Olmesartan medoxomil

What is Olmesartan medoxomil?

• Olmesartan medoxomil (Benicar) is an angiotensin II receptor blocker (ARB) used for the treatment of hypertension.

Olmesartan

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Olmesartan medoxomil hydrolysis to olmesartan

Olmesartan 3D structure

What are the uses of this medicine?

• Olmesartan medoxomil (Benicar) is used for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure.

How does this medicine work?

• Olmesartan (ol" me sar' tan) is an angiotensin II receptor blocker (ARB) used alone or in combination of other agents for therapy of hypertension. Olmesartan inhibits the renin-angiotensin system by blocking the angiotensin II type 1 receptor (AT1), which prevents the vasoconstriction and volume expansion induced by circulating angiotensin II which accounts for its antihypertensive activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are using aliskiren.

What drug interactions can this medicine cause?

• Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium.
• Concomitant NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect.
• Avoid combined use with RAS inhibitors.
• Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including BENICAR.
• Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose

Is this medicine FDA approved?

• Olmesartan was approved for use in the United States in 2002 and is available in 5, 20 and 40 mg tablets generically under the trade name Benicar.

How should this medicine be used?

Recommended dosage: Adult Hypertension:

• Dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted.
• For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect.

Pediatric Hypertension (6 Years of Age and Older):

• Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of Benicar is 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg.
• For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg.

Administration:

• Olmesartan may be administered with or without food.
• For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 20 mg, and 40 mg

This medicine is available in fallowing brand namesː

• Benicar

What side effects can this medication cause?

The most common side effects of this medicine include:

• Side effects are uncommon, but may include headache, dizziness, fatigue, cough, gastrointestinal upset, and fetal toxicity.
• In addition, olmesartan has been linked to instances of severe sprue-like enteropathy that arises after months or years of therapy and presents with chronic diarrhea, weight loss and abdominal discomfort.
• Intestinal biopsy shows villous flattening and atrophy, similar to celiac disease.
• However, symptoms do not improve with a gluten-free diet or corticsteroids, but do resolve promptly upon stopping olmesartan.
• A similar syndrome has been linked to use of other ARBs including valsartan and losartan.

What special precautions should I follow?

• Benicar can cause fetal harm when administered to a pregnant woman. Avoid fetal (in utero) exposure.
• Use of Benicar in children <1 year of age is not recommended.
• In patients with an activated renin-angiotensin-aldosterone system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may be anticipated after initiation of treatment with Benicar. Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation.
• Changes in renal function may be anticipated in susceptible individuals treated with Benicar. Monitor for worsening renal function in patients with renal impairment.
• Sprue-like enteropathy has been reported. Consider alternative antihypertensive therapy in cases where no other etiology is found.
• Serum potassium should be monitored in patients receiving Benicar.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• tachycardia
• bradycardia

Treatment of overdosage:

• If symptomatic hypotension occurs, initiate supportive treatment.
• The dialyzability of olmesartan is unknown.

Can this medicine be used in pregnancy?

• Benicar can cause fetal harm when administered to a pregnant woman.
• When pregnancy is detected, discontinue Benicar as soon as possible. Consider alternative antihypertensive therapy during pregnancy.

Can this medicine be used in children?

• The antihypertensive effects of Benicar were evaluated in one randomized, double-blind clinical study in pediatric patients 1 to 16 years of age.
• Use of Benicar in children <1 year of age is not recommended.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• OLMESARTAN MEDOXOMIL

Inactive ingredients:

• HYDROXYPROPYL CELLULOSE
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• TALC
• TITANIUM DIOXIDE
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

• Manufactured for Daiichi Sankyo, Inc., Basking Ridge, NJ

What should I know about storage and disposal of this medication?

• Store at 20-25°C (68-77°F).

• Dailymed label info on Olmesartan medoxomil
• FDA Olmesartan medoxomil

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