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Amturnide Prescribing Information

This information is not for clinical use. These highlights do not include all the information needed to use Amturnide safely and effectively. Before taking Amturnide please consult with your doctor. See full prescribing information for Amturnide.

Warning

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Amturnide as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Amturnide as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)

Indications And Usage

Amturnide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and hydrochlorothiazide (HCTZ). There are no controlled trials demonstrating risk reduction with Amturnide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed combination drug is not indicated for initial therapy of hypertension. Amturnide is a combination of aliskiren, a renin inhibitor, amlodipine besylate, a dihydropyridine calcium channel blocker, and hydrochlorothiazide (HCTZ), a thiazide diuretic. Amturnide is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions: Not indicated for initial therapy. (1)

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Dosage Forms And Strengths

Tablets are convex ovaloid with a beveled edge, film-coated, and unscored, in the following strengths: Aliskiren / Amlodipine /HCTZ (mg) Color Embossing Side 1/side 2 150/5/12.5 Violet white YIY/NVR 300/5/12.5 Light pink LIL/NVR 300/5/25 Pale orange brown OIO/NVR 300/10/12.5 Light red UIU/NVR 300/10/25 Brown VIV/NVR Tablets (aliskiren/ amlodipine/ HCTZ): 150/5/12.5, 300/5/12.5, 300/5/25, 300/10/12.5, 300/10/25 mg. (3)

Contraindications

Do not use aliskiren with ARBs or ACEIs in patients with diabetes [see Warnings and Precautions (5.2) and Clinical Studies (14.2)]. Amturnide is contraindicated in patients with anuria or known hypersensitivity to sulfonamide derived drugs like HCTZ or to any of the components [see Warnings and Precautions (5.8) and Adverse Reactions (6.1)]. Hypersensitivity reactions may range from urticaria to anaphylaxis. Do not use with angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) in patients with diabetes. (4) Anuria (4) Hypersensitivity to sulfonamide derived drugs or to any of the components (4)

