DESCRIPTION
id: 6DFD6806-FABE-B205-3C4F-C1577AB4FB40
displayName: DESCRIPTION section
FDA Article Code: 34089-3
BENICAR® (olmesartan medoxomil), a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.Olmesartan medoxomil is described chemically as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.Its empirical formula is C29H30N6O6 and its structural formula is:Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol. BENICAR® is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide.
INDICATIONS AND USAGE
id: 8B44A45F-A871-0ACE-E521-6A586399E767
displayName: INDICATIONS AND USAGE section
FDA Article Code: 34067-9
BENICAR® is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
CONTRAINDICATIONS
id: 252F25EB-506F-6F1E-F6CA-4DB516AAEE3E
displayName: CONTRAINDICATIONS section
FDA Article Code: 34070-3
BENICAR® is contraindicated in patients who are hypersensitive to any component of this product.
ADVERSE REACTIONS
id: 35096175-E2C5-5B20-6EDD-E912633DCCC6
displayName: ADVERSE REACTIONS section
FDA Article Code: 34084-4
BENICAR® has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Treatment with BENICAR® was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil.The overall frequency of adverse events was not dose-related. Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil and placebo-treated patients. The rate of withdrawals due to adverse events in all trials of hypertensive patients was 2.4% (i.e. 79/3278) of patients treated with olmesartan medoxomil and 2.7% (i.e. 32/1179) of control patients. In placebo-controlled trials, the only adverse event that occurred in more than 1% of patients treated with olmesartan medoxomil and at a higher incidence versus placebo was dizziness (3% vs. 1%).The following adverse events occurred in placebo-controlled clinical trials at an incidence of more than 1% of patients treated with olmesartan medoxomil, but also occurred at about the same or greater incidence in patients receiving placebo: back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.The incidence of cough was similar in placebo (0.7%) and BENICAR® (0.9%) patients.Other (potentially important) adverse events that have been reported with an incidence of greater than 0.5%, whether or not attributed to treatment, in the more than 3100 hypertensive patients treated with olmesartan medoxomil monotherapy in controlled or open-label trials are listed below. Body as a Whole:chest pain, peripheral edema
Central and Peripheral Nervous System: vertigo
Gastrointestinal: abdominal pain, dyspepsia, gastroenteritis, nausea
Heart Rate and Rhythm Disorders: tachycardia
Metabolic and Nutritional Disorders: hypercholesterolemia, hyperlipemia, hyperuricemia
Musculoskeletal: arthralgia, arthritis, myalgia
Skin and Appendages: rashFacial edema was reported in 5 patients receiving olmesartan medoxomil. Angioedema has been reported with angiotensin II antagonists.Laboratory Test Findings:In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of olmesartan medoxomil. Hemoglobin and Hematocrit:Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed. Liver Function Tests:Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to olmesartan medoxomil and one patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the five olmesartan medoxomil patients, three had elevated transaminases, which were attributed to alcohol use, and one had a single elevated bilirubin value, which normalized while treatment continued.Post-Marketing Experience:The following adverse reactions have been reported in post-marketing experience: Body as a Whole:Asthenia, angioedema
Gastrointestinal: Vomiting
Metabolic and Nutritional Disorders:Hyperkalemia
Musculoskeletal: Rhabdomyolysis
Urogenital System: Acute renal failure, increased blood creatinine levels
Skin and Appendages: Alopecia, pruritus, urticaria
OVERDOSAGE
id: 8040B365-29BE-E60C-3906-DE203FD6F533
displayName: OVERDOSAGE section
FDA Article Code: 34088-5
Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown.
DOSAGE AND ADMINISTRATION
id: 5D90FF75-3C56-377B-3280-E38341CC66CA
displayName: DOSAGE AND ADMINISTRATION section
FDA Article Code: 34068-7
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. Twice-daily dosing offers no advantage over the same total dose given once daily.No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40mL/min) or with moderate to marked hepatic dysfunction (see CLINICAL PHARMACOLOGY, Special Populations). For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), BENICAR® should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS, Hypotension in Volume- and Salt-Depleted Patients).BENICAR® may be administered with or without food.If blood pressure is not controlled by BENICAR® alone, a diuretic may be added. BENICAR® may be administered with other antihypertensive agents.
HOW SUPPLIED
id: 89B6C168-0755-5D16-F1C6-437F1BA8317B
displayName: HOW SUPPLIED section
FDA Article Code: 34069-5
BENICAR® is supplied as yellow, round, film-coated tablets containing 5 mg of olmesartan medoxomil, as white, round, film-coated tablets containing 20 mg of olmesartan medoxomil, and as white, oval-shaped, film-coated tablets containing 40 mg of olmesartan medoxomil. Tablets are debossed with Sankyo on one side and C12, C14, or C15 on the other side of the 5, 20, and 40 mg tablets, respectively.Tablets are supplied as follows:
|
5 mg |
20 mg |
40 mg |
| Bottle of 30 |
NDC 65597-101-30 |
NDC 65597-103-30 |
NDC 65597-104-30 |
| Bottle of 90 |
Not available |
NDC 65597-103-90 |
NDC 65597-104-90 |
| Blister 10 cards X 10 |
|
NDC 65597-103-10 |
NDC 65597-104-10 |
