Amlodipine and Valsartan

Overview

Amlodipine and Valsartan reduce the strain on a heart that can be caused by long-term hypertension by lowering the blood pressure. Amlodipine works to reduce the workload on the heart by relaxing the blood vessels, providing more blood flow and oxygen to the heart.

Valsartan also relaxes the blood vessels, but uses a different method of blocking a chemical that normally causes blood vessels to constrict.

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.

Combined, Amlodipine and Valsartan work to reduce blood pressure which in turn may reduce a patient’s risk of atherosclerosis or arteriosclerosis, kidney failure, stroke and fatal and non-fatal myocardial infarctions. Estimates from a study indicate that when used in a combined format, Amlodipine and Valsartan have a higher probability of the patient reaching a more tolerable systolic and diastolic blood pressure than when used alone. Amlodipine and valsartan tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Conditions Treated

  • Hypertension

Type of Medication

  • Calcium Channel Blocker
  • Angiotensin II Receptor Blocker

Side Effects

The most common side effect experienced with Amlodipine/Valsartan was peripheral edema. Primarily this swelling occurred in the hands, feet, and legs but some patients also experience swelling in the facial area. If at any point while taking this medication, should a patient experience facial edema, especially near the mouth, they need to seek immediate medical help. Another common side effect was rapid weight gain. Tingling sensations may be felt in the extremities. A patient may experience weight gain or loss when starting this medication.

Less common effects that have been reported when using Exforge are body aches, chills, weakness, feeling tired, ear congestion, headache, fever, loss of voice, dizziness, cough, and difficulty breathing.

Some patients have reported the following side effects, but they were rarer.

Sensory-related:

  • Burning sensation in skin
  • Itching skin
  • Crawling sensation in skin
  • Prickling “pins and needles” sensation in skin
  • Gastrointestinal-related:
  • Diarrhea
  • Indigestion
  • Nausea
  • Loss of appetite
  • Stomach cramps and/or pain
  • Bloody diarrhea
  • Vomiting
  • Dry mouth
  • Cardiac-related:
  • Chest pain
  • Orthostatic dizziness
  • Irregular heart beat
  • Fast heart rate
  • Ponding heart beat
  • Heart murmur
  • Tightness in chest
  • Vision-related:
  • Blurred
  • Loss of vision
  • Difficulty in perceiving colors

Pain-related:

  • Burning sensation in chest or stomach
  • Pain in lower back
  • Pain in bottom/hips
  • Pain in upper leg
  • Tenderness around eye/cheekbones

Urinary-related:

  • Bloody urine
  • Cloudy urine
  • Difficulty urinating
  • Painful urination
  • Burning sensation while urinating

Respiratory-related:

  • Congestion
  • Productive cough

Skin-related:

  • Cold sweats
  • Flushed skin
  • Dry skin
  • Hives
  • Rash
  • Sweating
  • Redness

Neurologically-related:

  • Confusion
  • Weakness

Miscellaneous:

  • Sinus congestion
  • Edema to facial area
  • Hoarseness

If the patient experiences any of the following side effects, they should seek immediate medical attention:

  • Lightheadedness
  • Fainting
  • Chest discomfort
  • Fast or weak pulse
  • Slow heartbeat
  • Flushing
  • Facial edema

In other studies, these medications have produced additional side effects. It has not been determined if the side effect was fully caused by the medications Amlodipine and Valsartan or if there was another causative factor.

Blood and Lymphatic Disorders: leukopenia, purpura, thrombocytopenia, lymphadenopathy, decrease in hemoglobin and hematocrit levels, and neutropenia.

Cardiac Disorders: palpitations, tachycardia, arrhythmia including ventricular tachycardia and atrial fibrillation, bradycardia, chest pain, peripheral ischemia, syncope, postural hypotension, and vasculitis.

Dermatologic Disorders: angioedema, erythema multiforme, rash erythematous, rash maculopapular, alopecia, bullous dermatitis.

