Amlodipine-Olmesartan

Amlodipine-Olmesartan is a combination of prescription medications used for the treatment of hypertension. 

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

Adult dosage

Tablet

• 5 mg/20 mg
• 5 mg/40 mg
• 10 mg/20 mg
• 10 mg/40 mg

Hypertension

Adult dosage

• 5 mg/20 mg orally every day initially; may increase the dose after 1-2 weeks; not to exceed 10 mg/40 mg

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Amlodipine-Olmesartan include:

• dizziness or
• lightheadedness as the body adjusts to the medication.

Serious side effects of Amlodipine-Olmesartan include:

• swelling hands/ankles/feet,
• fainting,
• fast heartbeat,
• unusual change in the amount of urine,
• symptoms of a high potassium blood level (such as muscle weakness, slow or irregular heartbeat), or
• severe or persistent diarrhea.

Rare side effects of Amlodipine-Olmesartan include:

• drowsiness,
• swelling hands/ankles/feet,
• flushing (warmth, redness, or tingly feeling),
• hair loss, or
• skin rash or itching.

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 such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result 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.

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.

• Amlodipine-Olmesartan has severe interactions with the following drugs:
  • aliskiren
  • dantrolene
• Amlodipine-Olmesartan has serious interactions with at least 27 other drugs.
• Amlodipine-Olmesartan has moderate interactions with at least 238 other drugs.
• Amlodipine-Olmesartan has minor interactions with at least 43 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 health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to olmesartan, amlodipine, or excipients
• Coadministration with aliskiren in patients with diabetes mellitus
• Also, see individual monographs:
• amlodipine
• olmesartan

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren is associated with increased risk for hyperkalemia and renal function changes (including acute renal failure) compared to monotherapy; monitor electrolytes periodically
• Changes in renal function may be anticipated in susceptible individuals treated with olmesartan medoxomil as a consequence of inhibiting the renin-angiotensin-aldosterone system; in patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (eg, patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria or progressive azotemia and (rarely) with acute renal failure and/or death; similar effects may occur in patients treated with the drug combination because of the olmesartan medoxomil component
• Increased angina or myocardial infarction reported, particularly those with severe obstructive coronary artery disease, may develop increased frequency duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase; the mechanism of this effect has not been elucidated
• Intestinal problems (e.g., sprue-like enteropathy) reported with olmesartan months to years after initiation; symptoms may include severe, chronic diarrhea with substantial weight loss; intestinal biopsies have demonstrated villous atrophy; if a patient develops these symptoms during treatment exclude other etiologies; discontinue therapy if no other etiology identified
• Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
• Titrate slowly when administering amlodipine to patients with severe hepatic impairment
• Hypotension
  • In patients with an activated renin-angiotensin system, such as volume­ and/or salt-depleted patients (eg, those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil; initiate treatment with the drug combination under close medical supervision
  • If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline; a transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized
  • Symptomatic hypotension is possible in patients taking amlodipine, particularly in patients with severe aortic stenosis; because of the gradual onset of action, acute hypotension is unlikely

Pregnancy & 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 (e.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.
• Lactation
  • There is limited information regarding the presence of the drug in human milk, 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