Amlodipine Valsartan And Hydrochlorothiazide (Exforge Hct)

Trade Name : Exforge HCT

Novartis Pharmaceuticals Corporation

TABLET, FILM COATED

Strength 516012.5 mg/1mg/1mg/1

Storage and handling for Exforge HCT

AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amlodipine Valsartan And Hydrochlorothiazide (Exforge Hct) which is also known as Exforge HCT and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 5; 160; 12.5 mg/1; mg/1; mg/1 per ml. Read more

Amlodipine Valsartan And Hydrochlorothiazide (Exforge Hct) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

WARNING: FETAL TOXICITY
See full prescribing information for complete boxed warning.

When pregnancy is detected, discontinue Exforge HCT as soon as possible. ()
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()

ntttttttExforge HCT (amlodipine, valsartan, hydrochlorothiazide) 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, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT.ntttttt
ntttttttControl 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 Programu2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).ntttttt
ntttttttNumerous 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 also have been seen regularly. ntttttt
ntttttttElevated 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. ntttttt
ntttttttSome 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.ntttttt
Limitation of Use
Exforge HCT is not indicated for the initial therapy of hypertension .
Exforge HCT is a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. Exforge HCT 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. ()ntttttttt
Limitation of Use
Exforge HCT is not indicated for initial treatment of hypertension.

No data

Dose once-daily. Titrate up to a maximum dose of 10/320/25 mgn
Exforge HCT may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.n
Exforge HCT may be substituted for its individually titrated components ()

Tablets: (amlodipine/valsartan/hydrochlorothiazide mg) 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25, 10/320/25 ()

ntttttttDo not use in patients with anuria, hypersensitivity to other sulfonamide-derived drugs, or hypersensitivity to any component of this product.ntttttt
ntttttttDo not coadminister aliskiren with Exforge HCT in patients with diabetes .ntttttt

Anuria ()
Hypersensitivity to sulfonamide-derived drugs ()
Known hypersensitivity to any component ()
Do not coadminister aliskiren with Exforge HCT in patients with diabetes ()

No data

Hypotension: Correct volume depletion prior to initiation ()n
Increased angina and/or myocardial infarction ()n
Monitor renal function and potassium in susceptible patients (, )n
Exacerbation or activation of systemic lupus erythematosus ()n
Observe for signs of fluid or electrolyte imbalance ()n
Acute angle-closure glaucoma ()

Most common adverse events (u2265 2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea, and nasopharyngitis. ()

No drug interaction studies have been conducted with Exforge HCT and other drugs, although studies have been conducted with the individual components. A pharmacokinetic drug-drug interaction study has been conducted to address the potential for pharmacokinetic interaction between the triple combination, Exforge HCT, and the corresponding 3 double combinations. No clinically relevant interaction was observed.
Amlodipine
Impact of other Drugs on Amlodipine
CYP3A Inhibitors
Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment .
CYP3A Inducers
No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is coadministered with CYP3A inducers (e.g., rifampicin, St. Johnu2019s Wort).
Sildenafil
Monitor for hypotension when sildenafil is coadministered with amlodipine [see Clinical Pharmacology (12.2)].
Impact of Amlodipine on Other Drugs
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 .
Immunosuppressants
Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate .
Valsartan
Agents Increasing Serum Potassium:
Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors):
The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR <60 mL/min).
Valsartan u2013 Hydrochlorothiazide
Lithium:
Hydrochlorothiazide
When administered concurrently the following drugs may interact with thiazide diuretics:
Antidiabetic drugs (oral agents and insulin):
Non-Steroidal Anti-inflammatory Drugs
Carbamazepine:
Ion exchange resins:n- [see Clinical Pharmacology (12.3)]
Cyclosporine:

If simvastatin is coadministered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin ()n
Antidiabetic drugs: Dosage adjustment of antidiabetic may be required ()n
Cholestyramine and colestipol: Reduced absorption of thiazides ()n
Lithium: Increased risk of lithium toxicity. Monitor serum lithium concentrations during concurrent use. ()n
Non-Steroidal Anti-Inflammatory Drug (NSAID) use may lead to increased risk of renal impairment and loss of anti-hypertensive effect ()
Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ()

Lactation:
Geriatric Patients:
Hepatic Impairment:

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur institute supportive treatment.
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, initiate cardiovascular support including elevation of the extremities and the judicious administration of fluids. 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
Depressed level of consciousness, circulatory collapse, and shock have been reported.
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 salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the MRHD on a mg/m basis) (Calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Hydrochlorothiazide
The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The most common signs and symptoms observed in patients are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
The oral LD of hydrochlorothiazide is greater than 10u00a0g/kg in both mice and rats, 2000 and 4000 times, respectively, the MRHD on au00a0mg/m basis (Calculations assume an oral dose of 25u00a0mg/day and a 60-kg patient).
Valsartan and Hydrochlorothiazide
In rats and marmosets, single oral doses of valsartan up to 1524 and 762u00a0mg/kg in combination with hydrochlorothiazide at doses up to 476 and 238u00a0mg/kg, respectively, were very well tolerated without any treatment-related effects. These no adverse effect doses in rats and marmosets, respectively, represent 46.5 and 23 times the MRHD of valsartan and 188 and 113 times the MRHD of hydrochlorothiazide on au00a0mg/mbasis. (Calculations assume an oral dose of 320u00a0mg/day valsartan in combination with 25u00a0mg/day hydrochlorothiazide and a 60 kg patient.)

