Dosing and uses of Tekturna (aliskiren)
Adult dosage forms and strengths
irbesartan/hydrochlorothiazide
(tablet)
- 150mg/12.5mg
- 300mg/12.5mg
Hypertension
150 mg/12.5 mg PO qDay intially; if needed, after 1-2 weeks may titrate up to 300 mg/25 mg PO qDay
Pediatric dosage forms and strengths
Safety and efficacy not established
Tekturna (aliskiren) adverse (side) effects
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
- AnorexiaEpigastric 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
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 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
Cautions
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 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.