Ear and Labyrinth Disorders: Ear pain, tinnitus

Gastrointestinal Disorders: Constipation, vomiting, diarrhea, dyspepsia, abdominal pain, gastritis, distension, colitis, anorexia, dysphagia, pancreatitis, gingival hyperplasia, and hepatitis.

General Disorders: Fatigue, asthenia, pitting edema, pyrexia, allergic reaction, hot flushes, malaise, rigors, weight gain and/or loss.

Infections: Nasopharyngitis, sinusitis, bronchitis, gastroenteritis, pharyngotonsillitis, acute bronchitis, and tonsillitis.

Injury: Epicondylitis, joint pain.

Metabolic Disorders: Arthralgia, muscle spasms, extremity pain, myalgia, osteoarthritis, joint swelling, musculoskeletal chest pain, arthrosis.

Metabolism and Nutrition Disorders: Gout, non-insulin dependent diabetes mellitus hypercholesterolemia, hyperglycemic, and thirst.

Nervous System Disorders: Headaches, sciatica, paresthesia, cervicobrachial syndrome, carpal tunnel syndrome, hypoesthesia, somnolence, peripheral neuropathy, and tremors.

Ocular Disorders: Diplopia, conjunctivitis

Psychiatric Disorders: Insomnia, anxiety, depression, sexual dysfunction in both make and females, nervousness, abnormal dreams, and depersonalization.

Respiratory Disorders: Dyspnea, sinusitis, pharyngitis

Urinary-Genital Disorders: Micturition frequency, nocturia, impotence, impaired renal function, and renal failure.

Lab Values: Increased levels found in:

  • Creatinine
  • Liver enzymes
  • Serum potassium
  • Blood urea nitrogen

Vascular Disorders: rhabdomyolysis

Many of these side effects were seen in an extremely small number of patients. As with any medication, side effects may be experienced. The patient’s medical team will take into consideration if the potential risks of any side effects outweigh the potential benefit in treating hypertension with this method. It will be up to the patient or caregiver to decide if the benefit outweighs any risks.

Dosage

As with any medication, patients should take this medication exactly as prescribed by their physician. Do not take excess medication or miss dosages. If the patient accidently takes more than prescribed, they should contact their medical provider or 911 if previously indicated.

If the patient misses a dose, they need to refer to the directions as to when they should take next dose. Habitually missing doses can cause serious problems and will reduce the effect of the medicine.

The following are the dosages for Amlodipine and Valsartan 5 mg-160 mg; 10 mg-160 mg; 5 mg-320 mg; 10 mg-320 mg.

Initially the patient will be started on the Amlodipine 5mg and Valsartan 160mg dose once daily. If needed, the dosage may be increased after 1 to 2 weeks of initial therapy. Most of the antihypertensive effect will be achieved within two weeks of initial therapy or a dosage change.

If the patient should experience any dose-related adverse reactions, may be dropped to a lower dose. If the blood pressure remains uncontrolled, the dose may be increased to a maximum of 10/320mg, titrating to effects.

Amlodipine and Valsartan may be taken with or without food. Other hypertensive medications may be used in conjunction with Amlodipine and Valsartan.

If the patient exhibits signs or symptoms of an overdose, such as severe chest pain, extreme dizziness or shortness of breath, or unconsciousness, immediately call 911.

Major Drug Interactions

All drugs interact with other drugs. Some have minor effects while others can produce severe reactions or completely negate the intended effect. Over-the-counter medications and even natural supplements can cause adverse reactions in a patient. It is imperative that a patient inform their doctor of every medication, whether prescribed, OTC, or natural supplements, and the dosages, routes, and frequency. Some medications can be taken concomitantly with other medicines but have restrictions as to when they can be taken together.

Patients are advised to keep current and up-to-date lists including all medications, OTC medicines, and natural supplements. Dosages, routes, and frequency should be included for all items. The patient is advised to supply a copy to their doctor and make sure before any new medication is taken, that the doctor is aware of all current medicines.