Warning and Cautions

Avoid concomitant use with ARBs or ACEIs particularly in patients with renal impairment [creatinine clearance (CrCl) <60 mL/min]. (5.2, 5.4) Anaphylactic Reactions and Head and Neck Angioedema.(5.3) Hypotension: Correct imbalances in volume and/or salt-depleted patients.(5.4) Increased angina or myocardial infarction may occur upon dosage initiation or increase in amlodipine. (5.5) Impaired Renal Function: Monitor serum creatinine periodically. (5.6) Systemic lupus erythematosus activation or exacerbation. (5.8) Hyperkalemia: Monitor potassium levels periodically. (5.9) Acute Myopia and Secondary Angle Closure Glaucoma. (5.11) 5.1 Fetal Toxicity Pregnancy Category D 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 neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Amturnide as soon as possible [see Use in Specific Populations (8.1)]. Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possible other adverse reactions that have occurred in adults. 5.2 Renal Impairment/Hyperkalemia/Hypotension when Amturnide is Given in Combination with ARBs or ACEIs Amturnide is contraindicated in patients with diabetes who are receiving ARBs or ACEIs because of the increased risk of renal impairment, hyperkalemia, and hypotension. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with creatinine clearance (CrCl) less than 60 mL/min [see Contraindications (4), Drug Interactions (7) and Clinical Studies (14.2)]. 5.3 Anaphylactic Reactions and Head and Neck Angioedema Aliskiren Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been reported in patients treated with aliskiren and has necessitated hospitalization and intubation. This may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACEIs or angiotensin receptor antagonists. Anaphylactic reactions have been reported from postmarketing experience with unknown frequency. If angioedema involves the throat, tongue, glottis or larynx, or if the patient has a history of upper respiratory surgery, airway obstruction may occur and be fatal. Patients who experience these effects, even without respiratory distress, require prolonged observation and appropriate monitoring measures since treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement. Prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and measures to ensure a patent airway may be necessary. Discontinue Amturnide immediately in patients who develop anaphylactic reactions or angioedema, and do not re-administer [see Dosage and Administration (2.1) and Contraindications (4)]. 5.4 Hypotension Symptomatic hypotension may occur after initiation of treatment with Amturnide in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the RAAS. The volume or salt depletion should be corrected prior to administration of Amturnide, or the treatment should start under close medical supervision. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized. Amlodipine besylate Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.5 Risk of Myocardial Infarction or Increased Angina Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly with severe obstructive coronary artery disease. 5.6 Impaired Renal Function Monitor renal function periodically in patients treated with Amturnide. Changes in renal function, including acute renal failure, can be caused by drugs that affect the RAAS and by diuretics. Patients whose renal function may depend in part on the activity of the RAAS (e.g., patients with renal artery stenosis, severe heart failure, post-myocardial infarction or volume depletion) or patients receiving ARB, ACEI, or nonsteroidal anti-inflammatory drug (NSAID), including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors), therapy may be at particular risk of developing acute renal failure on Amturnide [see Warnings and Precautions (5.2), Drug Interactions (7), Use in Specific Populations (8.7) and Clinical Studies (14.2)]. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Amturnide [see Dosage and Administration (2.1)]. 5.7 Hypersensitivity Reactions Hydrochlorothiazide (HCTZ) Hypersensitivity reactions to HCTZ may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. 5.8 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus (SLE). 5.9 Serum Electrolyte Abnormalities Amturnide In a short-term controlled trial the incidence of patients with hypertension not concomitantly treated with an ARB or ACEI who developed hypokalemia (serum potassium less than 3.5 mEq/L) was 11.0% of Amturnide-treated patients compared to 19.0% of amlodipine/HCTZ patients, 4.4% of aliskiren/HCTZ patients, and 2.1% of aliskiren/amlodipine patients; the incidence of hyperkalemia (serum potassium greater than 5.5 mEq/L) was 3.0% compared to 2.0% of amlodipine/HCTZ patients, 0.7% of aliskiren/HCTZ patients, and 0.7% of aliskiren/amlodipine patients. No Amturnide-treated patients discontinued due to increase or decrease of serum potassium. Aliskiren Monitor serum potassium periodically in patients receiving aliskiren. Drugs that affect the RAAS can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, combination use with ARBs or ACEIs [see Contraindications (4), Warnings and Precautions (5.2), and Clinical Studies (14.2)], NSAIDs, or potassium supplements or potassium-sparing diuretics. Hydrochlorothiazide (HCTZ) HCTZ can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. If hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations), Amturnide should be discontinued. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides. 5.10 Cyclosporine or Itraconazole When aliskiren was given with cyclosporine or itraconazole, the blood concentrations of aliskiren were significantly increased. Avoid concomitant use of Amturnide with cyclosporine or itraconazole [see Drug Interactions (7)]. 5.11 Acute Myopia and Secondary Angle-Closure Glaucoma HCTZ, a sulfonamide, can cause an idiosyncratic reaction, resulting in transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue HCTZ as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. 5.12 Metabolic Disturbances Hydrochlorothiazide (HCTZ) Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. HCTZ may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients. HCTZ decreases urinary calcium excretion and may cause elevation of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Amturnide.

