telmisartan/hydrochlorothiazide (Micardis HCT, MicardisPlus)

Dosing and uses of Micardis HCT, MicardisPlus (telmisartan-hydrochlorothiazide)

• Adult
• Pediatric

 

Adult dosage forms and strengths

telmisartan/hydrochlorothiazide

tablet

• 40mg/12.5mg
• 80mg/12.5mg
• 80mg/25mg

 

Hypertension

Dosage range: 80-160 mg telmisartan/12.5-25 mg hydrochlorothiazide PO qDay

 

Renal impairment

Dose adjustment not necessary

Hemodialysis patients are more susceptible to hypotension

 

Hepatic Impairment

Biliary obstruction or hepatic insufficiency is expected to reduce clearance

Initiate therapy with low dose; titrate slowly; monitor

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Micardis HCT, MicardisPlus (telmisartan-hydrochlorothiazide) adverse (side) effects

1-10%

Telmisartan

• 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

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

 

Warnings

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

 

Contraindications

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)

Anuria

Do not coadminister with aliskiren in patients with diabetes

Not for initial treatment

 

Cautions

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 and lactation

Pregnancy category: C (1st trimester); D (2nd & 3rd trimesters)

Lactation: discontinue drug or do not nurse

 

Pregnancy categories

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.