Omacor

omega-3-acid ethyl esters

Dosage Form: Capsules

Omacor Description

Omacor, a lipid-regulating agent, is supplied as a liquid-filled gel capsule for oral administration. Each one gram capsule of Omacor (omega-3 acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).

The structural formula of EPA ethyl ester is:

The empirical formula of EPA ethyl ester is C22H34O2, and the molecular weight of EPA ethyl ester is 330.51.

The structural formula of DHA ethyl ester is:

The empirical formula of DHA ethyl ester is C24H36O2, and the molecular weight of DHA ethyl ester is 356.55.

Omacor capsules also contain the following inactive ingredients: 4 mg α-tocopherol (in a carrier of partially hydrogenated vegetable oils including soybean oil), and gelatin, glycerol, and purified water (components of the capsule shell).

Omacor - Clinical Pharmacology

Mechanism of Action

The mechanism of action of Omacor is not completely understood. Potential mechanisms of action include inhibition of acyl CoA:1,2-diacylglycerol acyltransferase and increased peroxisomal β-oxidation in the liver. Omacor may reduce the synthesis of triglycerides (TGs) in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.

Pharmacokinetic and Bioavailability Studies

In healthy volunteers and in patients with hypertriglyceridemia (HTG), EPA and DHA were absorbed when administered as ethyl esters orally. Omega-3-acids administered as ethyl esters (Omacor) induced significant, dose–dependent increases in serum phospholipid EPA content, though increases in DHA content were less marked and not dose-dependent when administered as ethyl esters. Uptake of EPA and DHA into serum phospholipids in subjects treated with Omacor was independent of age (<49 years vs. ≥49 years). Females tended to have more uptake of EPA into serum phospholipids than males. Pharmacokinetic data on Omacor in children are not available.

Drug Interactions

Cytochrome P450-Dependent Monooxygenase Activities

The effect of a mixture of free fatty acids (FFA), EPA/DHA and their FFA-albumin conjugate on cytochrome P450-dependent monooxygenase activities was assessed in human liver microsomes. At the 23 μM concentration, FFA resulted in a less than 32% inhibition of CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A. At the 23 μM concentration, the FFA-albumin conjugate resulted in a less than 20% inhibition of CYP2A6, 2C19, 2D6, and 3A, with a 68% inhibition being seen for CYP2E1. Since the free forms of the EPA and DHA are undetectable in the circulation (<1 μM), clinically significant drug-drug interactions due to inhibition of P450 mediated metabolism EPA/DHA combinations are not expected in humans.

Clinical Studies

The effects of Omacor 4 g per day were assessed in two randomized, placebo-controlled, double-blind, parallel-group studies of 84 adult patients (42 on Omacor, 42 on placebo) with very high triglyceride levels (Table 1). Patients whose baseline triglyceride levels were between 500 and 2000 mg/dL were enrolled in these two studies of 6 and 16 weeks duration. The median triglyceride and LDL-C levels in these patients were 792 mg/dL and 100 mg/dL, respectively. Median HDL-C level was 23.0 mg/dL.

Table 1. Median Baseline and Percent Change From Baseline in Lipid Parameters in Patients with Very High TG Levels (≥ 500 mg/dL)

	TG		LDL-C		CHOL		HDL-C		VLDL-C		non-HDL-C
	BL	% Chg	BL	% Chg	BL	% Chg	BL	% Chg	BL	% Chg	BL	% Chg
Placebo	788	+6.7	108	-4.8	314	-1.7	24	0.0	175	-0.9	292	-3.6
Omacor 4g/day	816	-44.9	89	+44.5	296	-9.7	22	+9.1	175	-41.7	271	-13.8
Difference		-51.6		+49.3		-8.0		+9.1		-40.8		-10.2

BL = Baseline (mg/dL); % Chg = Percent Change from Baseline; Difference = Omacor - Placebo

Omacor 4 g per day reduced median TG, VLDL-C, and non HDL-C levels and increased median HDL-C from baseline relative to placebo. Omacor treatment to reduce very high TG levels may result in elevations in LDL-C and non-HDL-C in some individuals. Patients should be monitored to ensure that the LDL-C level does not increase excessively.

The effect of Omacor on the risk of pancreatitis in patients with very high TG levels has not been evaluated. The effect of Omacor on cardiovascular mortality and morbidity in patients with very high TG levels has not been determined.

Indications and Usage for Omacor

Omacor is indicated as an adjunct to diet to reduce very high (≥ 500 mg/dL) triglyceride (TG) levels in adult patients.

Usage Considerations

According to accepted clinical guidelines, excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia (HTG) and should be addressed before initiating any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, (such as hypothyroidism or diabetes mellitus) should be looked for and adequately treated. Estrogen therapy, thiazide diuretics, and beta blockers are sometimes associated with massive rises in plasma TG levels. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy for HTG.

The use of lipid-regulating agents should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use lipid-regulating agents, the patient should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet. (See PRECAUTIONS).

Contraindications

Omacor is contraindicated in patients who exhibit hypersensitivity to any component of this medication.

