Olmesartan-Amlodipine-Hydrochlorothiazide

Olmesartan-Amlodipine-Hydrochlorothiazide is a combination medication used for the treatment of high blood pressure.

• Olmesartan-Amlodipine-Hydrochlorothiazide is available under the following different brand names: Tribenzor

Common side effects of Olmesartan-Amlodipine-Hydrochlorothiazide include:

• Dizziness,
• Lightheadedness,
• Tiredness,
• Headache,
• Diarrhoea,
• Muscle spasms or twitching,
• Cold symptoms (stuffy or runny nose, sneezing, sore throat),
• Flushing (warmth, redness, or tingly feeling),
• Swelling of the hands or feet,
• Nausea,
• Upper respiratory tract infection,
• Urinary tract infection, and
• Swelling of the joints.

Serious side effects of Olmesartan-Amlodipine-Hydrochlorothiazide include:

• Fainting,
• Severe tiredness,
• Big toe/joint pain,
• Swelling hands/ankles/feet,
• Symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat),
• Unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), and
• Severe or persistent diarrhea.

Rare side effects of Olmesartan-Amlodipine-Hydrochlorothiazide include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 20 mg/5 mg/12.5 mg
• 40 mg/5mg/12.5 mg
• 40 mg/5 mg/25 mg
• 40 mg/10 mg/12.5 mg
• 40 mg/10 mg/25 mg

Hypertension

Adult dosage

• Add-on/switch/replacement therapy: 5-10 mg amlodipine, 20-40 mg olmesartan, 12.5-25 mg hydrochlorothiazide daily; dosage may be increased at 2-week intervals; titrate by increasing 1 component at a time; not to exceed 40 mg olmesartan/10 mg amlodipine/25 mg hydrochlorothiazide once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Olmesartan-Amlodipine-Hydrochlorothiazide has severe interactions with the following drugs.
  • aliskiren
  • dantrolene
• Olmesartan-Amlodipine-Hydrochlorothiazide has serious interactions with at least 38 other drugs.
• Olmesartan-Amlodipine-Hydrochlorothiazide has serious interactions with at least 335 other drugs.
• Olmesartan-Amlodipine-Hydrochlorothiazide has serious interactions with at least 189 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to any drug component or sulfonamide-derived drug
• Anuria
• Concomitant use of aliskiren in patients with diabetes mellitus
• Pregnancy (2nd and 3rd trimesters): significant risk of fetal/neonatal morbidity and mortality

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Olmesartan-Amlodipine-Hydrochlorothiazide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Olmesartan-Amlodipine-Hydrochlorothiazide?”

Cautions

• Angioedema, severe CHF, surgery/anesthesia, volume depletion (consider lower dose)
• Discontinue STAT if pregnant: potential risk of congenital malformations (see Black Box Warnings)
• Risk of hypotension, especially in patients with volume/salt depletion; correct volume depletion before administration
• Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase
• Risk of hyperkalemia
  • Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or alsike associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy; closely monitor blood pressure
  • Intestinal problems (. e, sprue-like enteropathy) reported with Olmesartan; symptoms may include severe, chronic diarrhea with substantial weight loss.
  • Photosensitivity may occur; instruct patients to protect their skin from the sun and undergo regular skin cancer screening
  • Avoid severe renal impairment (below 30 mL/min)
  • Withhold/discontinue if progressive renal impairment occurs
  • Thiazides: use with caution with mild/moderate liver impairment or progressive liver disease; avoid in patients with severe liver impairment
• Monitor for fluid/electrolyte imbalance
  • Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
• Thiazide diuretics may exacerbate or activate SLE
  • Acute transient myopia and acute angle-closure glaucoma have been reported, particularly with a history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
  • Caution in aortic mitral stenosis, hepatic impairment, hypercholesterolemia, hypercalcemia, parathyroid disease, pre-existing renal insufficiency, systemic lupus erythematosus, bilateral renal artery stenosis or anuria
  • Increased incidence of impaired renal function was reported in subjects receiving triple drug combination therapy compared to subjects receiving dual combination therapy of olmesartan medoxomil and amlodipine, olmesartan medoxomil and hydrochlorothiazide or amlodipine and hydrochlorothiazide; if progressive renal impairment becomes evident consider withholding or discontinuing therapy
  • Amlodipine is extensively metabolized by the liver; titrate slowly while administering to patients with severe hepatic impairment
  • Hydrochlorothiazide can cause hypokalemia, hyponatremia, and hypomagnesemia; hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion; the drug combination therapy also contains olmesartan, a drug that affects the renin-angiotensin system (RAS); drugs that inhibit the RAS can also cause hyperkalemia; hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides; hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium; monitor calcium levels
  • The recommended initial dose of amlodipine in patients 75 years of age or older is 2.5 mg, a dose not available with the drug combination therapy
  • The recommended initial dose of amlodipine in patients with severe hepatic impairment is 2.5 mg, a dose not available with the drug combination therapy

Pregnancy and Lactation

• Therapy can cause fetal harm in pregnant women; the use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
• Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents
• When pregnancy is detected, discontinue therapy as soon as possible; consider alternative antihypertensive therapy during pregnancy
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (. g, need for cesarean section and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly.
• Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
• Perform serial ultrasound examinations to assess the intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
• Closely observe infants with histories of in-utero exposure to olmesartan for hypotension, oliguria, and hyperkalemia; in neonates with a history of in-utero exposure to olmesartan
• If oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function.
• Thiazides cross the placental barrier and appear in cord blood; adverse reactions include fetal or neonatal jaundice and thrombocytopenia.
• Lactation
  • There is limited information regarding the presence of the drug in human milk, and its effects on the breastfed infant, or milk production; amlodipine is present in human milk; olmesartan is present in rat milk.
  • Because of the potential for adverse effects on the nursing infant, advise a nursing woman that breastfeeding is not recommended during treatment.