Olmesartan, amlodipine, and hydrochlorothiazide

Generic name: Olmesartan, Amlodipine, And Hydrochlorothiazide
Drug class: Miscellaneous antihypertensive combinations

Usage of Olmesartan, amlodipine, and hydrochlorothiazide

Olmesartan, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Olmesartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. Olmesartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. Amlodipine relaxes the blood vessels and lowers blood pressure.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine. This helps lower blood pressure.

This medicine is available only with your doctor's prescription.

Olmesartan, amlodipine, and hydrochlorothiazide side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

cough

difficult, burning, or painful urination

difficulty with breathing

fainting

frequent urge to urinate

headache

loss of voice

lower back or side pain

swelling of the joints

unusual tiredness or weakness

Incidence not known

Persistent non-healing sore

pink growth

reddish patch or irritated area

shiny bump

white, yellow or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Diarrhea

muscle aches or spasms

nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Olmesartan, amlodipine, and hydrochlorothiazide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of olmesartan, amlodipine, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olmesartan, amlodipine, and hydrochlorothiazide combination in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Aliskiren

Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Acarbose

Aceclofenac

Acemetacin

Acetyldigoxin

Albiglutide

Albuterol

Alogliptin

Amphetamine

Amtolmetin Guacil

Arsenic Trioxide

Aspirin

Atazanavir

Benzphetamine

Bromfenac

Bromocriptine

Bufexamac

Buprenorphine

Canagliflozin

Celecoxib

Ceritinib

Chlorpropamide

Choline Salicylate

Clarithromycin

Clonixin

Clopidogrel

Codeine

Conivaptan

Cyclosporine

Dantrolene

Dapagliflozin

Darunavir

Deslanoside

Desmopressin

Dexibuprofen

Dexketoprofen

Dextroamphetamine

Diclofenac

Diflunisal

Digitalis

Digitoxin

Digoxin

Dipyrone

Domperidone

Droperidol

Droxicam

Dulaglutide

Empagliflozin

Epirubicin

Erythromycin

Etodolac

Etofenamate

Etoricoxib

Exenatide

Fedratinib

Felbinac

Fenoprofen

Fepradinol

Feprazone

Fexinidazole

Flecainide

Floctafenine

Flufenamic Acid

Flurbiprofen

Formoterol

Fosnetupitant

Glimepiride

Glipizide

Glyburide

Ibuprofen

Indomethacin

Insulin

Insulin Aspart, Recombinant

Insulin Bovine

Insulin Degludec

Insulin Detemir

Insulin Glulisine

Itraconazole

Ketanserin

Ketoprofen

Ketorolac

Lacosamide

Levomethadyl

Linagliptin

Liraglutide

Lisdexamfetamine

Lithium

Lixisenatide

Lornoxicam

Loxoprofen

Lumiracoxib

Mavacamten

Meclofenamate

Mefenamic acid

Meloxicam

Melphalan

Methamphetamine

Methotrexate

Metildigoxin

Miglitol

Morniflumate

Nabumetone

Naproxen

Nateglinide

Nepafenac

Netupitant

Niflumic Acid

Nimesulide

Nimesulide Beta Cyclodextrin

Omaveloxolone

Ouabain

Oxaprozin

OxyphenbUTAzone

Parecoxib

Phenobarbital

Phenylbutazone

Piketoprofen

Pioglitazone

Piperaquine

Piroxicam

Porfimer

Pramlintide

Primidone

Proglumetacin

Propyphenazone

Proquazone

Proscillaridin

Repaglinide

Rifampin

Ritonavir

Rofecoxib

Rosiglitazone

Salicylic Acid

Salsalate

Saxagliptin

Simvastatin

Sitagliptin

Sodium Salicylate

Sotalol

Sulindac

Tacrolimus

Tapentadol

Tegafur

Telaprevir

Tenoxicam

Tiaprofenic Acid

Tolazamide

Tolbutamide

Tolfenamic Acid

Tolmetin

Topiramate

Trimethoprim

Valdecoxib

Vildagliptin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aminolevulinic Acid

Amprenavir

Aprepitant

Bepridil

Boceprevir

Carbamazepine

Cholestyramine

Cimetidine

Ciprofloxacin

Clofazimine

Cobicistat

Colesevelam

Crizotinib

Diltiazem

Dronedarone

Duvelisib

Fluconazole

Fluvoxamine

Fosamprenavir

Ginkgo

Gossypol

Idelalisib

Indinavir

Ketoconazole

Letermovir

Licorice

Lonafarnib

Mifepristone

Nefazodone

Nelfinavir

Nilotinib

Posaconazole

Ribociclib

Rifapentine

Saquinavir

Schisandra sphenanthera

Telithromycin

Troleandomycin

Tucatinib

Verapamil

Voriconazole

Voxelotor

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Olmesartan, amlodipine, and hydrochlorothiazide

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

In addition to using this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, strokes, or kidney disease.

Swallow the tablet whole. Do not break, crush, or chew it. You may take this medicine with or without food.

If you are also using colesevelam (Welchol®), take it at least 4 hours after taking Tribenzor®.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For high blood pressure:

Adults—One tablet once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than olmesartan 40 milligrams (mg), amlodipine 10 mg, and hydrochlorothiazide 25 mg per day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away. You may need to stop using this medicine.

This medicine may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from a lying or sitting position. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially if you have severe nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

This medicine may cause angina (chest pain) or a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, or sweating.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

This medicine may affect blood sugar levels. Diabetic patients may notice a change in the results of blood or urine glucose tests. Talk to your doctor if you have any questions.

Severe, chronic diarrhea with weight loss may develop months to years after taking this medicine. Tell your doctor right away if you have these symptoms.

This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Use a sunscreen when you are outdoors. Talk to your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

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