Precautions

General

Initial Therapy

Laboratory studies should be performed to ascertain that the patient’s TG levels are consistently abnormal before instituting Omacor therapy. Every attempt should be made to control serum TG levels with appropriate diet, exercise, weight loss in overweight patients, and control of any medical problems (such as diabetes mellitus and hypothyroidism) that may be contributing to the patient’s TG abnormalities. Medications known to exacerbate HTG (such as beta blockers, thiazides, and estrogens) should be discontinued or changed, if possible, before considering TG–lowering drug therapy.

Continued Therapy

Laboratory studies should be performed periodically to measure the patient’s TG levels during Omacor therapy. Omacor therapy should be withdrawn in patients who do not have an adequate response after 2 months of treatment.

Information for Patients

Omacor should be used with caution in patients with known sensitivity or allergy to fish.

Patients should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet.

Laboratory Tests

In some patients, increases in alanine aminotransferase (ALT) levels without a concurrent increase in aspartate aminotransferase (AST) levels were observed. Alanine aminotransferase levels should be monitored periodically during Omacor therapy.

In some patients, Omacor increased low-density lipoprotein cholesterol (LDL-C) levels. As with any lipid-regulating product, LDL-C levels should be monitored periodically during Omacor therapy.

Drug Interactions

Anticoagulants

Some studies with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical studies have not been done to thoroughly examine the effect of Omacor and concomitant anticoagulants. Patients receiving treatment with both Omacor and anticoagulants should be monitored periodically.

Cytochrome P450-Dependent Monooxygenase Activities

Omega-3-fatty acid containing products have been shown to increase hepatic concentrations of cytochrome P450 and activities of certain P450 enzymes in rats. The potential of Omacor to induce P450 activities in humans has not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a rat carcinogenicity study with oral gavage doses of 100, 600, 2000 mg/kg/day by oral gavage, males were treated with omega-3-acid ethyl esters for 101 weeks and females for 89 weeks without an increased incidence of tumors (up to 5 times human systemic exposures following an oral dose of 4 g/day based on a body surface area comparison). Standard lifetime carcinogenicity bioassays were not conducted in mice.

Omega-3-acid ethyl esters were not mutagenic or clastogenic with or without metabolic activation in the bacterial mutagenesis (Ames) test with Salmonella typhimurium and Escherichia coli or in the chromosomal aberration assay in Chinese hamster V79 lung cells or human lymphocytes. Omega-3-acid ethyl esters were negative in the in vivo mouse micronucleus assay.

In a rat fertility study with oral gavage doses of 100, 600, 2000 mg/kg/day, males were treated for 10 weeks prior to mating and females were treated for 2 weeks prior to and throughout mating, gestation and lactation. No adverse effect on fertility was observed at 2000 mg/kg/day (5 times human systemic exposure following an oral dose of 4 g/day based on a body surface area comparison).

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. It is unknown whether Omacor can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Omacor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 g/day based on a body surface area comparison.

In female rats given oral gavage doses of 100, 600, 2000 mg/kg/day beginning two weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high dose group (5 times human systemic exposure following an oral dose of 4 g/day based on body surface area comparison).

In pregnant rats given oral gavage doses of 1000, 3000, 6000 mg/kg/day from gestation day 6 thorough 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 g/day based on a body surface area comparison).

In pregnant rats given oral gavage doses of 100, 600, 2000 mg/kg/day from gestation day 14 through lactation day 21, no adverse effects were seen at 2000 mg/kg/day (5 times the human systemic exposure following an oral dose of 4 g/day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3000mg/kg/day (7 times the human systemic exposure following an oral dose of 4 g/day based on a body surface area comparison).

In pregnant rabbits given oral gavage doses of 375, 750, 1500 mg/kg/day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human systemic exposure following an oral dose of 4 g/day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 g/day based on a body surface area comparison).

Nursing Mothers

It is not known whether omega-3-acid ethyl esters are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Omacor is administered to a woman who is breastfeeding.

Pediatric Use

Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Geriatric Use

A limited number of patients over 65 years of age were enrolled in the clinical studies. In the pooled analyses, safety and efficacy findings in subjects over 60 years of age (approximately 25% of the study population) did not appear to differ from those of subjects less than 60 years of age.

Adverse Reactions

Treatment-emergent adverse events reported in at least 1% of patients treated with Omacor 4 g per day or placebo during 8 randomized, placebo-controlled, double-blind, parallel-group studies for HTG are listed in Table 2. Adverse events led to discontinuation of treatment in 3.5% of patients treated with Omacor and 2.6% of patients treated with placebo.

Table 2. Adverse Events in Randomized, Placebo-Controlled, Double-Blind, Parallel–Group Studies for Hypertriglyceridemia That Used Omacor 4 g per Day

BODY SYSTEM Adverse Event	Omacor (N = 226)		Placebo* (N = 228)
	n	%	n	%
Subjects with at least 1 adverse event	80	35.4	63	27.6
Body as a whole
Back pain	5	2.2	3	1.3
Flu syndrome	8	3.5	3	1.3
Infection	10	4.4	5	2.2
Pain	4	1.8	3	1.3
Cardiovascular
Angina pectoris	3	1.3	2	0.9
Digestive
Dyspepsia	7	3.1	6	2.6
Eructation	11	4.9	5	2.2
Skin
Rash	4	1.8	1	0.4
Special senses
Taste perversion	6	2.7	0	0.0
Adverse events were coded using COSTART, version 5.0. Subjects were counted only once for each body system and for each preferred term. *Placebo was corn oil for all studies.

