ATACAND

DistributionThe volume of distribution of candesartan is 0.13 L/kg. Candesartan is highly bound to plasma proteins (>99%) and does not penetrate red blood cells. The protein binding is constant at candesartan plasma concentrations well above the range achieved with recommended doses. In rats, it has been demonstrated that candesartan crosses the blood-brain barrier poorly, if at all. It has also been demonstrated in rats that candesartan passes across the placental barrier and is distributed in...

14.1 Hypertension Adult The antihypertensive effects of ATACAND were examined in 14 placebo-controlled trials of 4- to 12-weeks duration, primarily at daily doses of 2 to 32 mg per day in patients with baseline diastolic blood pressures of 95 to 114 mm Hg. Most of the trials were of candesartan cilexetil as a single agent, but it was also studied as add-on to hydrochlorothiazide and amlodipine. These studies included a total of 2350 patients randomized to one of several doses of candesartan cilexetil and 1027 to placebo. Except for a study in diabetics, all studies showed significant effects, ...

• Most common adverse reactions which caused adult patients to discontinue therapy for:
• Hypertension were headache (0.6%) and dizziness (0.3%) (6.1) .
• Heart Failure were hypotension (4.1%) (5.3) , abnormal renal function (6.3%) (5.4) , and hyperkalemia (2.4%) (5.5) . To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely var...

ATACAND is contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with ATACAND in patients with diabetes [see Drug Interactions (7.4) ]. Known hypersensitivity to product components (4) . Do not co-administer aliskiren with ATACAND in patients with diabetes (4) .

• Observe for signs and symptoms of hypotension (5.3) .
• Monitor renal function (5.4) and potassium levels (5.5) . 5.1 Fetal Toxicity ATACAND can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential ...

7 DRUG INTERACTIONS

• Lithium: Increases in serum lithium concentrations and toxicity (7) .
• NSAIDs use may lead to increased risk of renal impairment and loss of antihypertensive effect (7) .
• Combined inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7) . 7.1 Agents Increasing Serum Potassium Co-administration of ATACAND with potassi...