Adverse Reactions

The most common adverse events (incidence ≥2%) are: peripheral edema, dizziness, headache and nasopharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience The following serious adverse reactions are discussed in greater detail in other sections of the label: Fetal Toxicity [see Warnings and Precautions (5.1)] Anaphylactic Reactions and Head and Neck Angioedema [see Warnings and Precautions (5.3)] Hypotension [see Warnings and Precautions (5.4)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Amturnide Amturnide has been evaluated for safety in 1155 patients treated with Amturnide, including 182 patients for over 1 year. In a short-term controlled trial, there were 60.5% males, 84.1% Caucasians, 10% blacks, 6.4% Hispanics, and 19.1% who were 65 years of age and older. In this study, the overall incidence of adverse events on therapy with Amturnide was similar to that observed with the individual components. The overall frequency of adverse events was similar between men and women and black and Caucasian patients. Discontinuation of therapy because of a clinical adverse event in this study occurred in 3.6% of patients treated with Amturnide versus 2.4% in aliskiren/amlodipine, 0.7% in aliskiren/HCTZ, and 2.7% in amlodipine/HCTZ. Table 1. Adverse Events in a Short-term Controlled Trial that Occurred in at Least 2% of Patients Treated with Amturnide Amturnide Ali/amlo Ali/HCTZ Amlo/HCTZ Edema peripheral 7.1% 8.0% 2.0% 4.1% Dizziness 3.6% 2.4% 3.4% 1.7% Headache 3.6% 3.1% 4.0% 5.1% Nasopharyngitis 2.6% 0.7% 2.0% 3.4% In a long-term safety trial, the safety profile was similar to that seen in the short-term controlled trial. Aliskiren Aliskiren has been evaluated for safety in 6460 patients, including 1740 treated for longer than 6 months, and 1250 for longer than 1 year. In placebo-controlled clinical trials, discontinuation of therapy because of a clinical adverse event, including uncontrolled hypertension, occurred in 2.2% of patients treated with aliskiren, versus 3.5% of patients given placebo. These data do not include information from the ALTITUDE study which evaluated the use of aliskiren in combination with ARBs or ACEIs [see Contraindications (4), Warnings and Precautions (5.2), and Clinical Studies (14.2)]. Two cases of angioedema with respiratory symptoms were reported with aliskiren use in the clinical studies. Two other cases of periorbital edema without respiratory symptoms were reported as possible angioedema and resulted in discontinuation. The rate of these angioedema cases in the completed studies was 0.06%. In addition, 26 other cases of edema involving the face, hands, or whole body were reported with aliskiren use, including 4 leading to discontinuation. In the placebo-controlled studies, however, the incidence of edema involving the face, hands, or whole body was 0.4% with aliskiren compared with 0.5% with placebo. In a long-term active-controlled study with aliskiren and HCTZ arms, the incidence of edema involving the face, hands, or whole body was 0.4% in both treatment arms. Aliskiren produces dose-related gastrointestinal (GI) adverse reactions. Diarrhea was reported by 2.3% of patients at 300 mg, compared to 1.2% in placebo patients. In women and the elderly (age 65 years and older) increases in diarrhea rates were evident starting at a dose of 150 mg daily, with rates for these subgroups at 150 mg similar to those seen at 300 mg for men or younger patients (all rates about 2%). Other GI symptoms included abdominal pain, dyspepsia, and gastroesophageal reflux, although increased rates for abdominal pain and dyspepsia were distinguished from placebo only at 600 mg daily. Diarrhea and other GI symptoms were typically mild and rarely led to discontinuation. Aliskiren was associated with a slight increase in cough in the placebo-controlled studies (1.1% for any aliskiren use versus 0.6% for placebo). In active-controlled trials with ACE inhibitor (ramipril, lisinopril) arms, the rates of cough for the aliskiren arms were about one-third to one-half the rates in the ACE inhibitor arms. Other adverse reactions with increased rates for aliskiren compared to placebo included rash (1% versus 0.3%), and renal stones (0.2% versus 0%). Single episodes of tonic-clonic seizures with loss of consciousness were reported in 2 patients treated with aliskiren in the clinical trials. One patient had predisposing causes for seizures and had a negative electroencephalogram (EEG) and cerebral imaging following the seizures; for the other patient, EEG and imaging results were not reported. Aliskiren was discontinued and there was no re-challenge in either case. No clinically meaningful changes in vital signs or in ECG (including QTc interval) were observed in patients treated with aliskiren. Amlodipine Amlodipine (Norvasc®) has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. Other adverse events that have been reported at less than 1% but greater than 0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain were: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis Central and Peripheral Nervous System: neuropathy peripheral, paresthesia, tremor, vertigo Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia General: allergic reaction, asthenia,** back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease Musculoskeletal System: arthralgia, arthrosis, muscle cramps,** myalgia Psychiatric: sexual dysfunction (male** and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization Respiratory System: dyspnea, epistaxis Skin and Appendages: angioedema, erythema multiforme, pruritus,** rash,** rash erythematous, rash maculopapular **These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies. Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus Urinary System: micturition frequency, micturition disorder, nocturia Autonomic Nervous System: dry mouth, sweating increased Metabolic and Nutritional: hyperglycemia, thirst Hemopoietic : leukopenia, purpura, thrombocytopenia Other events reported with amlodipine at a frequency of less than or equal to 0.1% of patients include: cardiac failure, pulse irregularity, extrasystoles, skin discoloration, urticaria, skin dryness, alopecia, dermatitis, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, rhinitis, dysuria, polyuria, parosmia, taste perversion, abnormal visual accommodation, and xerophthalmia. Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina. HCTZ Other adverse reactions not listed above that have been reported with HCTZ, without regard to causality, are listed below: Body as a Whole: weakness Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation Hematologic : aplastic anemia, agranulocytosis, hemolytic anemia Hypersensitivity: photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions Musculoskeletal: muscle spasm Nervous System/Psychiatric: restlessness Renal: renal failure, renal dysfunction, interstitial nephritis Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis Special Senses: transient blurred vision, xanthopsia Clinical Laboratory Test Abnormalities Clinical laboratory findings for Amturnide in patients with hypertension not concomitantly treated with an ARB or ACEI were obtained in a controlled trial of Amturnide administered at the maximal dose of 300/10/25 mg compared to maximal doses of dual therapies, i.e., aliskiren/amlodipine 300/10 mg, aliskiren/HCTZ 300/25 mg and amlodipine/HCTZ 10/25 mg. RBC Count, Hemoglobin, and Hematocrit Small mean changes from baseline were seen in RBC count, hemoglobin and hematocrit in patients treated with Amturnide. This effect is also seen with other agents acting on the renin angiotensin system. In aliskiren monotherapy trials, these decreases led to slight increases in rates of anemia compared to placebo (0.1% for any aliskiren use, 0.3% for aliskiren 600 mg daily, versus 0% for placebo). No patients discontinued Amturnide because of anemia. Blood Urea Nitrogen (BUN)/Creatinine No patients with hypertension not concomitantly treated with an ARB or ACEI treated with Amturnide had elevations in BUN greater 40 mg/dL or creatinine greater 2.0 mg/dL. Liver Function Tests Occasional elevations (greater than 150% from baseline) in ALT (SGPT) were observed in 2.7% of patients treated with Amturnide, compared with 1.7% to 2.7% in patients treated with the dual combinations. No patients were discontinued due to abnormal liver function tests. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of either aliskiren, amlodipine or HCTZ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Aliskiren: Hypersensitivity: anaphylactic reactions and angioedema requiring airway management and hospitalization. Peripheral edema, severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, urticaria, hepatic enzyme increase with clinical symptoms of hepatic dysfunction, pruritus, erythema, nausea, vomiting. Amlodipine: The following postmarketing event has been reported infrequently where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. Hydrochlorothiazide (HCTZ): Acute renal failure, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasm, asthenia, acute angle-closure glaucoma, bone marrow failure, worsening of diabetes control, hypokalemia, blood lipids increased, hyponatremia, hypomagnesemia, hypercalcemia, hyperchloremic alkalosis, impotence, visual impairment. Pathological changes in the parathyroid gland of patients with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. If hypercalcemia occurs, further diagnostic evaluation is necessary.

