Avalide Drug Description

AVALIDE (irbesartan-hydrochlorothiazide) Tablets are a combination of an angiotensin II receptor antagonist (AT₁ subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Irbesartan is a non-peptide compound, Caverta chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C₂₅H₂₈N₆O, and its structural formula is:

Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1dioxide. Its empirical formula is C₇H₈ClN₃O₄S₂ and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution.

AVALIDE is available for oral administration in film-coated tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. All dosage strengths contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, silicon dioxide, ferric oxide red, ferric oxide yellow, polyethylene glycol, titanium dioxide, and carnauba wax. In addition, the 300/25 mg film-coated tablets contain pregelatinized starch and ferric oxide black.

SIDE EFFECTS:Dizziness, lightheadedness, or upset stomach may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, muscle cramps/weakness, slow/fast/irregular heartbeat, unusual decrease in the amount of urine, unusual dry mouth/thirst, decrease in vision, eye pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS:Before taking this medication, tell your doctor or pharmacist if you are allergic to irbesartan or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: gout, kidney disease, liver disease, lupus.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Severe sweating, diarrhea, or vomiting can increase the risk for lightheadedness or a serious loss of body water (dehydration). Report prolonged diarrhea or vomiting to your doctor. To prevent dehydration, drink plenty of fluids unless your doctor directs you otherwise.

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if irbesartan passes into breast milk. Hydrochlorothiazide passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

About Hypertension: Prevalence, Costs, and Control

According to the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Viagra Professional Pressure (JNC 7), current control rates for hypertension in the United States are clearly unacceptable.

High awareness, low control

Nearly 1 in 3 adults (30%) in the US has hypertension. However, only about 33% of all those with hypertension have their blood pressure controlled, defined as <140/90 mm Hg in non-diabetic patients or, for patients with diabetes, <130/80 mm Hg.


Hypertension control rates, while improving, continue to be low despite the fact that 78% of Americans were aware that they had hypertension in the period 2005-2006.

Estimated cost of hypertension in the United States

The estimated cost of cardiovascular diseases and stroke in the United States for 2008 is $448.5 billion. This figure includes direct costs (eg, physicians/other healthcare providers, hospital/nursing home care, home healthcare, medications and medical durables) as well as indirect costs, including lost productivity resulting from morbidity and mortality.


An estimated $69.4 billion, or 21%, can be directly attributed to hypertensive disease. This is larger than the costs associated with stroke ($65.5 billion) or heart failure ($34.8 billion).

JNC 7 recommendations for the management of hypertension

The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure provides a classification of BP for adults aged 18 years and older composed of four categories: normal, prehypertension, stage 1 hypertension, and stage 2 hypertension.


Prehypertension is not a disease category, but rather a range of BP values that can be used to identify individuals at high risk of developing hypertension. The JNC 7 states that individuals who are prehypertensive are not candidates for antihypertensive drug therapy.

The JNC 7 recommends treating systolic blood pressure (SBP) and diastolic blood pressure (DBP) to targets that are less than 140/90 mm Hg, which may help to avoid future complications. For hypertensive patients with diabetes or renal disease, the BP goal is less than 130/80 mm Hg.

Why is hypertension such a widespread problem?

Patients, healthcare systems, and even healthcare providers can create barriers to control.