Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Breastfeeding
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.
Drug Interactions
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
- Avacopan
- Benzhydrocodone
- Benzphetamine
- Bromfenac
- Bromocriptine
- Bufexamac
- Buprenorphine
- Canagliflozin
- Carbamazepine
- Cefepime
- Celecoxib
- Ceritinib
- Chlorpropamide
- Choline Salicylate
- Clarithromycin
- Clonidine
- Clonixin
- Clopidogrel
- Codeine
- Conivaptan
- Cyclosporine
- Dantrolene
- Dapagliflozin
- Darunavir
- Deslanoside
- Desmopressin
- Dexibuprofen
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
Other Interactions
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.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Angina (severe chest pain), history of or
- Diabetes or
- Glaucoma, secondary angle-closure or
- Gout or
- Heart attack, history of or
- Hypercalcemia (high calcium in the blood) or
- Hypercholesterolemia (high cholesterol in the blood) or
- Hyperuricemia (high uric acid in the blood) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Myopia (changes in the eyeball causing vision problems), acute or
- Systemic lupus erythematosus (immune system disease)—Use with caution. May make these conditions worse.
- Anuria (not able to create urine) or
- Diabetes patients who are also using aliskiren (Tekturna®) or
- Kidney disease, severe or
- Sulfa drug allergy, history of—Should not be used in patients with these conditions.
- Aortic stenosis (heart valve problem), severe or
- Asthma, history of or
- Dehydration, severe or
- Heart disease, severe, history of or
- Hyponatremia (low sodium in the blood)—Use with caution. May cause side effects to become worse.
- Congestive heart failure, severe—Use may lead to kidney problems.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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.
- For high blood pressure:
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.
Precautions
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.
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.
CON-XXXXXXXX