Drug Interactions

No drug interaction studies have been conducted between Amturnide and other drugs. In a phase III sub-study, there was no clinically relevant change in the exposure of aliskiren, amlodipine, and HCTZ observed with Amturnide compared to the dual combinations of aliskiren and amlodipine, amlodipine and HCTZ, and aliskiren and HCTZ. Studies with the individual aliskiren, amlodipine, and HCTZ components are described below. Aliskiren Cyclosporine: Avoid coadministration of cyclosporine with aliskiren [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.3)]. Itraconazole: Avoid coadministration of itraconazole with aliskiren [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.3)]. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors with agents that affect the RAAS, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy. The antihypertensive effect of aliskiren may be attenuated by NSAIDs. Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS): The concomitant use of aliskiren with other agents acting on the RAAS such as ACEIs or ARBs is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with CrCl less than 60 mL/min. Monitor blood pressure, renal function, and electrolytes in patients on aliskiren and other agents that affect the RAAS [see Warnings and Precautions (5.4, 5.6, 5.9)]. The concomitant use of aliskiren with an ARB or an ACEI in diabetic patients is contraindicated [see Contraindications (4)]. Furosemide: Oral coadministration of aliskiren and furosemide reduced exposure to furosemide. Monitor diuretic effects when furosemide is coadministered with aliskiren. Amlodipine Simvastatin: Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily. CYP3A4 Inhibitors: Coadministration with CYP3A inhibitors (moderate and strong) result in increased systemic exposure to amlodipine warranting dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A4 inhibitors to determine the need for dose adjustment. CYP3A4 Inducers: No information is available on the quantitative effects of CYP3A4 inducers on amlodipine. Blood pressure should be monitored when amlodipine is coadministered with CYP3A4 inducers. HCTZ When administered concurrently, the following drugs may interact with thiazide diuretics. Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required. Lithium: Diuretic agents increase the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitoring of serum lithium levels is recommended during concomitant use. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and COX-2 selective agents: When Amturnide and NSAIDs are used concomitantly, observe the patient to determine if the desired effect of the diuretic is obtained. Ion-exchange Resins: Staggering the dosage of HCTZ and resin (e.g., cholestyramine, colestipol) such that HCTZ is administered at least 4 hours before or 4 to 6 hours after the administration of resins would potentially minimize the interaction [see Clinical Pharmacology (12.3)]. Cyclosporine or Itraconazole: Avoid concomitant use (5.10, 7, 12.3) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Increased risk of renal impairment and loss of antihypertensive effect. (7) Simvastatin: Avoid doses greater than 20 mg daily. (7) Antidiabetic Drugs: Antidiabetic dosage adjustment may be required. (7) Cholestyramine and Colestipol: Reduce absorption of thiazides. (7) Lithium: Increased risk of lithium toxicity when used with diuretics.(7)