Additional adverse events reported by 1 or more patients from 22 clinical studies for HTG are listed below:

BODY AS A WHOLE: enlarged abdomen, asthenia, body odor, chest pain, chills, suicide, fever, generalized edema, fungal infection, malaise, neck pain, neoplasm, rheumatoid arthritis, sudden death, and viral infection.

CARDIOVASCULAR SYSTEM: arrhythmia, bypass surgery, cardiac arrest, hyperlipemia, hypertension, migraine, myocardial infarct, myocardial ischemia, occlusion, peripheral vascular disorder, syncope, and tachycardia.

DIGESTIVE SYSTEM: anorexia, constipation, dry mouth, dysphagia, colitis, fecal incontinence, gastritis, gastroenteritis, gastrointestinal disorder, increased appetite, intestinal obstruction, melena, pancreatitis, tenesmus, and vomiting.

HEMATOLOGIC-LYMPHATIC SYSTEM: lymphadenopathy.

METABOLIC AND NUTRITIONAL DISORDERS: edema, hyperglycemia, increased ALT, and increased AST.

MUSCULOSKELETAL SYSTEM: arthralgia, arthritis, myalgia, pathological fracture, and tendon disorder.

NERVOUS SYSTEM: central nervous system neoplasia, depression, dizziness, emotional lability, facial paralysis, insomnia, vasodilatation, and vertigo.

RESPIRATORY SYSTEM: asthma, bronchitis, increased cough, dyspnea, epistaxis, laryngitis, pharyngitis, pneumonia, rhinitis, and sinusitis.

SKIN: alopecia, eczema, pruritis, and sweating.

SPECIAL SENSES: cataract.

UROGENITAL SYSTEM: cervix disorder, endometrial carcinoma, epididymitis, and impotence.

 

DRUG ABUSE AND DEPENDENCE

Omacor does not have any known drug abuse or withdrawal effects.

Overdosage

In the event of an overdose, the patient should be treated symptomatically, and general supportive care measures instituted, as required.

Dosage and Administration

Patients should be placed on an appropriate lipid-lowering diet before receiving Omacor, and should continue this diet during treatment with Omacor. In clinical studies, Omacor was administered with meals.

The daily dose of Omacor is 4 g per day. The daily dose may be taken as a single 4-g dose (4 capsules) or as two 2-g doses (2 capsules given twice daily).

How Supplied

Omacor (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation Omacor in bottles of 60 (NDC 65726-424-15) and 120 (NDC 65726-424-27).

Recommended Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not freeze.

Keep out of reach of children.

Rx only

April 2005

Distributed by:

Reliant Pharmaceuticals, Inc.

Liberty Corner, NJ 07938

Address Medical Inquiries to:

Reliant Pharmaceuticals, Inc.

Medical Affairs

110 Allen Road

Liberty Corner, NJ 07938

©2005 Reliant Pharmaceuticals, Inc.

4241F-00

PRINTED IN USA

Omacor  omega-3-acid ethyl esters  capsule, liquid filled

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65726-424 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength omega-3-acid ethyl esters (omega-3-acid ethyl esters) Active 1 GRAM  In 1 CAPSULE alpha-tocopherol Inactive 4 MILLIGRAM  In 1 CAPSULE gelatin Inactive   glycerol Inactive   water Inactive

Product Characteristics Color YELLOW Score no score Shape CAPSULE (CAPSULE) Size 24mm Flavor Imprint Code Omacor Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 65726-424-15 60 CAPSULE In 1 BOTTLE None 2 65726-424-27 120 CAPSULE In 1 BOTTLE None

Revised: 01/2007Reliant Pharmaceuticals, Inc.

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Olopatadine Drops

Pronunciation: oh-loe-pa-TA-deen
Generic Name: Olopatadine
Brand Name: Examples include Pataday and Patanol

Olopatadine Drops are used for:

Preventing itchy, red, or watery eyes due to allergies (eg, pollen, pollution, dust, animal dander). Olopatadine Drops may be used alone or with other allergy medicines.

Olopatadine Drops are an antihistamine. It works by blocking the action of histamine, which reduces the eye symptoms of an allergic reaction (eg, itchy, red, watery).

Do NOT use Olopatadine Drops if:

• you are allergic to any ingredient in Olopatadine Drops

Contact your doctor or health care provider right away if any of these apply to you.

Before using Olopatadine Drops:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you wear contact lenses

Some MEDICINES MAY INTERACT with Olopatadine Drops. However, no specific interactions with Olopatadine Drops are known at this time.

Ask your health care provider if Olopatadine Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Olopatadine Drops:

Use Olopatadine Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Olopatadine Drops are only for the eye. Do not get it in your nose or mouth.


• Do NOT use Olopatadine Drops in your eyes while you are wearing contact lenses. Soft contact lenses may absorb a chemical in Olopatadine Drops; wait 10 minutes after you use Olopatadine Drops before you put your contacts back in. Only reinsert your contact lenses if your eyes are not red.


• To use Olopatadine Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Olopatadine Drops works best when used regularly, before signs and symptoms begin to occur. If your symptoms continue, contact your health care provider. Do not use Olopatadine Drops for a longer period of time than your health care provider prescribed it for.