Exforge HCT is a fixed combination of amlodipine, valsartan, and hydrochlorothiazide.
Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylateu2019s chemical name is 3-Ethyl 5-methyl (u00b1)-2-[(2-aminoethoxy)methyl]-4-(-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate; its structural formula is:
Its empirical formula is CHClNOu2022CHOS and its molecular weight is 567.1.
Valsartan, USP 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. Valsartanu2019s chemical name is N-(1-oxopentyl)-N-[[2u2032-(1-tetrazol-5-yl)[1,1u2032-biphenyl]-4-yl]methyl]-L-valine; its structural formula is:
Its empirical formula is CHNO and its molecular weight is 435.5.
Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is CHClNOS, its molecular weight is 297.73, and its structural formula is:
Exforge HCT film-coated tablets are formulated in 5 strengths for oral administration with a combination of amlodipine besylate,u00a0valsartan, and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets includeu00a0microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000, and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide, and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide.

No data

Studies with amlodipine/valsartan/hydrochlorothiazide:
Studies with amlodipine:
Mutagenicity studies conducted with amlodipine maleate revealed no drug-related effects atu00a0either the gene or chromosome level.
There was no effect on the fertility of rats treated orally with amlodipine maleate (males foru00a064 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/dayu00a0(about 10 times the MRHD of 10 mg/day on a mg/mbasis).
Studies with valsartan:
Mutagenicity assays did not reveal any valsartan-related effects at either the gene oru00a0chromosome level. These assays included bacterial mutagenicity tests with Salmonella and E.u00a0coli, a gene mutation test with Chinese hamster V79 cells, a cytogenetic test with Chineseu00a0hamster ovary cells, and a rat micronucleus test.
Valsartan had no adverse effects on the reproductive performance of male or female rats atu00a0oral doses of up to 200 mg/kg/day. This dose is about 6 times the MRHD on a mg/mu00a0basis.
Studies with hydrochlorothiazide:
Hydrochlorothiazide was not genotoxic in the Ames mutagenicity assay of Salmonella Typhimurium strains TAu00a098, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained in the CHO Sister Chromatid Exchange (clastogenicity) and Mouse Lymphoma Cell (mutagenicity) assays and in the Aspergillus Nidulans non-disjunction assay.
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed via diet at doses of up to 100 and 4u00a0mg/kg, respectively, prior to mating and throughout gestation. These doses of hydrochlorothiazide in mice and rats are 19 and 1.5 times, respectively, the MRHD on au00a0mg/m basis (Calculations assume an oral dose of 25u00a0mg/day and a 60-kg patient).

Exforge HCT was studied in a double-blind, active controlled study in hypertensive patients. A total of 2271 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,u00a0valsartan/HCTZ 320/25 mg, amlodipine/valsartan 10/320 mg, or HCTZ/amlodipine 25/10 mg. At study initiation, patients assigned to the 2-component arms received lower doses of their treatment combination while patients assigned to the Exforge HCT arm received 160/12.5 mg valsartan/hydrochlorothiazide. After 1 week, Exforge HCT patients were titrated to 5/160/12.5 mg amlodipine/valsartan/hydrochlorothiazide, while all other patients continued receiving their initial doses. After 2 weeks, all patients were titrated to their full treatment dose. A total of 55% of patients were male, 14%u00a0were 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 3 dual combination treatments (pu00a0<0.0001 for both diastolic and systolic blood pressures reductions). The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mmHg greater than with valsartan/HCTZ, 6.2/3.3 mmHg greater than with amlodipine/valsartan, and 8.2/5.3 mmHg greater than with amlodipine/HCTZ (see Figure 1). The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT (see Figure 2 and Figure 3). As the pivotal study was an active-controlled trial, the treatment effects shown in Figures 1, 2, and 3 include a placebo effect of unknown size.
A subgroup of 283u00a0patients 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 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, hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. All strengths are packaged in bottles of 30 tablets.
5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets u2013 White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing u201cNVRu201d on one side and u201cVCLu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0559-15
10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets u2013 Pale yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing u201cNVRu201d on one side and u201cVDLu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0561-15
5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets u2013 Yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing u201cNVRu201d on one side and u201cVELu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0560-15
10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets u2013 Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing u201cNVRu201d on one side and u201cVHLu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0562-15
10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets u2013 Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing u201cNVRu201d on one side and u201cVFLu201d on the other side.
ntttttttu00a0u00a0u00a0u00a0u00a0ntttttttBottles of 30ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0563-15
Store at 20u00b0C-25u00b0C (68u00b0F-77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [see USP controlled room temperature].
Protect from moisture.
Dispense in tight container (USP).

