Exforge Hct Information
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz) Dosage And Administration
Dose once-daily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge hct (Amlodipine/valsartan/hctz) . The maximum recommended dose of Exforge hct (Amlodipine/valsartan/hctz) is 10/320/25 mg.
Exforge hct (Amlodipine/valsartan/hctz) may be administered with or without food.
No initial dosage adjustment is required for elderly patients.
Exforge hct (Amlodipine/valsartan/hctz) may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Exforge hct (Amlodipine/valsartan/hctz) may be switched to Exforge hct (Amlodipine/valsartan/hctz) containing a lower dose of that component to achieve similar blood pressure reductions.
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz) Use In Specific Populations
Pregnancy Category D
Valsartan, like other drugs that act on the renin angiotensin system, can cause fetal and neonatal morbidity and death when used during the second or third trimester of pregnancy. If Exforge hct (Amlodipine/valsartan/hctz) is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Angiotensin II receptor antagonists, like valsartan, and angiotensin converting enzyme (ACE) inhibitors exert similar effects on the renin-angiotensin system. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios was also reported, presumably from decreased fetal renal function. In this setting, oligohydramnios was associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus were also reported, although it is not clear whether these occurrences were due to exposure to the drug. In a retrospective study, first trimester use of ACE inhibitors, a specific class of drugs acting on the renin angiotensin system, was associated with a potential risk of birth defects.
When pregnancy occurs in a patient using Exforge hct (Amlodipine/valsartan/hctz) , the physician should discontinue Exforge hct (Amlodipine/valsartan/hctz) treatment as soon as possible. The physician should inform the patient about potential risks to the fetus based on the time of gestational exposure to Exforge hct (Amlodipine/valsartan/hctz) (first trimester only or later). If exposure occurs beyond the first trimester, an ultrasound examination should be done.
In rare cases when another antihypertensive agent can not be used to treat the pregnant patient, serial ultrasound examinations should be performed to assess the intraamniotic environment. Routine fetal testing with non-stress tests, biophysical profiles, and/or contraction stress tests may be appropriate based on gestational age and standards of care in the community. If oligohydramnios occurs in these situations, individualized decisions about continuing or discontinuing Exforge hct (Amlodipine/valsartan/hctz) treatment and about pregnancy management should be made by the patient, her physician, and experts in the management of high risk pregnancy. Patients and physicians should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with histories of in utero exposure to Exforge hct (Amlodipine/valsartan/hctz) should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, these infants may require blood pressure and renal perfusion support. Exchange transfusion or dialysis may be required to reverse hypotension and/or support decreased renal function.
Healthcare professionals who prescribe drugs acting directly on the renin angiotensin system should counsel women of childbearing potential about the risks of these agents during pregnancy [see(13.3)].
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz) clinical Studies
Exforge hct (Amlodipine/valsartan/hctz) was studied in a double-blind, active controlled study in hypertensive patients. A total of 2,271 patients with moderate to severe hypertension (mean baseline systolic/diastolic blood pressure was 170/107 mmHg) received treatments of amlodipine/valsartan/HCTZ 10/320/25 mg, valsartan/HCTZ 320/25 mg, amlodipine/valsartan 10/320 mg, or HCTZ/amlodipine 25/10 mg. At study initiation patients assigned to the two-component arms received lower doses of their treatment combination while patients assigned to the Exforge hct (Amlodipine/valsartan/hctz) arm received 160/12.5 mg valsartan/hydrochlorothiazide. After one week, Exforge hct (Amlodipine/valsartan/hctz) patients were titrated to 5/160/12.5 mg amlodipine/valsartan/hydrochlorothiazide, while all other patients continued receiving their initial doses. After two weeks, all patients were titrated to their full treatment dose. A total of 55% of patients were male, 14% were 65 years or older, 72% were Caucasian, and 17% were Black.
At week 8, the triple combination therapy produced greater reductions in blood pressure than each of the three dual combination treatments (p
A subgroup of 283 patients was studied with ambulatory blood pressure monitoring. The blood pressure lowering effect in the triple therapy group was maintained throughout the 24-hour period (see Figure 4 and Figure 5).
There are no trials of the Exforge hct (Amlodipine/valsartan/hctz) combination tablet demonstrating reductions in cardiovascular risk in patients with hypertension, but both the amlodipine and hydrochlorothiazide components and several ARBs, which are the same pharmacological class as the valsartan component, have demonstrated such benefits.
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
Exforge hct (Amlodipine/valsartan/hctz)
