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 olmesartan, amlodipine, and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to olmesartan, amlodipine, and hydrochlorothiazide 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.

Pregnancy

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 olmesartan, amlodipine, and hydrochlorothiazide, 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 olmesartan, amlodipine, and hydrochlorothiazide 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 olmesartan, amlodipine, and hydrochlorothiazide 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.

• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Amiodarone
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Atazanavir
• Benazepril
• Benzphetamine
• Bromfenac
• Bufexamac
• Captopril
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clarithromycin
• Clonixin
• Clopidogrel
• Conivaptan
• Cyclophosphamide
• Cyclosporine
• Dantrolene
• Deslanoside
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Domperidone
• Droperidol
• Droxicam
• Eliglustat
• Enalapril
• Enalaprilat
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fosinopril
• Ibuprofen
• Idelalisib
• Indomethacin
• Ketanserin
• Ketoprofen
• Ketorolac
• Lacosamide
• Levomethadyl
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenylbutazone
• Piketoprofen
• Piperaquine
• Piroxicam
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Rofecoxib
• Salicylic Acid
• Salsalate
• Simvastatin
• Sodium Salicylate
• Sotalol
• Sulindac
• Tacrolimus
• Tegafur
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trandolapril
• Trimethoprim
• Valdecoxib

Using olmesartan, amlodipine, and hydrochlorothiazide 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
• Bepridil
• Carbamazepine
• Cholestyramine
• Colesevelam
• Ginkgo
• Gossypol
• Indinavir
• Licorice
• Topiramate

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.

Other Medical Problems

The presence of other medical problems may affect the use of olmesartan, amlodipine, and hydrochlorothiazide. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain), history of or
• Diabetes or
• Glaucoma, 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 (nearsighted; can't see objects at a distance) 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Upset stomach.
• Sore throat.
• Stuffy nose.
• Runny nose.
• Feeling tired or weak.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Amlodipine Besylate, Olmesartan Medoxomil, and Hydrochlorothiazide
• Amlodipine, Hydrochlorothiazide, and Olmesartan
• Hydrochlorothiazide, Olmesartan, and Amlodipine
• Olmesartan Med/Amlodipine/Hctz
• Olmesartan, Hydrochlorothiazide, and Amlodipine

• Angiotensin II Receptor Blocker
• Antianginal Agent
• Antihypertensive
• Calcium Channel Blocker
• Calcium Channel Blocker, Dihydropyridine
• Diuretic, Thiazide

Olmesartan: Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II.

Amlodipine: Directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.

Hydrochlorothiazide: Inhibits sodium reabsorption in the distal tubules causing increased excretion of sodium and water as well as potassium and hydrogen ions.

Hypertension: Management of hypertension (monotherapy or with other antihypertensive agents).

Limitations of use: Not indicated for initial therapy.

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: There are no specific dosage adjustments provided in the manufacturer’s labeling. Use with caution; titrate slowly. Recommended initial daily dose of amlodipine (2.5 mg) in these patients is not available in this combination product.

Reactions/percentages reported with combination product; also see individual agents.

1% to 10%:

Cardiovascular: Edema (8%), syncope (1%)

Central nervous system: Dizziness (6% to 9%), headache (6%), fatigue (4%)

Gastrointestinal: Diarrhea (3%), nausea (3%)

Genitourinary: Urinary tract infection (2%)

Neuromuscular & skeletal: Muscle spasm (3%), joint swelling (2%)

Respiratory: Nasopharyngitis (4%), upper respiratory tract infection (3%)

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