Dosing & Uses
Dosage Forms & Strengths
Dosage range: 80-160 mg telmisartan/12.5-25 mg hydrochlorothiazide PO qDay
Dose adjustment not necessary
Hemodialysis patients are more susceptible to hypotension
Biliary obstruction or hepatic insufficiency is expected to reduce clearance
Initiate therapy with low dose; titrate slowly; monitor
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
- Upper respiratory infection (7%)
- Urinary tract infection (1%)
- Back pain (3%)
- Diarrhea (3%)
- Myalgia (3%)
- Fatigue (1%)
- Sinusitis (3%)
- Peripheral edema (1%)
- Chest pain (1%)
- Hypertension (1%)
- Dyspepsia (1%)
- Headache (1%)
- Dizziness (1%)
- Pharyngitis (1%)
Frequency Not Defined
- Epigastric distress
- Orthostatic hypotension
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Hypokalemia and/or hypomagnesemia
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 (anaphylaxis, angioedema) to telmisartan, hydrochlorothiazide, or sulfonamides
Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality (see Black Box Warnings)
Do not coadminister with aliskiren in patients with diabetes
Not for initial treatment
Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Fixed combination product is not recommended in patients with severe renal or hepatic impairment
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
Electrolyte disturbances may occur
Photosensitivity may occur
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
As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAA), changes in renal function may be anticipated in susceptible individuals; in patients whose renal function depends on RAA (eg, severe CHF), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death
Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy; avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function and electrolytes in patients on benazepril and other agents that affect the RAS
Not for coadministration with aliskiren in patients with diabetes; avoid use of aliskiren with benazepril in patients with renal impairment (GFR <60 ml/min/1.73 m²)
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.
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