Use In Specific Populations

Nursing Mothers: Discontinue drug or nursing. (8.3) 8.1 Pregnancy Pregnancy Category D [See Warnings and Precautions (5.1)] 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 neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Amturnide as soon as possible. These adverse outcomes are usually associated with use of drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Amturnide, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Amturnide for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4)]. Animal Data No reproductive toxicity studies have been conducted with the combination of aliskiren, amlodipine besylate and HCTZ. However, these studies have been conducted for aliskiren, amlodipine besylate, and HCTZ alone. Aliskiren In developmental toxicity studies, pregnant rats and rabbits received oral aliskiren hemifumarate during organogenesis at doses up to 20 and 7 times the maximum recommended human dose (MRHD) based on body surface area (mg/m2), respectively, in rats and rabbits. (Actual animal doses were up to 600 mg/kg/day in rats and up to 100 mg/kg/day in rabbits.) No teratogenicity was observed; however, fetal birth weight was decreased in rabbits at doses 3.2 times the MRHD based on body surface area (mg/m2). Aliskiren was present in placentas, amniotic fluid and fetuses of pregnant rabbits. Amlodipine No evidence of teratogenicity or embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day during their respective periods of major organogenesis. However, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose. HCTZ When pregnant mice and rats were given HCTZ at doses up to 3000 and 1000 mg/kg/day, respectively (about 600 and 400 times the MRHD), during their respective periods of major organogenesis, there was no evidence of fetal harm. Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. HCTZ, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of EPH (Edema, Proteinuria, Hypertension) gestosis (pre eclampsia), these drugs should not be used to treat hypertension in pregnant women. The use of HCTZ for other indications (e.g., heart disease) in pregnancy should be avoided. 8.3 Nursing Mothers It is not known whether aliskiren or amlodipine is excreted in human milk, but thiazides are excreted in human milk. Both aliskiren and amlodipine are secreted in the milk of lactating rats. Because of the potential for serious adverse reactions in human milk-fed infants from Amturnide, a decision should be made whether to discontinue nursing or discontinue Amturnide, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness of Amturnide in pediatric patients have not been established. Preclinical studies indicate a potential for substantial increase in exposure to aliskiren in pediatric patients [see Nonclinical Toxicology (13.2)]. Neonates with a history of in utero exposure to Amturnide If oliguria or hypotension occurs, direct attention towards support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. 8.5 Geriatric Use As individual components, exposure to aliskiren, amlodipine and HCTZ is increased in patients age 65 years and older. Consider starting with the lowest available dose of amlodipine. The lowest strength of Amturnide contains 5 mg of amlodipine [see Clinical Pharmacology (12.3)]. In the short-term controlled clinical trial of Amturnide, 19% of patients treated with Amturnide were 65 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Hepatic Impairment Exposure to amlodipine is increased in patients with hepatic insufficiency, thus consider using lower doses of Amturnide [see Clinical Pharmacology (12.3)]. Hydrochlorothiazide (HCTZ) Minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease. 8.7 Renal Impairment Exposure to HCTZ increases in patients with renal insufficiency, thus consider using lower doses of Amturnide [see Clinical Pharmacology (12.3)]. Safety and effectiveness of Amturnide in patients with severe renal impairment [creatinine clearance (CrCl) less than 30 mL/min] have not been established as these patients were excluded in clinical trials [see Warnings and Precautions (5.6), Clinical Pharmacology (12.3) and Clinical Studies (14)].

Always pay a fair price for your medication!

Our FREE Amturnide discount card helps you save money on the exact same Amturnide prescription you're already paying for. Print the card in seconds, then take it to your pharmacy the next time you get your Amturnide prescription filled. Hand it to them and save between 10% - 85% off this prescription!

7 Great Reasons To Print Your Amturnide Coupon Card Today

  • 100% FREE (no fees, ever)
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  • Everyone qualifies
  • Easy To Use
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  • Unlimited uses and no expiration date
  • Accepted at over 63,000 pharmacies nationwide!

Save on the cost of your prescription with our free Amturnide Discount Card

Be sure to ask your pharmacist not to substitute another card for ours as we are confident we offer the highest savings possible.

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