With many patients have multiple doctors and providers, the danger of using multiple medications has increased and all precautions should be taken by all parties involved to insure no adverse interactions take place. Alcohol, tobacco, and illegal drugs can all cause harmful interactions and need to be discussed with physician.

Following are some medications known to have major interactions with Amlodipine and Valsartan:

  • Accupril (quinapril)
  • Accuretic (hydrochlorothiazide / quinapril)
  • Aceon (perindopril)
  • Aldactazide (hydrochlorothiazide / spironolactone)
  • Aldactone (spironolactone)
  • Aliskiren
  • Aliskiren / amlodipine
  • Aliskiren / amlodipine / hydrochlorothiazide
  • Aliskiren / valsartan
  • Alka-Seltzer Gold (citric acid / potassium bicarbonate / sodium bicarbonate)
  • Altace (ramipril)
  • Amiloride
  • Amiloride / hydrochlorothiazide
  • Aminophylline / ephedrine / phenobarbital / potassium iodide
  • Aminosyn II 3.5%-Dextrose 25%,Electrolytes,Ca (parenteral nutrition solution w/ electrolytes)
  • Aminosyn II 4.25%-Dextrose 25%,Electrolyte,Ca (parenteral nutrition solution w/ electrolytes)
  • Aminosyn II with Electrolytes Sulfite-Free (parenteral nutrition solution w/ electrolytes)
  • Aminosyn with Electrolytes (parenteral nutrition solution w/ electrolytes)
  • Aminosyn with Electrolytes Sulfite-Free (parenteral nutrition solution w/ electrolytes)
  • Amlobenz (amlodipine / benazepril)
  • Amlodipine / benazepril
  • Amlodipine / perindopril
  • Amturnide (aliskiren / amlodipine / hydrochlorothiazide)
  • Anzemet (dolasetron)
  • Av-Phos 250 Neutral (potassium phosphate / sodium phosphate)
  • Azuphen MB (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Bactrim (sulfamethoxazole / trimethoprim)
  • Bactrim DS (sulfamethoxazole / trimethoprim)
  • Bactrim IV (sulfamethoxazole / trimethoprim)
  • Bactrim Pediatric (sulfamethoxazole / trimethoprim)
  • Benazepril
  • Benazepril / hydrochlorothiazide
  • Bethaprim (sulfamethoxazole / trimethoprim)
  • Bethaprim Pediatric (sulfamethoxazole / trimethoprim)
  • Bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride
  • Bisacodyl / sodium biphosphate / sodium phosphate
  • Buffered Salt (potassium chloride / sodium chloride)
  • Capoten (captopril)
  • Capozide (captopril / hydrochlorothiazide)
  • Captopril
  • Captopril / hydrochlorothiazide
  • CaroSpir (spironolactone)
  • Cena K (potassium chloride)
  • Chlorpheniramine / codeine / phenylephrine / potassium iodide
  • Citric acid / potassium bicarbonate
  • Citrolith (potassium citrate / sodium citrate)
  • Clinimix E Sulfite Free (parenteral nutrition solution w/ electrolytes)
  • Co-trimoxazole (sulfamethoxazole / trimethoprim)
  • Cotrim (sulfamethoxazole / trimethoprim)
  • Cotrim DS (sulfamethoxazole / trimethoprim)
  • Cotrim Pediatric (sulfamethoxazole / trimethoprim)
  • Demi-Cof (chlorpheniramine / codeine / phenylephrine / potassium iodide)
  • Dextrose 10% and Electrolyte No 48 (lvp solution with potassium)
  • Dextrose 5% And Electrolyte No. 48 Injection (lvp solution with potassium)
  • Diltiazem / enalapril
  • Disposable Enema (sodium biphosphate / sodium phosphate)
  • Dolasetron
  • Dyazide (hydrochlorothiazide / triamterene)
  • Dyrenium (triamterene)
  • Ed K+10 (potassium chloride)
  • Effervescent Potassium / Chloride (potassium bicarbonate / potassium chloride)
  • Elixophyllin KI (potassium iodide / theophylline)
  • Enalapril / felodipine
  • Enalapril / hydrochlorothiazide
  • Ephedrine / phenobarbital / potassium iodide / theophylline
  • Ephedrine / potassium iodide
  • Epiklor (potassium chloride)
  • Ezetimibe / simvastatin
  • Fleet Enema (sodium biphosphate / sodium phosphate)
