Olmesartan

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Olmesartan falls into category D. There is evidence of risk to the unborn baby based on studies in humans or adverse reaction data. This medication may be given to a pregnant woman if her healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if olmesartan is excreted in human breast milk or if it will harm your nursing baby.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Tell all of your health care providers that you take olmesartan. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• If you also take colesevelam, take it at least 4 hours after you take olmesartan.
• If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• Talk with your doctor before you drink alcohol.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• This medicine may not work as well in black patients. Talk with the doctor.
• Do not give olmesartan to a child younger than 1 year of age.

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.

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• If a liquid (suspension) is made from the tablets, store in a refrigerator. Do not freeze. Throw away any part not used after 28 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• Benicar

AUC and Cmax increased 10% to 15% in women.

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported rarely with some angiotensin II receptor antagonists (ARBs) and may occur at any time during treatment (especially following first dose). It may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). Patients with idiopathic or hereditary angioedema or previous angioedema associated with ACE-inhibitor therapy may be at an increased risk. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. Intramuscular (IM) administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Gastrointestinal effects: Symptoms of sprue-like enteropathy (ie, severe, chronic diarrhea with significant weight loss) has been reported; may develop months to years after treatment initiation with villous atrophy commonly found on intestinal biopsy. Once other etiologies have been excluded, discontinue treatment and consider other antihypertensive treatment. Clinical and histologic improvement was noted after treatment was discontinued in a case series of 22 patients (Ianiro, 2014; Rubio-Tapia, 2012).

• Hyperkalemia: May occur; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium containing salts. Use cautiously, if at all, with these agents and monitor potassium closely.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with olmesartan.

• Renal function deterioration: May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

Disease-related concerns:

• Aortic/mitral stenosis: Use caution in patients with significant aortic/mitral stenosis.

• Renal artery stenosis: Use olmesartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution with pre-existing renal insufficiency.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Olmesartan has not been shown to be effective for hypertension in children younger than 6 years. Children younger than 1 year must not receive olmesartan for hypertension. The renin-angiotensin-aldosterone system plays a critical role in kidney development. Administering drugs that act directly on the renin-angiotensin-aldosterone system can have effects on the development of immature kidneys and alter normal renal development.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic ARB therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis, 2011).

Applies to olmesartan: oral tablet

Along with its needed effects, olmesartan 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 while taking olmesartan:

• Blood in the urine
• body aches or pain
• chills
• cough or cough producing mucus
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• tightness in the chest
• unusual tiredness or weakness

• Bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain
• cloudy urine
• difficult, burning, or painful urination
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• joint pain, stiffness, or swelling
• lower back, side, or stomach pain
• swelling of the feet or lower legs

• Confusion
• dark-colored urine
• diarrhea (severe) with weight loss
• dizziness
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle cramps or spasms
• muscle pain or stiffness
• nausea or vomiting
• weakness or heaviness of the legs

Get emergency help immediately if any of the following symptoms of overdose occur while taking olmesartan:

• Blurred vision
• chest pain or discomfort
• dizziness, faintness, or lightheadedness
• sweating

Some side effects of olmesartan 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:

• Back pain
• diarrhea
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• muscle aches
• pain or tenderness around the eyes and cheekbones
• shivering
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• unexplained weight loss

• Acid or sour stomach
• belching
• difficulty with moving
• feeling of constant movement of self or surroundings
• heartburn
• indigestion
• rapid weight gain
• rash
• sensation of spinning
• tingling of the hands or feet
• unusual weight gain or loss

• Hair loss or thinning of the hair
• lack or loss of strength
• redness of the skin
• welts

Applies to olmesartan: oral tablet

General

The most common side effect in adults was dizziness.[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Respiratory

Common (1% to 10%): Bronchitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, coughing, nasopharyngitis, pharyngolaryngeal pain, rhinorrhea[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, chest pain, fatigue, peripheral edema, pain, inflicted injury, fever
Uncommon (0.1% to 1%): Vertigo, asthenia, malaise
Rare (less than 0.1%): Lethargy[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, nausea, tooth ache, abdominal pain, vomiting, dyspepsia
Uncommon (0.1% to 1%): Dyspepsia
Very rare (less than 0.01%): Sprue-like enteropathy[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, creatine phosphokinase increased, gout, arthralgia, arthritis, skeletal pain
Uncommon (0.1% to 1%): Myalgia
Rare (less than 0.1%): Muscle spasm
Postmarketing reports: Rhabdomyolysis[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia, hypertriglyceridemia, hyperuricemia, pseudohyperkalemia
Uncommon (0.1% to 1%): Hypercholesterolemia, hyperlipemia
Rare (less than 0.1%): Hyperkalemia[Ref]

Hepatic

Common (1% to 10%): GGT increased, AST increased, ALT increased, hepatic enzymes increased
Uncommon (0.1% to 1%): Bilirubinemia
Frequency not reported: Serum bilirubin elevated[Ref]

Genitourinary

Common (1% to 10%): Hematuria, impotence, urinary tract infection[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis
Uncommon (0.1% to 1%): Rash, exanthema, allergic dermatitis, urticaria, pruritus, face edema
Postmarketing reports: Alopecia[Ref]

Immunologic

Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Anaphylactic reaction
Rare (less than 0.1%): Angioedema[Ref]

Renal

Common (1% to 10%): Blood urea increased
Rare (less than 0.1%): Acute renal failure, renal insufficiency, blood creatinine increased[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Tachycardia, angina pectoris
Rare (less than 0.1%): Hypotension[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia
Frequency not reported: Small decreases in hemoglobin and hematocrit[Ref]

Some side effects of olmesartan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.