• If you miss a dose of Olopatadine Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Olopatadine Drops.

Important safety information:

• Do not use Olopatadine Drops to treat contact lens irritation. Redness due to contact lens wear may not be caused by allergies. Do not wear contact lenses if your eyes are red. If redness continues, talk to your health care provider.


• Do not use Olopatadine Drops for future eye problems without first checking with your health care provider.


• Olopatadine Drops should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Olopatadine Drops while you are pregnant. It is not known if Olopatadine Drops are found in breast milk. If you are or will be breast-feeding while you use Olopatadine Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Olopatadine Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; burning or stinging; change in taste; dryness of the eye; eye pain; feeling that something is in your eye; head congestion; headache; itching; redness in the eye; runny nose; sore throat; tearing; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Olopatadine Drops may be harmful if swallowed.

Proper storage of Olopatadine Drops:

Store Olopatadine Drops between 39 and 77 degrees F (4 and 25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Olopatadine Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Olopatadine Drops, please talk with your doctor, pharmacist, or other health care provider.


• Olopatadine Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Olopatadine Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Ogen

Pronunciation: ES-troe-PIP-ate
Generic Name: Estropipate
Brand Name: Ortho-Est

Ogen should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens with or without progestins have been shown to increase the risk of heart disease (including heart attacks), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Ogen. Talk with your doctor if you have questions about the benefits and risks of using Ogen.

Ogen should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Ogen.

Ogen is used for:

Treating certain conditions caused by menopause (eg, hot flashes; vaginal itching, burning, or dryness). It is used to prevent osteoporosis (weak bones) in women who have been through menopause. It is also used for estrogen replacement therapy in certain conditions where the body does not make enough estrogen.

Ogen is a female hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Ogen if:

• you are allergic to any ingredient in Ogen


• you are pregnant or suspect you may be pregnant


• you have vaginal bleeding of unknown cause, known or suspected breast cancer or estrogen-dependent growths, or a history of breast cancer


• you have an active blood clot (eg, in the leg or lung), a history of blood clots, or liver problems


• you have had a recent (within the past year) stroke or heart attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ogen:

Some medical conditions may interact with Ogen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if a family member has a history of breast cancer or blood clots (eg, in the leg, lung, eye)


• if you have had yellowing of the eyes or skin during pregnancy or with past estrogen use


• if you have high or low blood calcium levels or a history of asthma, a certain blood disorder (porphyria), diabetes, eye or vision problems, gallbladder disease, pancreas inflammation (pancreatitis), heart problems, high blood pressure, high cholesterol or triglyceride levels, kidney problems, a certain type of liver growth (hemangioma), mental or mood problems (eg, depression), thyroid problems, or migraine headaches


• if you have a history of breast lumps or an abnormal mammogram, endometriosis, cancer (eg, ovarian), fluid-retention or swelling (edema), lupus, or seizures (epilepsy)


• if you smoke or use other tobacco products, are overweight, you still have a uterus, or you will be having surgery or will be on bedrest

Some MEDICINES MAY INTERACT with Ogen. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Ogen


• Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Ogen's side effects


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifamycins (eg, rifampin), or St. John's wort because they may decrease Ogen's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ogen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ogen:

Use Ogen as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ogen. Talk to your pharmacist if you have questions about this information.


• Take Ogen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Eating grapefruit or drinking grapefruit juice while you are taking Ogen may increase the amount of Ogen in your blood, which may increase your risk for side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.


• If you miss a dose of Ogen, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ogen.

Important safety information:

• Ogen may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.


• Ogen may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke.


• Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.


• Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Ogen.


• Follow your doctor's instructions for examining your breasts, and report any lumps immediately.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• Tell your doctor or dentist that you take Ogen before you receive any medical or dental care, emergency care, or surgery.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight, bedrest), notify your doctor beforehand. You may need to stop Ogen 4 to 6 weeks beforehand as directed by your doctor.


• If you are taking Ogen to prevent osteoporosis, nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.


• Ogen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ogen.


• Diabetes patients - Ogen may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including blood pressure measurements, blood hormone levels, and liver function, may be performed to monitor your condition or check for side effects. You should have regular complete physical examinations, including blood pressure measurements, Pap tests (for vaginal cancer), and yearly breast and pelvic examinations. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments. Be sure to keep all doctor and lab appointments.


• Use Ogen with caution in the ELDERLY; they may be more sensitive to its effects.


• Ogen should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Ogen if you are pregnant. If you think you may be pregnant, contact your doctor right away. Ogen is found in breast milk. If you are or will be breast-feeding while you use Ogen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ogen:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast tenderness or enlargement; changes in sex drive; hair loss; headache; nausea; stomach cramps, bloating, or upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); breast lumps or pain; calf or leg pain, redness, swelling, tenderness, or warmth; changes in vision (eg, double vision, loss of vision); chest pain; coughing up blood; dizziness; fainting; mental or mood changes (eg, depression); migraine; new or worsening seizures; nipple discharge; pain, swelling, or tenderness in the stomach; severe or persistent headache; sudden shortness of breath; swelling of the hands, ankles, or feet; symptoms of a heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of a stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual vaginal discharge, itching, or odor; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ogen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea or vomiting.

Proper storage of Ogen:

Store Ogen at room temperature, below 77 degrees F (25 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ogen out of the reach of children and away from pets.