  • Fleet EZ-Prep (sodium biphosphate / sodium phosphate)
  • Fleet Phospho Soda (sodium biphosphate / sodium phosphate)
  • FloLipid (simvastatin)
  • Fosinopril
  • Freamine III with Electrolytes (parenteral nutrition solution w/ electrolytes)
  • HalfLytely and Bisacodyl (bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride)
  • Hydrochlorothiazide / Lisinopril
  • Hydrochlorothiazide / Moexipril
  • Hydrochlorothiazide / Quinapril
  • Hydrochlorothiazide / Spironolactone
  • Hydrochlorothiazide / Triamterene
  • Hyolev MB (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Indiomin MB (hyoscyamine / methenamine / methylene blue / sodium biphosphate)
  • Iodine / potassium iodide
  • Ionosol B and 5% Dextrose (lvp solution with potassium)
  • Ionosol MB and 5% Dextrose (lvp solution with potassium)
  • Ionosol T and 5% Dextrose (lvp solution with potassium)
  • Iosat (potassium iodide)
  • Isolyte E (lvp solution with potassium)
  • IsonaRif (isoniazid / rifampin)
  • Isoniazid / pyrazinamide / rifampin
  • Isoniazid / rifampin
  • Itraconazole
  • Juvisync (simvastatin / sitagliptin)
  • Kabiven (parenteral nutrition solution w/ electrolytes)
  • Kal Potassium 99 (potassium chloride)
  • Kaochlor (potassium chloride)
  • Kaon (potassium gluconate)
  • Kato (potassium chloride)
  • Kay Ciel (potassium chloride)
  • KCl (potassium chloride)
  • KIE (ephedrine / potassium iodide)
  • Klor-Con (potassium chloride)
  • Klor-Con 10(potassium chloride)
  • Klor-Con 8 (potassium chloride)
  • Klorvess (potassium chloride)
  • Klorvess Effervescent (potassium bicarbonate / potassium chloride)
  • Klotrix (potassium chloride)
  • Lexxel (enalapril / felodipine)
  • Lidocaine / potassium chloride
  • Lisinopril
  • Lotensin (benazepril)
  • Lotensin HCT (benazepril / hydrochlorothiazide)
  • Lotrel (amlodipine / benazepril)
  • Lugol's (iodine / potassium iodide)
  • lvp solution with potassium
  • Mavik (trandolapril)
  • Maxzide (hydrochlorothiazide / triamterene)
  • Maxzide-25 (hydrochlorothiazide / triamterene)
  • Methenamine / sodium biphosphate
  • Micro-K (potassium chloride)
  • Micro-K 10 (potassium chloride)
  • Midamor (amiloride)
  • Moduretic (amiloride / hydrochlorothiazide)
  • Moduretic 5-50 (amiloride / hydrochlorothiazide)
  • moexipril
  • Monopril (fosinopril)
  • Monopril HCT (fosinopril / hydrochlorothiazide)
  • Mudrane (aminophylline / ephedrine / phenobarbital / potassium iodide)
  • Mycobutin (rifabutin)
  • Neutra-Phos (potassium phosphate / sodium phosphate)
  • Neutra-Phos-K (potassium phosphate)
  • Niacin / simvastatin
  • Normosol-M and 5% Dextrose (lvp solution with potassium)
  • Onmel (itraconazole)
  • OsmoPrep (sodium biphosphate / sodium phosphate)
  • Parenteral nutrition solution w/ electrolytes
  • PC-10 (potassium chloride)
  • Pedia-Lax Enema (sodium biphosphate / sodium phosphate)
  • Pediacof (chlorpheniramine / codeine / phenylephrine / potassium iodide)
  • Pedituss (chlorpheniramine / codeine / phenylephrine / potassium iodide)
  • Perikabiven (parenteral nutrition solution w/ electrolytes)
  • Perindopril
  • PHOS-NaK (potassium phosphate / sodium phosphate)
  • Phospha 250 Neutral (potassium phosphate / sodium phosphate)
  • Phosphasal (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Phosphate Laxative (sodium biphosphate / sodium phosphate)
  • Phospho-Trin 250 Neutral (potassium phosphate / sodium phosphate)
  • Pima (potassium iodide)
  • Plasma-Lyte 56 (lvp solution with potassium)
  • Poly-Citra K Crystals (citric acid / potassium citrate)
  • Potassium acetate / potassium bicarbonate / potassium citrate
  • Potassium acid phosphate
  • Potassium bicarbonate / potassium chloride
