Irbesartan / Hydrochlorothiazide

Irbesartan / Hydrochlorothiazide

DAE Class; Rx

Common Brand Names; Avalide

• ARB/HCTZ Combos

Thiazide diuretic and angiotensin II blocker; used for additive efficacy in HTN; once-daily product; irbesartan decreases potassium loss due to HCTZ.

Indicated for the treatment of hypertension in patients who do not respond to monotherapy and/or as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Individualize the dosage by titration of the separate components. If the optimal dose corresponds to the ratio contained in the combination formulation, this product can be used for convenient dosing.

Hypersensitivity to irbesartan, hydrochlorothiazide, or sulfonamides

Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality

Anuria

Do not coadminister with aliskiren in patients with diabetes mellitus

Adverse reactions with combination products and individual agents

>10%

Irbesartan

• Hyperkalemia (19%)

1-10%

Chest pain (2%)

Tachycardia (1%)

Abnormal urination (2%)

Musculoskeletal pain (6%)

Flu-like syndrome (3%)

Edema (3%)

Tachycardia (1%)

Chest pain (2%)

Creatinine increased (1%)

Increased BUN (2%)

Irbesartan

• Dizziness (10%)
• URI (9%)
• Orthostatic hypotension (5%)
• Fatigue (4%)
• Diarrhea (3%)
• Dyspepsia (2%)

Frequency Not Defined

Hydrochlorothiazide

• Anorexia Epigastric distress
• Hypotension
• Orthostatic hypotension
• Photosensitivity
• Anaphylaxis
• Anemia
• Confusion
• Erythema multiforme
• Stevens-Johnson syndrome
• Exfoliative dermatitis including toxic epidermal necrolysis
• Dizziness
• Hypokalemia and/or hypomagnesemia
• Hyperuricemia
• Headache

Postmarketing Reports

Urticaria

Angioedema

Hepatitis

Jaundice (with irbesartan)

Heart failure

Sexual dysfunction

Thrombocytopenia

Impaired renal function, including renal failure (with irbesartan)

Increased CPK levels (with ARBs)

Tinnitus

Hydrochlorothiazide

• Non-melanoma skin cancer
• Acute angle-closure glaucoma, acute myopia, choroidal effusion
• Hypoglycemia in diabetic patients

Black Box Warnings

Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death

Cautions

If CrCl <30 mL/min, use loop diuretic instead of hydrochlorothiazide

Hyperkalemia, particularly when coadministered with potassium-sparing diuretics, potassium supplements, or salt substitutes; concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect; monitor serum potassium levels periodically

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease since minor alterations of fluid and electrolyte balance may precipitate hepatic coma

Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for renal function changes (including acute renal failure) compared to monotherapy

Instruct patients to protect skin from sun and undergo regular skin cancer screening

Caution in aortic mitral stenosis, hypercholesterolemia, hypercalcemia, parathyroid disease, or anuria

Pregnancy

Therapy can cause fetal harm when administered to a pregnant woman

Lactation

There are no available data on the presence of irbesartan in human milk, effects on milk production, or breastfed infant; irbesartan or some metabolite of irbesartan is secreted in the milk of lactating rats

Thiazides appear in human milk; because of potential for adverse effects on nursing infant, the drug is not recommended in breastfeeding women

Adults

300 mg/day PO irbesartan and 25 mg/day PO hydrochlorothiazide.

Geriatric

300 mg/day PO irbesartan and 25 mg/day PO hydrochlorothiazide.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Irbesartan / Hydrochlorothiazide