

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

✓
Increased blood sugar: frequent urination, thirst, and hunger✓
Rare

Rhabdomyolysis

: muscle pain that you cannot explain, muscle tenderness or weakness, dark brown urine

✓

Decreased White

Blood Cells:

infections, fatigue, fever, aches, pains, and flu-like symptoms

✓

Decreased

Platelets:

bruising, bleeding, fatigue and weakness

✓
Very rare

Toxic Epidermal

Necrolysis:

severe skin peeling, especially in mouth and eyes

✓
Unknown

Eye disorders:

  • Myopia: sudden near sightedness or blurred vision
  • Glaucoma:

increased pressure in your eyes, eye pain

✓
Anemia: fatigue, loss of energy, weakness, shortness of breath.✓

Inflammation of the Pancreas:

abdominal pain that lasts and gets worse when you lie down, nausea, vomiting

✓

This is not a complete list of side effects. For any unexpected effects while taking TEVA-IRBESARTAN/HCTZ, contact your doctor, nurse or pharmacist.

HOW TO STORE IT

Store TEVA-IRBESARTAN/HCTZ tablets at room temperature (15 to 30ºC).

Keep out of the 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:

----------------------------------------------------------------

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, ON 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 found by contacting Teva Canada Limited

at: 1-800-268-4127 ext. 1255005 (English)

or 1-877-777-9117 (French)

or druginfo@TevaCanada.com

Teva Canada Limited.

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

Last revised: January 18, 2016

RASILEZ® is a trade-mark of Novartis AG, Switzerland

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02316021

Revision date stated in the text: January 18, 2016

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Teva-Irbesartan/HCTZ

Rx or OTC
Prescription (Rx)?
DIN 02316021, 02316013, 02316048
Schedule(s) PRESCRIPTION
Active ingredient(s) Irbesartan, Hydrochlorothiazide
Dosage form(s) Tablet
Route(s) of administration Oral
Drug class (WHO ATC)
  1. C Cardiovascular system drugs
    1. C09 Agents acting on the renin-angiotensin system
      1. C09D Angiotensin II receptor blockers (ARBs), combinations
        1. C09DA Angiotensin II receptor blockers (ARBs) and diuretics
          1. C09DA04 Irbesartan and diuretics
Company TEVA CANADA LIMITED
Current status Cancelled Post Market
Current status date April 10, 2018
Strengths and forms
DIN Strength Dosage form(s) Current status
02316021 300 MG / 12.5 MG Tablet Cancelled Post Market April 10, 2018
02316013 150 MG / 12.5 MG Tablet Cancelled Post Market April 10, 2018
02316048 300 MG / 25 MG Tablet Cancelled Post Market April 10, 2018

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.