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy:n- [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]
Lactation:n- [see Use in Specific Populations (8.2)]
Symptomatic Hypotension:n- [see Warnings and Precautions (5.2)]
Potassium Supplements:n- [see Drug Interactions (7)]
T2020-26

Information for Patients
Patient Information
Exforge HCT (X-phorj HCT)
Read the Patient Information that comes with EXFORGE HCT before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about EXFORGE HCT?
What is EXFORGE HCT?
EXFORGE HCT contains 3 prescription medicines:
EXFORGE HCT may be used to lower blood pressure in adults when 2 medicines to lower your high blood pressure are not enough.
EXFORGE HCT has not been studied in children under 18 years of age.
Who should not take EXFORGE HCT?
Do not take EXFORGE HCT if you have low or no urine output (anuria).
What should I tell my doctor before taking EXFORGE HCT?
Tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines and EXFORGE HCT could affect each other, causing serious side effects.
Especially tell your doctor if you take:
Know the medicines you take. Keep a list of your medicines and show it to your doctor or pharmacist when you get a new medicine.
How should I take EXFORGE HCT?
What are the possible side effects of EXFORGE HCT?
EXFORGE HCT may cause including:
Lie down if you feel faint or dizzy. If you faint (lose consciousness), stop taking EXFORGE HCT. Call your doctor right away.
The side effects of EXFORGE HCTu00a0include:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of EXFORGE HCT. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store EXFORGE HCT?
Keep EXFORGE HCT and all medicines out of the reach of children.
General Information about EXFORGE HCT
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use EXFORGE HCT for a condition for which it was not prescribed. Do not give EXFORGE HCT to other people, even if they have the same symptoms that you have. It may harm them.
This patient information leaflet summarizes the most important information about EXFORGE HCT. If you would like more information about EXFORGE HCT, talk with your doctor. You can ask your doctor or pharmacist for information about EXFORGE HCT that is written for health professionals. For more information, go to www.EXFORGE.com or call 1-888-839-3674.u00a0
What are the ingredients in EXFORGE HCT?
Active ingredients: amlodipine besylate, valsartan, and hydrochlorothiazide
The inactive ingredients of all strengths of the tablets are crospovidone, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous silica. The film coating contains hypromellose, talc, macrogol 4000, and may contain titanium dioxide or yellow and red iron oxides.
What is high blood pressure (hypertension)?
Blood pressure is the force of blood in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. EXFORGE HCT can help your blood vessels relax so your blood pressure is lower. Medicines that lower blood pressure lower your chance of having a stroke or heart attack.
High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9u00a0Novartis
T2020-27Revised: March 2020

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 5 mg / 160 mg / 12.5 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0559-15
Exforge HCTu00ae
(amlodipine, valsartan, hydrochlorothiazide)
5 mg* / 160 mg / 12.5 mg
*each tablet contains 6.9 mg of amlodipine besylate
30 Tablets

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 10n- mg / 160 mg / 12.5 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0561-15
Exforge HCTu00ae
(amlodipine, valsartan, hydrochlorothiazide)
10 mg* / 160 mg / 12.5 mg
*each tablet contains 13.9 mg of amlodipine besylate
30 Tablets

PRINCIPAL DISPLAY PANEL
Package Label u2013 5 mg / 160 mg / 25 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0560-15
Exforge HCTu00ae
(amlodipine, valsartan, hydrochlorothiazide)
5 mg* / 160 mg / 25 mg
*each tablet contains 6.9 mg of amlodipine besylate
30 Tablets

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 10n- mg / 160 mg / 25 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0562-15
Exforge HCTu00ae
(amlodipine, valsartan, hydrochlorothiazide)
10 mg* / 160 mg / 25 mg
*each tablet contains 13.9 mg of amlodipine besylate
30 Tablets

PRINCIPAL DISPLAY PANEL
Package Label u2013 n- 10n- mgn- / 32n- 0 mg / 25 mg
Rx Onlyntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttNDC 0078-0563-15
Exforge HCTu00ae
(amlodipine, valsartan, hydrochlorothiazide)
10 mg* / 320 mg / 25 mg
*each tablet contains 13.9 mg of amlodipine besylate
30 Tablets

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