Dosing & Uses
Dosage Forms & Strengths
150 mg/12.5 mg PO qDay intially; if needed, after 1-2 weeks may titrate up to 300 mg/25 mg PO qDay
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Adverse reactions with combination products and individual agents
- Hyperkalemia (19%)
Chest pain (2%)
Abnormal urination (2%)
Musculoskeletal pain (6%)
Flu-like syndrome (3%)
Chest pain (2%)
Creatinine increased (1%)
Increased BUN (2%)
- Dizziness (10%)
- URI (9%)
- Orthostatic hypotension (5%)
- Fatigue (4%)
- Diarrhea (3%)
- Dyspepsia (2%)
Frequency Not Defined
- AnorexiaEpigastric distress
- Orthostatic hypotension
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Hypokalemia and/or hypomagnesemia
Jaundice (with irbesartan)
Impaired renal function, including renal failure (with irbesartan)
Increased CPK levels (with ARBs)
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
Hypersensitivity to irbesartan, hydrochlorothiazide, or sulfonamides
Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality
Do not coadminister with aliskiren in patients with diabetes mellitus
Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
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
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
Hypotension may occur in patients who are salt or volume depleted (correct the volume depletion especially in patients receiving high dose diuretics)
Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion
Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically
Hyperuricemia may occur or gout may be precipitated in certain patients receiving thiazide therapy
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides
Thiazides may decrease urinary calcium excretion
Caution in aortic mitral stenosis, hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, bilateral renal artery stenosis or anuria
Pregnancy & Lactation
Pregnancy Category: C (1st trimester); D (2nd & 3rd trimesters)
Lactation: discontinue drug or do not nurse
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.