  • Potassium bicarbonate / potassium citrate
  • Potassium chloride
  • Potassium gluconate
  • Potassium iodide
  • Potassium iodide / theophylline
  • Potassium phosphate / sodium phosphate
  • Prestalia (amlodipine / perindopril)
  • Primsol (trimethoprim)
  • Prinivil (lisinopril)
  • Prinzide (hydrochlorothiazide / lisinopril)
  • Procalamine (parenteral nutrition solution w/ electrolytes)
  • Proloprim (trimethoprim)
  • Qbrelis (lisinopril)
  • Quadrinal (ephedrine / phenobarbital / potassium iodide / theophylline)
  • Quick-K (potassium bicarbonate)
  • Quinapril
  • Quinaretic (hydrochlorothiazide / quinapril)
  • ramipril
  • Rifabutin
  • Rifadin (rifampin)
  • Rifamate (isoniazid / rifampin)
  • Rifater (isoniazid / pyrazinamide / rifampin)
  • Rimactane (rifampin)
  • Rum-K (potassium chloride)
  • Septra (sulfamethoxazole / trimethoprim)
  • Simcor (niacin / simvastatin)
  • Simvastatin
  • Simvastatin / sitagliptin
  • Slow-K (potassium chloride)
  • SMZ-TMP DS (sulfamethoxazole / trimethoprim)
  • Sodium biphosphate / sodium phosphate
  • Spironolactone
  • Sporanox (itraconazole)
  • Sporanox PulsePak (itraconazole)
  • SSKI (potassium iodide)
  • Sulfamethoxazole / trimethoprim
  • Sulfatrim (sulfamethoxazole / trimethoprim)
  • Sulfatrim Pediatric (sulfamethoxazole / trimethoprim)
  • Tarka (trandolapril / verapamil)
  • Teczem (diltiazem / enalapril)
  • Tekamlo (aliskiren / amlodipine)
  • Tekturna HCT (aliskiren / hydrochlorothiazide)
  • Ten-K (potassium chloride)
  • Theophylline KI (potassium iodide / theophylline)
  • Thermotabs (potassium chloride / sodium chloride)
  • ThyroShield (potassium iodide)
  • Tizanidine
  • Trandolapril
  • Trandolapril / verapamil
  • Travasol with Electrolytes (parenteral nutrition solution w/ electrolytes)
  • Travert 10% and Electrolyte No2 (lvp solution with potassium)
  • Travert 5% and Electrolyte No2 (lvp solution with potassium)
  • Tri-K (potassium acetate / potassium bicarbonate / potassium citrate)
  • Triamterene
  • Tricitrates (citric acid / potassium citrate / sodium citrate)
  • trimethoprim
  • Trimpex (trimethoprim)
  • Twin-K (potassium citrate)
  • Uniretic (hydrochlorothiazide / moexipril)
  • Univasc (moexipril)
  • UR N-C (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Uramit MB (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Urelle (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Uribel (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Urimar-T (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Urin D / S (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Uro Blue (hyoscyamine / methenamine / methylene blue / sodium biphosphate)
  • Urocit-K (potassium citrate)
  • Urogesic Blue (hyoscyamine / methenamine / methylene blue / sodium biphosphate)
  • Urolet MB (hyoscyamine / methenamine / methylene blue / sodium biphosphate)
  • Uroplus (sulfamethoxazole / trimethoprim)
  • Ustell (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Uta (hyoscyamine / methenamine / methylene blue / sodium biphosphate)
  • Utira-C (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Valturna (aliskiren / valsartan)
  • Vaseretic (enalapril / hydrochlorothiazide)
  • Vilevev MB (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)
  • Virt-Phos 250 Neutral (potassium phosphate / sodium phosphate)
  • Virtrate-3 (citric acid / potassium citrate / sodium citrate)
  • Vis-Phos N (potassium phosphate / sodium phosphate)
  • Visicol (sodium biphosphate / sodium phosphate)
  • Vytorin (ezetimibe / simvastatin)
  • Yodefan (potassium iodide)
  • Zanaflex (tizanidine)
  • Zestoretic (hydrochlorothiazide / lisinopril)
  • Zestril (lisinopril)
  • Zocor (simvastatin

