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Exforge
Overview
What is Exforge?
Exforge is a fixed combination of amlodipine and valsartan.
Exforge contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is:
Its empirical formula is CHClNO•CHOS and its molecular weight is 567.1.
Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is:
Its empirical formula is CHNO and its molecular weight is 435.5.
Exforge tablets are formulated in 4 strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.
The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.
What does Exforge look like?
What are the available doses of Exforge?
Tablets (amlodipine/valsartan mg): 5/160, 10/160, 5/320, 10/320 ()
What should I talk to my health care provider before I take Exforge?
Nursing Mothers:
Geriatric Patients:
Hepatic Impairment:
How should I use Exforge?
Exforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge 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.
Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.
Exforge may be administered with or without food.
Exforge may be administered with other antihypertensive agents.
What interacts with Exforge?
Sorry No Records found
What are the warnings of Exforge?
Sorry No Records found
What are the precautions of Exforge?
Sorry No Records found
What are the side effects of Exforge?
Sorry No records found
What should I look out for while using Exforge?
Do not use in patients with known hypersensitivity to any component.
Do not coadminister aliskiren with Exforge in patients with diabetes .
What might happen if I take too much Exforge?
Amlodipine
Single oral doses of amlodipine maleate equivalent to 40 mg/kg and 100 mg/kg amlodipine in mice and rats, respectively, caused deaths. Single oral doses equivalent to 4 or more mg/kg amlodipine in dogs (11 or more times the maximum recommended human dose on a mg/m basis) caused a marked peripheral vasodilation and hypotension.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension. In humans, experience with intentional overdosage of amlodipine is limited. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
Valsartan
Limited data are available related to overdosage in humans. The most likely effect of overdose with valsartan would be peripheral vasodilation, hypotension, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse, and shock have been reported. If symptomatic hypotension should occur, supportive treatment should be instituted.
Valsartan is not removed from the plasma by hemodialysis.
Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for the salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 37 times, respectively, the maximum recommended human dose (MRHD) on a mg/m basis). (Calculations assume an oral dose of 320 mg/day and a 60 kg patient.)
How should I store and handle Exforge?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture. Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.All strengths are packaged in bottles of 30 tablets.5/160 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side. Bottles of 30 NDC 0078-0488-1510/160 mg Tablets - light yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “UIC” on the other side. Bottles of 30 NDC 0078-0489-155/320 mg Tablets - very dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side. Bottles of 30 NDC 0078-0490-1510/320 mg Tablets - dark yellow, ovaloid shaped, film-coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side. Bottles of 30 NDC 0078-0491-15Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Amlodipine
Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Valsartan
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.
There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT receptor than for the AT receptor. The increased plasma levels of angiotensin following AT receptor blockade with valsartan may stimulate the unblocked AT receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT receptor about one-200 that of valsartan itself.
Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II), it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.
Non-Clinical Toxicology
Do not use in patients with known hypersensitivity to any component.Do not coadminister aliskiren with Exforge in patients with diabetes .
The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Concomitant use of isosorbide dinitrate with phosphodiesterase inhibitors in any form is contraindicated (see ).
Concomitant use of isosorbide dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see ).
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 Exforge as soon as possible .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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