General information:

• If you have any questions about Ogen, please talk with your doctor, pharmacist, or other health care provider.


• Ogen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ogen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ogen resources

• Ogen Side Effects (in more detail)
• Ogen Dosage
• Ogen Use in Pregnancy & Breastfeeding
• Ogen Drug Interactions
• Ogen Support Group
• 2 Reviews for Ogen - Add your own review/rating

Compare Ogen with other medications

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Olmesartan Medoxomil

Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: Cyclic 2,3 carbonate 2,3 - dihydroxy - 2 - butenyl - 4 - (1 - hydroxy - 1 - methylethyl) - 1 - propyl - 1 - [p - (o - 1H - tetrazol - 5 - ylphenyl)benzyl]imidazole - 5 - carboxylate
Molecular Formula: C₂₉H₃₀N₆O₆
CAS Number: 144689-63-4
Brands: Azor (combination), Benicar, Benicar HCT

• 
  

  May cause fetal and neonatal morbidity and mortality if used during pregnancy.^{1 31 42 43 44} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue the drug as soon as possible.^{1 31 43 44}

  
  

Introduction

Olmesartan is an angiotensin II type 1 (AT₁) receptor antagonist.^{1 2 3 16 28 31 44}

Uses for Olmesartan Medoxomil

Hypertension

Olmesartan is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);^{1 2 3 8 9 28 31 44} may be used in fixed combination with amlodipine or hydrochlorothiazide when such combined therapy is indicated.^{31 44}

Angiotensin II receptor antagonists are one of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.³⁰

Angiotensin II receptor antagonists can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.³⁰

Diabetic Nephropathy

Angiotensin II receptor antagonists or ACE inhibitors are first-line agents in the treatment of diabetic nephropathy† in patients with type 2 diabetes mellitus and hypertension.

CHF

Angiotensin II receptor antagonists are second-line agents in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.

Olmesartan Medoxomil Dosage and Administration

General

Hypertension

• 
  

  Fixed-combination olmesartan/amlodipine and olmesartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.^{31 44}

  
  

Administration

Oral Administration

Administer olmesartan orally once daily without regard to meals.^{1 2}

Dosage

Olmesartan is available as olmesartan medoxomil; dosage expressed in terms of the salt.^{1 31 44}

Adults

Hypertension

Olmesartan Therapy for Hypertension

Oral

Initially, olmesartan medoxomil 20 mg once daily in adults without intravascular volume depletion.¹ Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.^{4 30}

Usual olmesartan medoxomil dosage: 20–40 mg once daily; no additional therapeutic benefit with higher dosages^{1 30} or with twice-daily dosing.^{1 28}

Olmesartan/Amlodipine Fixed-combination Therapy for Hypertension

Oral

If BP is not adequately controlled by monotherapy with olmesartan (or another angiotensin II receptor antagonist) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to the fixed-combination preparation containing olmesartan medoxomil 20 mg and amlodipine 5 or 10 mg or, alternatively, olmesartan medoxomil 40 mg and amlodipine 5 or 10 mg.⁴⁴

Can use the fixed combination as a substitute for the individually titrated drugs.⁴⁴ Can switch to the fixed-combination preparation containing the corresponding individual doses of olmesartan and amlodipine; alternatively, can increase the dosage of one or both components for additional antihypertensive effects.⁴⁴

Adjust dosage of olmesartan/amlodipine fixed combination, up to a maximum dosage of olmesartan medoxomil 40 mg and amlodipine 10 mg daily, according to patient’s response after ≥2 weeks at the current dosage.⁴⁴

Olmesartan/Hydrochlorothiazide Fixed-combination Therapy for Hypertension

Oral

If BP is not adequately controlled by monotherapy with olmesartan or hydrochlorothiazide, can switch to fixed-combination olmesartan/hydrochlorothiazide tablets.³¹ In patients already receiving olmesartan, initiate hydrochlorothiazide at dosage of 12.5 mg once daily; in those receiving hydrochlorothiazide, consider reducing hydrochlorothiazide dosage to 12.5 mg and initiate olmesartan medoxomil at dosage of 20 mg once daily.³¹ Increase dosages to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg once daily, if needed, to control BP.³¹

If BP is controlled with olmesartan and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.³¹

Adjust dosage of olmesartan/hydrochlorothiazide fixed combination according to patient’s response after 2–4 weeks at the current dosage.³¹

Special Populations

The following information addresses dosage of olmesartan in special populations. Dosages of drugs administered in fixed combination with olmesartan also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.^{31 44}

Hepatic Impairment

No adjustment of initial olmesartan dosage necessary in patients with moderate to severe hepatic impairment.^{1 31}

Amount of amlodipine in olmesartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.⁴⁴

Renal Impairment

Manufacturer states that no adjustment of initial olmesartan dosage is necessary in patients with moderate to severe renal impairment (Cl_cr <40 mL/minute).^{1 31 44} However, some clinicians recommend lower initial dosage in patients with Cl_cr <20 mL/minute, with maximum dosage of 20 mg once daily in such patients.¹⁰

Dosage of olmesartan in patients with end-stage renal disease not determined.²⁹

Olmesartan/hydrochlorothiazide fixed combination not recommended in patients with severe renal impairment (Cl_cr ≤30 mL/minute).³¹ Loop diuretics are preferred to thiazides in these patients.³¹

Geriatric Patients

No adjustment of initial olmesartan dosage is necessary.^{1 31}

Amount of amlodipine in olmesartan/amlodipine fixed combinations exceeds the recommended initial dosage of amlodipine (2.5 mg daily) in patients ≥75 years of age.⁴⁴

Volume- and/or Salt-depleted Patients

Correct volume and/or salt depletion prior to initiation of olmesartan therapy or initiate therapy under close medical supervision using lower initial dosage.^{1 31 44}

Cautions for Olmesartan Medoxomil

Contraindications

• 
  

  Known hypersensitivity to olmesartan or any ingredient in the formulation.^{1 31}

  
  


• 
  

  When olmesartan is used in fixed combination with hydrochlorothiazide or amlodipine, consider contraindications associated with the concomitant agent.^{31 41}

  
  

Warnings/Precautions

Warnings

Cardiovascular Effects

Possible symptomatic hypotension with olmesartan, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics).^{1 31 44} (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate olmesartan therapy cautiously after BP is stabilized (e.g., with volume expansion).^{1 31 44}

Results of 2 randomized controlled trials in patients with type 2 diabetes mellitus showed an increased risk of death from cardiovascular causes (e.g., MI, sudden death, stroke) in patients receiving olmesartan compared with placebo.¹²⁴ FDA is continuing to evaluate the data and has not concluded that the drug increases risk of cardiovascular death.¹²⁴ Numerous controlled studies have evaluated olmesartan and other angiotensin II receptor antagonists in patients at high risk of cardiovascular events and have not suggested an increased risk of cardiovascular mortality.¹²⁴ Because benefits of olmesartan in hypertensive patients continue to outweigh potential risks, FDA states that patients should continue to take the drug as prescribed unless otherwise instructed by a clinician.¹²⁴

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when drugs that act directly on the renin-angiotensin system (e.g., angiotensin II receptor antagonists, ACE inhibitors) are used during the second and third trimesters of pregnancy.^{1 4 31 43 44} (See Boxed Warning.) ACE inhibitors also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.^{42 43}

Discontinue olmesartan as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.^{1 31 42 43 44} Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.¹³

Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.^{120 121 123 126} However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.^{126 127 128 129} Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.¹²⁶

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible with angiotensin II receptor antagonists;^{1 2 7 14} extreme caution in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.^{7 15 45}

General Precautions

Use of Fixed Combinations

When olmesartan is used in fixed combination with amlodipine or hydrochlorothiazide, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent.^{31 44} Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.^{31 44}

Renal Effects

Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe CHF.^{1 31 44}

Increases in BUN and S_cr possible in patients with unilateral or bilateral renal artery stenosis.^{1 31 44}

Specific Populations

Pregnancy

Olmesartan: Category C (1st trimester); Category D (2nd and 3rd trimesters).^{1 31 44} (See Boxed Warning.)

Lactation

Olmesartan is distributed into milk in rats; not known whether olmesartan is distributed into human milk.^{1 31 44} Discontinue nursing or the drug.^{1 31 44}

Pediatric Use

Safety and efficacy of olmesartan alone or in fixed combination with amlodipine or hydrochlorothiazide not established.^{1 31 44}

Geriatric Use

No substantial differences in safety or efficacy of olmesartan alone or in fixed combination with amlodipine relative to younger adults, but increased sensitivity cannot be ruled out.^{1 44}

Insufficient experience with olmesartan given in fixed combination with hydrochlorothiazide in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; select dosage with caution.³¹

Hepatic Impairment

Systemic exposure to olmesartan may be increased.^{1 31 44} (See Special Populations under Absorption, in Pharmacokinetics.)

Renal Impairment

Systemic exposure to olmesartan may be increased.^{1 31 44} (See Special Populations under Absorption, in Pharmacokinetics.) Some clinicians recommend initial dosage adjustment in patients with severe renal impairment.¹⁰ (See Renal Impairment under Dosage and Administration.)

Use of olmesartan in fixed combination with hydrochlorothiazide is not recommended in patients with Cl_cr ≤30 mL/minute.³¹

Deterioration of renal function may occur.^{1 31 44} (See Renal Effects under Cautions.)

Blacks

BP reduction with olmesartan may be smaller in black patients compared with nonblack patients; use in combination with a diuretic.^{1 5 30 31}

Common Adverse Effects

Olmesartan: Dizziness,^{1 2 3} back pain,¹ bronchitis,^{1 2 12} diarrhea¹ , headache,^{1 2 3 12} hematuria,¹ hyperglycemia,¹ hypertriglyceridemia,¹ influenza-like symptoms,^{1 2 12} pharyngitis,¹ rhinitis,¹ sinusitis,¹ upper respiratory tract infection.^{2 3 12}

Interactions for Olmesartan Medoxomil

The following information addresses potential interactions with olmesartan. When olmesartan is used in fixed combination with hydrochlorothiazide or amlodipine, consider interactions associated with the concomitant agent.^{31 44}

Olmesartan is not metabolized by and does not inhibit or induce CYP isoenzymes.^{1 2}

Specific Drugs

Drug	Interaction
Antacids	Pharmacokinetic interactions unlikely1 2 28
Digoxin	Pharmacokinetic interactions unlikely1 2 28
Hydrochlorothiazide	Pharmacokinetic interactions unlikely1 2 28 Additive hypotensive effects1 31
Warfarin	Pharmacokinetic interaction unlikely1 2 28

Olmesartan Medoxomil Pharmacokinetics

Absorption

Bioavailability

Olmesartan medoxomil (prodrug) is rapidly and completely hydrolyzed to olmesartan during absorption in the GI tract.^{1 31 44}

Absolute bioavailability of olmesartan is about 26%.^{1 31 44}

Peak plasma olmesartan concentration generally reached 1–2 hours following oral administration.^{1 31 44}

Onset

Antihypertensive effect of olmesartan is evident within 2 weeks, with maximum BP reduction after 4–6 weeks.^{1 3}

Food

Food does not affect bioavailability of olmesartan.^{1 31 44}

Special Populations

In patients with moderate hepatic impairment, peak plasma concentration of olmesartan is increased; AUC increased by about 60%.^{1 31 44}

In patients with severe renal impairment (Cl_cr <20 mL/minute), plasma concentrations and AUC of olmesartan are increased.^{1 31 44} After repeated dosing, AUC values are approximately triple those in patients with normal renal function.^{1 31 44}

In women, peak plasma concentration and AUC of olmesartan are about 10–15% higher than values in men.^{1 31 44}

Distribution

Extent

Olmesartan crosses the placenta and is distributed in the fetus in animals.^{1 31 44}

Olmesartan crosses the blood-brain barrier poorly, if at all, in animals.^{1 31 44}

Olmesartan is distributed into milk in rats; not known whether olmesartan is distributed into human milk.^{1 31 44}

Plasma Protein Binding

Olmesartan: 99%.^{1 31 44}

Elimination

Metabolism

Olmesartan medoxomil undergoes rapid and complete ester hydrolysis to olmesartan.^{1 2 28 31 44} Virtually no further metabolism of olmesartan occurs; not metabolized by CYP isoenzymes.^{1 2 28 31 44}

Elimination Route

Olmesartan is eliminated mainly in urine (35–50%) and feces (via bile).^{1 2 31 44}

Half-life

Biphasic; terminal half-life of olmesartan is approximately 13 hours.^{1 31 44}

Special Populations

In geriatric patients, renal clearance of olmesartan is decreased by approximately 30%.^{1 31 44}

Stability

Storage

Oral

Tablets

Olmesartan or olmesartan/hydrochlorothiazide fixed combination: 20–25°C.^{1 31}

Olmesartan/amlodipine fixed combination: 25ºC (may be exposed to 15–30ºC).⁴⁴

Actions

• 
  

  Olmesartan medoxomil (prodrug) has little pharmacologic activity until hydrolyzed to olmesartan during absorption.^{1 2 31 44}

  
  


• 
  

  Olmesartan blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.^{1 31 44}

  
  


• 
  

  Olmesartan does not interfere with response to bradykinins and substance P.^{1 31 44}

  
  

• 
  

  Olmesartan does not share the ACE inhibitor common adverse effect of dry cough.¹

  
  

Advice to Patients

• 
  

  When olmesartan is used in fixed combination with hydrochlorothiazide or amlodipine, importance of advising patients of important precautionary information about the concomitant agent.^{31 44}

  
  


• 
  

  Risks of use during pregnancy.^{1 31 42 43 44}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 31 44}

  
  

• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{1 31 44}

  
  

• 
  

  Importance of informing patients of other important precautionary information.^{1 31 44} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Olmesartan Medoxomil

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg	Benicar	Daiichi-Sankyo
		20 mg	Benicar	Daiichi-Sankyo
		40 mg	Benicar	Daiichi-Sankyo

Olmesartan Medoxomil Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	20 mg with Amlodipine Besylate 5 mg (of amlodipine)	Azor	Daiichi-Sankyo
		20 mg with Amlodipine Besylate 10 mg (of amlodipine)	Azor	Daiichi-Sankyo
		40 mg with Amlodipine Besylate 5 mg (of amlodipine)	Azor	Daiichi-Sankyo
		40 mg with Amlodipine Besylate 10 mg (of amlodipine)	Azor	Daiichi-Sankyo
	Tablets, film-coated	20 mg with Hydrochlorothiazide 12.5 mg	Benicar HCT	Daiichi-Sankyo
		40 mg with Hydrochlorothiazide 12.5 mg	Benicar HCT	Daiichi-Sankyo
		40 mg with Hydrochlorothiazide 25 mg	Benicar HCT	Daiichi-Sankyo

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Azor 10-20MG Tablets (SANKYO): 30/$117.76 or 90/$340.05

Azor 10-40MG Tablets (SANKYO): 90/$442.99 or 270/$1,298.97

Azor 5-20MG Tablets (SANKYO): 30/$121.06 or 90/$349.97

Azor 5-40MG Tablets (SANKYO): 30/$154.35 or 90/$450.93

Benicar 20MG Tablets (SANKYO): 30/$93.99 or 90/$270.96

Benicar 40MG Tablets (SANKYO): 30/$128.99 or 90/$371.99

Benicar 5MG Tablets (SANKYO): 30/$77.99 or 90/$225.97

Benicar HCT 20-12.5MG Tablets (SANKYO): 30/$96.99 or 90/$275.96

Benicar HCT 40-12.5MG Tablets (SANKYO): 30/$131.00 or 90/$375.96

Benicar HCT 40-25MG Tablets (SANKYO): 30/$131.00 or 90/$360.98

Tribenzor 20-5-12.5MG Tablets (SANKYO): 30/$118.74 or 90/$330.31

Tribenzor 40-10-25MG Tablets (SANKYO): 30/$152.14 or 90/$433.29

Tribenzor 40-5-12.5MG Tablets (SANKYO): 30/$152.14 or 60/$304.27

Tribenzor 40-5-25MG Tablets (SANKYO): 30/$154.49 or 90/$444.01

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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2. Song JC, White CM. Olmesartan medoxomil (CS-866): an angiotensin II receptor blocker for treatment of hypertension. Formulary. 2001; 36:487-99.

3. Neutel JM. Clinical studies of CS-866, the newest angiotensin II receptor antagonist. Am J Cardiol. 2001; 87(Suppl):37-43C.

4. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98?4080.)

5. Anon. Drugs for hypertension. Med Lett Drugs Ther. 2001; 43:17-22. [PubMed 11242494]

6. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9-38A.

7. Warner KK, Visconti JA, Tschampel MM. Angiotensin II receptor blockers in patients with ACE inhibitor-induced angioedema. Ann Pharmacother. 2000; 34:526-8. [IDIS 443518] [PubMed 10772441]

8. Oparil S, Williams D, Chrysant SG et al. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension. J Clin Hypertens (Greenwich). 2001; 3:283-91, 318. [PubMed 11588406]

9. Ball KJ, Williams PA, Stumpe KO. Relative efficacy of an angiotensin II antagonist compared with other antihypertensive agents. Olmesartan medoxomil versus antihypertensives. J Hypertens. 2001; 19(Suppl 1):S49-56.

10. von Bergmann K, Laeis P, Puchler K et al. Olmesartan medoxomil: influence of age, renal and hepatic function on the pharmacokinetics of olmesartan medoxomil. J Hypertens. 2001; 19(Suppl 1):S33-40.

11. Walser M. Angiotensin-Receptor Blockers, Type 2 Diabetes, and Renoprotection. N Engl J Med. 2002; 346:706.

12. Puchler K, Laeis P, Stumpe KO. Blood pressure response, but not adverse event incidence, correlates with dose of angiotensin II antagonist. J Hypertens. 2001; 19(Suppl 1):S41-8.

13. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

14. Mazzolai L, Burnier M. Comparative safety and tolerability of angiotensin II receptor antagonists. Drug Safety. 1999; 21:23-33. [PubMed 10433351]

15. Kirk JK. Therapy with angiotensin II receptor antagonists. Clin Geriatrics. From the MultiMedia Health Care website.

16. Sankyo Pharma, New York, NY: Personal communication.

17. AstraZeneca, Wayne, PA: personal communication on Candesartan 24:32.08.

18. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25(Suppl 1):S71-73.

19. Brenner BM, Cooper ME, de Zeeuw D et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001; 345:861-9. [IDIS 469607] [PubMed 11565518]

20. Lewis EJ, Hunsicker LG, Claarke WR et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001; 345:851-60. [IDIS 469606] [PubMed 11565517]

21. DA, Bakris GL. Type 2 diabetes: RENAAL and IDNT-the emergence of new treatment options. J Clin Hypertens (Greenwich). 2002; 4:52-7. [PubMed 11821641]

22. Parving HH, Brenner BM, Cooper ME et al. [Effect of losartan on renal and cardiovascular complications of patients with type 2 diabetes and nephropathy.] (Danish; with English abstract.) Ugeskr Laeger. 2001; 163:5514-9.

23. Weekers L, Krzesinski JM. [Clinical study of the month. Nephroprotective role of angiotensin II receptor antagonists in type 2 diabetes: results of IDNT and RENAAL trials.] (French with English abstract.) Rev Med Liege. 2001; 56:723-6.

24. Parving HH, Lehnert H, Brochner-Mortensen J et al and the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001; 345:870-8. [IDIS 469608] [PubMed 11565519]

25. Walser M. Angiotensin-Receptor Blockers, Type 2 Diabetes, and Renoprotection. N Engl J Med. 2002; 346:706.

26. Unger T. Significance of angiotensin type 1 receptor blockade: why are angiotensin II receptor blockers different? Am J Cardiol. 1999; 84:9-15S.

27. Martineau P, Goulet J. New competition in the realm of renin-angiotensin axis inhibition; the angiotensin II receptor antagonists in congestive heart failure. Ann Pharmacother. 2001; 35:71-84. [IDIS 457649] [PubMed 11197588]

28. Warner GT, Jarvis B. Olmesartan medoxomil. Drugs. 2002; 62:1345-53. [PubMed 12076183]

29. Sankyo Pharma, New York, NY: Personal communication.

30. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

31. Daiichi Sankyo, Inc. Benicar HCT (olmesartan medoxomil and hydrochlorothiazide) tablets prescribing information. Parsippany, NJ; 2007 Jul.

32. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

33. Joint National Committee on Detection, Evaluation. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

34. Joint National Committee on Detection, Evaluation. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

35. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

36. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

37. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

38. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

39. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

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