Warnings

Along with informing their doctor of all current medications, the patient is advised to give the doctor a detailed medical history along with any recent or current symptoms. The doctor needs to be aware of all past medical history to insure no disease process is present that will negatively be affected by taking Amlodipine and Valsartan. The patients history needs to include all medical conditions, surgical procedures, and traumatic injuries. The doctor needs to be made aware of any psychiatric history such as depression, suicidal ideations or attempts, and any addictions or mental disorders.

Amlodipine and Valsartan are not to be taken during pregnancy. If a patient is prescribed Amlodipine and Valsartan and becomes pregnant, the medication should be stopped immediately as it has been proven to cause serious and fatal outcome in fetal development.

For a woman who is still capable of becoming pregnant, caution should be used when prescribing Exforge and other antihypertensive medication should be considered.

Amlodipine and Valsartan should be taken with caution in patients who are also on high-dose or multiple diuretics. Volume depletion coupled with the angiotensin receptor blockers can cause symptomatic hypotension. If a patient exhibits symptomatic hypotension, place in a supine position and intravenous solution should be administered if warranted.

Caution should be exercised with close monitoring in patients with Coronary Artery Disease as acute myocardial infarction can occur when starting or increasing Amlodipine.

Frequent monitoring of renal function is required when administering Amlodipine and Valsartan to patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, and volume depletion. Acute renal failure can occur in these patients.

Serum electrolytes should be evaluated periodically as patients may experience hyperkalemia when taking this medication.

Storage

Amlodipine and Valsartan (Exforge) should be kept at 25℃(77℉); excursions permitted to 15 to 30℃(59 to 86℉). [See USP Controlled Room Temperature.] Protect the medication from moisture.

If the doctor advises the patient to stop taking the medication, advise the patient to ask how best to dispose of any remaining medications.

Summary

Amlodipine and Valsartan are used in the treatment of hypertensive. The combined effect has proven to be useful in controlling high blood pressures, especially in patients with difficult to control hypertension and those requiring multiple antihypertensive medications.

Any medication presents possible risks and those risks must be thoroughly discussed with the patient. The patient and doctor must decide if the potential benefits of using the medication outweighs the inherent risks.

It is the responsibility of the patient to fully inform the doctor of all past medical history, including surgical, traumatic, and psychiatric disorders. The patient should also inform the doctor of all current medications, any known drug and food allergies, any tobacco or alcohol use, any illegal drug use, and any over-the-counter medicines, including natural supplements.

The patient should update all doctors providing care on all current prescriptions.

If at any time the patient begins having adverse side effects, they should contact their physician and request direction. If any of the symptoms are life-threatening, call 911 immediately.

Amlodipine and Valsartan can provide blood pressure control in hypertensive patients who have had difficulty achieving regulation. Taking appropriately, these medications can reduce the patient’s risk of life-threatening events such as strokes and myocardial infarctions.

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Last Reviewed:
December 10, 2017
Last Updated:
December 22, 2017
Content Source: